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biotecMAX™ - Dec/Nov/Oct 2020 insight
biotecMAX™ December/November/October 2020 insight
Helix™ Biotherapeutic Delivery System
BioCardia Announces Positive DSMB Review and Recommendation to Continue Phase III Pivotal CardiAMP Heart Failure Study as Designed
December 17, 2020
SAN CARLOS, Calif. – BioCardia (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for the Phase III pivotal CardiAMP™ Heart Failure Trial. The DSMB based its review on all available data for the 86 patients enrolled in the trial, including 60 randomized patients who have reached their one-year follow-up. The DSMB performed a risk-benefit assessment, indicated no safety concerns, and recommended that the study continue as designed.
Helix™ Biotherapeutic Delivery System
Helix Biotherapeutic Delivery System
Leading physicians have described the current Helix Biotherapeutic Delivery System as elegant in its simplicity.
BioCardia issued U.S. patent for Helix Biotherapeutic Delivery system
Dec. 30, 2020 9:13 AM ET BioCardia, Inc. (BCDA)By: Pranav Ghumatkar, SA News Editor
- BioCardia (NASDAQ:BCDA) up 3.9% premarket on issuance of U.S. Patent No: 10,874,831 for “Devices and Methods for Accessing the Vasculature of a Patient” that further protects the Helix Biotherapeutic Delivery System and enhances its cell therapy delivery capabilities.
For more information, visit www.BioCardia.com.
https://seekingalpha.com/symbol/BCDA
Surufatinib (Sulanda® in China)
30 Dec 2020
Chi-Med Announces the NMPA Approval of Surufatinib (Sulanda® in China) for Non-Pancreatic Neuroendocrine Tumors
– Sulanda® is Chi-Med’s first oncology drug brought to market without a partnership and the company’s second oncology drug approved in China –
– The pivotal Phase III SANET-ep trial demonstrated surufatinib reduced risk of progression or death by 67%, extending PFS in all subgroups of non-pancreatic NET patients with an acceptable risk/benefit ratio –
– ~400-strong oncology commercial team in place to bring Sulanda® to patients in China –
Hong Kong, Shanghai, & Florham Park, NJ: Wednesday, December 30, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM)
Surufatinib (Sulanda® in China)
About Surufatinib (Sulanda® in China)
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.
Chi-Med currently retains all rights to surufatinib worldwide.
For more information, please visit: www.chi-med.com.
Chi-Med Announces the NMPA Approval of Surufatinib (Sulanda® in China) for Non-Pancreatic Neuroendocrine Tumors
Wed December 30, 2020 7:00 AM|GlobeNewswire|About: HCM
– Sulanda® is Chi-Med’s first oncology drug brought to market without a partnership and the company’s second oncology drug approved in China –
– The pivotal Phase III SANET-ep trial demonstrated surufatinib reduced risk of progression or death by 67%, extending PFS in all subgroups of non-pancreatic NET patients with an acceptable risk/benefit ratio –
– ~400-strong oncology commercial team in place to bring Sulanda® to patients in China –
HONG KONG and FLORHAM PARK, N.J., Dec. 30, 2020 (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited (HCM) (“Chi-Med”) (Nasdaq/AIM: HCM)
https://seekingalpha.com/symbol/HCM
ALKS 3831 (olanzapine/samidorphan)
FDA Accepts Alkermes' Resubmission of New Drug Application for ALKS 3831
- FDA Sets PDUFA Target Action Date of June 1, 2021 -
DUBLIN, Dec. 29, 2020 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the company's New Drug Application (NDA) resubmission for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder, and has assigned the application a new Prescription Drug User Fee Act (PDUFA) target action date of June 1, 2021.
ALKS 3831 (olanzapine/samidorphan)
About ALKS 3831 (olanzapine/samidorphan)
ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. ALKS 3831 is composed of samidorphan, a novel, new molecular entity, co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.
For more information, please visit Alkermes' website at www.alkermes.com.
FDA Accepts Alkermes' Resubmission of New Drug Application for ALKS 3831
Tue December 29, 2020 7:00 AM|PR Newswire|About: ALKSPR Newswire
DUBLIN, Dec. 29, 2020 /PRNewswire/ -- Alkermes plc (ALKS) (Nasdaq: ALKS)
https://seekingalpha.com/symbol/ALKS
biotecMAX™ December/November/October 2020 insight
COMIRNATY®
PFIZER AND BIONTECH TO SUPPLY THE EUROPEAN UNION WITH 100 MILLION ADDITIONAL DOSES OF COMIRNATY®
Tuesday, December 29, 2020 - 01:11pm
- European Union orders 100 million additional doses of COMIRNATY® bringing total doses to 300 million for 27 EU member states
- All 300 million doses expected to be delivered in 2020 and 2021
NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they will supply an additional 100 million doses of COMIRNATY®, the companies’ COVID-19 Vaccine, to the 27 European Union (EU) member states in 2021. This announcement is a result of the European Commission’s decision to exercise its option to purchase an additional 100 million doses under its Advanced Purchase Agreement signed on November 11, 2020. This agreement brings the total number of doses to be delivered to the EU to 300 million.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201229005380/en/
COMIRNATY®
Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine.com
We routinely post information that may be important to investors on our website at www.Pfizer.com. I
Pfizer and Biontech to supply additional 100M doses of COMIRNATY to EU
Dec. 29, 2020 1:55 PM ETPfizer Inc. (PFE)By: Aakash Babu, SA News Editor7 Comments
- Pfizer (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) will supply an additional 100M doses of their COVID-19 vaccine COMIRNATY, to the 27 European Union (EU) member states in 2021, bringing the total number of doses to be delivered to the EU to 300M.
For more information, please visit www.BioNTech.de.
https://seekingalpha.com/symbol/BNTX
https://seekingalpha.com/symbol/PFE
PFIZER AND BIONTECH CELEBRATE HISTORIC FIRST AUTHORIZATION IN THE U.S. OF VACCINE TO PREVENT COVID-19
Friday, December 11, 2020 - 11:12pm
- U.S. FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S. immediately
- Pfizer and BioNTech previously announced an agreement with the U.S. Government to supply doses in 2020 & 2021
- In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other vaccine companies are expected to deliver hundreds of millions of vaccine doses to Americans by the end of 2021
- Historic science-driven efforts will seek to help bring an end to the most devastating pandemic in a century
- Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021
NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the U.S. Food and Drug Administration (FDA) has authorized the emergency use of the mRNA vaccine, BNT162b2, against COVID-19 in individuals 16 years of age or older. The vaccine is now authorized under an Emergency Use Authorization (EUA) while Pfizer and BioNTech gather additional data and prepare to file a planned Biologics License Application (BLA) with the FDA for a possible full regulatory approval in 2021.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201211005640/en/
Astra-Oxford Covid-19 Vaccine Gets U.K. Clearance
•Dec 30, 2020
Bloomberg Markets and Finance Bloomberg Markets and Finance
COVID-19 Vaccine AstraZeneca, formerly AZD1222
Oxford-AstraZeneca Covid vaccine approved by UK regulator
PUBLISHED WED, DEC 30 20201:57 AM ESTUPDATED WED, DEC 30 20207:34 AM ESTMatt Clinch@MATTCLINCH81Holly Ellyatt@HOLLYELLYATTKEY POINTS
- The Oxford-AstraZeneca vaccine is cheaper than others and does not need to be kept at the ultra-low temperatures required by the Pfizer and Moderna vaccines.
- The shot is expected to be rolled out next week.
- A vaccine by Pfizer-BioNTech has been given to 600,000 people in the U.K., according to government statistics.
AstraZeneca-Oxford Covid Vaccine Gains First Clearance With U.K. Nod
Here’s What Happens Now That Oxford-AstraZeneca Vaccine Won U.K. Clearance
U.S. Vaccinations at 200,000 a Day Run Far Short of ‘Warp Speed’
U.K.’s Mutated Coronavirus Found for First Time in U.S.
Oxford-AstraZeneca vaccine approved for emergency use in the U.K.
Dec. 30, 2020 2:39 AM ETAstraZeneca PLC (AZN)By: Yoel Minkoff, SA News Editor19 Comments
https://seekingalpha.com/news/3647819-oxford-astrazeneca-vaccine-approved-for-emergency-use-in-u-k
AstraZeneca and Government of Canada announce agreement to supply up to 20 million doses of the AZD1222 COVID-19 vaccine
PUBLISHED25 September 2020
https://www.astrazeneca.ca/en/astrazeneca-in-canada.html
https://seekingalpha.com/symbol/AZN
Casirivimab and imdevimab is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively)
December 29, 2020 at 4:30 PM EST Back
REGENERON ANNOUNCES ENCOURAGING INITIAL DATA FROM COVID-19 ANTIBODY COCKTAIL TRIAL IN HOSPITALIZED PATIENTS ON LOW-FLOW OXYGEN
TARRYTOWN, N.Y., Dec. 29, 2020 /PRNewswire/ --
Phase 3 program in hospitalized patients to continue based on passing futility analysis on ability to reduce incidence of death or mechanical ventilation
As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes
First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)
About Regeneron Antibody Cocktail
Casirivimab and imdevimab is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.
On November 21, 2020, the casirivimab and imdevimab antibody combination received EUA from the FDA for the treatment of mild to moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization. The clinical evidence from Regeneron's outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who are seronegative and/or who have high viral load. The criteria for 'high-risk' patients are described in the Fact Sheet for Healthcare Providers.
To develop this novel medicine, Regeneron scientists evaluated thousands of fully-human antibodies produced by the company's VelocImmune® mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19. The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.
please visit www.regeneron.com
https://seekingalpha.com/symbol/REGN
Regeneron's COVID-19 antibody therapy yields 'encouraging' trial data
Dec. 29, 2020 5:17 PM ET Regeneron Pharmaceuticals, Inc. (REGN)By: Dulan Lokuwithana, SA News Editor2 Comments
ORGOVYX™ (relugolix)
Myovant Sciences and Pfizer Announce Collaboration to Develop and Commercialize Relugolix in Oncology and Women’s Health
December 28, 2020 at 6:30 AM ESTPDF Version
- Myovant and Pfizer to jointly develop and commercialize ORGOVYX™ (relugolix) and relugolix combination tablet and share profits and expenses in the U.S. and Canada
- Myovant to receive an upfront payment of $650 million in addition to potential regulatory and sales milestones for a total payment of up to $4.2 billion
- Myovant to host conference call and webcast today at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time
BASEL, Switzerland and NEW YORK, Dec. 28, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced a collaboration to develop and commercialize relugolix – a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist – in oncology and women’s health in the U.S. and Canada. Pfizer will also receive an exclusive option to commercialize relugolix in oncology outside the U.S. and Canada, excluding certain Asian countries.
ORGOVYX™ (relugolix)
What is ORGOVYX?
ORGOVYX is a prescription medicine used in adults for the treatment of advanced prostate cancer.
It is not known if ORGOVYX is safe or effective in females or children.
Please see full Prescribing Information and Patient Product Information for ORGOVYX.
Reference:
- ORGOVYX (relugolix) [prescribing information]. Brisbane, CA: Myovant Sciences, Inc.; 2020.
About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces testicular testosterone, a hormone known to stimulate the growth of prostate cancer, and ovarian estradiol, a hormone known to stimulate the growth of uterine fibroids and endometriosis. Relugolix (120 mg) is FDA-approved as ORGOVYX™ for adult patients with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis.
About ORGOVYX™ (relugolix)
ORGOVYX (relugolix) is the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the FDA for the treatment of adult patients with advanced prostate cancer. As a GnRH antagonist, ORGOVYX blocks the GnRH receptor and reduces production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer.
For full prescribing information, including patient information, please click here.
Indication
ORGOVYX is approved for the treatment of adult patients with advanced prostate cancer.
For more information, please visit our website at www.myovant.com.
https://seekingalpha.com/symbol/MYOV
https://seekingalpha.com/symbol/PFE
Myovant Sciences and Pfizer Announce Collaboration to Develop and Commercialize Relugolix in Oncology and Women’s Health
Mon December 28, 2020 6:30 AM|GlobeNewswire|About: MYOV, PFE
- Myovant (MYOV) and Pfizer (PFE) to jointly develop and commercialize ORGOVYX™ (relugolix) and relugolix combination tablet and share profits and expenses in the U.S. and Canada
- Myovant to receive an upfront payment of $650 million in addition to potential regulatory and sales milestones for a total payment of up to $4.2 billion
- Myovant to host conference call and webcast today at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time
BASEL, Switzerland and NEW YORK, Dec. 28, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences and Pfizer Inc.
We have two clinical programs for relugolix combination therapy which consisted of four international Phase 3 clinical trials, two in women with heavy menstrual bleeding associated with uterine fibroids (LIBERTY 1 & 2) and two in women with endometriosis-associated pain (SPIRIT 1 & 2).
We are also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, as a potential trigger of egg maturation in women undergoing assisted reproduction, including in vitro fertilization (IVF).
https://www.myovant.com/our-science/pipeline/
TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor)
Dec 28, 2020
Vertex Announces New Drug Submission for Investigational Triple Combination Medicine for the Treatment of Cystic Fibrosis Has Been Accepted for Priority Review by Health Canada
BOSTON, Dec. 28, 2020 /CNW/ - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced its New Drug Submission for TRIKAFTA®, Vertex's investigational triple combination medicine, has been accepted for Priority Review by Health Canada for the treatment of cystic fibrosis (CF) in people ages 12 years and older.
For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com
TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor)
What is TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor)?
TRIKAFTA is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or another mutation that is responsive to treatment with TRIKAFTA.
Talk to your doctor to learn if you have an indicated CF gene mutation.
It is not known if TRIKAFTA is safe and effective in children under 12 years of age.
https://seekingalpha.com/symbol/VRTX
TAGRISSO® (osimertinib)
Tagrisso approved in the US for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer
PUBLISHED21 December 2020
21 December 2020 07:05 GMT
Approval based on unprecedented results from the ADAURA Phase III trial where Tagrisso reduced the risk of disease recurrence or death by 80%
AstraZeneca’s Tagrisso (osimertinib) has been approved in the US for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumour resection with curative intent. Tagrisso is indicated for EGFRm patients whose tumours have exon 19 deletions or exon 21 L858R mutations as detected by an approved test.
Tagrisso (osimertinib)
Tagrisso was recently granted Breakthrough Therapy Designation for patients in the early-stage disease setting by the US FDA. In April 2020, an Independent Data Monitoring Committee recommended for the ADAURA trial to be unblinded two years early based on a determination of overwhelming efficacy. Investigators and patients continue to participate in the trial and remain blinded to treatment. The results from the ADAURA trial were presented during the plenary session of the American Society of Clinical Oncology ASCO20 Virtual Scientific Program in May 2020 and were recently published in The New England Journal of Medicine.
Tagrisso
Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with clinical activity against central nervous system metastases Tagrisso 40mg and 80mg once-daily oral tablets have received approval in the US, Japan, China, the EU and many countries around the world for 1st-line EGFRm advanced NSCLC and EGFR T790M mutation-positive advanced NSCLC.
What is TAGRISSO?
TAGRISSO is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that has certain abnormal epidermal growth factor receptor (EGFR) gene(s):
- to help prevent your lung cancer from coming back after your tumor(s) has been removed by surgery, or
- as your first treatment when your lung cancer has spread to other parts of the body (metastatic), or
- when your lung cancer has spread to other parts of the body (metastatic) and you have had previous treatment with an EGFR tyrosine kinase inhibitor (TKI) medicine that did not work or is no longer working
Your healthcare provider will perform a test to make sure that TAGRISSO is right for you.
It is not known if TAGRISSO is safe and effective in children.
Please see complete Prescribing Information, including Patient Information.
You may report side effects related to AstraZeneca products by clicking here.
Please visit astrazeneca.com
ADDING MULTIMEDIA TAGRISSO Approved in the US for the Adjuvant Treatment of Patients With Early-Stage EGFR-mutated Lung Cancer
Mon December 21, 2020 7:00 AM|Business Wire|About: AZN
Approval based on unprecedented results from the ADAURA Phase III trial where TAGRISSO reduced the risk of disease recurrence or death by 80%
WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca’s TAGRISSO® (osimertinib)
https://seekingalpha.com/symbol/AZN
Phesgo® (Fixed-Dose Combination Of Perjeta® And Herceptin® For Subcutaneous Injection) Utilizing Halozyme's ENHANZE® Technology
Halozyme Announces Roche Receives European Commission Approval For Phesgo® (Fixed-Dose Combination Of Perjeta® And Herceptin® For Subcutaneous Injection) Utilizing Halozyme's ENHANZE® Technology For The Treatment Of Patients With HER2-Positive Breast Cancer
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12/23/2020- Phesgo® Can be Administered in 5 to 8 Minutes Compared with Hours for the Standard Sequential IV Administration of Perjeta® and Herceptin® -
- First Subcutaneous Fixed-dose Combination of Two Monoclonal Antibodies Approved in Europe Utilizing Halozyme's ENHANZE® Technology -
SAN DIEGO, Dec. 23, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the European Commission has approved Roche's Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with Halozyme's ENHANZE® technology, administered by subcutaneous injection for the treatment of patients with early and metastatic HER2-positive breast cancer. This is the first time the European Commission has approved a product combining two monoclonal antibodies that can be administered by a single subcutaneous injection utilizing Halozyme's ENHANZE® technology.
