Moorestown, New Jersey, United States
BIOTECNOVA™
biotecNOVA™ - Let The Light In
biotecNOVA™ - Let The Light In
Jul. 11, 2020 12:00 PM ET|About: Amgen Inc. (AMGN), BGNE, GILD, GSK, NVAX, PFE, AZN, JNJ
Summary
some encouraging biotech news events and hopeful USA investments in vaccine development and anti-viral development.
The number of Covid-19 cases in the USA is the highest in the world and getting worse.
a temporary truce between politicos and the biopharma community.
if there is a business sector that can unite Americans, Europeans and Chinese more than any other sector it is the biotech sector.
BIOTECNOVA™
BIOTECNOVA™
BIOTECNOVA™ -First Group Page
BIOTECNOVA™
I
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OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab)
I
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab)
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab)
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab)
European Medicines Agency Validates Bristol Myers Squibb’s Type II Variation Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for First-line Treatment of Malignant Pleural Mesothelioma
Tue September 15, 2020 6:59 AM|Business Wire|About: BMY
Opdivo plus Yervoy would potentially be the first immunotherapy option for the first-line treatment of this cancer with high unmet needs
Application based on positive results from pivotal Phase 3 CheckMate -743 trial
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)
https://seekingalpha.com/symbol/BMY
Please see U.S. Full Prescribing Information for OPDIVO and YERVOY.
European Medicines Agency Validates Bristol Myers Squibb’s Type II Variation Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for First-line Treatment of Malignant Pleural Mesothelioma
09/15/2020CATEGORY:
Opdivo plus Yervoy would potentially be the first immunotherapy option for the first-line treatment of this cancer with high unmet needs
Application based on positive results from pivotal Phase 3 CheckMate -743 trial
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)
View source version on businesswire.com: https://www.businesswire.com/news/home/20200915005684/en/
IMFINZI® (durvalumab)
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab)
IMBRUVICA® (ibrutinib) in Combination with Rituximab
Imfinzi approved in the EU for the treatment of extensive-stage small cell lung cancer
PUBLISHED1 September 2020
1 September 2020 07:00 BST
Only PD-1/PD-L1 immunotherapy to demonstrate a significant survival benefit and improved response rate in combination with a choice of chemotherapies
AstraZeneca's Imfinzi OK'd in Europe for first-line lung cancer
Sep. 1, 2020 5:56 AM ET|About: AstraZeneca PLC (AZN)|By: Mamta Mayani, SA News Editor
https://seekingalpha.com/news/3610330-astrazenecas-imfinzi-okd-in-europe-for-first-line-lung-cancer
https://seekingalpha.com/symbol/AZN
https://www.imfinzi.com/patient.html
IMBRUVICA® (ibrutinib) in Combination with Rituximab
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab)
IMBRUVICA® (ibrutinib) in Combination with Rituximab
Janssen Announces European Commission Decision for Expanded Use of IMBRUVICA® (ibrutinib) in Combination with Rituximab for Previously Untreated Patients with Chronic Lymphocytic Leukaemia (CLL)
Mon September 7, 2020 4:45 AM|Business Wire|About: JNJ
Patients who were new to CLL treatment lived longer without disease progression with the IMBRUVICA®-based regimen compared to patients treated with a chemo-immunotherapy regimen1
BEERSE, Belgium--(BUSINESS WIRE)-- The Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ)
The primary study results were published previously in The New England Journal of Medicine,
For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200907005149/en/
https://seekingalpha.com/symbol/JNJ
https://seekingalpha.com/symbol/ABBV
https://www.rituxan.com/patient/what-is-rituxan.html
https://seekingalpha.com/symbol/RHHBY
BIOTECNOVA™
Veklury® (Remdesivir)
Tecentriq® (atezolizumab) and bevacizumab combination
Tecentriq® (atezolizumab) and bevacizumab combination
Gilead’s Investigational Antiviral Veklury® (Remdesivir) Receives U.S. Food and Drug Administration Emergency Use Authorization for the Treatment of Patients With Moderate COVID-19
Fri August 28, 2020 4:45 PM|Business Wire|About: GILD
-- Expands Previous Authorization of Veklury to Treat Hospitalized Patients with COVID-19 Regardless of Oxygen Status --
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD)
please review the Fact Sheets and FDA Letter of Authorization available at www.gilead.com/remdesivir.
