Moorestown, New Jersey, United States
biotecMAX™ January 2021 Insight
CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab)
Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) as a First-Line Treatment for Patients with Advanced Renal Cell Carcinoma PDF Version
– FDA approval based on CheckMate -9ER trial, in which the combination of CABOMETYX and OPDIVO significantly improved overall survival while doubling progression-free survival and objective response rate versus sunitinib as a first-line treatment for patients with advanced RCC –
– Exelixis prepared to fully support expanded indication immediately –
– Application approved prior to Prescription Drug User Fee Act action date of February 20, 2021 and reviewed under the Real-Time Oncology Review pilot program –
ALAMEDA, Calif.--(BUSINESS WIRE)--Jan. 22, 2021-- Exelixis, Inc. (NASDAQ: EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX® (cabozantinib) for patients with advanced renal cell carcinoma (RCC) as a first-line treatment in combination with OPDIVO® (nivolumab). RCC is the most common form of kidney cancer, which is among the 10 most frequently diagnosed cancers in the U.S. annually.1
CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab)
Press Release
Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) as a First-Line Treatment for Patients with Advanced Renal Cell Carcinoma PDF Version
– FDA approval based on CheckMate -9ER trial, in which the combination of CABOMETYX and OPDIVO significantly improved overall survival while doubling progression-free survival and objective response rate versus sunitinib as a first-line treatment for patients with advanced RCC –
– Exelixis prepared to fully support expanded indication immediately –
– Application approved prior to Prescription Drug User Fee Act action date of February 20, 2021 and reviewed under the Real-Time Oncology Review pilot program –
ALAMEDA, Calif.--(BUSINESS WIRE)--Jan. 22, 2021-- Exelixis, Inc. (NASDAQ: EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX® (cabozantinib) for patients with advanced renal cell carcinoma (RCC) as a first-line treatment in combination with OPDIVO® (nivolumab). RCC is the most common form of kidney cancer, which is among the 10 most frequently diagnosed cancers in the U.S. annually.1
“This combination of cabozantinib and nivolumab significantly improved key efficacy measures compared to sunitinib – progression-free survival, overall survival and objective response rate – while showing a low rate of treatment discontinuations due to side effects. The therapeutic benefit demonstrated in CheckMate -9ER and quality of life measures explored emphasize the role of this combination for patients with advanced kidney cancer,” said Dr. Toni Choueiri, Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and the Jerome and Nancy Kohlberg Professor of Medicine at Harvard Medical School. “With this important FDA approval, the combination is poised to become a standard in newly diagnosed metastatic kidney cancer.”
The approval is based on results from CheckMate -9ER, a phase 3 pivotal trial evaluating the combination of CABOMETYX and OPDIVO compared with sunitinib in previously untreated advanced or metastatic RCC. These results were presented during the European Society of Medical Oncology Virtual Congress 2020 in September. The FDA reviewed the application for CABOMETYX and OPDIVO under the Real-Time Oncology Review (RTOR) pilot program and Fast Track designation. The RTOR pilot program, which allows an applicant to pre-submit components of the application to allow the FDA to review clinical trial data before the complete filing is submitted, aims to explore a more efficient review process to ensure safe and effective treatments are available to patients sooner.
“As the only combination treatment regimen to double median progression-free survival and objective response rate compared with sunitinib while also significantly improving overall survival, we are excited that CABOMETYX in combination with OPDIVO is now available for the first-line treatment of patients with advanced kidney cancer,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. “This approval is a meaningful milestone for this patient community and speaks to the broad potential of CABOMETYX as we continue to generate important clinical trial results supporting its use in combination with immune checkpoint inhibitors to benefit patients with other difficult-to-treat cancers. We would like to thank the clinical trial participants, the physicians and their staff who participated in the CheckMate -9ER trial and to acknowledge the team at the FDA for their collaboration during the review of our application.”
In CheckMate -9ER, the combination regimen significantly improved overall survival (OS) compared with sunitinib (HR= 0.60, 98.89% CI 0.40-0.89; p=0.001). Median OS has not yet been reached in either treatment arm. Median progression-free survival (PFS) was doubled at 16.6 months for CABOMETYX in combination with OPDIVO compared with 8.3 months for sunitinib (HR 0.51, 95% CI 0.41-0.64; p<0.0001). Objective response rate (ORR) was also doubled: 56% with CABOMETYX in combination with OPDIVO and 27% with sunitinib (p<0.0001). Consistent results for PFS were observed across subgroups of International Metastatic RCC Database Consortium risk status and PD-L1 tumor expression with CABOMETYX in combination with OPDIVO.
CABOMETYX in combination with OPDIVO was generally well tolerated and reflected the known safety profiles of the tyrosine kinase inhibitor and immunotherapy components in previously untreated advanced RCC. The most common adverse reactions reported in at least 20% of patients treated with CABOMETYX in combination with OPDIVO were diarrhea, fatigue, hepatotoxicity, palmar-plantar erythrodysesthesia, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough and upper respiratory tract infection. The discontinuation rate due to all causality adverse events in the CABOMETYX in combination with OPDIVO arm was 20% for either CABOMETYX or OPDIVO (8% for CABOMETYX only, 7% for OPDIVO only and 6% for both CABOMETYX and OPDIVO due to the same adverse event at the same time).
About CABOMETYX® (cabozantinib)
In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced RCC; for the treatment of patients with HCC who have been previously treated with sorafenib; and for patients with advanced RCC as a first-line treatment in combination with OPDIVO (nivolumab). CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the United States.
Please see accompanying full Prescribing Information https://cabometyx.com/downloads/CABOMETYXUSPI.pdf.
For more information about Exelixis, please visit www.exelixis.com
Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) as a First-Line Treatment for Patients with Advanced Renal Cell Carcinoma
Fri January 22, 2021 1:10 PM| Business Wire|About: EXEL
– FDA approval based on CheckMate -9ER trial, in which the combination of CABOMETYX and OPDIVO significantly improved overall survival while doubling progression-free survival and objective response rate versus sunitinib as a first-line treatment for patients with advanced RCC –
– Exelixis (EXEL) prepared to fully support expanded indication immediately –
– Application approved prior to Prescription Drug User Fee Act action date of February 20, 2021 and reviewed under the Real-Time Oncology Review pilot program –
ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (NASDAQ: EXEL)
Exelixis' CABOMETYX-OPDIVO combo wins FDA approval for renal cell carcinoma
Jan. 22, 2021 1:25 PM ET Exelixis, Inc. (EXEL)
By: Aakash Babu, SA News Editor9 Comments
- Exelixis (EXEL +2.6%) announces that the FDA has approved its CABOMETYX (cabozantinib) drug in combination with Bristol-Myers Squibb's (BMY +1.2%) OPDIVO (nivolumab) for treating patients with advanced renal cell carcinoma (RCC) in the first-line setting.
https://seekingalpha.com/symbol/EXEL
LUPKYNIS™ (voclosporin)
FDA Approves Aurinia Pharmaceuticals’ LUPKYNIS™ (voclosporin) for Adult Patients with Active Lupus Nephritis
DOWNLOAD AS PDF JANUARY 22, 2021
- LUPKYNIS is the first FDA-approved oral therapy for lupus nephritis (LN), a condition that causes irreversible kidney damage and increases the risk of kidney failure, cardiac events, and death -
- LUPKYNIS demonstrated significantly improved renal response rates compared to typical standard-of-care (SoC) in clinical trials
- LUPKYNIS is now commercially available in the U.S. -
- Multimedia components are available with this press release (link here) -
- Conference call to be hosted Monday, January 25, 2021, 8:30 a.m. ET -
VICTORIA, British Columbia & ROCKVILLE, Md.--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (“Aurinia” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved LUPKYNISTM (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN). LUPKYNIS is the first FDA-approved oral therapy for LN. LN causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death. It is one of the most serious and common complications of the autoimmune disease systemic lupus erythematosus (SLE). LUPKYNIS is now available to patients in the United States (U.S.).
LUPKYNIS™ (voclosporin)
LUPKYNIS was approved by the FDA under Priority Review and was previously granted Fast Track designation from the Agency in 2016. To learn more visit www.auriniapharma.com.
To learn more about Aurinia Alliance or LUPKYNIS, visit www.LUPKYNIS.com.
INDICATIONS
LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN). Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.
Please see Prescribing Information, including Boxed Warning, and Medication Guide for LUPKYNIS.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210122005501/en/
Aurinia gets FDA approval for lupus nephritis therapy
Jan. 22, 2021 11:39 PM ET Aurinia Pharmaceuticals Inc. (AUPH)
By: Dulan Lokuwithana, SA News Editor13 Comments
- The FDA has approved LUPKYNISTM (voclosporin) from Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) as a treatment for adults with active lupus nephritis (“LN”) in combination with a background immunosuppressive therapy regimen.
https://seekingalpha.com/news/3653727-aurinia-gets-fda-approval-for-lupus-nephritis-therapy
https://seekingalpha.com/symbol/AUPH
NVX-CoV2373
Novavax and Government of Canada Finalize Advance Purchase Agreement for COVID-19 Vaccine
Jan 22, 2021 at 5:22 PM ESTDownload PDFCanadian government commits to purchase 52 million doses with option for additional 24 million of Novavax candidate vaccine, NVX-CoV2373
GAITHERSBURG, Md., Jan. 22, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has finalized an agreement with the Government of Canada to supply up to 76 million doses of NVX-CoV2373, the company’s recombinant protein-based COVID-19 vaccine. Canada has committed to purchase 52 million doses of the vaccine with the option for up to an additional 24 million doses. NVX-CoV2373 is currently in Phase 3 clinical development for the prevention of COVID-19.
NVX-CoV2373
About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax’ patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that completed enrollment in November and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: A Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.
For more information, visit www.novavax.com
https://www.novavax.com/our-pipeline#nvx-cov2373
Government of Canada fnalizes advance purchase agreement for COVID-19 Vaccine with Novavax
Jan. 22, 2021 5:30 PM ETNovavax, Inc. (NVAX)By: Manshi Mamtora, CFA6 Comments
https://seekingalpha.com/symbol/NVAX
CABENUVA (rilpivirine and cabotegravir)
Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIVCABENUVA offers adults living with HIV a new once-monthly injectable option for maintaining viral suppression
TITUSVILLE, N.J., January 21, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. The novel regimen was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen’s 25-year commitment to make HIV history. In the U.S., ViiV Healthcare is the marketing authorization holder for CABENUVA.
Results from these trials were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI).
CABENUVA (rilpivirine and cabotegravir)
About CABENUVA (rilpivirine and cabotegravir)
CABENUVA is approved as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. CABENUVA is administered by a healthcare provider once-monthly as two individual intramuscular injections in the buttocks.
The complete regimen combines rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland UC, with the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare.
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.
Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which in turn stops the virus from multiplying.
About EDURANT® (rilpivirine)
EDURANT® (rilpivirine), in combination with other antiretroviral agents, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy.
Limitations of Use:
- More EDURANT®-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to EDURANT®-treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL
EDURANT® is also indicated in combination with VOCABRIA (oral cabotegravir) for short-term treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine, for use as:
- Oral lead-in to assess the tolerability of rilpivirine prior to administration of rilpivirine extended-release injectable suspension, a component of CABENUVA (cabotegravir, rilpivirine) extended-release injectable suspensions
- Oral therapy for patients who will miss planned injection dosing with CABENUVA (cabotegravir; rilpivirine) extended-release injectable suspensions
Janssen is the marketing authorization holder for EDURANT® in the U.S.
Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies.
Please see full Prescribing Information.
EDURANT® Important Safety Information
Please refer to the EDURANT® Prescribing Information for additional information.
Learn more at www.janssen.com
To learn more about Janssen’s commitment to the prevention and treatment of HIV, please visit jnj.com/HIV.
Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV
Thu January 21, 2021 10:57 PM|PR Newswire PR Newswire
TITUSVILLE, N.J., Jan. 21, 2021 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson
FDA OK's Janssen's HIV drug combo Cabenuva
Jan. 21, 2021 11:51 PM ET Johnson & Johnson (JNJ) By: Mamta Mayani, SA News Editor1 Comment
https://seekingalpha.com/news/3653426-fda-oks-janssens-hiv-drug-combo-cabenuva
https://seekingalpha.com/symbol/JNJ
Jyseleca® ▼(filgotinib)
NICE recommends Jyseleca® ▼(filgotinib) on NHS in landmark decision for rheumatoid arthritis
January 21, 2021 02:08 ET | Source: Galapagos NVmultilang-release
NOT FOR DISTRIBUTION IN THE UNITED KINGDOM
- NICE guidance, for the first time in the UK, supports access to an advanced therapy for people with moderate as well as severe rheumatoid arthritis (RA) - aiming to avoid irreversible damage as early as possible1
- More than 400,000 people across the UK live with RA2 and around 70% have moderate or severe disease3
Mechelen, Belgium, 21 January 2021, 08:05 CET – Galapagos NV (Euronext & Nasdaq: GLPG) today welcomed the news that the National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) recommending the use of the daily oral pill, JYSELECA®▼ (filgotinib) on the National Health Service (NHS) in England for the treatment of eligible adult patients with moderate to severe active rheumatoid arthritis (RA).1 It is the first time in the UK that an advanced therapy has been recommended in people with moderate RA, offering thousands more the potential to achieve remission earlier - potentially slowing the irreversible damage and life-limiting symptoms RA can cause.2 RA is a degenerative auto-immune disease that can cause life-threatening complications.4 The sooner treatment begins, the better the chance of slowing disease progression.2 With thousands of people potentially eligible, the recommendation could help improve many lives as well as lessen the significant societal burden RA has in England.5,6
https://www.glpg.com/press-releases
Jyseleca® ▼(filgotinib)
About filgotinib7
Filgotinib is a Janus-kinase (JAK) inhibitor and works by preferentially targeting JAK1, part of a specific pathway involved in inflammation – an immune response of the body that causes symptoms of RA. In clinical studies, filgotinib has been shown to significantly improve the chance of disease remission (a DAS28-CRP score of <2.6, indicating few or no symptoms).7 In the FINCH 1 study of 1,755 patients with RA who had an inadequate response to methotrexate, 34% of patients given filgotinib 200mg + methotrexate (n=475) achieved disease remission after just 12 weeks, compared to 9% of a group given placebo (n=475). After 24 weeks, 48% of patients in this group had achieved remission vs. 16% of those on placebo and these response levels were sustained through 52 weeks. In many cases, responses were seen within two weeks (measured using an ACR20 score).