Phesgo® (Fixed-Dose Combination Of Perjeta® And Herceptin® For Subcutaneous Injection) Utilizing Halozyme's ENHANZE® Technology
About ENHANZE® Technology
Halozyme's proprietary ENHANZE® drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE® may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.
Phesgo®
Phesgo® is available in single-dose vials and can be administered via subcutaneous injection in approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose.(1) This is compared to approximately 150 minutes for a sequential infusion of a loading dose of Perjeta® and Herceptin® using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions of the two medicines.(2,3)
The approval of Phesgo® in Europe is based on results from the pivotal phase III FeDeriCa study, which met its primary endpoint, with Phesgo® showing non-inferior levels of Perjeta® and Herceptin® in the blood and demonstrated comparable efficacy versus IV administration of the two medicines. The safety profile of Phesgo® with chemotherapy was comparable to IV administration of Perjeta® plus Herceptin® and chemotherapy. No new safety signals were identified, including no meaningful difference in cardiac toxicity.(1,4)
Phesgo® has the potential to help minimize pressure on healthcare systems by reducing administration time, as well as other costs associated with treatment, such as time spent in the infusion chair and drug preparation(5). In addition, Roche's phase II PHranceSCa study showed that 85% (136/160) of people receiving treatment for HER2-positive breast cancer preferred treatment under the skin to IV administration due to less time in the clinic and more comfortable treatment administration.(1)
PHESGO is a prescription medicine approved for use in combination with docetaxel in adults who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.
Halozyme Announces Roche Receives European Commission Approval For Phesgo® (Fixed-Dose Combination Of Perjeta® And Herceptin® For Subcutaneous Injection) Utilizing Halozyme's ENHANZE® Technology For The Treatment Of Patients With HER2-Positive Breast Cancer
Wed December 23, 2020 1:25 AM|PR Newswire|About: HALO
- First Subcutaneous Fixed-dose Combination of Two Monoclonal Antibodies Approved in Europe Utilizing Halozyme's ENHANZE® Technology -
PR Newswire
SAN DIEGO, Dec. 23, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (HALO)
For more information visit www.halozyme.com.
https://seekingalpha.com/symbol/HALO
https://seekingalpha.com/symbol/RHHBY
Sinovac’s Covid-19 Vaccine Shown Effective in Brazil Trials
Brazil is first country to complete Phase 3 trials of Chinese company’s vaccine; official results due out Wednesday
By Samantha Pearson and Luciana Magalhaes
Updated Dec. 21, 2020 6:55 pm ET SÃO PAULO—Sinovac Biotech Ltd
Sinovac’s COVID-19 shot effective in Brazil trials - WSJ
Dec. 22, 2020 4:49 AM ET Sinovac Biotech Ltd. (SVA)By: Mamta Mayani, SA News Editor3 Comments
- Sinovac Biotech's (NASDAQ:SVA) coronavirus vaccine has passed the 50% threshold for efficacy in late-stage trials in Brazil, WSJ reports.
https://seekingalpha.com/news/3646499-sinovac-s-covidminus-19-shot-effective-in-brazil-trials-wsj
https://seekingalpha.com/symbol/SVA
DECEMBER 21, 20204:13 PMUPDATED 21 HOURS AGO
China's Sinovac COVID-19 vaccine proves effective in Brazil trials - WSJ By Reuters Staff
Brazil scientists say Sinovac vaccine CoronaVac has proven effective in late-stage trials: Report
Brazil scientists say Sinovac vaccine CoronaVac has proven effective in late-stage trials: Report
Brazil is the first country to complete late-stage trials of CoronaVac, which is also being tested in Indonesia and Turkey.
WORLD Updated: Dec 22, 2020, 13:31 IST Reuters |
Posted by Shankhyaneel Sarkar
Sao Paolo/Rio De Janeiro
Lynparza (olaparib)
Lynparza approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers
PUBLISHED28 December 2020
28 December 2020 07:00 GMT
Approvals based on the PAOLA-1, PROfound and POLO Phase III trials
AstraZeneca and MSD’s Lynparza (olaparib) has been approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers.
Lynparza (olaparib)
WHAT IS LYNPARZA?
LYNPARZA is a prescription medicine used to treat adults who have:
- advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. LYNPARZA is used alone as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
- advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of abnormal BRCA gene or a positive laboratory tumor test for genomic instability called HRD. LYNPARZA is used in combination with another anti-cancer medicine, bevacizumab, as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
- ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, as maintenance treatment, when the cancer has come back. LYNPARZA is used after the cancer has responded to treatment with platinum-based chemotherapy
- advanced ovarian cancer with a certain type of abnormal inherited BRCA gene, and have received treatment with 3 or more prior types of chemotherapy medicines. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
- a certain type of abnormal inherited BRCA gene, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic). You should have received chemotherapy medicines, either before or after your cancer has spread. If you have hormone receptor (HR)-positive disease, you should have been treated with hormonal therapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
- metastatic pancreatic cancer with a certain type of abnormal inherited BRCA gene. LYNPARZA is used as a maintenance treatment after your cancer has not progressed on at least 16 weeks of treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure LYNPARZA is right for you
- prostate cancer with certain inherited or acquired abnormal genes called homologous recombination repair (HRR genes). LYNPARZA is used when the cancer has spread to other parts of the body (metastatic), and no longer responds to a medical or surgical treatment that lowers testosterone, and has progressed after treatment with enzalutamide or abiraterone. Your healthcare provider will perform a test to make sure LYNPARZA is right for you
It is not known if LYNPARZA is safe and effective in children.
Lynparza
Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in HRR, such as mutations in BRCA1 and/or BRCA2. Inhibition of PARP with Lynparza leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. Lynparza is being tested in a range of PARP-dependent tumour types with defects and dependencies in the DDR pathway.
The concurrent approvals by the Japanese Ministry of Health, Labour, and Welfare are based on positive results from the PAOLA-1, PROfound and POLO Phase III trials, which each were published in The New England Journal of Medicine.
The AstraZeneca and MSD strategic oncology collaboration
In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza, the world’s first PARP inhibitor, and Koselugo (selumetinib), a mitogen-activated protein kinase (MEK) inhibitor, for multiple cancer types. Working together, the companies will develop Lynparza and Koselugo in combination with other potential new medicines and as monotherapies. Independently, the companies will develop Lynparza and Koselugo in combination with their respective PD-L1 and PD-1 medicines.
Please visit astrazeneca.com
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AstraZeneca, Merck’s Lynparza OK'd in Japan for cancers
Dec. 28, 2020 7:16 AM ETAstraZeneca PLC (AZN)By: Mamta Mayani, SA News Editor
https://seekingalpha.com/news/3647466-astrazeneca-merck-s-lynparza-okd-in-japan-for-cancers
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TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) and KALYDECO® (ivacaftor)
Dec 21, 2020
Vertex Announces FDA Approvals of TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) and KALYDECO® (ivacaftor) for Use in People With CF With Certain Rare Mutations
- More than 600 people with certain rare CF mutations are now eligible for TRIKAFTA, SYMDEKO or KALYDECO -
BOSTON--(BUSINESS WIRE)--Dec. 21, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) expanded the eligibility for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include people with cystic fibrosis (CF) ages 12 years and older with certain mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that are responsive to TRIKAFTA based on in vitro data. SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) and KALYDECO® (ivacaftor) also received approvals to include additional responsive mutations in people with CF ages 6 years and older and age 4 months and older, respectively. These approvals allow more than 600 people with CF not previously eligible for these medicines an opportunity to potentially benefit from treatment that targets the underlying cause of their disease.
TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) and KALYDECO® (ivacaftor)
What is KALYDECO?
KALYDECO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients
age 4 months and older who have at least one mutation in their CF gene that is responsive to KALYDECO. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. It is not known if KALYDECO is safe and effective in children under 4 months of age.
What is SYMDEKO?
SYMDEKO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have two copies of the F508del mutation, or who have at least one mutation in the CF gene that is responsive to treatment with SYMDEKO. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. It is not known if SYMDEKO is safe and effective in children under 6 years of age.
What is TRIKAFTA?
TRIKAFTA is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or another mutation that is responsive to treatment with TRIKAFTA. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. It is not known if TRIKAFTA is safe and effective in children under 12 years of age.
Patients should not take KALYDECO, SYMDEKO, or TRIKAFTA if they take certain medicines or herbal supplements, such as: the antibiotics rifampin or rifabutin; seizure medications such as phenobarbital, carbamazepine, or phenytoin; or St. John’s wort.
These are not all the possible side effects of KALYDECO, SYMDEKO, or TRIKAFTA. Please click product link to see the full Prescribing Information for KALYDECO, SYMDEKO or TRIKAFTA.
visit www.vrtx.com
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Vertex Announces FDA Approvals of TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) and KALYDECO® (ivacaftor) for Use in People With CF With Certain Rare Mutations
Mon December 21, 2020 2:30 PM|Business Wire|About: VRTX
- More than 600 people with certain rare CF mutations are now eligible for TRIKAFTA, SYMDEKO or KALYDECO -
BOSTON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (VRTX)
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IMBRUVICA® (ibrutinib)
December 23, 2020
IMBRUVICA® (ibrutinib) U.S. Prescribing Information Updated to Include Long-Term Data for Waldenström's Macroglobulinemia (WM)
- Updates are based on more than five years of Phase 3 iNNOVATE final analysis data, which demonstrated IMBRUVICA plus rituximab significantly prolonged progression-free survival (PFS) versus rituximab alone in adults with WM
- IMBRUVICA is the first and only FDA-approved treatment for adults with WM and has been used to treat more than 200,000 patients worldwide across approved indications
NORTH CHICAGO, Ill., Dec. 23, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today that the U.S. Food and Drug Administration (FDA) approved the update of the IMBRUVICA® (ibrutinib) Prescribing Information to include efficacy and safety data for the combination of IMBRUVICA with rituximab for the treatment of Waldenström's macroglobulinemia (WM), based on the final analysis of the Phase 3 iNNOVATE study. First approved in 2013, IMBRUVICA is currently available to patients with several types of blood cancer, as well as chronic graft-versus-host disease. It was approved as a mo
IMBRUVICA® (ibrutinib)
About IMBRUVICA
IMBRUVICA is a once-daily, first-in-class BTK inhibitor that is administered orally, and is jointly developed and commercialized by Pharmacyclics, LLC, an AbbVie Company, and Janssen Biotech, Inc. (Janssen). The BTK protein sends important signals that tell B cells to mature and produce antibodies. BTK signaling is needed by specific cancer cells to multiply and spread.3,4 By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.5
Since its launch in 2013, IMBRUVICA has received 11 FDA approvals across six disease areas: chronic lymphocytic leukemia (CLL) with or without 17p deletion (del17p); small lymphocytic lymphoma (SLL) with or without del17p; WM; previously-treated patients with mantle cell lymphoma (MCL)*; previously-treated patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy* – and previously-treated patients with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.6
IMBRUVICA is now approved in 101 countries and has been used to treat more than 200,000 patients worldwide across its approved indications. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA has been granted four Breakthrough Therapy Designations from the U.S. FDA. This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway.
As of early 2019, the National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 28 leading cancer centers devoted to patient care, research, and education, recommends ibrutinib (IMBRUVICA) as a preferred regimen for the initial treatment of CLL/SLL and is a Category 1 treatment for treatment-naïve patients without deletion 17p. In January 2020, the NCCN Guidelines® were updated to recommend IMBRUVICA, with or without rituximab, as a preferred regimen for the treatment of relapsed/refractory MCL, regardless of response duration to prior chemoimmunotherapy. In September 2020, the NCCN guidelines for WM were updated and now recommends IMBRUVICA, with or without rituximab, as the only Category 1 Preferred regimen for patients with previously untreated or previously treated WM.
IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA is the most comprehensively studied BTK inhibitor, with more than 150 ongoing clinical trials. There are approximately 30 ongoing company-sponsored trials, 14 of which are in Phase 3, and more than 100 investigator-sponsored trials and external collaborations that are active around the world. For more information, visit www.IMBRUVICA.com.
*Accelerated approval was granted for the MCL and MZL indications based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.
Please click here for full Prescribing Information.
For more information about AbbVie, please visit us at www.abbvie.com
AbbVie's Imbruvica wins expanded prescribing information approval from FDA
Dec. 23, 2020 8:44 AM ET AbbVie Inc. (ABBV) By: Aakash Babu, SA News Editor8 Comments
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biotecMAX™ December/November/October 2020 insight
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Combination Demonstrated Statistically Significant Improvement in Overall Survival, Progression-Free Survival and Objective Response Rate Versus Chemotherapy in Patients With Advanced Endometrial Cancer Following Prior Systemic Therapy in Phase 3 Study
December 16, 2020 6:45 am EST
First Overall Survival Analysis for KEYTRUDA Plus LENVIMA Combination in a Phase 3 Study in Advanced Endometrial Cancer
KENILWORTH, N.J. & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the pivotal Phase 3 KEYNOTE-775/Study 309 trial evaluating the investigational use of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) and its secondary efficacy endpoint of objective response rate (ORR) in patients with advanced endometrial cancer following at least one prior platinum-based regimen.
KEYTRUDA® (pembrolizumab) Injection, 100 mg
About KEYTRUDA® (pembrolizumab) Injection, 100 mg
KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,300 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.
Selected KEYTRUDA® (pembrolizumab) Indications in the U.S.
Melanoma
KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.
KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
Non-Small Cell Lung Cancer
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
Small Cell Lung Cancer
KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Head and Neck Squamous Cell Cancer
KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) ≥1] as determined by an FDA-approved test.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
Classical Hodgkin Lymphoma
KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.
Primary Mediastinal Large B-Cell Lymphoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.
Urothelial Carcinoma
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (CPS ≥10), as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
Microsatellite Instability-High or Mismatch Repair Deficient Cancer
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
- solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
- colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.
Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer
KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).
Gastric Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Esophageal Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.
Cervical Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Hepatocellular Carcinoma
KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Merkel Cell Carcinoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Renal Cell Carcinoma
KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
Endometrial Carcinoma
KEYTRUDA, in combination with LENVIMA, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.
Tumor Mutational Burden-High
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.
Cutaneous Squamous Cell Carcinoma
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
Triple-Negative Breast Cancer
KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Selected Important Safety Information for KEYTRUDA
Severe and Fatal Immune-Mediated Adverse Reactions
KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment.
Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.
Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.
Please see Prescribing Information for KEYTRUDA (pembrolizumab) at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf and Medication Guide for KEYTRUDA at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf.
About LENVIMA® (lenvatinib) Capsules
LENVIMA® (lenvatinib) is a kinase inhibitor that is indicated:
- For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-refractory DTC)
- In combination with everolimus, for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy
- For the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC)
- In combination with KEYTRUDA, for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy, and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial
LENVIMA (lenvatinib) is available as 10 mg and 4 mg capsules.
Please see Prescribing Information for LENVIMA (lenvatinib) at http://www.lenvima.com/pdfs/prescribing-information.pdf.
For more information, visit www.merck.com
For more information about Eisai, please visit www.eisai.com (for global), us.eisai.com (for U.S.) or www.eisai.eu (for Europe, Middle East, Africa)
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Merck/Eisai's Keytruda and Lenvima combo meet endpoints in late-stage uterine cancer study
Dec. 16, 2020 7:25 AM ETMerck & Co., Inc. (MRK)By: Vandana Singh, SA News Editor
- Merck (NYSE:MRK) and Eisai (OTCPK:ESALF) have announced data demonstrating positive top-line results from Phase 3 KEYNOTE-775/Study 309, evaluating Merck's Keytruda plus Eisai's Lenvima in patients with advanced endometrial cancer following at least one prior platinum-based regimen.
Beovu (brolucizumab)
Novartis reports positive topline results from second Phase III trial of Beovu® in patients with diabetic macular edema
Dec 15, 2020
- In Phase III KESTREL study, Beovu (brolucizumab 6 mg) achieved its primary endpoint of non-inferiority to aflibercept 2 mg in change in best-corrected visual acuity (BCVA) at year one (week 52)1
- In a secondary endpoint, more than half of Beovu patients in the 6 mg arm were maintained on a three-month dosing interval through year one, following the loading phase1
- Significant improvement with Beovu 6 mg in change of central subfield thickness (CST) from baseline over the period of week 40 through week 52 was observed1
- Beovu demonstrated an overall well-tolerated safety profile1
- Novartis intends to submit the data from KESTREL, together with the data from the pivotal Phase III KITE2 study in DME, to health authorities in H1 2021
Basel, December 15, 2020 — Novartis
Find out more at https://www.novartis.com.