Gilead Sciences Update On The Company’s Ongoing Response To COVID-19
https://www.gilead.com/purpose/advancing-global-health/covid-19
View source version on businesswire.com: https://www.businesswire.com/news/home/20200828005370/en/
https://seekingalpha.com/symbol/GILD
FDA OKs emergency use of Gilead's remdesivir for moderate COVID-19
Aug. 28, 2020 4:56 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor
Remdesivir Emergency Use
Tecentriq® (atezolizumab) and bevacizumab combination
Tecentriq® (atezolizumab) and bevacizumab combination
Tecentriq® (atezolizumab) and bevacizumab combination
Health Canada grants market authorization for Tecentriq® in combination with bevacizumab,[1] the first immunotherapy combination treatment, for the most common form of liver cancer
Wed August 19, 2020 7:00 AM|Canada Newswire
Tecentriq in combination with bevacizumab improved overall survival and progression-free survival compared to the previous standard of care[3]
MISSISSAUGA, ON, Aug. 19, 2020 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) today announced that Health Canada has granted market authorization for Tecentriq (atezolizumab for injection), in combination with bevacizumab, for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who require systemic therapy.[4]
please visit www.RocheCanada.com.
https://seekingalpha.com/symbol/BMY
https://seekingalpha.com/symbol/RHHBY
Imfinzi (durvalumab)
Tecentriq® (atezolizumab) and bevacizumab combination
Imfinzi (durvalumab)
Imfinzi granted FDA Priority Review for less-frequent,
fixed-dose use
PUBLISHED18 August 2020
18 August 2020 07:00 BST
Option would extend dosing to four weeks in non-small cell lung and bladder cancer reducing medical visits by half
AstraZeneca's Imfinzi (durvalumab) has received acceptance for its supplemental Biologics License Application (sBLA) and has also been granted Priority Review in the US for a new four-week, fixed-dose regimen for treatment in the approved indications of non-small cell lung cancer (NSCLC) and bladder cancer.
https://seekingalpha.com/symbol/AZN
https://www.imfinzi.com/stage-3-nsclc.html
Imfinzi approved in Japan for the treatment of extensive-stage small cell lung cancer
PUBLISHED21 August 2020
21 August 2020 07:00 BST
Only PD-1/PD-L1 immunotherapy to demonstrate both a significant survival benefit and improved response rate in combination with a choice of chemotherapies
AstraZeneca’s Imfinzi (durvalumab) has been approved in Japan for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC), in combination with etoposide plus a choice of platinum chemotherapy (either carboplatin or cisplatin). SCLC is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly, despite initial response to chemotherapy.1,2
OPDIVO® (nivolumab)
Opdivo® (nivolumab) Plus Yervoy® (ipilimumab)
Imfinzi (durvalumab)
CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival
Tue August 11, 2020 6:59 AM|Business Wire|About: BMY
Opdivo is the first and only treatment to demonstrate superior efficacy in patients with esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy and resection
Second tumor, in addition to melanoma, where Opdivo has demonstrated a benefit in the adjuvant setting
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)
Please see U.S. Full Prescribing Information for OPDIVO and YERVOY
https://www.businesswire.com/news/home/20200811005248/en/
CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival
Opdivo is the first and only treatment to demonstrate superior efficacy in patients with esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy and resection
Second tumor, in addition to melanoma, where Opdivo has demonstrated a benefit in the adjuvant setting
CATEGORY:
CORPORATE/FINANCIAL NEWSTUESDAY, AUGUST 11, 2020 6:59 AM EDT
Bristol Myers' Opdivo successful in two late-stage studies
Aug. 11, 2020 7:31 AM ET|About: Bristol-Myers Squibb C... (BMY)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3603939-bristol-myers-opdivo-successful-in-two-late-stage-studies
CheckMate-577: Opdivo as adjuvant therapy in patients with resected esophageal or gastroesophageal junction (GEJ) cancer.