Data supporting filgotinib include more than 3,800 patients treated across the Phase 3 FINCH and Phase 2 DARWIN programmes. In the FINCH studies, filgotinib consistently achieved ACR20/50/70 criteria, with improvements in all individual ACR components compared with placebo or methotrexate.
Across the FINCH and DARWIN trials, the most common adverse reactions were nausea, upper respiratory tract infection, urinary tract infection and dizziness. Rates of herpes zoster and pneumonia were uncommon. The frequency of serious infections in the filgotinib 200mg group was 1.0 percent compared with 0.6 percent in the placebo group. In an integrated safety analysis in seven clinical trials the rates of major adverse cardiac events (MACE) and venous thromboembolism (VTE) with filgotinib were comparable to placebo. The rates of serious infections remained stable with long-term exposure.
More information at www.glpg.com.
Jyseleca®, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. or its related companies.
NICE recommends Jyseleca® ▼(filgotinib) on NHS in landmark decision for rheumatoid arthritis
Thu January 21, 2021 2:08 AM|GlobeNewswire|About: GLPG
NOT FOR DISTRIBUTION IN THE UNITED KINGDOM
- NICE guidance, for the first time in the UK, supports access to an advanced therapy for people with moderate as well as severe rheumatoid arthritis (RA) - aiming to avoid irreversible damage as early as possible1
- More than 400,000 people across the UK live with RA2 and around 70% have moderate or severe disease3
Mechelen, Belgium, 21 January 2021, 08:05 CET – Galapagos NV (GLPGF) (Euronext & Nasdaq: GLPG)
Galapagos' filgotinib recommended for use in England for rheumatoid arthritis
Jan. 21, 2021 6:43 AM ET Galapagos NV (GLPG) By: Mamta Mayani, SA News Editor2 Comments
https://seekingalpha.com/symbol/GLPG
VASCEPA® (icosapent ethyl) Capsules
ICOSAPENT ETHYL INCLUDED IN THE CHINESE SOCIETY OF CARDIOLOGY (CSC) UPDATED GUIDELINES FOR PRIMARY PREVENTION OF CARDIOVASCULAR DISEASES
PDF Version Jan 21, 2021
DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 21, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that the Chinese Society of Cardiology (CSC) has included icosapent ethyl in its updated Guidelines for Primary Prevention of Cardiovascular Diseases for 2021 as published in the Chinese Journal of Cardiovascular Diseases. The guideline authors include “icosapent ethyl 2 grams twice a day (as studied in REDUCE-IT®) as a treatment consideration to further lower atherosclerotic cardiovascular disease (ASCVD) in the appropriate patient population.”1
VASCEPA® (icosapent ethyl) Capsules
About VASCEPA® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the U.S. 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 U.S. 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.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
About REDUCE-IT®
REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort).
REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.2 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.3 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.4 These and other publications can be found in the R&D section on the company’s website at www.amarincorp.com.
Icosapent Ethyl Included in the Chinese Society of Cardiology (CSC) Updated Guidelines for Primary Prevention of Cardiovascular Diseases
Thu January 21, 2021 4:30 PM|GlobeNewswire |About: AMRN
DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 21, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN)
Chinese Society of Cardiology recommends use of Amarin's icosapent ethyl in cardiovascular diseases
Jan. 22, 2021 7:01 AM ET
By: Mamta Mayani, SA News Editor4 Comments
- The Chinese Society of Cardiology has included Amarin's (NASDAQ:AMRN) icosapent ethyl in its updated Guidelines for Primary Prevention of Cardiovascular Diseases for 2021.
ORLADEYO™ (berotralstat)
BioCryst Announces Approval of ORLADEYO™ (berotralstat) in Japan for the Prophylactic Treatment of Hereditary Angioedema
ORLADEYO™ (berotralstat) 150 mg, for Japan
ORLADEYO™ (berotralstat) 150 mg, for Japan
RESEARCH TRIANGLE PARK, N.C., Jan. 22, 2021 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing approval for oral, once-daily ORLADEYO™ (berotralstat) 150 mg for prophylactic treatment of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.
ORLADEYO™ (berotralstat)
About ORLADEYO™ (berotralstat)
ORLADEYO™ (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older. One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.
U.S. Indication and Important Safety Information
INDICATION
ORLADEYOTM (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.
ORLADEYO is the first and only prophylactic HAE medication approved in Japan. One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.
ORLADEYO will be commercialized in Japan by BioCryst’s partner, Torii Pharmaceutical Co., Ltd. OrphanPacific, Inc. is BioCryst’s representative partner in Japan and holds the marketing authorization.
Torii will launch ORLADEYO in Japan following the successful completion of BioCryst’s pricing negotiations with the Japanese National Health Insurance System (NHI).
Please see full Prescribing Information.
For more information, please visit the company’s website at www.biocryst.com.
For more information, please visit www.orphanpacific.com/en/.
https://www.globenewswire.com/NewsRoom/AttachmentNg/3c7764e3-37b3-428c-8dbf-b81655b08a6c
BioCryst Announces Approval of ORLADEYO™ (berotralstat) in Japan for the Prophylactic Treatment of Hereditary Angioedema
Fri January 22, 2021 7:00 AM |GlobeNewswire|About: BCRX
RESEARCH TRIANGLE PARK, N.C., Jan. 22, 2021 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (BCRX) (Nasdaq: BCRX)
BioCryst's hereditary angioedema med OK'd in Japan
Jan. 22, 2021 7:10 AM ET BioCryst Pharmaceuticals, Inc. (BCRX)
By: Vandana Singh, SA News Editor3 Comments
- BioCryst Pharmaceuticals' (NASDAQ:BCRX) gains 7% in premarket, as Ministry of Health, Labor and Welfare in Japan has approved oral, once-daily Orladeyo (berotralstat) 150 mg for prophylactic treatment of hereditary angioedema adults and pediatric patients 12 years and older.
https://seekingalpha.com/news/3653476-biocrysts-hereditary-angioedema-med-okd-in-japan
https://seekingalpha.com/symbol/BCRX
Retifanlimab (formerly INCMGA0012)
Incyte Announces Acceptance and Priority Review of BLA for Retifanlimab as a Potential Treatment for Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)
January 21, 2021 DownloadPDF Format (opens in new window)
WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy.
For more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03597295.
Retifanlimab (formerly INCMGA0012)
About Retifanlimab
Retifanlimab (formerly INCMGA0012), an investigational intravenous anti-PD1 antibody, is currently under evaluation in registration-directed trials as a monotherapy for patients with microsatellite instability-high endometrial cancer, Merkel cell carcinoma and squamous cell carcinoma of the anal canal (SCAC); and in combination with platinum-based chemotherapy for patients with non-small cell lung cancer and SCAC.
Retifanlimab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of anal cancer.
In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab. In 2019, Incyte and Zai Lab announced a collaboration and license agreement for the development and commercialization of retifanlimab in Greater China.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210121005917/en/
For additional information on Incyte, please visit Incyte.com
Incyte Announces Acceptance and Priority Review of BLA for Retifanlimab as a Potential Treatment for Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)
Thu January 21, 2021 4:30 PM| Business Wire|About: INCY
WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (INCY)
Incyte's retifanlimab wins FDA's Priority Review status
Jan. 21, 2021 4:37 PM ET Incyte Corporation (INCY)
By: Aakash Babu, SA News Editor
https://seekingalpha.com/news/3653339-incytes-retifanlimab-wins-fdas-priority-review-status
https://seekingalpha.com/symbol/INCY
True Human™ COVID-19 Therapy
XBiotech Candidate True Human™ COVID-19 Therapy Found to Target Highly Infectious Emerging Strain
Jan 21, 2021Download PDFWith New Infectious Strain Rapidly Spreading, XBiotech Establishes Data Indicating its Candidate True Human™ COVID-19 Therapy may be Effective for Treating New Mutant Strain
AUSTIN, Texas, Jan. 21, 2021 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) announces that its COVID-19 candidate True Human™ antibody therapy may also be used for treating the COVID-19 mutant virus that recently emerged in the UK and is now rapidly spreading across the US.
For more information, visit www.xbiotech.com.
True Human™ COVID-19 Therapy
About True Human™ Therapeutic Antibodies
XBiotech’s True Human™ antibodies are the only available antibodies derived without modification from humans who possess natural immunity to certain diseases. (Unlike all commercially available antibodies, which are called “Humanized” or “Fully Human”, XBiotech’s True Human™ antibodies are directly sourced from the natural human immune response for specific diseases without modification, and thereby have not been shown to cause immunogenicity.) With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.
XBiotech Candidate True Human™ COVID-19 Therapy Found to Target Highly Infectious Emerging Strain
Thu January 21, 2021 8:15 AM|GlobeNewswire|About: XBITGlobeNewswire
AUSTIN, Texas, Jan. 21, 2021 (GLOBE NEWSWIRE) -- XBiotech Inc. (XBIT)
XBiotech says its antibody therapy is effective against new COVID-19 strain
Jan. 21, 2021 10:05 AM ETXBiotech Inc. (XBIT)By: Dulan Lokuwithana, SA News Editor
- After an analysis against mutant COVID-19 virus found in the U.K., XBiotech (XBIT +4.6%) says its COVID-19 candidate True Human™ antibody therapy may also be used for treating the new coronavirus strain.
https://seekingalpha.com/symbol/XBIT
biotecMAX™ January 2021 Insight
Bamlanivimab (LY-CoV555)
Lilly's neutralizing antibody bamlanivimab (LY-CoV555) prevented COVID-19 at nursing homes in the BLAZE-2 trial, reducing risk by up to 80 percent for residents
January 21, 2021 Download PDF
INDIANAPOLIS, Jan. 21, 2021 /PRNewswire/ -- Bamlanivimab (LY-CoV555) significantly reduced the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities, Eli Lilly and Company (NYSE: LLY) announced. The Phase 3 BLAZE-2 COVID-19 prevention trial – conducted in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the COVID-19 Prevention Network (CoVPN) – enrolled residents and staff at skilled nursing and assisted living facilities, commonly referred to as nursing homes, across the U.S.
Bamlanivimab (LY-CoV555)
neutralizing antibody bamlanivimab (LY-CoV555)
Bamlanivimab is authorized for emergency use by the U.S. Food and Drug Administration for the treatment of mild to moderate COVID-19 in high-risk patients. For more information about the use of bamlanivimab, contact Lilly's 24-hour support line at 1-855-LillyC19 (1-855-545-5921). Patients and physicians can visit covid.infusioncenter.org or the HHS Therapeutics Distribution locator to find a potential treatment location near you. Visit combatcovid.hhs.gov to find out more about antibody therapy.
Important Information about bamlanivimab
Bamlanivimab has not been approved by the FDA for any use. It is not known if bamlanivimab is safe and effective for the treatment of COVID-19.
Bamlanivimab is authorized under an Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bamlanivimab under Section 564(b)(1) of the Act, 21 U.S.C § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Healthcare providers should review the Fact Sheet for information on the authorized use of bamlanivimab and mandatory requirements of the EUA. Please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents, and Caregivers (English) (Spanish).
About bamlanivimab
Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.
Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628). A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.
Bamlanivimab is authorized in the U.S. for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.
To learn more about Lilly, please visit us at www.lilly.com
View original content to download multimedia:http://www.prnewswire.com/news-releases/lillys-neutralizing-antibody-bamlanivimab-ly-cov555-prevented-covid-19-at-nursing-homes-in-the-blaze-2-trial-reducing-risk-by-up-to-80-percent-for-residents-301212159.html
Lilly's neutralizing antibody bamlanivimab (LY-CoV555) prevented COVID-19 at nursing homes in the BLAZE-2 trial, reducing risk by up to 80 percent for residents
Thu January 21, 2021 8:00 AM|PR Newswire|About: LLY
INDIANAPOLIS, Jan. 21, 2021 /PRNewswire/ -- Bamlanivimab (LY-CoV555)
Eli Lilly's bamlanivimab effective in reducing COVID-19 risk in late-stage trial
Jan. 21, 2021 8:30 AM ETEli Lilly and Company (LLY)By: Jonathan M Block, SA News Editor
- Eli Lilly (NYSE:LLY) reports that bamlanivimab was effective in reducing COVID-19 in residents and staff at long-term care facilities. https://seekingalpha.com/news/3653068-
https://seekingalpha.com/symbol/LLY
Esbriet (pirfenidone)
Wednesday, Jan 20, 2021
FDA Grants Priority Review to Genentech’s Esbriet (pirfenidone) for Unclassifiable Interstitial Lung Disease
South San Francisco, CA -- January 20, 2021 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review for Esbriet® (pirfenidone) for the treatment of unclassifiable interstitial lung disease (UILD). The FDA is expected to make a decision on approval by May 2021.