Beovu (brolucizumab)
About Beovu (brolucizumab)
Beovu (brolucizumab, also known as RTH258) is approved in more than 50 countries, including in the US6, EU7, UK7, Japan8, Canada9 and Australia10, for the treatment of wet AMD. Additional trials are currently ongoing which study the effects of brolucizumab in patients with AMD, diabetic macular edema, retinal vein occlusion and proliferative diabetic retinopathy. Brolucizumab is the most clinically advanced humanized single-chain antibody fragment (scFv)11-13. Single-chain antibody fragments are highly sought after in drug development due to their small size, enhanced tissue penetration, rapid clearance from systemic circulation and drug delivery characteristics13-15.
INDICATION
BEOVU® (brolucizumab-dbll) injection is used for the treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD).
Novartis' Beovu meets primary endpoint in late-stage study in diabetic macular edema
Dec. 15, 2020 5:00 AM ETNovartis AG (NVS)By: Mamta Mayani, SA News Editor
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Vocabria (cabotegravir injection and tablets) to be used with Janssen’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets)
ViiV Healthcare announces the Marketing Authorisation of the first complete long-acting injectable HIV treatment in Europe
Mon December 21, 2020 2:09 AM|Business Wire|About: GSK, PFE
- Marketing Authorisation granted by European Commission for ViiV Healthcare’s Vocabria (cabotegravir injection and tablets) to be used with Janssen’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets)
- New treatment can enable people living with HIV to reduce the days they receive treatment from 365 to 12 or 6 per year
- The long-acting injectable regimen was preferred by majority of clinical trial patients who tried the treatment over their previous daily oral therapy
LONDON--(BUSINESS WIRE)-- ViiV Healthcare
Vocabria (cabotegravir injection and tablets) to be used with Janssen’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets)
About cabotegravir
Cabotegravir is an INI developed by ViiV Healthcare for the treatment of HIV-1 in virologically suppressed adults. It is being evaluated in combination with injectable rilpivirine as a long-acting formulation.
INSTIs, like cabotegravir, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.
About rilpivirine and rilpivirine long-acting
The oral formulation of rilpivirine is also authorised for the treatment of HIV-1 infection in combination with other antiretroviral agents in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35 kg with a viral load ≤ 100,000 HIV RNA copies/mL.
Rilpivirine long-acting is a prolonged-release suspension for IM injection being developed by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which in turn stops the virus from multiplying.
Vocabria (cabotegravir) injection is indicated, in combination with rilpivirine injection, for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class.
Vocabria injection is indicated for the treatment of HIV-1 in combination with rilpivirine injection, therefore, the prescribing information for rilpivirine injection should be consulted for recommended dosing.
Vocabria tablets are indicated in combination with rilpivirine tablets for the short-term treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class for:
- oral lead in to assess tolerability of Vocabria and rilpivirine prior to administration of long acting Vocabria injection plus long acting rilpivirine injection.
- oral therapy for adults who will miss planned dosing with Vocabria injection plus rilpivirine injection.
Vocabria tablets are only indicated for treatment of HIV-1 in combination with rilpivirine tablets, therefore, the prescribing information for Edurant tablets should also be consulted for recommended dosing.
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ViiV, Janssen's cabotegravir + rilpivirine wins marketing approval in Europe for HIV treatment
Dec. 21, 2020 5:07 AM ETJohnson & Johnson (JNJ)By: Mamta Mayani, SA News Editor
DARZALEX® (daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd)
Janssen Announces Health Canada Approval of DARZALEX®* Combination Regimen for Newly Diagnosed, Transplant-Eligible Patients with Multiple Myeloma
Tue December 22, 2020 7:30 AM|Canada Newswire|About: JNJ
Data show DARZALEX® in combination with bortezomib, thalidomide and dexamethasone (VTd) before and after autologous stem cell transplant improved response rates and progression-free survival compared to VTd alone
TORONTO, Dec 22, 2020 /CNW/ - The Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ) announce that Health Canada has approved DARZALEX® (daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd) for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT).1 This represents the first Canadian approval of a biologic for newly diagnosed patients who are eligible for a stem cell transplant and it is the fifth approval for DARZALEX®.
DARZALEX® (daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd)
About DARZALEX®
DARZALEX® is the first CD38-directed monoclonal antibody approved to treat multiple myeloma. In 2020, the subcutaneous formulation, DARZALEX® SC, was approved by Health Canada to treat patients with multiple myeloma.11
DARZALEX® binds to CD38, a surface protein highly expressed across multiple myeloma cells.12 DARZALEX® induces tumor cell death through cell lysis via multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).13 DARZALEX® has also demonstrated immunomodulatory effects such as increasing CD4+ and CD8+ T-cells counts, which may contribute to clinical response.14
In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize DARZALEX®. Janssen Inc. commercializes DARZALEX® and DARZALEX® SC in Canada. For full Prescribing Information and more information about DARZALEX® and DARZALEX® SC, please visit www.janssen.com/canada.
What is DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj)?
DARZALEX FASPRO™ is a prescription medicine used to treat adult patients with multiple myeloma:
- in combination with the medicines bortezomib, melphalan and prednisone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant)
- in combination with the medicines lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant) and in people whose multiple myeloma has come back or did not respond to treatment, who have received at least one prior medicine to treat multiple myeloma
https://www.janssen.com/oncology
https://seekingalpha.com/symbol/JNJ
BCMA CAR-T Therapy Ciltacabtagene Autoleucel (cilta-cel)
Janssen Initiates Rolling Submission of a Biologics License Application to U.S. FDA for BCMA CAR-T Therapy Ciltacabtagene Autoleucel (cilta-cel) for the Treatment of Relapsed and/or Refractory Multiple Myeloma
December 21, 2020 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the initiation of a rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adults with relapsed and/or refractory multiple myeloma.
BCMA CAR-T Therapy Ciltacabtagene Autoleucel (cilta-cel)
About ciltacabtagene autoleucel (cilta-cel)
Cilta-cel is an investigational CAR-T therapy being studied in a comprehensive clinical development program for the treatment of patients with relapsed and/or refractory multiple myeloma and in earlier lines of treatment. Cilta-cel is a unique, structurally differentiated CAR-T cell therapy containing a 4-1BB co-stimulatory domain and two BCMA-targeting single-domain antibodies with a preferential CD8+ T-cell expansion. BCMA is a protein that is highly expressed on myeloma cells.[1] CAR-T cells are an innovative approach to eradicating cancer cells by harnessing the power of a patient’s own immune system. The safety profile observed to date for cilta-cel supports the potential for outpatient dosing, which will be evaluated in ongoing clinical studies.
In December 2017, Janssen Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Legend Biotech USA Inc. to develop and commercialize cilta-cel.
In addition to a U.S. BTD granted in December 2019, cilta-cel received a PRIority MEdicines (PRiME) designation from the European Commission in April 2019, and a BTD in China in August 2020. Janssen also received Orphan Drug Designation for cilta-cel from the FDA in February 2019 and from the European Commission in February 2020.
About CARTITUDE-1
CARTITUDE-1 (NCT03548207) is an ongoing Phase 1b/2, open-label, multi-center study evaluating the safety and efficacy of cilta-cel in adults with relapsed and/or refractory multiple myeloma,
99 percent of whom were refractory to the last line of treatment and 88 percent of whom were
triple-class refractory, meaning their cancer did not respond, or no longer responds, to an immunomodulatory agent (IMiD), a proteasome inhibitor (PI) and an anti-CD38 antibody.
Learn more at www.janssen.com.
https://seekingalpha.com/symbol/JNJ
SOLIQUA®
Health Canada approves expanded indication for SOLIQUA®
Fri December 18, 2020 7:00 AM|Canada Newswire
- New indication for SOLIQUA® offers an alternative approach for Canadians living with type 2 diabetes requiring treatment intensification
- From the makers of Lantus®, the efficacy, safety, and convenient once-daily administration schedule of SOLIQUA® provides a new treatment option for Canadians with type 2 diabetes
LAVAL, QC, Dec. 18, 2020 /CNW Telbec/ - Sanofi Canada announced that Health Canada has approved expanded use of SOLIQUA®.
SOLIQUA®
About SOLIQUA®
SOLIQUA® is an injectable prescription medicine that contains 2 diabetes medicines, insulin glargine and lixisenatide, which may improve blood sugar (glucose) control in adults with type 2 diabetes when used with diet and exercise.
The treatment is a titratable fixed-ratio combination that shows improved efficacy and comparable or improved safety outcomes relative to its separate constituents, offering an alternative approach to intensification of therapy in T2D.2
https://www.soliqua100-33.com/
https://seekingalpha.com/symbol/SNY
KEYTRUDA® (pembrolizumab) Plus Chemotherapy
FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as First-Line Treatment for Locally Advanced Unresectable or Metastatic Esophageal and Gastroesophageal Junction Cancer
December 17, 2020 6:45 am EST
Application Based on Overall Survival and Progression-Free Survival Data Comparing KEYTRUDA Plus Chemotherapy to Chemotherapy Alone From Pivotal Phase 3 KEYNOTE-590 Trial
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum and fluoropyrimidine based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus and gastroesophageal junction (GEJ). This sBLA is based on data from the pivotal Phase 3 KEYNOTE-590 trial, in which KEYTRUDA plus chemotherapy demonstrated significant improvements in the primary endpoints – overall survival (OS) and progression-free survival (PFS) – versus chemotherapy in these patients regardless of PD-L1 expression status and tumor histology. These data were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of April 13, 2021.
KEYTRUDA® (pembrolizumab) Plus Chemotherapy
About KEYTRUDA® (pembrolizumab) Injection, 100 mg
KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,300 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.
A BREAKTHROUGH IMMUNOTHERAPY THAT MAY HELP YOU FACE YOUR CANCER
IT’S TRU. KEYTRUDA.
SELECT A TYPE OF CANCER
- Advanced non–small cell lung cancer
- Melanoma
- Head and neck squamous cell cancer
- High-risk non-muscle invasive bladder cancer (NMIBC)
- Advanced urothelial bladder cancer
- Advanced kidney cancer (RCC)
- Advanced MSI-H/dMMR colorectal cancer
- Microsatellite instability-high cancer (MSI-H/dMMR)
- Classical Hodgkin lymphoma (cHL)
- Advanced gastric cancer
- Advanced cervical cancer
- Primary mediastinal B‑cell lymphoma (PMBCL)
- Advanced liver cancer (HCC)
- Advanced Merkel cell carcinoma
- Advanced esophageal squamous cell carcinoma
- Cutaneous squamous cell carcinoma (cSCC)
Please see Prescribing Information for KEYTRUDA (pembrolizumab) at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf and Medication Guide for KEYTRUDA at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201217005083/en/
For more information, visit www.merck.com
https://seekingalpha.com/symbol/MRK
BENLYSTA (belimumab)
FDA approves GSK's BENLYSTA as the first medicine for adult patients with active lupus nephritis in the US
Thu December 17, 2020 8:59 AM|PR Newswire|About: GSKPR Newswire
LONDON, Dec. 17, 2020 /PRNewswire/ -- GlaxoSmithKline plc (GSK)
BENLYSTA (belimumab)
About BENLYSTA (belimumab)
BENLYSTA, a BLyS-specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS. BENLYSTA does not bind B cells directly. By binding BLyS, BENLYSTA inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. First approved in 2011, it is the first and only approved biologic for both SLE and LN in more than 50 years.
The following information is based on the US Prescribing Information for BENLYSTA in licensed indications only. Please consult the full Prescribing Information for all the labelled safety information for BENLYSTA.
INDICATION
BENLYSTA is indicated for patients aged ≥5 years with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy and patients aged ≥18 with active lupus nephritis who are receiving standard therapy. The subcutaneous (SC) formulation is approved for patients aged ≥18 years. BENLYSTA is not recommended in patients with severe active central nervous system lupus or in combination with other biologics.
What is BENLYSTA?
BENLYSTA is a prescription medicine for patients with active systemic lupus erythematosus (SLE or lupus) receiving other lupus medicines. Intravenous dosing of BENLYSTA is approved for patients 5 years and older, and subcutaneous dosing is only approved for adults. It is not known if BENLYSTA is safe and effective in people with severe active lupus nephritis or severe active central nervous system lupus.
For further information please visit www.gsk.com/about-us.
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SOURCE GlaxoSmithKline
GlaxoSmithKline's Benlysta wins FDA approval for lupus nephritis
Dec. 17, 2020 10:23 AM ETGlaxoSmithKline plc (GSK)By: Vandana Singh, SA News Editor
- The FDA has approved GlaxoSmithKline's (GSK +0.8%) intravenous and subcutaneous Benlysta for Lupus nephritis (LN), making it the first therapy ever approved for the indication.
https://seekingalpha.com/symbol/GSK
ENTRESTO® (sacubitril and valsartan) tablets
Novartis announces positive FDA Advisory Committee recommendation for use of Entresto® to treat patients with HFpEF
Dec 16, 2020
- The Committee voted 12 to 1 that the data presented support the use of Entresto in treatment of patients with heart failure with preserved ejection fraction (HFpEF)
- Potential Q1 2021 sNDA approval could make Entresto the first therapy indicated for use in treatment of patients with both major types of chronic heart failure: HFpEF and HFrEF; and the only chronic heart failure treatment studied in both conditions against active comparators1,2
- HFpEF patients currently have no approved treatment options and face worsening symptoms that result in frequent HF hospitalizations, emergency room and urgent office visits1,3,4
Basel, December 16, 2020 — Novartis
Entresto® ENTRESTO® (sacubitril and valsartan) tablets
About Entresto for heart failure with reduced ejection fraction
In Europe, Entresto is indicated in adult patients for the treatment of symptomatic chronic HF with reduced ejection fraction14. In the United States, Entresto is indicated for the treatment of HF (New York Heart Association class II-IV) in patients with systolic dysfunction15. It has been shown to reduce the rate of cardiovascular death and HF hospitalization, to reduce the rate of all-cause mortality and to improve aspects of health-related quality of life (including physical and social activities), compared to enalapril7,16,17. Entresto is usually administered in conjunction with other HF therapies, in place of an ACE inhibitor or other angiotensin receptor blocker (ARB)14. Approved indications may vary depending upon the individual country.
Entresto is a twice-a-day medicine that reduces the strain on the failing heart14. It does this by enhancing the protective neurohormonal systems (natriuretic peptide system) while simultaneously inhibiting the harmful effects of the overactive renin-angiotensin-aldosterone system (RAAS)14,18. Other common HF medicines, called angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARBs), only block the harmful effects of the overactive RAAS. Entresto contains the neprilysin inhibitor sacubitril and the angiotensin receptor blocker (ARB) valsartan14,15.
https://www.entresto.com/index.jsp
INDICATION
What is ENTRESTO?
ENTRESTO is a prescription medicine used to reduce the risk of death and hospitalization in adults with long-lasting (chronic) heart failure. ENTRESTO is usually used with other heart failure therapies, in place of an angiotensin-converting enzyme (ACE) inhibitor or other angiotensin II receptor blocker (ARB) therapy.
https://www.entresto.com/index.jsp
This information is not comprehensive. Please see full Prescribing Information, including Boxed WARNING, and Patient Prescribing Information.
Find out more at https://www.novartis.com.
FDA advisory committee backs use of Novartis' Entresto in heart failue
Dec. 16, 2020 6:03 AM ET Novartis AG (NVS) By: Mamta Mayani, SA News Editor
- The FDA's Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted 12 to 1 supporting the use of Novartis' (NYSE:NVS) Entresto (sacubitril/valsartan) in treatment of patients with heart failure with preserved ejection fraction (HFpEF).
https://seekingalpha.com/symbol/NVS
NILEMDO® * (bempedoic acid) tablet and its combination with ezetimibe NUSTENDI® * (bempedoic acid and ezetimibe) tablet
Dec 16, 2020
First-in-class cholesterol-lowering treatment NILEMDO® * (bempedoic acid) tablet and its combination with ezetimibe NUSTENDI® * (bempedoic acid and ezetimibe) tablet approved in Switzerland
- NILEMDO® (bempedoic acid) is the first oral, once-daily treatment approved in almost two decades to lower low-density lipoprotein cholesterol (LDL-C) for indicated patients -
- Bempedoic acid and its fixed combination drug product with ezetimibe both deliver significant reductions in LDL-C when added to a statin or other lipid-lowering therapies1,2 -
- Two-thirds of patients in Switzerland with very high cardiovascular risk do not achieve LDL-C target values set out by the European Society of Cardiology,3 indicating a need for additional treatment options -
MUNICH, Germany, and ANN ARBOR, Mich., Dec. 16, 2020 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and Esperion Therapeutics (NASDAQ: ESPR) announced today Swissmedic approval for NILEMDO®* (bempedoic acid) tablet and NUSTENDI®* (bempedoic acid and ezetimibe) tablet, offering new treatment options for people with high low-density lipoprotein cholesterol (LDL-C) in Switzerland.
NILEMDO® * (bempedoic acid) tablet and its combination with ezetimibe NUSTENDI® * (bempedoic acid and ezetimibe) tablet
“Bempedoic acid is a first-in-class adenosine triphosphate-citrate lyase (ACL) inhibitor that lowers LDL-C by inhibiting cholesterol synthesis in the liver. This unique mechanism of action allows it to work alongside existing treatments,” said Ashley Hall, Chief Development Officer of Esperion. “Our focus is finding convenient, affordable ways for appropriate patients to manage LDL-C. That is why we also developed a single-tablet combination of bempedoic acid and ezetimibe, to help reduce pill burden.”
Bempedoic acid and its fixed combination drug product with ezetimibe were approved in the European Union and the United States earlier this year with different labels and indications.1,6,7,8 In Europe, the products are marketed as NILEMDO® and NUSTENDI®, and in the U.S. as NEXLETOL® and NEXLIZET® (respectively).1,6,7,8 The Esperion team discovered and developed bempedoic acid, drawing on its deep expertise in developing cholesterol-lowering medicines. With strong commercial capabilities, particularly in cardiovascular medicine, Daiichi Sankyo has licensed exclusive commercialization rights to bempedoic acid and the fixed combination drug product of bempedoic acid and ezetimibe in the European Economic Area, Turkey and Switzerland from Esperion. Marketing Authorization for both products in Switzerland will be transferred to Daiichi Sankyo.
Bempedoic Acid/Ezetimibe
Oral, small molecule in fixed-dose combination
https://www.esperion.com/science/bempedoic-acid-ezetimibe-combo-tablet/
First-in-class cholesterol-lowering treatment NILEMDO® * (bempedoic acid) tablet and its combination with ezetimibe NUSTENDI® * (bempedoic acid and ezetimibe) tablet approved in Switzerland
Wed December 16, 2020 3:00 AM|GlobeNewswire|About: ESPR
- NILEMDO® (bempedoic acid) is the first oral, once-daily treatment approved in almost two decades to lower low-density lipoprotein cholesterol (LDL-C) for indicated patients -
- Bempedoic acid and its fixed combination drug product with ezetimibe both deliver significant reductions in LDL-C when added to a statin or other lipid-lowering therapies1,2 -
- Two-thirds of patients in Switzerland with very high cardiovascular risk do not achieve LDL-C target values set out by the European Society of Cardiology,3 indicating a need for additional treatment options -
MUNICH, Germany, and ANN ARBOR, Mich., Dec. 16, 2020 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and Esperion Therapeutics (ESPR) announced today Swissmedic approval for NILEMDO®* (bempedoic acid) tablet and NUSTENDI®* (bempedoic acid and ezetimibe) tablet, offering new treatment options for people with high low-density lipoprotein cholesterol (LDL-C) in Switzerland.
For more information, please visit: www.daiichisankyo.com.
https://www.daiichisankyo.com/
https://www.daiichisankyo.com/investors/tokyo_stock_exchange/
For more information, please visit www.esperion.com
https://seekingalpha.com/symbol/ESPR
Optune® in Combination With Temozolomide
Novocure Announces National Reimbursement in Switzerland for Optune® in Combination With Temozolomide for the Treatment of Newly Diagnosed Glioblastoma
December 14, 2020
ST. HELIER, Jersey–(BUSINESS WIRE)–Novocure (NASDAQ:NVCR) announced today that the Swiss Federal Office of Public Health (BAG) has added Optune in combination with temozolomide to the List of Remedies and Equipment (MiGeL) for the treatment of patients with newly diagnosed glioblastoma (GBM), effective April 1, 2021. The List of Remedies and Equipment defines which medical devices are covered by compulsory health insurance in Switzerland.
Optune® in Combination With Temozolomide
About Optune
Optune is a noninvasive, antimitotic cancer treatment for GBM. Optune delivers Tumor Treating Fields to the region of the tumor.
Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells with specific membrane properties. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with GBM and in the U.S. for MPM, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.
Approved Indications
Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery, and completion of radiation therapy together with concomitant standard of care chemotherapy.
For the treatment of recurrent GBM, Optune is indicated following histologically- or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
TEMODAR ® (temozolomide) capsules
https://www.merck.com/product/usa/pi_circulars/t/temodar_capsules/temodar_pharm.pdf
For additional information about the company, please visit www.novocure.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20201213005052/en/
https://seekingalpha.com/symbol/NVCR
OCREVUS® (ocrelizumab)
FDA approves Roche’s OCREVUS® (ocrelizumab) shorter 2-hour infusion for relapsing and primary progressive multiple sclerosis
- Approval based on data from the randomised, double-blind ENSEMBLE PLUS study, showing consistent safety to the conventional OCREVUS dosing regimen
- Shorter infusion time will further improve the twice-yearly treatment experience for OCREVUS, the only B-cell therapy for relapsing and primary progressive MS with a twice-yearly dosing schedule
Basel, 14 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a shorter two-hour infusion time for OCREVUS® (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have not experienced any prior serious infusion reactions (IRs). The approval was based on data from the randomised, double-blind ENSEMBLE PLUS study.
OCREVUS® (ocrelizumab)
About OCREVUS® (ocrelizumab)
OCREVUS is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with MS. Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, suggesting that important functions of the immune system may be preserved. OCREVUS is administered by intravenous infusion every six months. The initial dose is given as two 300 mg infusions given two weeks apart. Subsequent doses are given as single 600 mg infusions.
What is OCREVUS?
OCREVUS is a prescription medicine used to treat:
- Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults
- Primary progressive MS, in adults.
It is not known if OCREVUS is safe or effective in children.
FDA OK's Roche’s Ocrevus shorter 2-hour infusion for multiple sclerosis
Dec. 15, 2020 4:44 AM ETRoche Holding AG (RHHBY)By: Mamta Mayani, SA News Editor
Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
https://seekingalpha.com/symbol/RHHBY
biotecMAX™ December/November/October 2020 insight
KEYTRUDA® (pembrolizumab) Injection, 100 mg
Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) as First-Line Treatment in Adult Patients With Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer
December 11, 2020 7:10 am EST
Opinion Granted Based on Significant Progression-Free Survival Benefit Demonstrated With KEYTRUDA Monotherapy Compared to Standard-of-Care Chemotherapy in Pivotal Phase 3 KEYNOTE-177 Trial
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada,
KEYTRUDA® (pembrolizumab) Injection, 100 mg
About KEYTRUDA® (pembrolizumab) Injection, 100 mg
KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,300 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.
Selected KEYTRUDA® (pembrolizumab) Indications in the U.S.
Melanoma
KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.
KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
Non-Small Cell Lung Cancer
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
Small Cell Lung Cancer
KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Head and Neck Squamous Cell Cancer
KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) ≥1] as determined by an FDA-approved test.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
Classical Hodgkin Lymphoma
KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.
Primary Mediastinal Large B-Cell Lymphoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.
Urothelial Carcinoma
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (CPS ≥10), as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
Microsatellite Instability-High or Mismatch Repair Deficient Cancer
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
- solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
- colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.
Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer
KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).
Gastric Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Esophageal Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.
Cervical Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Hepatocellular Carcinoma
KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Merkel Cell Carcinoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Renal Cell Carcinoma
KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
Tumor Mutational Burden-High
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.
Cutaneous Squamous Cell Carcinoma
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
Triple-Negative Breast Cancer
KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
For more information, visit www.merck.com
Please see Prescribing Information for KEYTRUDA (pembrolizumab) at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf and Medication Guide for KEYTRUDA at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf.
Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) as First-Line Treatment in Adult Patients With Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer
Fri December 11, 2020 7:10 AM |Business Wire |About: MRK
Opinion Granted Based on Significant Progression-Free Survival Benefit Demonstrated With KEYTRUDA Monotherapy Compared to Standard-of-Care Chemotherapy in Pivotal Phase 3 KEYNOTE-177 Trial
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK)
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VASCEPA® (ICOSAPENT ETHYL)
INVESTOR RELATIONS / AMARIN HIGHLIGHTS MULTIPLE VASCEPA® (ICOSAPENT ETHYL)-RELATED SCIENTIFIC FINDINGS PRESENTED AT NATIONAL LIPID ASSOCIATION (NLA) SCIENTIFIC SESSIONS 2020, INCLUDING FIRST COVID-19 CLINICAL RESULTS
BackPDF VersionDec 14, 2020
REDUCE-IT® EPA Encore Presentation reinforces Eicosapentaenoic Acid (EPA) levels from VASCEPA® (icosapent ethyl) strongly correlated to cardiovascular outcomes, more so than other biomarkers
VASCEPA COVID-19 CardioLink-9 Randomized Trial suggests improvement in outpatient-reported COVID-19 symptoms while achieving its primary endpoint by demonstrating a 25% reduction in high-sensitivity C-reactive protein (hsCRP) with encouraging short-term safety and tolerability data using VASCEPA loading dose
Amarin to Webcast Discussion of Presented Data Today, Monday, December 14, 2020 at 8:00 a.m., Eastern Standard Time
DUBLIN, Ireland and BRIDGEWATER, N.J., Dec. 14, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced the presentation of important VASCEPA® (icosapent ethyl)-related scientific findings during the National Lipid Association (NLA) Scientific Sessions 2020, held virtually from December 10 – 12, 2020, from a variety of academic collaborators and based on research or analyses supported by Amarin.
VASCEPA® (ICOSAPENT ETHYL)
About VASCEPA® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the FDA comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed over eight million times. VASCEPA is covered by most major medical insurance plans. The new, cardiovascular risk indication for VASCEPA was approved by the FDA in December 2019.
Indications and Limitation of Use
VASCEPA is indicated:
- As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and
- established cardiovascular disease or
- diabetes mellitus and two or more additional risk factors for cardiovascular disease.
- As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
For more information about Amarin, visit www.amarincorp.com.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Sotatercept
ACCELERON RECEIVES ORPHAN DESIGNATION FROM THE EUROPEAN COMMISSION (EC) FOR SOTATERCEPT IN PULMONARY ARTERIAL HYPERTENSION (PAH)
DECEMBER 14, 2020Download PDF
– Sotatercept received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) in PAH in 2019 –
– In the spring of 2020, sotatercept received Breakthrough Therapy designation from the FDA and Priority Medicines (PRIME) designation from the European Medicines Agency (EMA), both in PAH –
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Acceleron Pharma Inc. (Nasdaq: XLRN), a biopharmaceutical company dedicated to the discovery, development, and commercialization of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that the European Commission (EC) has granted orphan designation to sotatercept for the treatment of patients with pulmonary arterial hypertension (PAH).
For more information, please visit www.acceleronpharma.com.
Sotatercept
About Sotatercept
Sotatercept is an investigational reverse-remodeling agent designed to be a selective ligand trap for members of the TGF-beta superfamily to rebalance BMPR-II signaling, which is a key molecular driver of PAH. The PULSAR Phase 2 trial evaluating sotatercept in combination with approved PAH-specific medicines in patients with PAH achieved its primary endpoint of improvement in pulmonary vascular resistance and its key secondary endpoint of improvement in 6-minute walk distance. Sotatercept was generally well tolerated in the trial. Adverse events observed in the study were generally consistent with previously published data on sotatercept in other diseases. Following the PULSAR results, sotatercept was granted Breakthrough Therapy designation from the FDA and Priority Medicines designation from the EMA in PAH. Sotatercept is also being evaluated in the SPECTRA Phase 2 exploratory trial.
The Company recently presented details of its Phase 3 development plan, including the design for the registrational STELLAR trial, which is expected to be initiated before the end of 2020. Acceleron is planning two additional Phase 3 studies in patients with PAH: the HYPERION trial, exploring early intervention with sotatercept, and the ZENITH trial assessing later-stage intervention.
Sotatercept is an investigational therapy that is not approved for any use in any country. Sotatercept is part of a licensing agreement with Bristol Myers Squibb.
Source: Acceleron Pharma Inc.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201214005111/en/
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BNT162B2 COVID-19 VACCINE CANDIDATE
PFIZER AND BIONTECH RECEIVE FDA ADVISORY COMMITTEE VOTE SUPPORTING POTENTIAL FIRST EMERGENCY USE AUTHORIZATION FOR VACCINE TO COMBAT COVID-19 IN THE U.S.
Thursday, December 10, 2020 - 06:50pm
- FDA expected to make a decision on Emergency Use Authorization in the coming days
- Positive vote based on totality of scientific evidence presented by the companies, including Phase 3 efficacy and safety data
- If authorized, BNT162b2 would be the first COVID-19 vaccine available in the U.S.
NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17 to 4 in support of the FDA granting Emergency Use Authorization (EUA) for the companies’ COVID-19 mRNA vaccine (BNT162b2). There is one member of the Committee whose vote is not included in the 17 to 4 vote decision.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201210006182/en/
VRBPAC based its recommendation on the totality of scientific evidence shared by the companies, including data from a pivotal Phase 3 clinical study announced last month and published today in The New England Journal of Medicine. The Phase 3 data demonstrated a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. The Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine. Efficacy was consistent across age, gender, race and ethnicity demographics. All trial participants will continue to be monitored for an additional two years after their second dose to assess long-term protection and safety. The FDA will take the advisory committee’s recommendation into consideration when it makes a final determination.
We routinely post information that may be important to investors on our website at www.Pfizer.com.
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For more information, please visit www.BioNTech.de.
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Americans could begin getting Pfizer vaccine on Monday - HHS's Alex Azar
Dec. 11, 2020 7:33 AM ETPfizer Inc. (PFE)By: Stephen Alpher, SA News Editor
View source version on businesswire.com: https://www.businesswire.com/news/home/20201210006182/en/
FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting
The following is attributed to FDA Commissioner Stephen M. Hahn, M.D., and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
For Immediate Release: December 11, 2020Statement From: Commissioner of Food and Drugs - Food and Drug AdministrationStephen M. Hahn M.D.Director - Center for Biologics Evaluation and Research (CBER)Peter Marks M.D., PhD.
Hong Kong fourth wave: free coronajabs for all residents as city secures 15 million vaccine doses from Sinovac, Pfizer, with first batch arriving in January
Hong Kong leader Carrie Lam hails procurement deals as ‘groundbreaking’, and pledges that every resident will receive a free jab
Advance purchase agreements signed with two giant pharmaceutical giants and another deal with a third is in the works
Victor Ting , Chris Lau and Olga Wong
PFIZER AND BIONTECH ANNOUNCE PUBLICATION OF RESULTS FROM LANDMARK PHASE 3 TRIAL OF BNT162B2 COVID-19 VACCINE CANDIDATE IN THE NEW ENGLAND JOURNAL OF MEDICINE
Thursday, December 10, 2020 - 10:21am
- Data from 43,448 participants, half of whom received BNT162b2 and half of whom received placebo, showed that the vaccine candidate was well tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose
- Vaccine efficacy observed in the overall study population was also generally consistent across subgroups defined by age, gender, race, ethnicity, baseline body mass index (BMI), or presence of other underlying co-morbidities
- Partial protection from the vaccine candidate appears to begin as early as 12 days after the first dose
- These data were included in the requests for regulatory authorization submitted to regulatory agencies across the globe, including the U.S. Food and Drug Administration and the European Medicines Agency
NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicinehas published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. In the trial of 43,448 participants, who were 16 years and older, 21,720 of whom received BNT162b2 and 21,728 placebo, the two-dose regimen of 30 μg BNT162b2, which was given 21 days apart, was well-tolerated and demonstrated vaccine efficacy of 95% against COVID-19.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201210005703/en/
US says COVID-19 vaccine to start arriving in states Monday
Sat December 12, 2020 11:51 AM|Associated Press|About: BNTX, FDX, JNJ, MRNA, PFE, SNY, UPSAssociated Press, The
WASHINGTON (AP) — U.S. officials say the nation's first COVID-19 vaccine will begin arriving in states Monday morning.