Esbriet (pirfenidone)
About Esbriet
Esbriet is an oral medicine approved for the treatment of idiopathic pulmonary fibrosis (IPF) and is available in more than 60 countries worldwide. Esbriet was FDA-approved for use in people with IPF in October 2014.
Esbriet U.S. Indication
Esbriet is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF).
It is not known if Esbriet is safe and effective in children.
Please see full Prescribing Information, including Patient Information, for additional important safety information at http://www.esbriet.com.
Esbriet® (pirfenidone) is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF).
For additional information about the company, please visit http://www.gene.com.
FDA Grants Priority Review to Genentech’s Esbriet (pirfenidone) for Unclassifiable Interstitial Lung Disease
Thu January 21, 2021 1:00 AM|Business Wire|About: RHHBY
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)
Genentech's Esbriet nabs accelerated review in U.S. for interstitial lung disease
Jan. 21, 2021 2:16 AM ET Roche Holding AG (RHHBY)
By: Mamta Mayani, SA News Editor
- Under Priority Review status, the FDA accepts Roche (OTCQX:RHHBY) unit, Genentech's supplemental New Drug Application (sNDA) for Esbriet (pirfenidone) for the treatment of unclassifiable interstitial lung disease (UILD).
https://seekingalpha.com/symbol/RHHBY
VERQUVO® (vericiguat)
Merck Announces U.S. FDA Approval of VERQUVO® (vericiguat)
January 20, 2021 6:45 am EST
VERQUVO Approved for Reduction of Risk of Cardiovascular Death and Heart Failure (HF) Hospitalization Following a Hospitalization for HF or Need for Outpatient Intravenous (IV) Diuretics in Adults with Symptomatic Chronic Heart Failure and Ejection Fraction Less than 45%
VERQUVO is the First Soluble Guanylate Cyclase Stimulator, Approved to Treat Heart Failure
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 approved VERQUVO, a soluble guanylate cyclase (sGC) stimulator, to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous (IV) diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%. The approval of VERQUVO by the FDA, which is the first treatment for chronic heart failure approved specifically for patients following a hospitalization for heart failure or need for outpatient IV diuretics, is based on the results of the pivotal Phase 3 VICTORIA trial and follows a priority regulatory review. VERQUVO (vericiguat) 2.5 mg, 5 mg, and 10 mg tablets is being jointly developed with Bayer AG.
VERQUVO® (vericiguat)
About VERQUVO® (vericiguat) tablets for once daily oral use (2.5 mg, 5 mg and 10 mg)
Vericiguat is a stimulator of soluble guanylate cyclase (sGC), an important enzyme in the nitric oxide (NO) signaling pathway. When NO binds to sGC, the enzyme catalyzes the synthesis of intracellular cyclic guanosine monophosphate (cGMP), a second messenger that plays a role in the regulation of vascular tone, cardiac contractility, and cardiac remodeling. Heart failure is associated with impaired synthesis of NO and decreased activity of sGC, which may contribute to myocardial and vascular dysfunction. By directly stimulating sGC, independently of and synergistically with NO, vericiguat augments levels of intracellular cGMP, leading to smooth muscle relaxation and vasodilation.
About the Worldwide Collaboration Between Bayer and Merck
Since October 2014, Bayer and Merck (known as MSD outside of the United States and Canada) have pursued a worldwide collaboration in the field of sGC modulators. The collaboration brings together two leading companies that have stated their intent to fully evaluate this therapeutic class in areas of unmet medical need. The vericiguat program is being co-developed by Bayer and Merck. Merck has the commercial rights to vericiguat in the U.S. and Bayer has the exclusive commercial rights in the rest of world. The companies share equally the costs of the development of vericiguat.
For more information, visit www.merck.com
Please see Prescribing Information, including Boxed Warning, for VERQUVO (vericiguat) at https://www.merck.com/product/usa/pi_circulars/v/verquvo/verquvo_pi.pdf and Medication Guide at https://www.merck.com/product/usa/pi_circulars/v/verquvo/verquvo_mg.pdf.
Merck Announces U.S. FDA Approval of VERQUVO® (vericiguat)
Wed January 20, 2021 6:45 AM|Business Wire|About: MRK
https://seekingalpha.com/pr/18158044-merck-announces-u-s-fda-approval-of-verquvo-vericiguat
Merck/Bayer's Verquvo OK'd in U.S. for chronic heart failure
Jan. 20, 2021 7:14 AM ET Merck & Co., Inc. (MRK)
By: Mamta Mayani, SA News Editor
- The FDA approves Merck's (NYSE:MRK) Verquvo, a soluble guanylate cyclase (sGC) stimulator, to reduce the risk of cardiovascular death and heart failure following hospitalization or need for outpatient intravenous diuretics in adults with chronic heart failure and ejection fraction less than 45%.
https://seekingalpha.com/news/3652583-merckbayers-verquvo-okd-in-us-for-chronic-heart-failure
https://seekingalpha.com/symbol/BAYRY
https://seekingalpha.com/symbol/MRK
Opdivo® (nivolumab) Combined with Chemotherapy
U.S. Food and Drug Administration Accepts for Priority Review Application for Opdivo® (nivolumab) Combined with Chemotherapy as First-Line Treatment in Metastatic Gastric Cancer, Gastroesophageal Junction Cancer and Esophageal Adenocarcinoma
01/20/2021CATEGORY:
U.S. Food and Drug Administration assigned a target action date of May 25, 2021
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer (GEJC) or esophageal adenocarcinoma (EAC), based on results from the CheckMate -649 trial. The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 25, 2021.
Opdivo® (nivolumab) Combined with Chemotherapy
About Opdivo ®
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.
INDICATIONS
OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of patients with unresectable or metastatic melanoma.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.
OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).
OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.
OPDIVO® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma 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. 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.
OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab) 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 overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), 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 overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
OPDIVO® (nivolumab) is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
U.S. Food and Drug Administration Accepts for Priority Review Application for Opdivo® (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer
Wed January 20, 2021 6:59 AM|Business Wire|About: BMY
U.S. Food and Drug Administration assigned a target action date of May 20, 2021
Application based on Phase 3 CheckMate -577 trial, in which Opdivo doubled median disease-free survival versus placebo in patients with esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy and surgery
Opdivo demonstrated a manageable safety profile consistent with prior studies
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)
https://seekingalpha.com/symbol/BMY
Omnipod DASH® System
Jan 18, 2021
Insulet’s Omnipod DASH® System Now Available in Canada
ACTON, Mass.--(BUSINESS WIRE)--Jan. 18, 2021-- Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® Insulin Management System (Omnipod System), today announced the launch of the Omnipod DASH® Insulin Management System (Omnipod DASH System) in Canada.
Omnipod DASH® System
The Omnipod DASH System combines a tubeless, wearable, waterproof1 Pod with an easy-to-use, touchscreen PDM. The handheld, smartphone-like PDM features an intuitive interface that allows customers to wirelessly control the Pod to deliver customizable basal rates and bolus amounts. The Pod provides up to 72 hours2 of continuous insulin therapy and allows individuals to simplify life with no more daily injections.
“The Omnipod System has been a vital part of my diabetes management since 2013 and I am excited that the Omnipod DASH is coming to Canada,” said Esther Funk, a Registered Nurse and Certified Pump Trainer living with Type 1 diabetes. “The touchscreen design makes it simple and easy to operate. Thank you Insulet for continuing to provide new and innovative options for diabetes management.”
For more information visit please visit www.omnipod.com.
About the Omnipod DASH® System:
The Omnipod DASH Insulin Management System is the first and only tubeless device that can provide three days of non-stop insulin delivery. Its unique design consists of just two parts; a lightweight, tubeless, waterproof, wearable Pod controlled by a smartphone touch-screen Bluetooth® enabled controller, minimizing the number of components to carry. The Omnipod DASH System offers simple, smart, discreet insulin control for people diagnosed with Type 1 or insulin-requiring Type 2 diabetes. The Omnipod DASH System, which received FDA clearance in June 2018, is the only DTSec and ISO 27001 certified insulin pump for cyber and information security and safety.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210118005010/en/
For more information, please visit: www.insulet.com and www.omnipod.com.
https://seekingalpha.com/pr/18154831-insulet-s-omnipod-dash-system-now-available-in-canada
Insulet's insulin management system launched in Canada
Jan. 19, 2021 2:50 PM ET Insulet Corporation (PODD) By: Vandana Singh, SA News Editor
- Insulet (PODD +1.5%) has launched its Omnipod DASH Insulin Management System (Omnipod DASH System) in Canada.
https://seekingalpha.com/news/3652398-insulets-insulin-management-system-launched-in-canada
https://seekingalpha.com/symbol/PODD
Omnipod DASH® Insulin Management System: Prescribe a system that simplifies diabetes care from prescription through ongoing care.
https://www.omnipod.com/healthcareproviders/about-omnipod/DASH
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)
Genmab Announces that Janssen has been Granted U.S. FDA Approval for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis
Jan 15, 2021 at 8:18 PM CET
Company Announcement
- DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) approved by U.S. FDA as the first and only therapy for newly diagnosed Light-chain (AL) amyloidosis
- Accelerated approval of DARZALEX FASPRO-based combination regimen supported by the Phase 3 ANDROMEDA (AMY3001) study
- Genmab to receive USD 30 million milestone payment on first commercial sale
Copenhagen, Denmark; January 15, 2021 – Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (U.S. FDA) has approved the use of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd) for the treatment of adult patients with newly diagnosed light-chain (AL) amyloidosis.
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)
Full prescribing information will be available at www.DARZALEX.com.
About DARZALEX®(daratumumab)
DARZALEX® (daratumumab) has become a backbone therapy in the treatment of multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy; in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.6 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma.
DARZALEX is indicated for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy7. Daratumumab is the first subcutaneous CD38 antibody approved in Europe for the treatment of multiple myeloma. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S.
In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit www.DARZALEX.com.
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with newly diagnosed light-chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide, and dexamethasone. It is also approved in the U.S. for the treatment of adult patients with multiple myeloma: in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for ASCT; in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.8 DARZALEX FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology. .DARZALEX FASPRO is the first subcutaneous CD38 antibody approved in the U.S. for the treatment of multiple myeloma and the first and only approved treatment for patients with AL amyloidosis in the U.S.
Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).6,9,10,11,12
Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia (ALL). Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.
For more information, please visit Genmab.com.
Genmab Announces that Janssen has been Granted U.S. FDA Approval for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis
Fri January 15, 2021 2:17 PM|GlobeNewswire|About: GMAB
Company Announcement
- DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) approved by U.S. FDA as the first and only therapy for newly diagnosed Light-chain (AL) amyloidosis
- Accelerated approval of DARZALEX FASPRO-based combination regimen supported by the Phase 3 ANDROMEDA (AMY3001) study
- Genmab (GNMSF) to receive USD 30 million milestone payment on first commercial sale
Copenhagen, Denmark; January 15, 2021 – Genmab A/S (Nasdaq: GMAB)
Genmab's therapy for AL amyloidosis receives FDA approval
Jan. 15, 2021 3:01 PM ET Genmab A/S (GMAB)
By: Dulan Lokuwithana, SA News Editor
- Genmab A/S (NASDAQ:GMAB) has announced that the FDA has approved DARZALEX FASPRO® to treat newly diagnosed Light-chain (“AL”) amyloidosis, a rare disease affecting an estimated ~3,000 to 4,000 individuals in the U.S. annually.
https://seekingalpha.com/news/3651950-genmabs-therapy-for-al-amyloidosis-receives-fda-approval
XALKORI® (CRIZOTINIB)
PFIZER’S XALKORI® (CRIZOTINIB) APPROVED BY FDA FOR ALK-POSITIVE ANAPLASTIC LARGE CELL LYMPHOMA IN CHILDREN AND YOUNG ADULTS
Thursday, January 14, 2021 - 04:30pm
XALKORI is the first biomarker-driven therapy for relapsed or refractory ALCL in young people
NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for XALKORI® (crizotinib) for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. ALCL is a rare form of non-Hodgkin lymphoma (NHL) and accounts for approximately 30% of cases of NHL in young people.1,2,3 Approximately 90% of ALCL cases in young people are ALK-positive.4,5,6
XALKORI® (CRIZOTINIB)
About XALKORI® (crizotinib)
XALKORI is a tyrosine kinase inhibitor (TKI) indicated for the treatment of patients with metastatic NSCLC whose tumors are ALK- or ROS1-positive as detected by an FDA-approved test. In addition to the United States, XALKORI has received approval for patients with ALK-positive NSCLC in more than 90 countries including Australia, Canada, China, Japan, South Korea and the European Union. XALKORI is also approved for ROS1-positive NSCLC in more than 70 countries.
XALKORI is indicated for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.
The full prescribing information for XALKORI can be found here.