PFIZER AND BIONTECH PROVIDE DATA FROM GERMAN PHASE 1/2 STUDY FURTHER CHARACTERIZING IMMUNE RESPONSE FOLLOWING IMMUNIZATION WITH LEAD COVID-19 VACCINE CANDIDATE BNT162B2
Monday, December 14, 2020 - 06:30amEST
- Analysis of 37 participants immunized with BNT162b2 showed a broad immune response with SARS-CoV-2-specific neutralizing antibodies, TH1 type CD4+ T cells, and strong expansion of CD8+ T cells of the early effector memory phenotype
- All vaccinated participants demonstrated neutralizing antibody as well as T cell responses. T cell responses were directed against multiple regions of the spike protein, including the RBD, suggesting immune recognition of multiple independent epitopes
- Data confirm previous findings from the U.S. trial demonstrating a good safety profile and robust induction of antibody responses with a longer follow-up period of 85 days
- Antibodies generated in trial subjects were able to neutralize pseudo-viruses representing 19 diverse SARS-CoV-2 variants, indicating potential for broad protection against viruses with reported mutations
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced additional data on neutralizing antibody and T cell responses from the Phase 1/2 trial with BNT162b2 conducted in Germany. The study results demonstrate that BNT162b2 elicits a combined adaptive humoral and cellular immune response against SARS-CoV-2 and provide insights into the composite nature of BNT162b2-induced T cell immunity. The results were published on the preprint server MedRxiv and are available here. BNT162b2 is an investigational COVID-19 vaccine developed by Pfizer-BioNTech. It has been authorized for emergency use for individuals 16 years of age and older in several countries around the world.
EU greenlights COVID-19 vaccine after agency gives safety OK
Mon December 21, 2020 3:41 AM|Associated Press|About: AZN, BNTX, MRNA, PFE
AMSTERDAM (AP) — The European Union on Monday gave official approval for the coronavirus vaccine developed by BioNTech (NTGN) and Pfizer (PFE) to be put onto the market across the 27-nation bloc.
PFIZER AND BIONTECH RECEIVE AUTHORIZATION IN THE EUROPEAN UNION FOR COVID-19 VACCINE
Monday, December 21, 2020 - 02:09pm
- COMIRNATY® (also known as BNT162b2) receives conditional marketing authorization from the European Commission; this milestone represents a global joint effort to advance the first authorized mRNA vaccine
- Pfizer and BioNTech are ready to immediately ship initial doses to the 27 EU member states
- Pfizer and BioNTech previously announced an agreement with the European Commission to supply 200 million vaccine doses to EU member states; the EU also has an option to purchase an additional 100 million doses in 2021
- The vaccine has now been granted a conditional marketing authorization, emergency use authorization, or temporary authorization in more than 40 countries worldwide, including all 27 EU member states
NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the European Commission (EC) has granted a conditional marketing authorization (CMA) to Pfizer and BioNTech for COMIRNATY® (also known as BNT162b2), for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older. This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine earlier today. The EC granted this CMA in the interest of public health to help address the COVID-19 pandemic. The CMA is valid in all 27 member states of the European Union (EU).
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201221005672/en/
PFIZER AND BIONTECH TO SUPPLY THE U.S. WITH 100 MILLION ADDITIONAL DOSES OF COVID-19 VACCINE
December 23, 2020
- U.S. government orders 100 million additional doses of the Pfizer-BioNTech COVID-19 Vaccine bringing total doses for U.S. to 200 million
- All 200 million doses expected to be delivered by July 31, 2021, allowing for 100 million people in the U.S. to be vaccinated
NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced a second agreement with the U.S. government to supply an additional 100 million doses of the companies’ COVID-19 Vaccine from production facilities in the U.S. This agreement brings the total number of doses to be delivered to the U.S. to 200 million. The companies expect to deliver the full 200 million doses to Operation Warp Speed (OWS) by July 31, 2021. Consistent with the original agreement announced in July 2020, the U.S. government will pay $1.95 billion for the additional 100 million doses.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201223005185/en/
NERLYNX® (neratinib) tablets
121120 - PD13-09 Saura NALA CNS SABCS 2020 poster FINAL
Puma Biotechnology Presents Efficacy and Safety Outcomes from the Phase III NALA Trial at the 2020 SABCS
Results show improved CNS outcomes with neratinib-based regimens in the treatment and prevention of CNS metastases from HER2-positive breast cancer
LOS ANGELES, Calif., Dec. 11, 2020 - Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, presented efficacy and safety outcomes in a subgroup of patients from the NALA trial who had central nervous system (CNS) metastases at baseline, with a particular focus on CNS-specific endpoints, at the 2020 Virtual San Antonio Breast Cancer Symposium (SABCS) that is currently taking place. The presentation entitled, “Impact of neratinib plus capecitabine on outcomes in HER2-positive metastatic breast cancer patients with central nervous system disease at baseline: Findings from the phase 3 NALA trial,” is being presented at a Spotlight Poster Discussion Session by Cristina Saura, M.D., Ph.D., Head of Breast Cancer Unit, Vall d’Hebrón University Hospital, an investigator of the trial. A copy of this poster presentation is available on the Puma website.
Further information about Puma Biotechnology may be found at www.pumabiotechnology.com.
NERLYNX® (neratinib) tablets
INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated:
- As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
- In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer, who have received two or more prior anti-HER2 based regimens in the metastatic setting.
Please see Full Prescribing Information for additional safety information.
Puma Biotechnology Presents Efficacy and Safety Outcomes from the Phase III NALA Trial at the 2020 SABCS
Fri December 11, 2020 2:00 PM|Business Wire|About: PBYI
Results show improved CNS outcomes with neratinib-based regimens in the treatment and prevention of CNS metastases from HER2-positive breast cancer
LOS ANGELES--(BUSINESS WIRE)-- Puma Biotechnology, Inc. (PBYI)
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201211005419/en/
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Leqvio®* (inclisiran)
Novartis receives EU approval for Leqvio®* (inclisiran), a first-in-class siRNA to lower cholesterol with two doses a year**
Dec 11, 2020
- Leqvio® (inclisiran) is the first and only approved small-interfering RNA (siRNA) low-density lipoprotein cholesterol (LDL-C) lowering treatment in Europe1-3
- Cardiovascular disease causes 3.9 million deaths annually in Europe, and 80% of high-risk patients do not reach guideline-recommended LDL-C targets despite the widespread use of statins4-7
- Approval is based on a robust clinical development program demonstrating effective and sustained LDL-C reduction of up to 52% in patients with elevated LDL-C despite maximally tolerated statin therapy1,2
- Novartis is committed to improving population health outcomes in CVD by partnering with European healthcare systems to identify new ways of bringing transformative innovations to patients with atherosclerotic cardiovascular disease who are struggling to reach their LDL-C goals
- Leqvio is currently under review by the U.S. Food and Drug Administration and other health authorities
Basel, December 11, 2020
Leqvio®* (inclisiran)
About Leqvio (inclisiran)
Leqvio (inclisiran, KJX839) is the first and only small interfering RNA (siRNA) therapy to reduce low-density lipoprotein cholesterol (LDL-C) levels via an RNA interference (RNAi) mechanism of action and could help improve outcomes for patients with atherosclerotic cardiovascular disease (ASCVD), a deadly form of cardiovascular disease1-3. With two doses a year and effective and sustained LDL-C reduction, Leqvio works as a complement to statins1,2. Leqvio works differently from other therapies by preventing the production of the target protein in the liver, increasing hepatic uptake of LDL-C and clearing it from the bloodstream3. Leqvio is dosed initially, again at 3 months and then once every 6 months1,2. In three clinical trials, patients taking Leqvio maintained LDL-C reduction throughout each 6-month dosing interval1,2. Administered in-office as a subcutaneous injection, Leqvio is expected to integrate seamlessly into a patient’s healthcare routine1,2.
In the Phase III trials, inclisiran was well-tolerated. The most common adverse events reported (≥3% of patients treated with inclisiran and occurring more frequently than placebo) were injection site reaction, arthralgia, urinary tract infection, diarrhea, bronchitis, pain in extremity and dyspnea. Among those, injection site reactions were the most frequent ones. Those were generally mild and none were severe or persistent.
Novartis has obtained global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals, a leader in RNAi therapeutics.
Find out more at https://www.novartis.com.
Novartis' cholesterol lowering med, inclisiran, nabs EU nod
Dec. 11, 2020 3:27 PM ET Novartis AG (NVS)
By: Vandana Singh, SA News Editor
https://seekingalpha.com/news/3643823-novartis-cholesterol-lowering-med-inclisiran-nabs-eu-nod
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Inclisiran
HYPERCHOLESTEROLEMIA
Inclisiran (ALN-PCSsc) is a subcutaneously administered, investigational RNAi therapeutic targeting proprotein convertase subtilisin kexin type 9 (PCSK9) in development for the treatment of hypercholesterolemia by our collaborators at Novartis.
Inclisiran utilizes our Enhanced Stabilization Chemistry (ESC)-GalNAc delivery platform.
https://www.alnylam.com/alnylam-rnai-pipeline/
https://seekingalpha.com/symbol/ALNY
baricitinib (OLUMIANT ®)
Data from ACTT-2 Trial of Baricitinib in Hospitalized COVID-19 Patients Supportive of the EUA Published in New England Journal of Medicine
December 11, 2020Download PDF
INDIANAPOLIS, Dec. 11, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today that The New England Journal of Medicine has published peer-reviewed results from the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The Phase 3 study included 1,033 patients from 67 trial sites in eight countries. These results support the emergency use authorization (EUA) issued by the U.S. Food and Drug Administration (FDA) on Nov. 19 for baricitinib in combination with remdesivir in hospitalized patients with COVID-19 requiring supplemental oxygen.
Read the full NIAID press release on ACTT-2 results here.
For information on the authorized use of baricitinib and mandatory requirements under the EUA, please review the FDA Letter of Authorization, Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers (English; Spanish).
baricitinib (OLUMIANT ®)
About baricitinib (OLUMIANT ®)
OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. and more than 70 countries as a treatment for adults with moderate to severe rheumatoid arthritis (RA) and was recently approved in the European Union for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. The U.S. FDA-approved labeling for Olumiant includes a Boxed Warning for Serious Infections, Malignancy, and Thrombosis. See the full Prescribing Information here.
In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.
What is Olumiant?
Olumiant is a once-daily pill to treat adults with moderately to severely active rheumatoid arthritis (RA) who have tried at least one other medicine called a tumor necrosis factor (TNF) antagonist, such as Humira® (adalimumab), Enbrel® (etanercept), and Remicade® (infliximab), that did not work well or could not be tolerated.
Data from ACTT-2 Trial of Baricitinib in Hospitalized COVID-19 Patients Supportive of the EUA Published in New England Journal of Medicine
Fri December 11, 2020 2:01 PM|PR Newswire|About: INCY, LLY
INDIANAPOLIS, Dec. 11, 2020 /PRNewswire/ -- Eli Lilly and Company (LLY) and Incyte (INCY) announced today that The New England Journal of Medicine has published peer-reviewed results from the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The Phase 3 study included 1,033 patients from 67 trial sites in eight countries.
To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom.
For additional information on Incyte, please visit Incyte.com
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SOURCE Eli Lilly and Company
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Doptelet® (avatrombopag)
Doptelet® (avatrombopag) receives positive opinion from CHMP for treatment of ITP
Fri December 11, 2020 7:09 AM|PR Newswire
STOCKHOLM, Dec. 11, 2020 /PRNewswire/ -- Swedish Orphan Biovitrum AB (BIOVF) (publ) (Sobi™) (STO:SOBI)
Doptelet® (avatrombopag)
Om Doptelet® (avatrombopag)
Doptelet is an orally administered thrombopoietin receptor agonist (TPO-RA) that mimics the biologic effects of TPO in stimulating the development and maturation of megakaryocytes, resulting in increased platelet count. It is approved by both the US Food & Drug Administration (FDA) for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure and by the European Medicines Agency (EMA) for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo an invasive procedure. In June 2019, Doptelet was approved by the FDA for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Chronic ITP is a rare autoimmune bleeding disorder characterised by low number of platelets. The incidence of primary ITP in adults is 3.3/100 000 adults per year with a prevalence of 9.5 per 100 000 adults1.
https://www.doptelet.com/itp
What is DOPTELET® (avatrombopag)?
DOPTELET is a prescription medicine used to treat low blood platelet counts in adults with chronic immune thrombocytopenia (ITP) when other treatments have not worked well enough.
DOPTELET is not used to make platelet counts normal in adults with chronic immune thrombocytopenia. It is not known if DOPTELET is safe and effective in children.
Doptelet® (avatrombopag) receives positive opinion from CHMP for treatment of ITP
11 Dec, 2020 12:56
Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) today announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of Doptelet® (avatrombopag) for the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). The opinion is now referred to the European Commission for a decision.
You can find more information about Sobi at www.sobi.com.
https://seekingalpha.com/symbol/BIOVF
European advisory group backs SOBI's Gilead's Doptelet in thrombocytopenia
Dec. 11, 2020 8:03 AM ETSwedish Orphan Biovitrum AB (publ) (BIOVF)By: Vandana Singh, SA News Editor
https://seekingalpha.com/symbol/GILD
Trodelvy® (sacituzumab govitecan-hziy)
December 10, 2020
Gilead Advances Oncology Portfolio With New Data From Phase 3 ASCENT Trial of Trodelvy® in Metastatic Triple Negative Breast Cancer
-- sBLA Currently Under Review by the U.S. FDA for Full Marketing Approval in mTNBC --
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) is presenting new data from the Phase 3 ASCENT trial of Trodelvy® (sacituzumab govitecan-hziy) in metastatic triple-negative breast cancer (mTNBC) at the 2020 San Antonio Breast Cancer Symposium being held virtually December 8-11, 2020. The new data and analyses from the ASCENT trial continue to demonstrate the high clinical activity of Trodelvy in this patient population with traditionally poor outcomes.
Trodelvy® (sacituzumab govitecan-hziy)
About Trodelvy
Trodelvy is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated in the U.S. for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. Trodelvy binds to the cell-surface protein Trop-2 and delivers the anti-cancer drug SN-38 to kill cancer cells.
Trodelvy received accelerated approval as a treatment for adult patients with mTNBC who have received at least two prior therapies, based on results of a single-arm, multicenter Phase 2 study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
In addition to multiple ongoing studies of Trodelvy in triple-negative breast cancer, Trodelvy is being developed as an investigational treatment for metastatic urothelial cancer, hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer, and metastatic non-small cell lung cancer, either as a monotherapy or in combination with other agents.
Please see full Prescribing Information, including BOXED WARNING.
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.
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TUKYSA® (tucatinib)
Seagen Announces Positive CHMP Opinion for TUKYSA® (tucatinib) for the Treatment of Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer
12/11/2020
- Recommendation for Approval in the European Union Based on Results of Pivotal HER2CLIMB Trial -
BOTHELL, Wash.--(BUSINESS WIRE)-- Seagen Inc. (Nasdaq:SGEN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending the approval of TUKYSA® (tucatinib) in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least 2 prior anti-HER2 treatment regimens. TUKYSA is an oral, small molecule tyrosine kinase inhibitor (TKI) of HER2, a protein that contributes to cancer cell growth.1,2
TUKYSA® (tucatinib)
About TUKYSA (tucatinib)
TUKYSA is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein. In vitro (in lab studies), TUKYSA inhibited phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signaling and cell growth (proliferation), and showed anti-tumor activity in HER2-expressing tumor cells. In vivo (in living organisms), TUKYSA inhibited the growth of HER2-expressing tumors. The combination of TUKYSA and the anti-HER2 antibody trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either medicine alone.1
What is TUKYSA?
TUKYSA is a prescription medicine used with the medicines trastuzumab and capecitabine to treat adults with human epidermal growth factor receptor-2 (HER2) positive breast cancer that has spread to other parts of the body such as the brain (metastatic), or that cannot be removed by surgery, and who have received one or more anti-HER2 breast cancer treatments.
It is not known if TUKYSA is safe and effective in children.
Please see Important Facts about TUKYSA.
For more information on the company’s marketed products and robust pipeline, visit www.seagen.com
Seagen Announces Positive CHMP Opinion for TUKYSA® (tucatinib) for the Treatment of Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer
Fri December 11, 2020 7:23 AM|Business Wire|About: SGEN
- Recommendation for Approval in the European Union Based on Results of Pivotal HER2CLIMB Trial -
BOTHELL, Wash.--(BUSINESS WIRE)-- Seagen Inc. (SGEN) (Nasdaq:SGEN)
The positive CHMP opinion is based on results of the pivotal trial HER2CLIMB and were published in The New England Journal of Medicine in December 2019.
https://seekingalpha.com/symbol/SGEN
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Inrebic® (fedratinib)
Bristol Myers Squibb Receives Positive CHMP Opinion for Inrebic® (fedratinib) for Adult Patients with Newly Diagnosed and Previously Treated Myelofibrosis
12/11/2020CATEGORY:
If approved, Inrebic will become the first new therapy for myelofibrosis in Europe in nearly a decade
Inrebic, if approved, will also be the first once-daily, oral therapy to demonstrate clinically meaningful spleen and symptom response for patients with myelofibrosis where treatment with ruxolitinib has failed or who are JAK inhibitor naïve
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Inrebic® (fedratinib) for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis, who are Janus Associated Kinase(JAK) inhibitor naïve or have been treated with ruxolitinib. The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). If approved, Inrebic will be the first, once-daily oral therapy to significantly reduce spleen volume and symptom burden for patients with myelofibrosis where treatment with ruxolitinib has failed or who are JAK inhibitor naïve.
Inrebic® (fedratinib)
https://www.inrebic.com/
About Inrebic
Inrebic ® (fedratinib) is an oral kinase inhibitor with activity against wild type and mutationally activated Janus Associated Kinase 2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3). Inrebic is a JAK2-selective inhibitor with higher potency for JAK2 over family members JAK1, JAK3 and TYK2. Abnormal activation of JAK2 is associated with myeloproliferative neoplasms, including myelofibrosis and polycythemia vera. In cell models expressing mutationally active JAK2 or FLT3, Inrebic reduced phosphorylation of signal transducer and activator of transcription (STAT3/5) proteins, inhibited cell proliferation, and induced apoptotic cell death. In mouse models of JAK2V617F-driven myeloproliferative disease, Inrebic blocked phosphorylation of STAT3/5, increased survival and improved disease-associated symptoms, including reduction of white blood cells, hematocrit, splenomegaly and fibrosis.1
U.S. INDICATION
INREBIC® (fedratinib) is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).
Indication
What is INREBIC® (fedratinib)?
INREBIC is a prescription medicine used to treat adults with certain types of myelofibrosis (MF). It is not known if INREBIC is safe and effective in children.
Please see full Prescribing Information, including Boxed WARNING.
For more information about Bristol Myers Squibb, visit us at BMS.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20201211005278/en/
Bristol Myers Squibb
https://seekingalpha.com/symbol/BMY
BAVENCIO® (avelumab)
BAVENCIO® (AVELUMAB) RECEIVES POSITIVE CHMP OPINION FOR FIRST-LINE MAINTENANCE TREATMENT OF LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA
NOT INTENDED FOR UK-BASED MEDIA
Friday, December 11, 2020 - 07:40am
Rockland, MA and New York, US, December 11, 2020 – EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of BAVENCIO® (avelumab) as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy. The CHMP positive opinion will now be reviewed by the European Commission (EC), with a decision expected in early 2021.
BAVENCIO® (avelumab) Receives Positive CHMP Opinion for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma
Fri December 11, 2020 8:00 AM|PR Newswire|About: MKKGY, PFEPR Newswire
ROCKLAND, Mass. and NEW YORK, Dec. 11, 2020 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (PFE)
BAVENCIO® (avelumab)
About BAVENCIO® (avelumab)
BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.8-10 In November 2014, Merck KGaA, Darmstadt, Germany and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.
BAVENCIO Approved Indications
BAVENCIO® (avelumab) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
BAVENCIO in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.
BAVENCIO is currently approved for patients in 50 countries for at least one use.
https://www.bavencio.com/patients-and-caregivers
INDICATIONS
BAVENCIO is a prescription medicine used to treat:
- A type of skin cancer called Merkel cell carcinoma (MCC) in adults and children 12 years of age and older. BAVENCIO may be used when your skin cancer has spread
- A type of cancer in the bladder or urinary tract called urothelial cancer (UC). BAVENCIO may be used when your cancer has spread or cannot be removed by surgery (advanced UC), and you have received chemotherapy that contains a platinum and it did not work or is no longer working
These indications are approved under accelerated approval based on clinical trials that measured how many patients responded and how long they responded. Continued approval may depend on benefit demonstrated in ongoing clinical trials.
It is not known if BAVENCIO is safe and effective in children under the age of 12.
Please see full US Prescribing Information and Medication Guide available at http://www.BAVENCIO.com.
All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group Website. In case you are a resident of the USA or Canada please go to www.emdgroup.com/subscribe
https://seekingalpha.com/symbol/MKKGY
We routinely post information that may be important to investors on our website at www.pfizer.com.
https://seekingalpha.com/symbol/PFE
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SOURCE EMD Serono
biotecMAX™ December/November/October 2020 insight
RINVOQ™ (upadacitinib)
December 9, 2020
Upadacitinib (RINVOQ™) Meets Primary and All Ranked Secondary Endpoints in First Phase 3 Induction Study in Ulcerative Colitis
- Significantly more upadacitinib-treated (45 mg) patients achieved clinical remission (primary endpoint per Adapted Mayo Score) at week 8 compared to placebo in adults with moderate to severe ulcerative colitis[1]
- All ranked secondary endpoints, including clinical, endoscopic and histologic outcomes, were met[1]
- The safety results in this study were consistent with the known profile of upadacitinib, with no new safety risks observed[1-5]
- Upadacitinib, a selective and reversible JAK inhibitor discovered and developed by AbbVie, is being studied as an oral therapy for moderate to severe ulcerative colitis and several other immune-mediated diseases[1,6-14]
- Ulcerative colitis is a chronic, systemic, inflammatory disease caused by inflammation of the large intestine[15-17]
NORTH CHICAGO, Ill., Dec. 9, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive results from the Phase 3 induction study, U-ACHIEVE, which showed upadacitinib (45 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) at week 8, as well as all ranked secondary endpoints, in adult patients with moderate to severe ulcerative colitis.1 In the study, 26 percent of patients receiving upadacitinib achieved clinical remission compared to 5 percent of patients receiving placebo (p<0.001).1 U-ACHIEVE is the first of two Phase 3 induction studies to evaluate the safety and efficacy of upadacitinib in adults with moderate to severe ulcerative colitis.1
Upadacitinib (RINVOQ™) Meets Primary and All Ranked Secondary Endpoints in First Phase 3 Induction Study in Ulcerative Colitis
Wed December 9, 2020 8:45 AM|PR Newswire|About: ABBV
- All ranked secondary endpoints, including clinical, endoscopic and histologic outcomes, were met[1]
- The safety results in this study were consistent with the known profile of upadacitinib, with no new safety risks observed[1-5]
- Upadacitinib, a selective and reversible JAK inhibitor discovered and developed by AbbVie, is being studied as an oral therapy for moderate to severe ulcerative colitis and several other immune-mediated diseases[1,6-14]
- Ulcerative colitis is a chronic, systemic, inflammatory disease caused by inflammation of the large intestine[15-17]
PR Newswire
NORTH CHICAGO, Ill., Dec. 9, 2020 /PRNewswire/ -- AbbVie (ABBV)
RINVOQ™ (upadacitinib)
About Upadacitinib (RINVOQ)
Discovered and developed by AbbVie scientists, RINVOQ is an oral, once daily, selective and reversible JAK inhibitor studied in several immune-mediated inflammatory diseases.1,6-14 It was engineered to have greater inhibitory potency for JAK1 versus JAK2, JAK3 and TYK2.2 In August 2019, RINVOQ received U.S. Food and Drug Administration approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. In December 2019, RINVOQ also received approval by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. Phase 3 trials of RINVOQ in atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.7-14 Use of RINVOQ in ulcerative colitis is not approved and its safety and efficacy have not been evaluated by regulatory authoritie
USE
RINVOQ is a prescription medicine used to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be tolerated. It is not known if RINVOQ is safe and effective in children under 18 years of age.
If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.
Please click here for the Full Prescribing Information and Medication Guide.
For more information on AbbVie in gastroenterology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.html.
View original content:http://www.prnewswire.com/news-releases/upadacitinib-rinvoq-meets-primary-and-all-ranked-secondary-endpoints-in-first-phase-3-induction-study-in-ulcerative-colitis-301189012.html
SOURCE AbbVie
For more information about AbbVie, please visit us at www.abbvie.com. https://www.abbvie.com/
https://seekingalpha.com/symbol/ABBV
December 10, 2020
RINVOQ™ (upadacitinib) Achieved Superiority Versus DUPIXENT® (dupilumab) For Primary and All Ranked Secondary Endpoints in Phase 3b Head-to-Head Study in Adults with Atopic Dermatitis
- 71 percent of patients treated with upadacitinib achieved the primary endpoint of EASI 75 compared to 61 percent of patients treated with dupilumab at week 16 (p=0.006)[1]
- Upadacitinib showed superiority versus dupilumab for all ranked secondary endpoints, including early improvements in itch and skin clearance[1]
- The Heads Up study evaluated upadacitinib (30 mg, once daily) versus dupilumab (300 mg, every other week) in adults with moderate to severe atopic dermatitis[1]
- The safety profile of upadacitinib was consistent with previous atopic dermatitis studies, with no new safety risks observed[1-3]
- Upadacitinib, a selective and reversible JAK inhibitor discovered and developed by AbbVie, is being studied as a once-daily oral therapy for moderate to severe atopic dermatitis and in several other immune-mediated diseases[1-11]
- Atopic dermatitis is a chronic, relapsing inflammatory condition affecting an estimated 10 percent of adults and 25 percent of adolescents[12-15]
NORTH CHICAGO, Ill., Dec. 10, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced top-line results from the Phase 3b Heads Up study showing that upadacitinib (30 mg, once daily) achieved superiority to dupilumab (300 mg, every other week) for the primary endpoint, the proportion of patients with at least a 75 percent improvement in the Eczema Area Severity Index (EASI 75) at week 16, in adults with moderate to severe atopic dermatitis.1 Of patients treated with upadacitinib, 71 percent achieved EASI 75 at week 16 compared to 61 percent of dupilumab-treated patients (p=0.006).1 Upadacitinib also showed superiority compared to dupilumab for all ranked secondary endpoints, including additional measures of skin clearance and itch reduction.1
December 11, 2020
CHMP Recommends the Approvals of RINVOQ™ (Upadacitinib) for the Treatment of Adults with Active Psoriatic Arthritis and Ankylosing Spondylitis
- Across pivotal clinical trial programs, RINVOQ (15 mg, once daily) demonstrated efficacy across multiple measures of disease activity in psoriatic arthritis (PsA) and ankylosing spondylitis (AS), with a safety profile consistent with that seen in rheumatoid arthritis (RA)[1-4]
- If approved, RINVOQ will be the first oral, selective and reversible JAK inhibitor approved in three rheumatologic conditions in the European Union: rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis
- The European Commission decisions for both indications are anticipated in early 2021
NORTH CHICAGO, Ill., Dec. 11, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of RINVOQ™ (upadacitinib, 15 mg), an oral, once daily selective and reversible JAK inhibitor, for the expanded use in two additional rheumatic indications: the treatment of adult patients with active psoriatic arthritis and adult patients with active ankylosing spondylitis.5 The CHMP positive opinions are based on results from three pivotal clinical studies in which RINVOQ demonstrated efficacy across multiple measures of disease activity.1-3
https://seekingalpha.com/symbol/ABBV
Enhertu continues to demonstrate durable responses with new data from DESTINY-Breast01 in HER2-positive metastatic breast cancer
PUBLISHED10 December 2020
10 December 2020 07:00 GMT
Median duration of response exceeded 20 months
Update shows encouraging landmark survival in exploratory analysis with an estimated three out of four patients alive at 18 months
Updated results from the positive DESTINY-Breast01 Phase II trial showed AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) continued to demonstrate impressive efficacy and durable responses in patients with HER2-positive metastatic breast cancer following two or more prior HER2-based regimens.
The updated data were presented in a Spotlight Poster Discussion at the 2020 San Antonio Breast Cancer Symposium (SABCS).
PUBLISHED10 December 2020
10 December 2020 07:00 GMT
Median duration of response exceeded 20 months
Update shows encouraging landmark survival in exploratory analysis with an estimated three out of four patients alive at 18 months
Updated results from the positive DESTINY-Breast01 Phase II trial showed AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) continued to demonstrate impressive efficacy and durable responses in patients with HER2-positive metastatic breast cancer following two or more prior HER2-based regimens.
The updated data were presented in a Spotlight Poster Discussion at the 2020 San Antonio Breast Cancer Symposium (SABCS).
Summary of updated efficacy results from DESTINY-Breast01
i Data from the 1 August 2019 cut-off were presented at the 2019 SABCS and published in The New England Journal of Medicine
Enhertu was approved in the US and Japan for the treatment of HER2-positive, unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens in the metastatic setting based on the earlier results from the DESTINY-Breast01 trial. In the US, Enhertu was approved under FDA Accelerated Approval and confirmatory trials are underway.
Enhertu
Enhertu is a HER2-directed antibody drug conjugate (ADC). Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform.
ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy (‘payload’) to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Enhertu is comprised of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload by a tetrapeptide-based linker.
Enhertu (5.4mg/kg) is approved in the US and Japan for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting based on the DESTINY-Breast01 trial. Enhertu (6.4mg/kg) is approved in Japan for patients with HER2-positive unresectable advanced or recurrent gastric cancer that progressed after chemotherapy.
What is ENHERTU?
ENHERTU (en-HER-too) is a prescription medicine used in adults to treat human epidermal growth factor receptor 2 (HER2)-positive breast cancer that cannot be removed by surgery or that has spread to other parts of your body (metastatic), and who have received two or more prior anti-HER2 breast cancer treatments.
ENHERTU was FDA approved for this use based on a clinical study that measured how many patients responded and how long they responded. ENHERTU is still being studied to confirm these results.
It is not known if ENHERTU is safe and effective in children.
Please see accompanying full Prescribing Information, including Boxed WARNINGS, and Medication Guide.
For more information, please visit www.astrazeneca-us.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20201210005434/en/
https://seekingalpha.com/symbol/AZN
https://www.daiichisankyo.com/
https://seekingalpha.com/symbol/DSKYF
UX701
Dec 9, 2020 PDF Version
Ultragenyx Announces Orphan Drug Designation for UX701 for the Treatment of Wilson Disease
NOVATO, Calif., Dec. 09, 2020 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE)
UX701
About UX701
UX701 is an investigational AAV type 9 gene therapy designed to deliver stable expression of the ATP7B copper transporter following a single intravenous infusion. It has been shown in preclinical studies to normalize copper trafficking and excretion from the body. UX701 was granted Orphan Drug Designation in the United States.
For more information on Ultragenyx, please visit the Company's website at www.ultragenyx.com.
Ultragenyx is a biopharmaceutical company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases, with a focus on serious, debilitating genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no typically no approved therapies treating the underlying disease.
https://www.ultragenyx.com/pipeline/
Ultragenyx Announces Orphan Drug Designation for UX701 for the Treatment of Wilson Disease
Wed December 9, 2020 4:05 PM|GlobeNewswire|About: RARE
NOVATO, Calif., Dec. 09, 2020 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (RARE)
https://seekingalpha.com/symbol/RARE
Verzenio® (abemaciclib) in combination with standard adjuvant endocrine therapy (ET)
Lilly Presents Positive Primary Outcome Data from monarchE that Builds on Previous Definitive Analysis for Verzenio®
December 9, 2020 Download PDF Pre-planned primary outcome analysis continues to show clinically significant improvement in invasive disease-free survival as data mature for people with HR+, HER2- high risk early breast cancer
New data presented includes an additional 3.6 months of follow-up and more than 1400 patients completing two years of treatment
INDIANAPOLIS, Dec. 9, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced additional data from a pre-planned primary outcome analysis from the Phase 3 monarchE trial that showed Verzenio® (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) decreased the risk of breast cancer recurrence by 28.7 percent compared to standard adjuvant ET alone for people with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer (HR: 0.713; 95% CI: 0.583, 0.871; p = 0.0009). This statistically significant improvement corresponds to a three percent difference in the two-year rate of invasive disease-free survival (IDFS) between arms (92.3 percent in the Verzenio arm and 89.3 percent in the control arm). The data presented today during the 2020 Virtual San Antonio Breast Cancer Symposium (SABCS) included an additional 3.6 months of follow-up since the pre-planned interim analysis results announced in September 2020, and more than 1,400 patients have completed two years of treatment since the start of the study.
Verzenio® (abemaciclib) in combination with standard adjuvant endocrine therapy (ET)
About Verzenio® (abemaciclib)
Verzenio (abemaciclib) is an inhibitor of cyclin-dependent kinases (CDK)4 & 6, which are activated by binding to D-cyclins. In estrogen receptor-positive (ER+) breast cancer cell lines, cyclin D1 and CDK4 & 6 promote phosphorylation of the retinoblastoma protein (Rb), cell cycle progression, and cell proliferation.
In vitro, continuous exposure to Verzenio inhibited Rb phosphorylation and blocked progression from G1 to S phase of the cell cycle, resulting in senescence and apoptosis (cell death). Preclinically, Verzenio dosed daily without interruption resulted in reduction of tumor size. Inhibiting CDK4 & 6 in healthy cells can result in side effects, some of which may be serious. Clinical evidence also suggests that Verzenio crosses the blood-brain barrier. In patients with advanced cancer, including breast cancer, concentrations of Verzenio and its active metabolites (M2 and M20) in cerebrospinal fluid are comparable to unbound plasma concentrations.