IMPORTANT XALKORI® (crizotinib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION
to learn more, please visit us on www.Pfizer.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20210114006005/en/
Pfizer’s XALKORI® (crizotinib) Approved by FDA for ALK-positive Anaplastic Large Cell Lymphoma in Children and Young Adults
Thu January 14, 2021 4:30 PM|Business Wire|About: PFE
XALKORI is the first biomarker-driven therapy for relapsed or refractory ALCL in young people
NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE)
Pfizer’s XALKORI wins FDA's expanded approval for a form of lymphoma
Jan. 14, 2021 4:44 PM ETPfizer Inc. (PFE)By: Aakash Babu, SA News Editor3 Comments
- The FDA has approved Pfizer's (NYSE:PFE) supplemental New Drug Application ((sNDA)) for XALKORI (crizotinib) for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase positive.
https://seekingalpha.com/symbol/PFE
XALKORI® (CRIZOTINIB)
Indications
XALKORI is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by a defect in either a gene called ALK (anaplastic lymphoma kinase) or a gene called ROS1. It is not known if XALKORI is safe and effective in children.
ENHERTU® (trastuzumab deruxtecan
ENHERTU® Approved in the U.S. for the Treatment of Patients with Previously Treated HER2 Positive Advanced Gastric Cancer
Download the PDF version of Article
January 15, 2021
- First HER2 directed medicine approved for patients with gastric cancer in a decade
Tokyo, Munich and Basking Ridge, NJ – (January 15, 2021) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
This press release features multimedia. View the full release here.
ENHERTU® (trastuzumab deruxtecan
About ENHERTU
ENHERTU® (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S.) is a HER2 directed antibody drug conjugate (ADC). Designed using Daiichi Sankyo’s proprietary DXd ADC technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program 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 humanized anti-HER2 IgG1 monoclonal antibody with the same amino acid sequence as trastuzumab attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a tetrapeptide-based cleavable linker.
ENHERTU (5.4 mg/kg) is approved in the U.S. under accelerated approval, and in Japan, under the conditional early approval system, 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, and received a CHMP positive opinion in December 2020 as monotherapy 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. ENHERTU (6.4 mg/kg) is also approved in the U.S. and Japan for the treatment of previously treated patients with HER2 positive metastatic gastric cancer based on the DESTINY-Gastric01 trial.
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.
Please see accompanying full Prescribing Information, including Boxed WARNINGS, and Medication Guide.
AstraZeneca's antibody drug conjugate Enhertu wins expanded approval from the FDA
Jan. 15, 2021 4:43 PM ET Daiichi Sankyo Company, Limited (DSKYF) By: Aakash Babu, SA News Editor2 Comments
- AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo's (OTCPK:DSKYF) antibody drug conjugate Enhertu wins approval from the U.S. FDA for treating adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
Enhertu approved in the EU for the treatment of HER2-positive metastatic breast cancer
PUBLISHED20 January 2021
20 January 2021 07:00 GMT
Approval based on DESTINY-Breast01 Phase II trial which showed clinically meaningful and durable responses in patients with previously treated disease
Imfinzi (durvalumab)
15 January 2021 07:00 GMT
Imfinzi approved in the EU for less-frequent, fixed-
dose use in unresectable non-small cell lung cancer
New option extends dosing from two to four weeks,
reducing medical visits and improving patient convenience
AstraZeneca's Imfinzi (durvalumab) has been approved in the European Union and the UK for an additional dosing option, a 1,500mg fixed dose every four weeks, in locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on at least 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy (CRT).
AstraZeneca’s Imfinzi additional dosing option OK'd in the EU/UK
Jan. 15, 2021 7:27 AM ETAstraZeneca PLC (AZN)By: Vandana Singh, SA News Editor
- AstraZeneca's (NASDAQ:AZN) Imfinzi (durvalumab) has been approved in the EU and the U.K. for an additional dosing option. New dosing is a 1,500mg fixed dose every four weeks, in locally advanced, unresectable non-small cell lung cancer in adults whose tumors express PD-L1 on at least 1% of tumor cells and whose disease has not progressed following platinum-based chemoradiation therapy.
https://seekingalpha.com/news/3651756-astrazeneca-s-imfinzi-additional-dosing-option-okd-in-eu-uk
https://seekingalpha.com/symbol/AZN
Imfinzi (durvalumab)
IMFINZI® (durvalumab) is a prescription medicine used to treat adults with a type of cancer in the bladder and urinary tract called urothelial carcinoma. IMFINZI may be used when your urothelial carcinoma has spread or cannot be removed by surgery, and chemotherapy containing platinum did not work or is no longer working. IMFINZI was FDA approved for this use based on a clinical study that measured how many patients responded and how long they responded. The study is ongoing to confirm clinical benefit.
IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). IMFINZI may be used when your NSCLC has not spread outside your chest, cannot be removed by surgery, and has responded or stabilized with initial treatment with chemotherapy that contains platinum, given at the same time as radiation therapy.
IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called small cell lung cancer (SCLC). IMFINZI may be used with the chemotherapy medicines etoposide and carboplatin or cisplatin as your first treatment when your SCLC has spread within your lungs or to other parts of the body (extensive-stage small cell lung cancer, or ES-SCLC).
It is not known if IMFINZI is safe and effective in children.
. Please visit astrazeneca.com
IMBRUVICA®* (ibrutinib)
Health Canada Approves IMBRUVICA®* (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL)
Wed January 13, 2021 7:30 AM| Canada Newswire| About: JNJ
Patients aged 70 or younger with previously untreated CLL lived longer without disease progression compared to patients treated with FCR, a chemoimmunotherapy regimen
TORONTO, Jan. 13, 2021 /CNW/ - The Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ) announced today that Health Canada has approved IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).i Today's milestone marks the tenth Health Canada approval for IMBRUVICA® across five disease areas and is the fifth approval for IMBRUVICA® in CLL.ii
IMBRUVICA®* (ibrutinib)
About IMBRUVICA®
IMBRUVICA® contains the medicinal ingredient ibrutinib which is a targeted inhibitor of Bruton's tyrosine kinase (BTK), and it is the only once-daily BTK inhibitor in Canada. Ibrutinib blocks BTK activity, inhibiting cancer cell survival and spread.xv
IMBRUVICA® was first approved in Canada in 2014. It is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL),xvi including those with 17p deletion; or adult patients with CLL who have received at least one prior therapy, including those with 17p deletion.xvii It is indicated in combination with bendamustine and rituximab for the treatment of adult patients with CLL who have received at least one prior therapy, and in combination with obinutuzumab for treatment-naïve adult patients with CLL.xviii It is now also indicated in combination with rituximab for the treatment of adult patients with previously untreated CLL.xix
For adult patients with Waldenström's macroglobulinemia (WM), IMBRUVICA® is indicated as a single agent or in combination with rituximab.xx Other indications are for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL); patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy; and for patients with steroid dependent or refractory chronic graft-versus-host disease (cGVHD).xxi
IMBRUVICA® is co-developed by Cilag GmbH International (a member of the Janssen Pharmaceutical Companies) and Pharmacyclics LLC, an AbbVie company. Janssen Inc. commercializes IMBRUVICA® in Canada.
Learn more at www.janssen.com/canada.
Johnson & Johnson's Imbruvica combo OK'd in Canada in CLL setting
Jan. 13, 2021 8:25 AM ET Johnson & Johnson (JNJ)By: Aakash Babu, SA News Editor
- Health Canada has approved Johnson & Johnson's (NYSE:JNJ)
https://seekingalpha.com/news/3651021-johnson-johnsons-imbruvica-combo-okd-in-canada-in-cll-setting
https://www.janssen.com/canada/
https://seekingalpha.com/symbol/JNJ
Vicineum™
PRESS RELEASE
Sesen Bio and Qilu Pharmaceutical Announce IND Application for Vicineum™ Accepted for Review by the National Medical Products Administration in China
January 13, 2021 at 8:00 AM ESTPDF Version
Clinical trial expected to be initiated shortly after NMPA approval of the IND
Sesen Bio to receive $3M milestone payment upon IND approval
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 13, 2021-- Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today reported that the Investigational New Drug (IND) application submitted to the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) by the Company’s partner in China, Qilu Pharmaceutical, was accepted for review. If the IND is approved, Qilu will be authorized to conduct the proposed clinical trial to assess the efficacy and safety of VicineumTM in patients with non-muscle invasive bladder cancer (NMIBC) in Greater China. The Company’s lead program, Vicineum, also known as VB4-845, is currently in the follow-up stage of a Phase 3 registration trial in the United States (US) for the treatment of high-risk, bacillus Calmette-Guérin (BCG)-unresponsive NMIBC. In December 2020, the Company completed the Biologics License Application (BLA) submission for Vicineum to the FDA.
Vicineum™
About Vicineum™
Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. In December 2020, Sesen Bio completed the BLA submission for Vicineum to the FDA. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.
For more information, please visit the company’s website at www.sesenbio.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210113005062/en/
Sesen Bio and Qilu Pharmaceutical Announce IND Application for Vicineum™ Accepted for Review by the National Medical Products Administration in China
Wed January 13, 2021 8:00 AM|Business Wire|About: SESN
Clinical trial expected to be initiated shortly after NMPA approval of the IND
Sesen Bio (SESN) to receive $3M milestone payment upon IND approval
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sesen Bio
Sesen Bio/Qilu Pharma's Vicineum IND application accepted for review in China
Jan. 13, 2021 10:53 AM ETSesen Bio, Inc. (SESN)By: Vandana Singh, SA News Editor
- National Medical Products Administration in China has accepted for review the Investigational New Drug (IND) submitted by Sesen Bio's (SESN -4.7%) partner Qilu Pharmaceutical, to start proposed clinical trial to evaluate Vicineum in Greater China, in patients with non-muscle invasive bladder cancer (NMIBC).
https://seekingalpha.com/symbol/SESN
tislelizumab combined with either paclitaxel and carboplatin or nab-paclitaxel (ABRAXANE®) and carboplatin
China National Medical Products Administration Approves Tislelizumab in Combination with Chemotherapy in First-Line Advanced Squamous Non-Small Cell Lung Cancer
January 13, 2021 at 11:00 PM EST
BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 13, 2021-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that its anti-PD-1 antibody tislelizumab has received approval from the China National Medical Products Administration (NMPA) for use in combination with two chemotherapy regimens as a first-line treatment for patients with advanced squamous non-small cell lung cancer (NSCLC). This is the third approval in China for tislelizumab, and its first in a lung cancer indication.
tislelizumab combined with either paclitaxel and carboplatin or nab-paclitaxel (ABRAXANE®) and carboplatin
results of the interim analysis
About Tislelizumab
Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.v Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.
The China National Medical Products Administration (NMPA) has granted tislelizumab full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy. Tislelizumab has also received conditional approval from the NMPA for the treatment of patients with classical Hodgkin’s lymphoma who received at least two prior therapies and for the treatment of patients with locally advanced or metastatic urothelial carcinoma with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Complete approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.
In addition, two supplemental new drug applications for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the NMPA and are under review for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and for previously treated unresectable hepatocellular carcinoma.
Currently, 15 potentially registration-enabling clinical trials are being conducted in China and globally, including 13 Phase 3 trials and two pivotal Phase 2 trials.
Tislelizumab is not approved for use outside of China.
ABRAXANE® is a registered trademark of Abraxis Bioscience LLC, a Bristol-Myers Squibb company.
ABRAXANE is a prescription medicine used to treat
when used in combination
with gemcitabine, as the first
medicine you receive for
advanced pancreatic cancer
in combination with carboplatin, in
people who cannot be treated
with surgery or radiation
in people who have already
received certain other
medicines for their cancer
China National Medical Products Administration Approves Tislelizumab in Combination with Chemotherapy in First-Line Advanced Squamous Non-Small Cell Lung Cancer
Wed January 13, 2021 11:00 PM|Business Wire|About: BGNE
BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BeiGene, Ltd. (BGNE)
BeiGene's tislelizumab + chemotherapy OK'd in China for lung cancer
Jan. 13, 2021 11:33 PM ET BeiGene, Ltd. (BGNE)By: Mamta Mayani, SA News Editor
- The China National Medical Products Administration (NMPA) has approved BeiGene's (NASDAQ:BGNE) tislelizumab for use in combination with two chemotherapy regimens as a first-line treatment for patients with advanced squamous non-small cell lung cancer (NSCLC).
https://www.beigene.com/?loc=US
https://seekingalpha.com/symbol/BGNE
https://seekingalpha.com/symbol/BMY
biotecMAX™ January 2021 Insight
TYVYT® (sintilimab injection)
Innovent Announces NMPA Acceptance of a Supplemental New Drug Application for Sintilimab as Second-Line Therapy for Squamous Non-Small Cell Lung Cancer
NEWS PROVIDED BY Innovent Biologics Jan 12, 2021, 00:00 ET
SAN FRANCISCO and SUZHOU, China, Jan. 11, 2021 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced with Eli Lilly and Company ("Lilly",NYSE: LLY) that the National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application (sNDA) for TYVYT® (sintilimab injection) as second-line therapy for squamous non-small cell lung cancer (sqNSCLC). The application is the third sNDA for TYVYT® (sintilimab injection) in NSCLC.
TYVYT® (sintilimab injection)
About TYVYT® (Sintilimab Injection)
TYVYT® (sintilimab injection), an innovative drug with global quality standards jointly developed in China by Innovent and Eli Lilly and Company, has been granted marketing approval by the NMPA for the treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy, and is included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT® was included in the National Reimbursement Drug List (NRDL) in 2019 as the historically first PD-1 inhibitor entering in NRDL and the only PD-1 included in the list in that year.
In April 2020, the NMPA accepted the sNDA for TYVYT® (sintilimab injection) in combination with ALIMTA® (pemetrexed) and platinum chemotherapy as first-line therapy for the treatment of patients with non-squamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT® (sintilimab injection) monotherapy met the primary endpoint of overall survival in the Phase 2 ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma. In August 2020, the NMPA accepted the sNDA for TYVYT® in combination with GEMZAR® (gemcitabine for injection) and platinum chemotherapy as first-line therapy in squamous NSCLC. In September 2020, TYVYT® (sintilimab injection) in combination with BYVASDA® (bevacizumab biosimilar injection) as a first-line treatment in advanced hepatocellular carcinoma met the predefined primary endpoints of overall survival and progression-free survival in an interim analysis of the Phase 3 ORIENT-32 study. In January 2021, the NMPA accepted the sNDA for TYVYT® as second-line therapy for sqNSCLC.
TYVYT® (sintilimab injection), is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, block the PD-1 / PD-Ligand 1 (PD-L1) pathway and reactivate T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies with TYVYT® (sintilimab injection) to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials. Meanwhile, Innovent is conducting clinical research studies on TYVYT® (sintilimab injection) worldwide.
TYVYT® (sintilimab injection)
http://innoventbio.com/en/#/product/products
For more information, please visit: www.innoventbio.com.
To learn more about Lilly, please visit us at www.lilly.com and lilly.com/newsroom.
Innovent Announces NMPA Acceptance of a Supplemental New Drug Application for Sintilimab as Second-Line Therapy for Squamous Non-Small Cell Lung Cancer
Tue January 12, 2021 12:00 AM|PR Newswire|About: IVBIY, LLY
SAN FRANCISCO and SUZHOU, China, Jan. 11, 2021 /PRNewswire/ -- Innovent Biologics, Inc. (IVBIY) ("Innovent", HKEX: 01801)
https://seekingalpha.com/symbol/IVBIY
INNOVENT BIOLOGICS, INC. (1801)
https://www.hkex.com.hk/Market-Data/Securities-Prices/Equities/Equities-Quote?sym=1801&sc_lang=en
https://seekingalpha.com/symbol/LLY
ONUREG® (azacitidine tablets)
Health Canada Approves ONUREG® (azacitidine tablets), First Maintenance Therapy for Patients in Remission from Acute Myeloid Leukemia
Tue January 12, 2021 7:00 AM|Canada Newswire
ONUREG® has shown clinically meaningful increase in overall survival for patients
MONTREAL, Jan. 12, 2021 /CNW/ - Bristol Myers Squibb Canada (BMS)
ONUREG® (azacitidine tablets)
ONUREG® is a nucleoside metabolic inhibitor that is taken orally and works by preventing cancer cells from growing. ONUREG® becomes incorporated into the building blocks of cells (deoxyribonucleic acid (DNA) and ribonucleic acid (RNA)), which interferes with the production of new DNA and RNA. This is thought to kill cancerous cells in leukemia.10
"The approval of ONUREG® is an extension of our ongoing commitment to Canadians living with blood cancer," said Al Reba, General Manager, Bristol Myers Squibb Canada. "We are proud that this therapy will help to fill a significant need for Canadians living in remission from AML and hope that it will have a positive impact on their everyday life."
For more information about Bristol Myers Squibb global operations, visit www.bms.com
For more information, please visit www.bms.com/ca.
https://seekingalpha.com/symbol/BMY
Tafasitamab
MorphoSys and Incyte Announce Acceptance by Health Canada of the New Drug Submission for Tafasitamab
January 12, 2021 / 10:00 pm, CET Media Release
MorphoSys and Incyte Announce Acceptance by Health Canada of the New Drug Submission for Tafasitamab
PLANEGG/MUNICH, Germany and MONTREAL, Canada - January 12, 2021 - MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) and Incyte (NASDAQ: INCY) today announced that Health Canada has accepted the New Drug Submission (NDS) for tafasitamab, an anti-CD19 antibody. The application seeks approval of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not eligible for, or refuse, autologous stem cell transplant (ASCT).
For more information about L-MIND, visit https://clinicaltrials.gov/ct2/show/NCT02399085
For more information about RE-MIND, visit https://clinicaltrials.gov/ct2/show/NCT04150328.
Tafasitamab
About Tafasitamab
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Following approval by the U.S. Food and Drug Administration in July 2020, tafasitamab is being co-commercialized by MorphoSys and Incyte in the United States. Incyte has exclusive commercialization rights outside the United States.
Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.
More information at www.morphosys.com or www.morphosys-us.com.
For additional information on Incyte, please visit Incyte.com
Incyte and MorphoSys Announce Acceptance by Health Canada of the New Drug Submission for Tafasitamab
Tue January 12, 2021 4:00 PM|Canada Newswire|About: INCY, MOR
MONTREAL and PLANEGG/MUNICH, Germany, Jan. 12, 2021 /CNW/ - Incyte (INCY) and MorphoSys AG (MPSYF)
Incyte/MorphoSys' tafasitamab Canada application accepted for review
Jan. 12, 2021 4:15 PM ETIncyte Corporation (INCY)By: Vandana Singh, SA News Editor
- Health Canada has accepted for review Incyte (NASDAQ:INCY) and MorphoSys' (NASDAQ:MOR) marketing application seeking approval for tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.
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https://seekingalpha.com/symbol/MOR
(COVID-19 Vaccine Moderna)
United Kingdom Medicines and Healthcare products Regulatory Agency Authorizes Use of COVID-19 Vaccine Moderna
January 8, 2021 at 7:46 AM EST PDF Version
UK MHRA authorization is based on a rolling review of COVID-19 Vaccine Moderna data, including data from the Phase 3 COVE study
UK government secured an additional 10 million doses for a total of 17 million doses of the vaccine with supply beginning in early 2021
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 8, 2021-- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved its mRNA vaccine against COVID-19 (COVID-19 Vaccine Moderna) for use under Regulation 174. The temporary authorization permits the supply of COVID-19 Vaccine Moderna in Great Britain and is based upon the advice of the UK Commission on Human Medicines.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210108005274/en/
To learn more, visit www.modernatx.com.
(COVID-19 Vaccine Moderna)
To learn more about Moderna’s work on the COVID-19 Vaccine Moderna, visit www.modernatx.com/COVID19.
Moderna's COVID-19 vaccine wins U.K. regulators nod
Jan. 08, 2021 7:33 AM ETModerna, Inc. (MRNA)By: Mamta Mayani, SA News Editor1 Comment
- The U.K.'s Medicines and Healthcare products Regulatory Agency has authorized use of Moderna's (NASDAQ:MRNA) COVID-19 vaccine, the third to be licensed for use in the country.
https://seekingalpha.com/news/3649883-modernas-covidminus-19-vaccine-wins-u-k-regulators-nod
Moderna's COVID-19 vaccine wins U.K. regulators nod
Today, 7:33 AM | 1 Comment
Prognosis
U.K. Clears Moderna’s Vaccine to Add Third Covid-19 Shot
By Alex Morales, James Paton, and Suzi Ring January 8, 2021, 6:06 AM EST Updated on January 8, 2021, 8:44 AM EST
- Approval comes as pandemic surges anew across Britain
- U.K. also adds 10 million more vaccine doses from Moderna
https://seekingalpha.com/symbol/MRNA
Moderna COVID-19 Vaccine
https://www.modernatx.com/covid19vaccine-eua/
V114 =Investigational 15-valent Pneumococcal Conjugate Vaccine PNEUMOVAX 23
U.S. FDA Accepts for Priority Review the Biologics License Application for V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine, for Use in Adults 18 Years of Age and Older
January 12, 2021 6:45 am EST
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) accepted for priority review a Biologics License Application (BLA) for V114, Merck’s investigational 15-valent pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease in adults 18 years of age and older. The FDA set a Prescription Drug User Fee Act (PDUFA), or target action date, of July 18, 2021. The European Medicines Agency is also reviewing an application for licensure of V114 in adults.
Investigational 15-valent Pneumococcal Conjugate Vaccine
About V114
V114 is Merck’s investigational 15-valent pneumococcal conjugate vaccine candidate for the prevention of invasive pneumococcal disease in adults. V114 consists of pneumococcal polysaccharides from 15 serotypes conjugated to a CRM197 carrier protein and includes serotypes 22F and 33F, which are commonly associated with invasive pneumococcal disease in older adults worldwide and are not contained in the pneumococcal conjugate vaccine currently licensed for use in adults. Merck is also developing V114 for use in children. An overview of the late-stage development program for V114 is available here.
V114 previously received Breakthrough Therapy Designation from the FDA for the prevention of invasive pneumococcal disease in pediatric patients 6 weeks to 18 years of age and adults 18 years of age and older.
Indication for PNEUMOVAX 23 (Pneumococcal Vaccine Polyvalent)
PNEUMOVAX 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F and 33F).
PNEUMOVAX 23 is approved for use in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease.
PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.
Please see Prescribing Information for PNEUMOVAX 23
at http://www.merck.com/product/usa/pi_circulars/p/pneumovax_23/pneumovax_pi.pdf
and Patient Information for PNEUMOVAX 23
at http://www.merck.com/product/usa/pi_circulars/p/pneumovax_23/pneumovax_ppi.pdf.
PNEUMOVAX 23 is a vaccine that is given as a shot. It helps protect you from infection by certain germs or bacteria which are called pneumococcus (pronounced "noo-mo-ca-cus").
PNEUMOVAX 23 is for people 50 years of age and older, and those 2 years of age and older if they have certain medical conditions that put them at increased risk for infection.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210112005398/en/
For more information, visit www.merck.com
U.S. FDA Accepts for Priority Review the Biologics License Application for V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine, for Use in Adults 18 Years of Age and Older
Tue January 12, 2021 6:45 AM| Business Wire|About: MRK
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside the United States and Canada
Merck's V114 nabs accelerated review in U.S. for invasive pneumococcal disease in adults
Jan. 12, 2021 6:59 AM ET Merck & Co., Inc. (MRK)By: Mamta Mayani, SA News Editor
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BAVENCIO® (avelumab)
Health Canada Approves BAVENCIO® for the Maintenance Treatment of Patients with Advanced Bladder Cancer
Mon January 11, 2021 8:00 AM|Canada Newswire|About: MKKGY
BAVENCIO is the first and only maintenance therapy for unresectable locally advanced or metastatic urothelial carcinoma (UC) approved by Health Canada
MISSISSAUGA, ON, Jan. 11, 2021 /CNW/ - EMD Serono Canada, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Canada ULC announced that Health Canada has approved BAVENCIO® (avelumab) for the maintenance treatment of patients with unresectable locally advanced or metastatic UC whose disease has not progressed following first-line platinum-based chemotherapy.
BAVENCIO® (avelumab)
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.
About BAVENCIO® (avelumab)
BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody and is part of a class of immunotherapy drugs called immune checkpoint inhibitors. BAVENCIO was discovered by Merck KGaA, Darmstadt, Germany and is co-developed and co-commercialized by EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Canada ULC. BAVENCIO is also indicated for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC) and for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy.
https://www.emdserono.com/us-en
To learn more about Pfizer Canada, visit pfizer.ca
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https://seekingalpha.com/symbol/PFE
Health Canada OK's Pfizer/Merck KGaA's Bavencio for bladder cancer
Jan. 11, 2021 8:45 AM ET MERCK Kommanditgesellschaft auf Aktien (MKKGY) By: Aakash Babu, SA News Editor1 Comment
- Health Canada approves Pfizer (NYSE:PFE) and Merck KGaA (OTCPK:MKKGY) company EMD Serono Canada's Bavencio (avelumab)
Donanemab, an investigational antibody that targets a modified form of beta amyloid called N3pG,
Lilly's Donanemab Slows Clinical Decline of Alzheimer's Disease in Positive Phase 2 Trial
January 11, 2021Download PDF
INDIANAPOLIS, Jan. 11, 2021 /PRNewswire/ -- Donanemab, an investigational antibody that targets a modified form of beta amyloid called N3pG, showed significant slowing of decline in a composite measure of cognition and daily function in patients with early symptomatic Alzheimer's disease compared to placebo in results from Eli Lilly and Company's (NYSE: LLY) Phase 2 TRAILBLAZER-ALZ study. Donanemab met the primary endpoint of change from baseline to 76 weeks in the Integrated Alzheimer's Disease Rating Scale (iADRS), slowing decline by 32 percent relative to placebo, which was statistically significant. The iADRS is a clinical composite tool combining the cognitive measure ADAS-Cog13 and functional measure ADCS-iADL, two commonly used measures in Alzheimer's disease. Donanemab also showed consistent improvements in all prespecified secondary endpoints measuring cognition and function compared to placebo, but did not reach nominal statistical significance on every secondary endpoint.
About TRAILBLAZER-ALZ Study
TRAILBLAZER-ALZ (NCT03367403) is a randomized, placebo-controlled, double-blind, multi-center Phase 2 study to assess the safety, tolerability and efficacy of donanemab in patients with early symptomatic Alzheimer's disease.
Donanemab, an investigational antibody that targets a modified form of beta amyloid called N3pG,
The safety, tolerability and efficacy of donanemab are also being evaluated in the ongoing randomized, placebo-controlled, double-blind, multi-center Phase 2 study TRAILBLAZER-ALZ 2 (NCT04437511).