Verzenio is Lilly's first solid oral dosage form to be made using a faster, more efficient process known as continuous manufacturing. Continuous manufacturing is a new and advanced type of manufacturing within the pharmaceutical industry, and Lilly is one of the first companies to use this technology.
INDICATION
Verzenio is indicated for the treatment of HR+, HER2- advanced or metastatic breast cancer:
- in combination with an aromatase inhibitor for postmenopausal women as initial endocrine-based therapy
- in combination with fulvestrant for women with disease progression following endocrine therapy
- as a single agent for adult patients with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting
Lilly Presents Positive Primary Outcome Data from monarchE that Builds on Previous Definitive Analysis for Verzenio®
Wed December 9, 2020 9:00 AM|PR Newswire|About: LLY
New data presented includes an additional 3.6 months of follow-up and more than 1400 patients completing two years of treatment
PR Newswire
INDIANAPOLIS, Dec. 9, 2020 /PRNewswire/ -- Eli Lilly and Company (LLY)
Please see full Prescribing Information for Verzenio.
To learn more about Lilly's commitment to people with cancer, please visit www.LillyOncology.com.
To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom.
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SOURCE Eli Lilly and Company
https://seekingalpha.com/symbol/LLY
Kisqali® (ribociclib)
Novartis Kisqali® data demonstrate superior benefit across main intrinsic subtypes in metastatic breast cancer
Dec 09, 2020
- Findings presented at SABCS from largest intrinsic subtype analysis show Kisqali is unique among CDK4/6 inhibitors, delivers consistent efficacy across main HR+/HER2- intrinsic subtypes1
- Benefit seen even in patients with the endocrine-resistant HER2-enriched subtype, who face poor prognosis with endocrine therapy alone, reinforces Kisqali as first line treatment choice for all patients2
- Data presented at SABCS also show Kisqali more selectively inhibits CDK4, the active target in breast cancer and a pivotal driver of disease progression, compared to palbociclib3
- Kisqali remains the CDK4/6 inhibitor with longest reported overall survival, proven in two Phase III trials to help people with metastatic breast cancer live longer regardless of menopausal status, endocrine sensitivity or endocrine partner4-6
Basel, December 9, 2020
Novartis Kisqali® demonstrates nearly five years median overall survival in metastatic breast cancer
Wed December 9, 2020 9:10 AM|PR Newswire
Kisqali plus endocrine therapy had a median OS of nearly five years (58.7 months), the longest ever reported for premenopausal women with HR+/HER2- metastatic breast cancer (MBC), after a median of 53.5 months follow-up1
Kisqali offers the chance for more life for younger women with HR+/HER2- MBC, which remains the leading cause of cancer death in women 20-59 years old2,3
PR Newswire
EAST HANOVER, N.J., Dec. 9, 2020 /PRNewswire/ -- Novartis
bout Kisqali® (ribociclib)
Kisqali was initially approved by the US Food and Drug Administration (FDA) in March 2017 and by the European Commission (EC) in August 2017, as initial endocrine-based therapy for postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer in combination with an aromatase inhibitor based on findings from the pivotal MONALEESA-2 trial. Kisqali in combination with an aromatase inhibitor was approved for the treatment of pre-, peri- or postmenopausal women as initial endocrine based therapy, and also indicated for use in combination with fulvestrant as both first- or second-line therapy in postmenopausal women by the FDA in July 2018 and by the EC in December 2018. Regulatory filings are underway with other health authorities worldwide.
Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals (ASTX).
Approved Uses
KISQALI® (ribociclib) is a prescription medicine used in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer, as initial endocrine-based therapy; or fulvestrant for the treatment of postmenopausal women with HR+/HER2- advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy. It is not known if Kisqali is safe and effective in children or adolescents.
Kisqali® (ribociclib)
Approved Uses:
KISQALI® (ribociclib) is a prescription medicine used in combination with:
- an aromatase inhibitor to treat pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic), as the first endocrine-based therapy; or
- fulvestrant to treat postmenopausal women with HR-positive, HER2-negative metastatic breast cancer as the first endocrine-based therapy or with disease progression following endocrine therapy
It is not known if KISQALI is safe and effective in children.
https://www.us.kisqali.com/metastatic-breast-cancer/
Please see full Prescribing Information for Kisqali, available at www.Kisqali.com.
For more information, please visit https://www.novartis.us.
View original content:http://www.prnewswire.com/news-releases/novartis-kisqali-demonstrates-nearly-five-years-median-overall-survival-in-metastatic-breast-cancer-301188951.html
SOURCE Novartis Pharmaceuticals Corporation
https://seekingalpha.com/symbol/NVS
ENSPRYNG™ (satralizumab-mwge) injection
Chugai’s Enspryng Approved in Taiwan as First Approved Medicine for Neuromyelitis Optica Spectrum Disorder (NMOSD)
Wed December 9, 2020 3:00 AM|Business Wire|About: CHGCY, RHHBY
- Enspryng is the first approved medicine for NMOSD in Taiwan
- Subcutaneous injection for the treatment of NMOSD in both adults and adolescents
- Enspryng is the first approved medicine applying Chugai’s proprietary recycling antibody technology
- Enspryng showed a significantly reduced risk of relapse in people with NMOSD in two global phase III studies
TOKYO--(BUSINESS WIRE)-- Chugai Pharmaceutical Co., Ltd. (CHGCF) (TOKYO:4519) announced Chugai Pharma Taiwan Ltd., a wholly-owned subsidiary of Chugai, o
View source version on businesswire.com: https://www.businesswire.com/news/home/20201209005352/en/
・SAkuraSky study
Results from Phase III SAkuraSky Study for Chugai’s Enspryng in Neuromyelitis Optica Spectrum Disorder Published in The New England Journal of Medicine Online (November 29, 2019)
https://www.chugai-pharm.co.jp/english/news/detail/20191129110000_644.html
・SAkuraStar study
Positive Results from the Second Phase III SAkuraStar Study for Chugai’s Enspryng in Neuromyelitis Optica Spectrum Disorder (NMOSD) Published in The Lancet Neurology (April 24, 2020)
https://www.chugai-pharm.co.jp/english/news/detail/20200424150001_714.html
ENSPRYNG™ (satralizumab-mwge) injection
What is ENSPRYNG?
ENSPRYNG is a prescription medicine used to treat neuromyelitis optica spectrum disorder (NMOSD) in adults who are aquaporin-4 (AQP4) antibody positive. It is not known if ENSPRYNG is safe and effective in children.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555.
For more information call 1-844-NSPRYNG.
For additional safety information, please see the full Prescribing Information and Medication Guide.
Dec 09, 2020
Chugai’s Enspryng Approved in Taiwan as First Approved Medicine for Neuromyelitis Optica Spectrum Disorder (NMOSD)
- Enspryng is the first approved medicine for NMOSD in Taiwan
- Subcutaneous injection for the treatment of NMOSD in both adults and adolescents
- Enspryng is the first approved medicine applying Chugai’s proprietary recycling antibody technology
- Enspryng showed a significantly reduced risk of relapse in people with NMOSD in two global phase III studies
TOKYO, December 9, 2020 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced Chugai Pharma Taiwan Ltd., a wholly-owned subsidiary of Chugai, obtained an import drug license from the Taiwan Food and Drug Administration (TFDA) for Chugai’s Enspryng® for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult and adolescent over 12 years old patients who are anti-aquaporin-4 (AQP4) antibody positive.
https://www.chugai-pharm.co.jp/english/news/detail/20201209170000_784.html
https://seekingalpha.com/symbol/CHGCY
https://seekingalpha.com/symbol/RHHBY
KRASG12C inhibitor, sotorasib
Amgen's Sotorasib Granted Breakthrough Therapy Designation For Advanced Or Metastatic Non-Small Cell Lung Cancer Patients With KRAS G12C Mutation
Sotorasib Also Accepted Into FDA's Real-Time Oncology Review Pilot Program
New Drug Application Submission to FDA Planned by End of the Year
THOUSAND OAKS, Calif., Dec. 8, 2020 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for its investigational KRASG12C inhibitor, sotorasib, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation, as determined by an FDA-approved test, following at least one prior systemic therapy.
For information, please visit www.codebreaktrials.com.
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SOURCE Amgen
For more information, visit www.amgen.com
KRASG12C inhibitor, sotorasib
Sotorasib
About CodeBreaK
The CodeBreaK clinical development program for Amgen's investigational drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. As the most advanced KRAS G12C clinical development program, CodeBreaK has enrolled more than 600 patients across 13 tumor types since its inception.
CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 123 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and topline results are expected in 2021.
Amgen's sotorasib nabs accelerated review for lung cancer
Dec. 08, 2020 9:53 AM ETAmgen Inc. (AMGN)By: Vandana Singh, SA News Editor
https://seekingalpha.com/news/3642513-amgens-sotorasib-nabs-accelerated-review-for-lung-cancer
Amgen Submits Sotorasib New Drug Application To U.S. FDA For Advanced Or Metastatic Non-Small Cell Lung Cancer With KRAS G12C Mutation
FDA Granted Breakthrough Therapy Designation for Sotorasib
Sotorasib Application Being Reviewed Under FDA Real-Time Oncology Review (RTOR) Pilot Program
THOUSAND OAKS, Calif., Dec. 16, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sotorasib, an investigational KRASG12C inhibitor for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, following at least one prior systemic therapy.
https://seekingalpha.com/symbol/AMGN
20-valent pneumococcal conjugate vaccine (20vPnC) candidate
U.S. FDA ACCEPTS FOR PRIORITY REVIEW THE BIOLOGICS LICENSE APPLICATION FOR PFIZER’S INVESTIGATIONAL 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE FOR ADULTS 18 YEARS OF AGE AND OLDER
Tuesday, December 08, 2020 - 04:30pm
If approved, the vaccine will help protect adults against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia
NEW YORK--(BUSINESS WIRE)--
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a Biologics License Application (BLA) for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, as submitted for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older.
20-valent pneumococcal conjugate vaccine (20vPnC) candidate
About 20vPnC
On September 20, 2018, Pfizer announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for 20vPnC for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine candidate in adults age 18 years or older. Breakthrough Therapy Designation is designed to expedite the development and review of drugs and vaccines that are intended to treat or prevent serious conditions and preliminary clinical evidence indicates that the drug or vaccine may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).23 Drugs and vaccines that receive Breakthrough Therapy Designation are eligible for all features of the FDA’s Fast Track designation, which may include more frequent communication with the FDA about the drug’s development plan and eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.24
The FDA previously granted Fast Track designation for 20vPnC in September 2017 for use in adults aged 18 years or older.25 The FDA’s Fast Track approach is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address an unmet medical need.25
Additionally, in May 2017 the FDA granted Fast Track status and in August 2020 Breakthrough Therapy Designation for a pediatric indication for 20vPnC.26
For the full prescribing information for Prevnar 13®, please visit http://labeling.pfizer.com/showlabeling.aspx?id=501
to learn more, please visit us on www.pfizer.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20201208006015/en/
U.S. FDA Accepts for Priority Review the Biologics License Application for Pfizer’s Investigational 20-valent Pneumococcal Conjugate Vaccine for Adults 18 Years of Age and Older
Tue December 8, 2020 4:30 PM|Business Wire|About: PFE
If approved, the vaccine will help protect adults against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia
NEW YORK--(BUSINESS WIRE)--
Pfizer Inc. (PFE)
https://seekingalpha.com/symbol/PFE
Tirzepatide
Lilly's tirzepatide significantly reduced A1C and body weight in people with type 2 diabetes
December 9, 2020Download PDFMore than half of participants taking the highest dose achieved normal A1C levels, a key secondary endpoint in first phase 3 trial of SURPASS program
Participants in this monotherapy study had relatively recently diagnosed diabetes, with a mean duration of 4.7 years
INDIANAPOLIS, Dec. 9, 2020 /PRNewswire/ -- Tirzepatide led to superior A1C and body weight reductions from baseline in adults with type 2 diabetes after 40 weeks of treatment in topline results from Eli Lilly and Company's (NYSE: LLY) SURPASS-1 monotherapy clinical trial evaluating the efficacy and safety of tirzepatide compared to placebo. Using the efficacy estimandi, the highest dose of tirzepatide led to an A1C reduction of 2.07 percent and reduced body weight by 9.5 kg (11.0 percent). More than half (51.7 percent) of participants in this arm achieved an A1C less than 5.7 percent – the level seen in people without diabetes.
Tirzepatide
Tirzepatide is a novel investigational once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that integrates the actions of both incretins into a single molecule, representing a new class of medicines being studied for the treatment of type 2 diabetes. The primary and key secondary endpoints of SURPASS-1, the first phase 3 trial of the comprehensive SURPASS program, included superior A1C and mean body weight reductions compared to placebo. Study participants, 54.2 percent of whom were treatment-naïve, had a relatively short mean duration of diabetes of 4.7 years, a baseline A1C of 7.9 percent and a baseline weight of 85.9 kg.
"Tirzepatide delivered impressive A1C and weight reductions for people with type 2 diabetes in this trial, confirming and building upon the phase 2 data that were released in 2018," said Julio Rosenstock, M.D., Director of the Dallas Diabetes Research Center and Principal Investigator of SURPASS-1. "The study took a bold approach in assessing A1C targets. Not only did nearly 90 percent of all participants taking tirzepatide meet the standard A1C goal of less than 7 percent, more than half taking the highest dose also achieved an A1C less than 5.7 percent, the level seen in people without diabetes – an unprecedented finding and unique endpoint in trials evaluating glucose-lowering agents."
About tirzepatide
Tirzepatide is a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that integrates the actions of both incretins into a single novel molecule. GIP is a hormone that may complement the effects of GLP-1 receptor agonists. In preclinical models, GIP has been shown to decrease food intake and increase energy expenditure therefore resulting in weight reductions, and when combined with a GLP-1 receptor agonist, may result in greater effects on glucose and body weight. Tirzepatide is in phase 3 development for blood glucose management in adults with type 2 diabetes and for chronic weight management. It is also being studied as a potential treatment for non-alcoholic steatohepatitis (NASH).
For the latest updates, visit http://www.lillydiabetes.com/
View original content to download multimedia:http://www.prnewswire.com/news-releases/lillys-tirzepatide-significantly-reduced-a1c-and-body-weight-in-people-with-type-2-diabetes-301188988.html
SOURCE Eli Lilly and Company
Lilly's tirzepatide significantly reduced A1C and body weight in people with type 2 diabetes
Wed December 9, 2020 6:45 AM|PR Newswire|About: LLY
Participants in this monotherapy study had relatively recently diagnosed diabetes, with a mean duration of 4.7 years
PR Newswire
INDIANAPOLIS, Dec. 9, 2020 /PRNewswire/ -- Tirzepatide led to superior A1C and body weight reductions from baseline in adults with type 2 diabetes after 40 weeks of treatment in topline results from Eli Lilly and Company's (NYSE: LLY) SURPASS-1 monotherapy clinical trial evaluating the efficacy and safety of tirzepatide compared to placebo.
To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom.
https://seekingalpha.com/symbol/LLY
https://clinicaltrials.gov/ct2/show/NCT03954834
Oxford Covid vaccine 'safe and effective' study shows
By Michelle Roberts
Health editor, BBC News online
The Oxford/AstraZeneca Covid vaccine is safe and effective, giving good protection, researchers have confirmed in The Lancet journal.
Oxford-AstraZeneca COVID-19 vaccine 'safe and effective,' but questions remain for elderly - Lancet
Dec. 08, 2020 3:49 PM ET AstraZeneca PLC (AZN)By: Vandana Singh, SA News Editor
https://seekingalpha.com/symbol/AZN
AZD1222 Oxford Phase III trials interim analysis results published in The Lancet
PUBLISHED8 December 2020
8 December 2020 16:00 GMT
Interim analysis showed vaccine is effective at preventing COVID-19, with no severe cases and no hospitalisations more than 21 days after first injection
Regulatory submissions underway to support approval
Results of an interim analysis of the Phase III programme conducted by Oxford University with AZD1222, peer-reviewed and published in The Lancet today, demonstrated that the vaccine is safe and effective at preventing symptomatic COVID-19 and that it protects against severe disease and hospitalisation. The interim analysis for efficacy was based on 11,636 participants accruing 131 symptomatic infections from the Phase III UK and Brazil trials conducted by Oxford University.
Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32661-1/fulltext
BLINCYTO® (Blinatumomab)
BeiGene Announces the Approval in China of BLINCYTO® (Blinatumomab) for Injection for Adult Patients with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (ALL)
Mon December 7, 2020 7:00 PM|Business Wire|About: BGNE
BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BeiGene, Ltd. (BGNE)
BLINCYTO® (Blinatumomab)
About BLINCYTO® (blinatumomab)
BLINCYTO is a bispecific CD19-directed CD3 T cell engager (BiTE®) immuno-oncology molecule that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells
INDICATIONS
BLINCYTO® (blinatumomab) is a prescription medicine used to treat B-cell precursor acute lymphoblastic leukemia (ALL) in patients who still have detectable traces of cancer after chemotherapy.