To learn more about Lilly, please visit us at lilly.com
Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/lillys-donanemab-slows-clinical-decline-of-alzheimers-disease-in-positive-phase-2-trial-301204830.html
Lilly's Donanemab Slows Clinical Decline of Alzheimer's Disease in Positive Phase 2 Trial
Mon January 11, 2021 6:30 AM|PR Newswire| About: LLY
INDIANAPOLIS, Jan. 11, 2021 /PRNewswire/ -- Donanemab, an investigational antibody that targets a modified form of beta amyloid called N3pG, showed significant slowing of decline in a composite measure of cognition and daily function in patients with early symptomatic Alzheimer's disease compared to placebo in results from Eli Lilly and Company's (NYSE: LLY) Phase 2 TRAILBLAZER-ALZ study.
https://seekingalpha.com/symbol/LLY
Jardiance® (empagliflozin)
US FDA accepts supplemental New Drug Application for Jardiance® (empagliflozin) for adults with heart failure with reduced ejection fraction
January 11, 2021Download PDF
RIDGEFIELD, Conn. and INDIANAPOLIS, Jan. 11, 2021 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin) which is being investigated as a potential new treatment to reduce the risk of cardiovascular death and hospitalization for heart failure and to slow kidney function decline in adults with chronic heart failure with reduced ejection fraction, including those with and without type 2 diabetes, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.
- EMPEROR-Reduced [NCT03057977] investigated the safety and efficacy of Jardiance in patients with chronic heart failure with reduced ejection fraction (HFrEF).
- Primary composite endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure
- Number of patients: 3,730
- Completion: 2020
- EMPEROR-Preserved [NCT03057951] investigates the safety and efficacy of Jardiance in patients with chronic heart failure with preserved ejection fraction (HFpEF).
- Primary composite endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure [Time Frame: up to 38 months]
- Anticipated number of patients: approx. 5,990
- Estimated completion: 2021
Jardiance® (empagliflozin)
What is JARDIANCE? (www.jardiance.com)
JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
JARDIANCE is also used to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.
JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
For more information, please see Prescribing Information and Medication Guide.
For more information, please visit www.boehringer-ingelheim.us
About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people affected by diabetes and related conditions. We work to deliver breakthrough outcomes through innovative solutions—from medicines and technologies to support programs and more. For the latest updates, visit http://www.lillydiabetes.com/ or follow us on Twitter: @LillyDiabetes and Facebook: LillyDiabetesUS.
Jardiance® and EMPA-REG OUTCOME® are registered trademarks of Boehringer Ingelheim.
View original content to download multimedia:http://www.prnewswire.com/news-releases/us-fda-accepts-supplemental-new-drug-application-for-jardiance-empagliflozin-for-adults-with-heart-failure-with-reduced-ejection-fraction-301203589.html
https://seekingalpha.com/symbol/LLY
valoctocogene roxaparvovec
BioMarin Announces Positive Phase 3 Gene Therapy Trial Results in Adults with Severe Hemophilia A; Study Met All Primary and Secondary Efficacy Endpoints in One-Year Data Set
- Significantly Reduced Mean Annualized Bleeding Rate by 84% (p-value <0.0001) Demonstrating Superiority to Factor VIII Prophylaxis, and Reduced Mean Annualized Factor VIII Infusion Rate by 99% (p-value <0.0001)
- Mean Factor VIII Expression 42.9 IU/dL at One Year in Full Study Population
- In Subset Dosed More than Two Years Ago, Slower Rate of Decline in Factor VIII Expression Was Observed Compared to Prior Study: Mean ABR in This Population Was 0.9 Over These Two-Plus Years
- BioMarin Plans to Meet with EMA to Discuss Submission of One-Year Data and FDA to Review Two-Year Data Request
- Call and Webinar to be Held Today, Sunday, January 10, 2021 at 7:15 PM Eastern
Jan 10, 2021
SAN RAFAEL, Calif., Jan. 10, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN)
valoctocogene roxaparvovec
Valoctocogene roxaparvovec is an investigational AAV5 gene therapy under regulatory review for the treatment of severe hemophilia A.
https://www.biomarin.com/our-treatments/pipeline/valoctocogene-roxaparvovec-for-severe-hemophilia-a/
BioMarin Announces Positive Phase 3 Gene Therapy Trial Results in Adults with Severe Hemophilia A; Study Met All Primary and Secondary Efficacy Endpoints in One-Year Data Set
Sun January 10, 2021 6:44 PM|PR Newswire|About: BMRN
BioMarin's valoctocogene roxaparvovec gene therapy shows positive effect in hemophilia A
Jan. 11, 2021 1:47 AM ET BioMarin Pharmaceutical Inc. (BMRN)By: Mamta Mayani, SA News Editor7 Comments
- BioMarin Pharmaceutical (NASDAQ:BMRN)
For additional information, please visit www.biomarin.com.
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NVX-CoV2373, Novavax’ COVID-19 vaccine candidate
Novavax Finalizes Agreement with Commonwealth of Australia for 51 Million Doses of COVID-19 Vaccine
Jan 07, 2021 at 6:14 PM ESTDownload PDF
- Advance Purchase Agreement signed for NVX-CoV2373, Novavax’ adjuvanted protein vaccine candidate
- Initial doses expected to be delivered as early as mid-2021
GAITHERSBURG, Md., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has executed an Advance Purchase Agreement with the Commonwealth of Australia for 51 million doses of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. This follows an agreement in principle that was announced in November 2020. NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax’ proprietary Matrix-M™ to enhance the immune response.
NVX-CoV2373, Novavax’ COVID-19 vaccine candidate
About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. It is adjuvanted with Novavax’ patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. NVX-CoV2373 was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that completed enrollment in November and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.
For more information, visit www.novavax.com
Novavax Finalizes Agreement with Commonwealth of Australia for 51 Million Doses of COVID-19 Vaccine
Thu January 7, 2021 6:14 PM|Globe Newswire - Canada|About: NVAX
- Advance Purchase Agreement signed for NVX-CoV2373, Novavax’ adjuvanted protein vaccine candidate
- Initial doses expected to be delivered as early as mid-2021
GAITHERSBURG, Md., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NVAX)
Novavax finalizes deal with Australia for 51M doses of COVID-19 vaccine
Jan. 08, 2021 1:20 AM ET Novavax, Inc. (NVAX) By: Mamta Mayani, SA News Editor3 Comments
https://seekingalpha.com/symbol/NVAX
NUBEQA® (darolutamide)
FDA approves Bayer's application to add overall survival benefit to its Nubeqa prescription information
Jan. 08, 2021 12:13 PM ET Bayer Aktiengesellschaft (BAYZF)
By: Aakash Babu, SA News Editor
- The FDA has approved Bayer's (OTCPK:BAYZF -2.3%) supplemental marketing application allowing to add overall survival (OS) and other secondary endpoint data from Phase 3 ARAMIS trial to the prescribing information for its cancer treatment Nubeqa (darolutamide).
NUBEQA® (darolutamide)
INDICATION
NUBEQA® (darolutamide) is a prescription medicine used to treat men with prostate cancer that has not spread to other parts of the body and is no longer responding to a medical or surgical treatment that lowers testosterone.
It is not known if NUBEQA is safe and effective in women and children.
September 9, 2020Not intended for U.S. and UK Media
https://seekingalpha.com/symbol/BAYZF
SPINRAZA® (NUSINERSEN)
BIOGEN ANNOUNCES FIRST PATIENT TREATED IN RESPOND STUDY EVALUATING BENEFIT OF SPINRAZA® (NUSINERSEN) IN PATIENTS TREATED WITH ZOLGENSMA® (ONASEMNOGENE ABEPARVOVEC)
January 8, 2021 at 7:30 AM EST
- The global Phase 4 RESPOND study will evaluate the efficacy and safety of SPINRAZA in patients with a suboptimal clinical response to Zolgensma
- Clinical and real-world experience have reported that some patients previously treated with Zolgensma have also been treated with SPINRAZA1,2,3,4
- Biogen remains committed to exploring the potential of SPINRAZA to optimize outcomes for patients with SMA
CAMBRIDGE, Mass., Jan. 08, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the first patient has been treated in the global clinical study, RESPOND. The Phase 4 study will examine the clinical benefit and assess the safety of SPINRAZA® (nusinersen) in infants and children with spinal muscular atrophy (SMA) who still have unmet clinical needs following treatment with gene therapy Zolgensma® (onasemnogene abeparvovec). RESPOND will be conducted at approximately 20 sites worldwide and aims to enroll up to 60 children with SMA.
SPINRAZA® (NUSINERSEN)
More information on the study (NCT04488133) is available at clinicaltrials.gov.
About SPINRAZA® (nusinersen)
SPINRAZA is approved to treat infants, children and adults with spinal muscular atrophy (SMA) and is available in more than 50 countries. As a foundation of care in SMA, more than 11,000 individuals have been treated with SPINRAZA worldwide.6
SPINRAZA is an antisense oligonucleotide (ASO) that targets the root cause of SMA by continuously increasing the amount of full-length survival motor neuron (SMN) protein produced in the body.5 It is administered directly into the central nervous system, where motor neurons reside, to deliver treatment where the disease starts.5
SPINRAZA has demonstrated sustained efficacy across ages and SMA types with a well-established safety profile based on data in patients treated up to 7 years, combined with unsurpassed real-world experience.7 The SPINRAZA clinical development program encompasses 10 clinical studies, which have included more than 300 individuals across a broad spectrum of patient populations,7 including two randomized controlled studies (ENDEAR and CHERISH). The ongoing SHINE and NURTURE open-label extension studies are evaluating the long-term impact of SPINRAZA. The most common adverse events observed in clinical studies were respiratory infection, fever, constipation, headache, vomiting and back pain. Laboratory tests can monitor for renal toxicity and coagulation abnormalities, including acute severe low platelet counts, which have been observed after administration of some ASOs.
Biogen licensed the global rights to develop, manufacture and commercialize SPINRAZA from Ionis Pharmaceuticals, Inc. (Nasdaq: IONS), the leader in antisense therapeutics. Please click here for Important Safety Information and full Prescribing Information for SPINRAZA in the U.S., or visit your respective country’s product website.
We routinely post information that may be important to investors on our website at www.biogen.com.
https://www.biogen.com/en_us/home.html
Biogen moves forward with Spinraza study in SMA patients treated with Zolgensma
Jan. 08, 2021 8:42 AM ET Biogen Inc. (BIIB)By: Gaurav Batavia, SA News Editor
- Biogen (NASDAQ:BIIB) has announced that first patient has been treated in Phase 4 (RESPOND) study, assessing benefit and safety of Spinraza (nusinersen) in patients with spinal muscular atrophy (SMA) who have suboptimal clinical response to AveXis' SMA gene therapy Zolgensma (onasemnogene abeparvovec).
https://seekingalpha.com/symbol/BIIB
biotecMAX™ January 2021 Insight
Vutrisiran
Alnylam Reports Positive Topline Results from HELIOS-A Phase 3 Study of Vutrisiran in Patients with hATTR Amyloidosis with Polyneuropathy
Jan 07, 2021
– Vutrisiran Met Primary and All Secondary Endpoints at 9 Months, with Statistically Significant Improvements in Progression of Neuropathy, Quality of Life (QOL), and Gait Speed, Relative to Placebo –
– Majority of Patients Showed Reversal of Disease Manifestations with Improvements in Neuropathy Impairment and QOL, Relative to Baseline –
– Vutrisiran Showed Improvements in the 9-Month Exploratory Cardiac Endpoint of NT-proBNP, Relative to Placebo –
– In Addition, Vutrisiran Demonstrated Encouraging Safety and Tolerability Profile –
– Alnylam Intends to Present Full 9-Month Results and File New Drug Application (NDA) in Early 2021 –
– Alnylam to Host Conference Call Today at 8:00 am ET –
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 7, 2021-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY)
Vutrisiran
About Vutrisiran
Vutrisiran is an investigational, subcutaneously administered RNAi therapeutic in development for the treatment of ATTR amyloidosis, which encompasses both hereditary (hATTR) and wild-type (wtATTR) amyloidosis. It is designed to target and silence specific messenger RNA, blocking the production of wild-type and variant transthyretin (TTR) protein before it is made. Quarterly administration of vutrisiran may help to reduce deposition and facilitate the clearance of TTR amyloid deposits in tissues and potentially restore function to these tissues. Vutrisiran utilizes Alnylam’s Enhanced Stabilization Chemistry (ESC)-GalNAc-conjugate delivery platform, designed for increased potency and high metabolic stability that allows for infrequent subcutaneous injections. The safety and efficacy of vutrisiran have not been evaluated by the U.S. Food and Drug Administration, European Medicines Agency or any other health authority.
HELIOS-A (NCT03759379) is a Phase 3 global, randomized, open-label study to evaluate the efficacy and safety of vutrisiran.
For more information about our people, science and pipeline, please visit www.alnylam.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20210107005224/en/
Alnylam's vutrisiran successful in late-stage nerve disorder study
Today, 9:25 AM
https://seekingalpha.com/symbol/ALNY
OUR PIPELINE
Alnylam is leading the translation of RNAi (RNA interference) into a whole new class of innovative medicines to potentially address the needs of patients who have limited or inadequate treatment options. Our pipeline of investigational RNAi therapeutics is focused on diseases with high unmet medical need that fall under 4 Strategic Therapeutic Areas (STArs): genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases.
https://www.alnylam.com/alnylam-rnai-pipeline/
Somatrogon
US FDA ACCEPTS REGULATORY SUBMISSION FROM PFIZER AND OPKO FOR REVIEW OF SOMATROGON TO TREAT PEDIATRIC PATIENTS WITH GROWTH HORMONE DEFICIENCY
Monday, January 04, 2021 - 07:00amEST
- If approved, somatrogon will serve as a once-weekly treatment option –
NEW YORK & MIAMI--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced today that the US Food and Drug Administration (FDA) has accepted for filing the initial Biologics License Application (BLA) for somatrogon, a long-acting human growth hormone that is intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency (GHD).
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210104005200/en/
US FDA Accepts Regulatory Submission from Pfizer and OPKO for Review of Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency
Mon January 4, 2021 6:45 AM|Business Wire|About: OPK, PFE
- If approved, somatrogon will serve as a once-weekly treatment option –
NEW YORK & MIAMI--(BUSINESS WIRE)-- Pfizer Inc. (PFE) and OPKO Health Inc. (OPK)
GENOTROPIN® (somatropin)
About GENOTROPIN® (somatropin)
GENOTROPIN is a man-made, prescription treatment option, approved in the United States for children who do not make enough growth hormone on their own, have the genetic condition called Prader-Willi syndrome (PWS), were born smaller than most other babies, have the genetic condition called Turner syndrome (TS) or have idiopathic short stature (ISS). GENOTROPIN is also approved to treat adults with growth hormone deficiency. GENOTROPIN is taken by injection just below the skin and is available in a wide range of devices to fit a range of individual dosing needs. GENOTROPIN is just like the natural growth hormone that our bodies make and has an established safety profile.
About Somatrogon
Somatrogon is an investigational biologic product that is glycosylated and comprises the amino acid sequence of human growth hormone and one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and two copies of CTP (in tandem) at the C-terminus. The glycosylation and CTP domains account for the half-life of the molecule. Somatrogon has received Orphan Drug designation in the U.S. and the EU for the treatment of children and adults with growth hormone deficiency.
For more information, visit http://www.OPKO.com.
https://seekingalpha.com/symbol/OPK
to learn more, please visit us on www.pfizer.com
https://seekingalpha.com/symbol/PFE
COVID-19 Vaccine AstraZeneca, formerly AZD1222
UK rolls out Oxford-AstraZeneca vaccine as it battles against Covid surge
PUBLISHED MON, JAN 4 20213:01 AM ESTUPDATED MON, JAN 4 20217:22 AM ESTHolly Ellyatt@HOLLYELLYATT
LONDON — The U.K. has started rolling out the coronavirus vaccine developed by AstraZeneca and the University of Oxford, marking another step in its battle against the coronavirus pandemic.
UK begins Oxford-AstraZeneca vaccinations; official more concerned of South Africa variant
https://www.cnbc.com/2021/01/04/covid-live-updates.html
South Africa to import 1.5M doses of the AstraZeneca vaccine
Today, 7:02 AM
Coronavirus: UK rolls out Oxford-AstraZeneca vaccine but new strains are cause for ‘incredible worry’
The vaccine is seen as a game-changer by many experts because it does not require very cold temperatures for storage
However, scientists are reportedly concerned that vaccines may not work on a new variant of the coronavirus found in South Africa
Agence France-Presse Published: 5:52pm, 4 Jan, 2021
U.K. rolls out AstraZeneca-Oxford's COVID-19 vaccine - CNBC
Jan. 04, 2021 4:38 AM ETAstraZeneca PLC (AZN)By: Mamta Mayani, SA News Editor6 Comments
- Britain began rolling out the coronavirus vaccine developed by AstraZeneca (NASDAQ:AZN) and the University of Oxford - CNBC.
https://seekingalpha.com/news/3648217-u-k-rolls-out-astrazeneca-oxfords-covidminus-19-vaccine-cnbc
https://www.astrazeneca-us.com/
https://seekingalpha.com/symbol/AZN
Pfizer‑BioNTech COVID‑19 Vaccine (also known as BNT162b2)
Prognosis
The bloc is pursuing a deal that could double its Pfizer shot supply.
Pfizer COVID-19 Vaccine Production and Distribution Working Well New York, NY, December 17, 2020 – Pfizer Inc. (NYSE: PFE) today released the following statement to address public comments that allege there are issues in the production and distribution of the company’s COVID-19 vaccine:
JANUARY 6, 20219:05 AM
EU may soon approve new use of Pfizer vaccine increasing doses by 20% - source
By Francesco Guarascio BRUSSELS (Reuters) -
Pfizer/BioNTech to get EU approval for a change for its COVID-19 vaccine use - Reuters
Jan. 06, 2021 12:35 PM ET Pfizer Inc. (PFE)By: Dulan Lokuwithana, SA News Editor7 Comments
Pfizer‑BioNTech COVID‑19 Vaccine (also known as BNT162b2)
Please see EUA Fact Sheet at www.cvdvaccine.com.
Prognosis
The research comes as Covid-19 is spreading globally at record daily levels.
Pfizer vaccine 'works' against key variant mutation, study suggests
By James Gallagher
Health and science correspondent Related Topics Coronavirus pandemic
https://www.bbc.com/news/health-55587320
EU regulators OK increasing doses from virus vaccine vials
Fri January 8, 2021 5:20 AM |Associated Press|About: AZN, MRNA, PFE Associated Press, The
BRUSSELS (AP) — Germany’s Health Ministry says European Union regulators have approved doctors drawing up to six doses from each vial of the coronavirus vaccine made by BioNTech-Pfizer vaccine.
https://seekingalpha.com/pr/18144145-eu-regulators-ok-increasing-doses-from-virus-vaccine-vials
Prognosis
Pfizer, BioNTech Shot May Defeat New Variants, Study Shows
By Naomi Kresge and Jason GaleJanuary 8, 2021, 2:09 AM EST Updated on January 8, 2021, 10:17 AM EST
- Study looked at mutation common to U.K., South Africa strains
- The early data hasn’t yet been subjected to peer review
AN IN VITRO STUDY SHOWS PFIZER-BIONTECH COVID-19 VACCINE ELICITS ANTIBODIES THAT NEUTRALIZE SARS-COV-2 WITH A MUTATION ASSOCIATED WITH RAPID TRANSMISSION
Friday, January 08, 2021 - 12:00am
New York, NY and Mainz, Germany, January 8, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced results from an in vitro study conducted by Pfizer and the University of Texas Medical Branch (UTMB) that shows the antibodies from people who have received the Pfizer-BioNTech COVID-19 vaccine effectively neutralize SARS-CoV-2 with a key mutation that is also found in two highly transmissible strains. The results were published on the preprint server bioRxiv and are available here.
Pfizer-BioNTech vaccine found to be effective against Covid variant discovered in the UK
PUBLISHED WED, JAN 20 20215:30 AM ESTUPDATED WED, JAN 20 20216:43 AM EST KEY POINTS
- The variant, known as B.1.1.7., has an unusually high number of mutations and is associated with more efficient and rapid transmission.
- It had led to concerns about the effectiveness of Covid vaccines against it.
- Authors of the study warned the rapid spread of Covid variants worldwide required “continuous monitoring of the significance of changes for maintained protection by currently authorized vaccines.”
https://seekingalpha.com/symbol/BNTX
https://seekingalpha.com/symbol/PFE
Risankizumab (SKYRIZI®)
January 5, 2021
Risankizumab (SKYRIZI®) Phase 3 Results Demonstrate Improvements in Disease Activity Across Joint and Skin Symptoms Among Psoriatic Arthritis Patients
- In KEEPsAKE-1 and KEEPsAKE-2, 57 and 51 percent of patients receiving risankizumab achieved the primary endpoint of ACR20 response at week 24, respectively, versus 34 and 27 percent receiving placebo (p<0.001)[1]
- KEEPsAKE-1 and KEEPsAKE-2 evaluated risankizumab in adult patients with active psoriatic arthritis, and included patients who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs)[1]
- The safety results in these studies to-date were generally consistent with the known profile of risankizumab in psoriasis patients[1-4]
- Risankizumab (SKYRIZI), an interleukin-23 (IL-23) inhibitor, is being evaluated as a treatment for adults with active psoriatic arthritis and several other immune-mediated diseases[1,5-7]
NORTH CHICAGO, Ill., Jan. 5, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive top-line results from two Phase 3 studies in adults with active psoriatic arthritis, KEEPsAKE-1 and KEEPsAKE-2, showing that significantly more patients treated with risankizumab (150 mg) achieved the primary endpoint of ACR20 response at week 24 versus placebo.1 In KEEPsAKE-1 and KEEPsAKE-2, 57 and 51 percent of patients receiving risankizumab achieved ACR20 response at week 24, respectively, versus 34 and 27 percent receiving placebo (p<0.001).1
Risankizumab (SKYRIZI®)
About risankizumab (SKYRIZI®)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis.12,13 In April 2019, SKYRIZI received U.S. Food and Drug Administration approval for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The approved dose for SKYRIZI is 150 mg (two 75 mg injections), administered by subcutaneous injection at week 0 and 4, and every 12 weeks thereafter. SKYRIZI was also approved by the European Commission in April 2019. Phase 3 trials of SKYRIZI in psoriasis, Crohn's disease and psoriatic arthritis are ongoing.5-7,10,11 Use of SKYRIZI in psoriatic arthritis is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
About SKYRIZI (risankizumab-rzaa) in the United States13
SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
For more information about AbbVie, please visit us at www.abbvie.com.
AbbVie's risankizumab shows positive action in patients with psoriatic arthritis
Jan. 05, 2021 9:06 AM ETAbbVie Inc. (ABBV)By: Mamta Mayani, SA News Editor6 Comments
January 7, 2021
Risankizumab (SKYRIZI®) Demonstrates Significant Improvements in Clinical Remission and Endoscopic Response in Two Phase 3 Induction Studies in Patients with Crohn's Disease
- A significantly greater proportion of patients with Crohn's disease treated with either dose of risankizumab (600 mg or 1200 mg) achieved both primary endpoints, demonstrating statistically significant results for clinical remission and endoscopic response at week 12 compared to placebo[1,2]
- The overall safety results in these studies were generally consistent with the known safety profile of risankizumab, with no new safety risks observed[1-6]
- Risankizumab (SKYRIZI), an interleukin-23 (IL-23) inhibitor, is being evaluated as a treatment for adults with moderate to severe Crohn's disease and several other immune-mediated conditions[1,2,7,8]
- More than 3.5 million people globally live with inflammatory bowel diseases (IBD), including Crohn's disease, and the incidence continues to rise[9]
NORTH CHICAGO, Ill., Jan. 7, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV)
Multiplicity-adjusted key secondary endpoints included clinical response (per CDAI) at week 4 defined as a decrease in CDAI score from baseline of ≥100 points (CDAI100). More information can be found on www.clinicaltrials.gov (ADVANCE: NCT03105128; MOTIVATE: NCT03104413).
AbbVie's risankizumab shows improvements in clinical remission and endoscopic response in Crohn's disease
Today, 9:12 AM | 5 Comments
https://seekingalpha.com/symbol/ABBV
Tiragolumab Granted FDA Breakthrough Therapy Designation in Combination With Tecentriq
Monday, Jan 4, 2021
Genentech’s Novel Anti-TIGIT Tiragolumab Granted FDA Breakthrough Therapy Designation in Combination With Tecentriq for PD-L1-High Non-Small Cell Lung Cancer
Tiragolumab is the first anti-TIGIT therapy to be granted Breakthrough Therapy Designation (BTD) and marks the 37th BTD for Genentech’s portfolio of medicines
BTD is based on the randomized Phase II CITYSCAPE study that showed encouraging efficacy and safety with tiragolumab plus Tecentriq (atezolizumab) in people with PD-L1-positive metastatic non-small cell lung cancer
Broad tiragolumab development program is ongoing across various settings in different tumor types, including lung, esophageal and cervical cancers
South San Francisco, CA -- January 4, 2021 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)
Tiragolumab Granted FDA Breakthrough Therapy Designation in Combination With Tecentriq
About tiragolumab
Tiragolumab is a monoclonal antibody designed to bind with TIGIT, a protein receptor on immune cells. Tiragolumab works as an immune amplifier, by potentially enhancing the body’s immune response. By binding to TIGIT, tiragolumab blocks its interaction with a protein called poliovirus receptor (PVR, or CD155) that can suppress the body’s immune response. Blockade of TIGIT and PD-L1 may synergistically enable the re-activation of T cells and enhance NK cell anti-tumor activity.
Tiragolumab (anti-TIGIT)
(RG6058, MTIG7192A)
https://www.genentechoncology.com/pipeline-molecules/tiragolumab.html
About Tecentriq® (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.
Tecentriq U.S. Indications (pronounced ‘tē-SEN-trik’)
Tecentriq is a prescription medicine used to treat adults with:
A type of bladder and urinary tract cancer called urothelial carcinoma.
Please visit http://www.Tecentriq.com for the full Tecentriq Prescribing Information for additional Important Safety Information.
For additional information about the company, please visit http://www.gene.com.
https://seekingalpha.com/symbol/RHHBY
Genentech’s Novel Anti-TIGIT Tiragolumab Granted FDA Breakthrough Therapy Designation in Combination With Tecentriq for PD-L1-High Non-Small Cell Lung Cancer
Tue January 5, 2021 1:00 AM|Business Wire|About: RHHBY
– Tiragolumab is the first anti-TIGIT therapy to be granted Breakthrough Therapy Designation (BTD) and marks the 37th BTD for Genentech’s portfolio of medicines –
– BTD is based on the randomized Phase II CITYSCAPE study that showed encouraging efficacy and safety with tiragolumab plus Tecentriq (atezolizumab) in people with PD-L1-positive metastatic non-small cell lung cancer –
– Broad tiragolumab development program is ongoing across various settings in different tumor types, including lung, esophageal and cervical cancers –
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)
FARXIGA® (dapagliflozin)
FARXIGA granted Priority Review in the US for the treatment of patients with chronic kidney disease
PUBLISHED6 January 2021
FARXIGA could become the first SGLT2 inhibitor approved to treat
patients with chronic kidney disease, with and without type 2 diabetes
AstraZeneca’s FARXIGA (dapagliflozin) has been granted Priority Review in the US for the treatment of new or worsening chronic kidney disease (CKD) in adults with and without type 2 diabetes (T2D).