The approval of BLINCYTO® in these patients is based on a study that measured response rate and duration of response. There are ongoing studies to confirm clinical benefit.
BLINCYTO® (blinatumomab) is a prescription medication used to treat a certain type of acute lymphoblastic leukemia (ALL) in adults and children. ALL is a cancer of the blood and bone marrow in which a particular kind of white blood cell is replicating out of control.
“Our collaboration with BeiGene is advancing Amgen’s oncology pipeline for patients with significant unmet medical needs. We are confident the approval of BLINCYTO in China has the potential to make a meaningful difference to adult patients with R/R B-cell precursor acute lymphoblastic leukemia,” said My Linh Kha, Vice President & General Manager, Amgen Japan Asia-Pacific (JAPAC). “We are deeply committed to continuing to bring therapeutic options to treat debilitating cancers for patients in China, while also actively supporting the Government’s focus on healthy aging through innovative products and initiatives designed to prevent chronic diseases, such as cardiovascular disease and fragility fracture.”
Please see full Prescribing Information and medication guide for BLINCYTO at www.BLINCYTO.com.
To learn more about BeiGene, please visit www.beigene.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20201207005670/en/
BeiGene Pipeline
https://www.beigene.com/science-and-product-portfolio/pipeline
https://seekingalpha.com/symbol/BGNE
https://seekingalpha.com/symbol/AMGN
BeiGene Announces the Approval in China of BLINCYTO® (Blinatumomab) for Injection for Adult Patients with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (ALL)
December 7, 2020 at 7:00 PM EST
BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec. 7, 2020-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160),
BEIGENE, LTD. (6160)
https://www.hkex.com.hk/Market-Data/Securities-Prices/Equities/Equities-Quote?sym=6160&sc_lang=en
Nucala (mepolizumab)
For further information please visit www.gsk.com/about-us.
08 December 2020
FDA accepts GSK’s filing of Nucala (mepolizumab) for use in chronic rhinosinusitis with nasal polyps
If approved, Nucala would be the only treatment approved in the US for use in four eosinophil-driven diseases.
For media and investors only
Issued: London, UK
GlaxoSmithKline plc (GSK) today announced that the US Food and Drug Administration (FDA) has accepted a regulatory submission seeking approval for the use of its anti-IL5 biologic Nucala (mepolizumab) as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
Nucala (mepolizumab)
About mepolizumab
First approved in 2015 for severe eosinophilic asthma (SEA), mepolizumab is the first-in-class monoclonal antibody that targets IL-5. It is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils, restoring blood eosinophils to more normal levels. The mechanism of action for mepolizumab has not been definitively established.
Mepolizumab has been developed for the treatment of diseases that are driven by inflammation caused by eosinophils. It has been studied in over 3,000 patients in 26 clinical trials across a number of eosinophilic indications and has been approved under the brand name Nucala in the US, Europe and in over 20 other markets, as an add-on maintenance treatment for patients with SEA. It is approved for paediatric use in SEA from ages six to 17 in Europe, the US and several other markets. In the US, Japan, Canada and a number of other markets, it is approved for use in adult patients with EGPA. It was approved for use in HES in the US in September 2020. Mepolizumab is currently being investigated in CRSwNP and COPD. It is not currently approved for use in CRSwNP or COPD anywhere in the world.
Approved Use
NUCALA is an add-on, prescription maintenance treatment for patients 6 and older with severe eosinophilic asthma. NUCALA is not used to treat sudden breathing problems.
FDA accepts U.S. application for expanded use of Glaxo's Nucala
Dec. 08, 2020 8:12 AM ETGlaxoSmithKline plc (GSK)By: Vandana Singh, SA News Editor
https://seekingalpha.com/news/3642446-fda-accepts-u-s-application-for-expanded-use-of-glaxos-nucala
https://seekingalpha.com/symbol/GSK
biotecMAX™ December/November/October 2020 insight
VENCLEXTA®/VENCLYXTO® (venetoclax)
December 5, 2020
AbbVie Presents Extended Follow-Up Data for Fixed Duration Treatment VENCLEXTA®/VENCLYXTO® (venetoclax) in Chronic Lymphocytic Leukemia (CLL)
- New five-year, follow-up analysis from the Phase 3 MURANO trial shows median progression-free survival (PFS) of 53.6 months in previously treated CLL patients taking VENCLEXTA/VENCLYXTO in combination with rituximab compared to 17.0 months in patients taking bendamustine plus rituximab (BR) after three years or more off treatment[1]
- Two analyses of the Phase 3 CLL14 study evaluated minimal residual disease (MRD) measurements for previously untreated CLL patients taking VENCLEXTA/VENCLYXTO in combination with obinutuzumab[2],[3]
- Four-year follow-up analysis from the CLL14 study shows an overall survival (OS) rate of 85.3% with the VENCLEXTA/VENCLYXTO and obinutuzumab combination versus 83.1% with chlorambucil and obinutuzumab combination[3]
NORTH CHICAGO, Ill., Dec. 5, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new, updated results from the Phase 3 MURANO and CLL14 clinical trials evaluating VENCLEXTA®/VENCLYXTO® (venetoclax) fixed duration treatment combinations at the virtual 62nd American Society of Hematology (ASH) Annual Meeting & Exposition (abstracts 125, 127, and 1310, respectively). These findings add to the growing body of data supporting the use of VENCLEXTA/VENCLYXTO in first-line or previously treated chronic lymphocytic leukemia (CLL) patients.
VENCLEXTA®/VENCLYXTO® (venetoclax)
Uses
VENCLEXTA is a prescription medicine used:
- to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who:
- are 75 years of age or older, or
- have other medical conditions that prevent the use of standard chemotherapy.
VENCLEXTA was approved based on response rates. Continued approval for this use may depend on the results of an ongoing study to find out how VENCLEXTA works over a longer period of time.
It is not known if VENCLEXTA is safe and effective in children.
About VENCLEXTA®/VENCLYXTO® (venetoclax)
VENCLEXTA®/VENCLYXTO® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLEXTA/VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis.
VENCLEXTA/VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood and other cancers. VENCLEXTA/VENCLYXTO is approved in more than 50 countries, including the U.S.
See VENCLYXTO full summary of product characteristics (SmPC) at https://www.ema.europa.eu/en/documents/product-information/venclyxto-epar-product-information_en.pdf.
For more information about AbbVie, please visit us at www.abbvie.com.
Oral Formulations of Gilead’s Antiviral Remdesivir
Matinas BioPharma Announces Collaboration with the National Institute of Allergy and Infectious Diseases to Evaluate Oral Formulations of Gilead’s Antiviral Remdesivir Utilizing Matinas’ LNC Platform Delivery Technology
Download as PDFDecember 07, 2020 6:35am EST
BEDMINSTER, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, today announced that they plan to collaborate with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to test oral formulations of remdesivir in preclinical models. Remdesivir is owned by Gilead Sciences, Inc. (Nasdaq: GILD) and the lipid nanocrystal (LNC) platform is owned by Matinas. Any product generated as a part of efforts by Matinas and NIAID would require a license from Gilead for the use of remdesivir and a license from Matinas for the use of the LNC formulation.
Oral Formulations of Gilead’s Antiviral Remdesivir
Lipid Nanocrystal (LNC) platform delivery technology
LIPID NANO-CRYSTAL (LNC)
A disruptive platform for the safe and targeted delivery of therapeutics.
https://www.matinasbiopharma.com/lnc-technology/lnc-platform
Matinas BioPharma Announces Collaboration with the National Institute of Allergy and Infectious Diseases to Evaluate Oral Formulations of Gilead’s Antiviral Remdesivir Utilizing Matinas’ LNC Platform Delivery Technology
Mon December 7, 2020 6:35 AM|GlobeNewswire|About: GILD, MTNB
BEDMINSTER, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (MTNB) (NYSE AMER: MTNB)
https://www.matinasbiopharma.com/
https://seekingalpha.com/symbol/MTNB
https://seekingalpha.com/symbol/GILD
Tecartus™ (brexucabtagene autoleucel, formerly KTE-X19)
December 05, 2020
New Data for Tecartus™ Demonstrate Durable Responses at One Year Follow-Up in Relapsed or Refractory Mantle Cell Lymphoma
-- Median Overall Survival Still Not Reached After Single Infusion of Tecartus in Pivotal ZUMA-2 Trial --
-- Significant and Durable Rate of Complete Response Further Supports Tecartus as First and Only CAR T-Cell Therapy in Relapsed or Refractory MCL --
SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD),
Tecartus™ (brexucabtagene autoleucel, formerly KTE-X19)
About Tecartus
Tecartus is an autologous, anti-CD19 CAR T cell therapy. Tecartus uses the XLP™ manufacturing process that includes T cell enrichment, a necessary step in certain B-cell malignancies in which circulating lymphoblasts are a common feature. In addition to MCL, Tecartus is also currently in Phase 1/2 trials in acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL). The use of Tecartus in ALL and CLL is investigational, and its safety and efficacy have not been established in these cancer types.
Tecartus Indication
Tecartus is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
whose prior treatment either didn't work or stopped working
TECARTUS™ is a treatment for your mantle cell lymphoma. It is used following disease progression while on or after other treatment. TECARTUS is different than other cancer medicines because it is made from your own white blood cells, which have been modified to recognize and attack your lymphoma cells.
APPROVED USE
TECARTUS is a treatment for your mantle cell lymphoma. It is used following disease progression while on or after other treatment. TECARTUS is different than other cancer medicines because it is made from your own white blood cells, which have been modified to recognize and attack your lymphoma cells.
For more information on Kite, please visit www.kitepharma.com.
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.
U.S. Prescribing Information for Tecartus and Yescarta, including BOXED WARNINGS, is available at www.kitepharma.com and www.gilead.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201205005004/en/
New Data for TecartusTM Demonstrate Durable Responses at One Year Follow-Up in Relapsed or Refractory Mantle Cell Lymphoma
Sat December 5, 2020 10:00 AM|Business Wire|About: GILD
https://seekingalpha.com/symbol/GILD
These are not all the possible side effects of TECARTUS. Call your healthcare provider about any side effects that concern you. You may report side effects to the FDA at 1-800-FDA-1088.
Please see Medication Guide about TECARTUS, including important warnings.
APPROVED USE
TECARTUS is a treatment for your mantle cell lymphoma. It is used following disease progression while on or after other treatment. TECARTUS is different than other cancer medicines because it is made from your own white blood cells, which have been modified to recognize and attack your lymphoma cells.
Kite’s Tecartus™ (KTE-X19) Granted Conditional Marketing Authorization for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma in Europe
Wed December 16, 2020 3:01 AM|Business Wire|About: GILD
-- 93 Percent of Patients in ZUMA-2 Pivotal Trial Responded to Single Infusion of Tecartus --
-- Tecartus is First CAR T Therapy in Relapsed or Refractory MCL and Kite Becomes the First Company with Multiple Approved Cell Therapies in Europe --
SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD)
December 16, 2020
Calquence (acalabrutinib)
Calquence data across four trials reinforces cardiovascular safety profile in patients with chronic lymphocytic leukaemia
PUBLISHED7 December 2020
7 December 2020 15:00 GMT
Less than 1% of patients treated with Calquence discontinued treatment due to cardiac adverse events in pooled analysis
A pooled analysis of cardiovascular (CV) safety data from 762 patients treated with Calquence (acalabrutinib) monotherapy for chronic lymphocytic leukaemia (CLL), the most common type of adult leukaemia, across four clinical trials showed a low incidence of cardiac adverse events (AEs) leading to discontinuation.1,2 These results were presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition on 7 December 2020.
Calquence (acalabrutinib)
PUBLISHED7 December 2020
7 December 2020 15:00 GMT
Less than 1% of patients treated with Calquence discontinued treatment due to cardiac adverse events in pooled analysis
A pooled analysis of cardiovascular (CV) safety data from 762 patients treated with Calquence (acalabrutinib) monotherapy for chronic lymphocytic leukaemia (CLL), the most common type of adult leukaemia, across four clinical trials showed a low incidence of cardiac adverse events (AEs) leading to discontinuation.1,2 These results were presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition on 7 December 2020.
The analysis included patients with previously untreated and relapsed or refractory CLL treated with Calquence alone from the ELEVATE TN and ASCEND Phase III trials, as well as the 15-H-0016 Phase II trial and ACE-CL-001 Phase I/II trial. In the analysis, 129 patients (17%) reported a cardiac AE of any grade at a median follow up of 25.9 months, and seven patients (0.9%) discontinued treatment due to cardiac AEs.1
Jennifer Brown, MD, PhD, Director of the CLL Center of the Division of Hematologic Malignancies, Dana-Farber Cancer Institute, and principal investigator, said: “Cardiac adverse events have emerged as an important consideration for treating chronic lymphocytic leukaemia patients with Bruton’s tyrosine kinase inhibitors, as cardiovascular complications have become a frequent reason for discontinuation. The data presented in this study suggests a low risk of cardiac adverse events with acalabrutinib that is similar to those in a general population of untreated patients with chronic lymphocytic leukaemia, giving clinicians further reassurance when prescribing this therapy.”
José Baselga, Executive Vice President, Oncology R&D, said: “These combined results across four of our clinical trials reinforce the cardiovascular safety profile of Calquence for the treatment of chronic lymphocytic leukaemia. With Calquence, we aim to selectively target Bruton’s tyrosine kinase to help improve safety and long-term adherence while maintaining outstanding efficacy.”
Median exposure to Calquence was 24.9 months. Cardiac events that occurred in 2% or more of patients included atrial fibrillation (4%), atrial fibrillation/flutter (5%), palpitations (3%) and tachycardia (2%). The incidence of atrial fibrillation was similar to that in a general, previously untreated CLL patient population (6%).1,3
Grade 3 or higher cardiac AEs occurred in 37 patients (4%) treated with Calquence monotherapy, of which 25% were reported during the first six months of treatment. Grade 3 or higher cardiac AEs of interest included atrial fibrillation (1.3%), complete atrioventricular (AV) block (0.3%), acute coronary syndrome (0.1%), atrial flutter (0.1%), second degree AV block (0.1%) and ventricular fibrillation (0.1%). Two patients experienced Grade 5 AEs (one with congestive heart failure and one with heart attack).1
Overall, 91% of patients with cardiac AEs versus 79% patients without cardiac AEs had one or more CV risk factors before receiving Calquence. The most prevalent CV risk factors (greater than or equal to 20% of patients) among those who experienced cardiac AEs were hypertension (67%), hyperlipidemia (29%) and arrhythmias (22%).1
AstraZeneca is exploring additional trials in CLL, including the ELEVATE-RR Phase III trial (ACE-CL-006) evaluating Calquence versus ibrutinib in patients with previously treated high-risk CLL. Data is anticipated in 2021.
Chronic lymphocytic leukaemia
Chronic lymphocytic leukaemia (CLL) is the most common type of leukaemia in adults, with an estimated 105,000 new cases globally in 2016, and the number of people living with CLL is expected to grow with improved treatment as patients live longer with the disease.2,4,5,6 In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes and these abnormal cells have difficulty fighting infections. As the number of abnormal cells grows, there is less room for healthy white blood cells, red blood cells, and platelets. This could result in anaemia, infection, and bleeding.4 B-cell receptor signalling through Bruton’s tyrosine kinase (BTK) is one of the essential growth pathways for CLL.
Calquence
Calquence (acalabrutinib) is a next-generation, selective inhibitor of BTK. Calquence binds covalently to BTK, thereby inhibiting its activity.7,8 In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.7
Calquence is approved for the treatment of CLL and small lymphocytic lymphoma in the US and is approved for CLL in the EU and several other countries worldwide. Calquence is also approved for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy in the US and several other countries.
As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluating Calquence in more than 20 company-sponsored clinical trials. Calquence is being developed for the treatment of multiple B-cell blood cancers including CLL, MCL, diffuse large B-cell lymphoma, Waldenström’s macroglobulinaemia, follicular lymphoma, and other haematologic malignancies.
What is CALQUENCE?
CALQUENCE is a prescription medicine used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer, or adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
It is not known if CALQUENCE is safe and effective in children.
Please see full Prescribing Information, including Patient Information.
CALQUENCE Shows Long-Term Efficacy and Tolerability at Three Years for Patients With Relapsed or Refractory Mantle Cell Lymphoma
Sun December 6, 2020 10:00 AM|Business Wire|About: AZN
ACE-LY-004 Phase II trial results substantiate established efficacy and safety profile of CALQUENCE in mantle cell lymphoma
(WILMINGTON, Del.--(BUSINESS WIRE)
For more information, please visit astrazeneca-us.com
https://seekingalpha.com/symbol/AZN
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