In March 2020, an independent Data Monitoring Committee recommended the trial be stopped early, based on its determination of overwhelming efficacy. Detailed results from the DAPA-CKD trial were shared in August 2020 and published in The New England Journal of Medicine.
FARXIGA® (dapagliflozin)
Please see accompanying US Full Prescribing Information and Medication Guide for FARXIGA.
What is FARXIGA?
FARXIGA is a prescription medicine used to:
improve blood sugar control along with diet and exercise in adults with type 2 diabetes
reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and known cardiovascular disease or multiple cardiovascular risk factors
reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (when the heart is weak and cannot pump enough blood to the rest of your body)
FARXIGA should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in your blood or urine).
For more information, please visit www.astrazeneca-us.com
FARXIGA Granted Priority Review in the US for the Treatment of Patients With Chronic Kidney Disease
Wed January 6, 2021 7:00 AM|Business Wire|About: AZN
FARXIGA could become the first SGLT2 inhibitor approved to treat patients with chronic kidney disease, with and without type 2 diabetes
WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca’s FARXIGA (dapagliflozin) has been granted Priority Review in the US for the treatment of new or worsening chronic kidney disease (CKD) in adults with and without type 2 diabetes (T2D).
https://seekingalpha.com/symbol/AZN
AstraZeneca’s Farxiga nabs U.S. Priority Review for CKD
Jan. 06, 2021 9:15 AM ET AstraZeneca PLC (AZN)By: Vandana Singh, SA News Editor
https://seekingalpha.com/news/3649261-astrazeneca-s-farxiga-nabs-u-s-priority-review-for-ckd
selinexor, XPOVIO®
Antengene Submits NDA for ATG-010 (Selinexor) in South Korea for rrMM and rrDLBCL
Jan 04, 2021View PDF
Shanghai and Hong Kong, PRC, January 4, 2021-- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in class therapeutics in hematology and oncology, announced that it has submitted a New Drug Application (NDA) with Orphan Drug Designation (ODD) to the South Korean Ministry of Food and Drug Safety (MFDS) for ATG-010 (selinexor, XPOVIO®) in combination with low dose dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma (rrMM) and for ATG-010 (selinexor, XPOVIO®) as monotherapy to treat adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). ATG-010 (selinexor, XPOVIO®) was granted orphan drug designation in South Korea in October 2020 and our US partner Karyopharm received U.S. Food and Drug Administration (FDA) approval for the treatment of patients with multiple myeloma after at least one prior therapy on December 18, 2020.
Antengene Announces Submission of IND Application in China for a Global Phase 3 Trial of ATG-010 (Selinexor) in Advanced or Recurrent Endometrial Cancer
Mon January 4, 2021 7:00 PM|PR Newswire| About: KPTI
SHANGHAI and HONG KONG, Jan. 4, 2021 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK)
Karyopharm/Antengene files application for ATG-010 in China for endometrial cancer
Jan. 04, 2021 11:35 PM ET Karyopharm Therapeutics Inc. (KPTI)By: Mamta Mayani, SA News Editor
selinexor, XPOVIO®
About ATG-010 (selinexor, XPOVIO®)
ATG-010 (selinexor, XPOVIO®), a first-in-class and only-in-class oral selective inhibitor of nuclear export compound discovered and developed by Karyopharm Therapeutics Inc. (NASDAQ: KPTI), is currently being developed by Antengene, which has the exclusive development and commercial rights in certain Asia-Pacific markets, including the Greater China, South Korea, Australia, New Zealand and the ASEAN countries. In July 2019, the US Food and Drug Administration (FDA) approved selinexor (XPOVIO®) in combination with low-dose dexamethasone for the treatment of relapsed/refractory multiple myeloma (rrMM) and in June 2020 approved selinexor (XPOVIO®) as a single-agent for the treatment of relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). A Marketing Authorization Application (MAA) has also been submitted to the European Medicines Agency (EMA) with a request for conditional approval of selinexor (XPOVIO®) in this same rrMM indication. On December 18, 2020, the supplemental New Drug Application (sNDA) with a request for an expansion of its indication to include the treatment for patients with multiple myeloma after at least one prior therapy was approved by the FDA. Selinexor (XPOVIO®) is so far the first and only oral SINE compound approved by the FDA and is the first drug approved by the FDA for the treatment of both MM and DLBCL. Selinexor (XPOVIO®) is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. In November 2020, at the Connective Tissue Oncology Society 2020 Annual Meeting (CTOS 2020), Antengene’s partner, Karyopharm, presented positive results from the Phase 3 randomized, double blind, placebo controlled, cross-over SEAL study evaluating single agent, oral selinexor (XPOVIO®) versus matching placebo in patients with liposarcoma. Karyopharm also recently announced that the ongoing Phase 3 SIENDO study of selinexor (XPOVIO®) in patients with endometrial cancer passed the planned interim futility analysis and the Data and Safety Monitoring Board (DSMB) recommended the study should proceed as planned without any modifications. Top-line SIENDO study results are expected in the second half of 2021.
What is XPOVIO?
XPOVIO® (selinexor) is a prescription medicine used:
- in combination with bortezomib and dexamethasone to treat adult patients with multiple myeloma who have received at least one prior therapy.
Pipeline
https://www.antengene.com/rd#rd_4
https://seekingalpha.com/symbol/KPTI
Karyopharm/Antengene files South Korean application for ATG-010 in blood cancer
Jan. 04, 2021 2:11 AM ETKaryopharm Therapeutics Inc. (KPTI)By: Mamta Mayani, SA News Editor
Sinovac’s Covid Shot Proves 78% Effective in Brazil Trial
Prognosis
Sinovac’s Covid Shot Proves 78% Effective in Brazil Trial
By Andre Romani Pinto January 7, 2021, 9:19 AM EST Updated on January 7, 2021, 10:43 AM EST
- Previous data on Chinese-developed shot had sparked confusion
- Sinovac can make more than 600 million doses a year in China
Most definitive data so far may shore up confidence in vaccine’s effectiveness after previous findings sowed confusion and doubt
Jan 08, 2021 05:30 AM
Sinovac’s Covid-19 Vaccine Is 78% Effective in Brazil Late-Stage Trials
China’s shot also gives 100% protection against severe cases of the disease, raising hopes it can be widely used in the developing world
http://www.sinovac.com/?optionid=455
Tisotumab Vedotin
Genmab Announces Phase 3 Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer
Jan 4, 2021 at 8:00 PM CET
Media Release
COPENHAGEN, Denmark, Jan. 04, 2021
- Initiation of a global phase 3 trial for tisotumab vedotin versus investigator’s choice chemotherapy in recurrent or metastatic cervical cancer
Genmab A/S (Nasdaq: GMAB) announced today the initiation of innovaTV 301 trial, a global phase 3 study to evaluate the efficacy of tisotumab vedotin compared to chemotherapy in patients with recurrent or metastatic cervical cancer who have received one or two prior lines of systemic therapy. The innovaTV 301 trial is a global, randomized phase 3 trial in which tisotumab vedotin will be compared with physician’s choice single agent chemotherapy.
Tisotumab Vedotin
About Tisotumab Vedotin
Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) composed of Genmab’s fully human monoclonal antibody specific for tissue factor and Seagen’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody and releases it upon internalization, inducing target cell death. In cancer biology, tissue factor is a protein that can promote tumor growth, angiogenesis and metastasis.1 Based on its high expression on many solid tumors and its rapid internalization, tissue factor was selected as a target for an ADC approach. Tisotumab vedotin is being co-developed by Genmab and Seagen, under an agreement in which the companies share all costs and profits for the product on a 50:50 basis.
Tisotumab vedotin is being evaluated in ongoing clinical trials as monotherapy in a range of solid tumors, including recurrent and/or metastatic cervical cancer, ovarian cancer, and other solid tumors and in combination with commonly used therapies in recurrent or metastatic cervical cancer. These trials are evaluating tisotumab vedotin on a weekly or every three-week dosing schedule.
For more information, please visit Genmab.com.
Genmab A/S (Nasdaq: GMAB)
https://seekingalpha.com/symbol/GMAB
Genmab launches late-stage tisotumab study in cervical cancer
Jan. 04, 2021 3:33 PM ETGenmab A/S (GMAB)By: Aakash Babu, SA News Editor
https://seekingalpha.com/news/3648467-genmab-launches-late-stage-tisotumab-study-in-cervical-cancer
Tisotumab vedotin is designed to target tissue factor (TF) using our proprietary antibody–drug conjugate (ADC) technology. TF is highly expressed on many solid tumors, including ovarian, prostate, bladder, esophageal, endometrial, and lung tumors.1,2,3
Tisotumab vedotin is being developed in collaboration with Genmab.
https://www.seagen.com/science/pipeline/tisotumab-vedotin
PIPELINE
We turn science into medicine
https://www.genmab.com/pipeline/
https://seekingalpha.com/symbol/SGEN
Loncastuximab Tesirine
ADC Therapeutics Initiates Expanded Access Program for Loncastuximab Tesirine in the U.S.
JANUARY, 07, 2021
LAUSANNE, Switzerland--(BUSINESS WIRE)-- ADC Therapeutics SA (NYSE:ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, announced today the initiation of an expanded access program (EAP) for loncastuximab tesirine (Lonca, formerly ADCT-402) for patients in the U.S. with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The EAP is for patients who cannot be treated by currently available drugs, cell therapy, or clinical trials.
Loncastuximab Tesirine
About Loncastuximab Tesirine
Loncastuximab tesirine (Lonca, formerly ADCT-402) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody directed against human CD19 and conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Once bound to a CD19-expressing cell, Lonca is designed to be internalized by the cell, following which the warhead is released. The warhead is designed to bind irreversibly to DNA to create highly potent interstrand cross-links that block DNA strand separation, thus disrupting essential DNA metabolic processes such as replication and ultimately resulting in cell death. CD19 is a clinically validated target for the treatment of B-cell malignancies.
A Biologics License Application for Lonca for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) is currently under review with the U.S. Food and Drug Administration (FDA) and has been granted priority review status. The FDA has set a Prescription Drug User Fee Act target date of May 21, 2021. Lonca is being evaluated in LOTIS 3, a Phase 1/2 clinical trial in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma, and LOTIS 5, a Phase 3 confirmatory clinical trial in combination with rituximab in patients with relapsed or refractory DLBCL.
https://adctherapeutics.com/our-pipeline1-1/adct-402-lonca/
View source version on businesswire.com: https://www.businesswire.com/news/home/20210107005169/en/
https://ir.adctherapeutics.com/overview/default.aspx
ADC Therapeutics initiates expanded access program for loncastuximab tesirine in the U.S.
Today, 10:35 AM
https://seekingalpha.com/symbol/ADCT
Roche’s Actemra (tocilizumab) & Sanofi’s Kevzara (sarilumab)
Roche’s Actemra (tocilizumab) and Sanofi’s Kevzara (sarilumab)
Results
Tocilizumab and sarilumab both met the pre-defined triggers for efficacy. At the time of full analysis 353 patients had been assigned to tocilizumab, 48 to sarilumab and 402 to control. Median organ support-free
days were 10 (interquartile range [IQR] -1, 16), 11 (IQR 0, 16) and 0 (IQR -1, 15)for tocilizumab, sarilumab and control, respectively. Relative to control, median adjusted odds ratios were 1.64(95% credible intervals [CrI] 1.25, 2.14) for tocilizumab and 1.76(95%CrI 1.17, 2.91) for sarilumab, yielding >99.9% and 99.5% posterior probabilities of superiority compared with control. Hospital mortality was28.0% (98/350) for tocilizumab, 22.2% (10/45) for sarilumab and 35.8% (142/397) for control. All secondary outcomes and analyses supported efficacy of theseIL-6 receptor antagonists.
Tocilizumab and sarilumab
(ClinicalTrials.gov number: NCT02735707)
The new tongue-twisting drugs that can 'cut the risk of death by up to 24%': Boris Johnson hails 'life-saving' arthritis drugs trial (after stumbling over how to pronounce them)
- UK-led study investigated two drugs: tocilizumab and sarilumab
- These anti-inflammatory treatments are currently used to treat arthritis
- REMAP-CAP trial found they are effective at treating severely-ill Covid patients
- Without the drugs patients had a death rate of 35.8% and with the drugs this dropped to 25.3%
By JOE PINKSTONE FOR MAILONLINE
PUBLISHED: 11:00 EST, 7 January 2021 | UPDATED: 12:53 EST, 7 January 2021
Roche/Sanofi treatment combo improves survival rates in COVID-19 – Study
Jan. 07, 2021 12:54 PM ET Sanofi (SNY) By: Dulan Lokuwithana, SA News Editor
- A combination of drugs from Sanofi (NASDAQ:SNY) and Roche (OTCQX:RHHBY) has improved the survival rates and sped up the recovery in critically ill COVID-19 patients, Daily Mail reports, quoting the results of a study published online today.
By Carolyn Y. Johnson and Ben Guarino
https://www.washingtonpost.com/health/2021/01/08/covid-arthritis-drugs-treatment/
https://seekingalpha.com/symbol/SNY
https://seekingalpha.com/symbol/RHHBY