Aducanumab (BIIB037)
Opdivo® (nivolumab) Plus Yervoy® (ipilimumab)
Opdivo® (nivolumab) Plus Yervoy® (ipilimumab)
FDA Accepts Biogen’s Aducanumab Biologics License Application for Alzheimer's Disease with Priority Review
Fri August 7, 2020 7:30 AM|GlobeNewswire|About: BIIB
- Priority Review accelerates FDA review time, with a Prescription Drug User Fee Act (PDUFA) target action on March 7, 2021
- If approved, aducanumab would be the first treatment to meaningfully change the course of Alzheimer’s disease
CAMBRIDGE, Mass. and TOKYO, Aug. 07, 2020 (GLOBE NEWSWIRE) -- Biogen (BIIB) and Eisai, Co., Ltd. (Tokyo, Japan)
FDA ACCEPTS BIOGEN’S ADUCANUMAB BIOLOGICS LICENSE APPLICATION FOR ALZHEIMER'S DISEASE WITH PRIORITY REVIEW
August 7, 2020 at 7:30 AM EDT
- Priority Review accelerates FDA review time, with a Prescription Drug User Fee Act (PDUFA) target action on March 7, 2021
- If approved, aducanumab would be the first treatment to meaningfully change the course of Alzheimer’s disease
CAMBRIDGE, Mass. and TOKYO, Aug. 07, 2020 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan)
https://www.eisai.com/index.html
https://alzheimersnewstoday.com/aducanumab/
https://www.biogen.com/en_us/home.html
https://seekingalpha.com/symbol/BIIB
Opdivo® (nivolumab) Plus Yervoy® (ipilimumab)
Opdivo® (nivolumab) Plus Yervoy® (ipilimumab)
Opdivo® (nivolumab) Plus Yervoy® (ipilimumab)
Opdivo® (nivolumab) Plus Yervoy® (ipilimumab) Demonstrates Durable Survival Benefit vs. Chemotherapy in Patients with Previously Untreated Malignant Pleural Mesothelioma
Sat August 8, 2020 7:00 AM|Business Wire|About: BMY
https://www.businesswire.com/news/home/20200808005001/en/
Phase 3 clinical trial, CheckMate-743, comparing the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) (O+Y) to platinum-based chemo in patients with unresectable malignant pleural mesothelioma (MPM) in a first-line setting.
Opdivo® (nivolumab) Plus Yervoy® (ipilimumab) Demonstrates Durable Survival Benefit vs. Chemotherapy in Patients with Previously Untreated Malignant Pleural Mesothelioma
CheckMate -743 is the first and only Phase 3 trial in which first-line immunotherapy treatment improved survival in patients with malignant pleural mesothelioma
With these positive results, Opdivo plus Yervoy has now shown clinical benefit in six different tumor types, including durable, superior overall survival vs. chemotherapy in two thoracic cancers
CATEGORY:
CORPORATE/FINANCIAL NEWSSATURDAY, AUGUST 8, 2020 7:00 AM EDT
https://www.opdivohcp.com/home
https://seekingalpha.com/symbol/BMY
KEYTRUDA® (pembrolizumab)
KEYTRUDA® (pembrolizumab)
KEYTRUDA® (pembrolizumab)
Merck Announces Two US Regulatory Milestones for KEYTRUDA® (pembrolizumab) in Triple-Negative Breast Cancer (TNBC)
Thu July 30, 2020 6:45 AM|Business Wire|About: MRK
FDA Grants Priority Review to Supplemental Biologics License Application (sBLA) for KEYTRUDA Plus Chemotherapy for the Treatment of Certain Patients With Metastatic TNBC Based on KEYNOTE-355 Trial
FDA Accepts sBLA for KEYTRUDA for the Treatment of Patients with High-Risk Early-Stage TNBC Based on KEYNOTE-522 Trial
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK)
KEYNOTE-355 is a randomized, double-blinded, Phase 3 trial (ClinicalTrials.gov, NCT02819518) evaluating KEYTRUDA in combination with one of three different chemotherapies (investigator’s choice of nab-paclitaxel, paclitaxel or gemcitabine/carboplatin)
KEYNOTE-522 is a randomized, double-blind, Phase 3 trial (ClinicalTrials.gov, NCT03036488) evaluating KEYTRUDA in combination with chemotherapy compared with placebo plus chemotherapy as neoadjuvant therapy
https://seekingalpha.com/symbol/MRK
https://www.businesswire.com/news/home/20200730005275/en/
Veklury® (Remdesivir)
KEYTRUDA® (pembrolizumab)
KEYTRUDA® (pembrolizumab)
Health Canada Grants Marketing Authorization with Conditions (NOC/c) for Gilead's Veklury® (Remdesivir) for the Treatment of Coronavirus Disease 2019 (COVID-19)
Tue July 28, 2020 10:30 AM|Canada Newswire
-- Veklury is the First Approved Treatment Option for COVID-19 in Canada --
MISSISSAUGA, ON, July 28, 2020 /CNW/ - Gilead Sciences Canada, Inc.
For more information about Gilead Sciences, visit the company's website at www.gilead.com
https://seekingalpha.com/symbol/GILD
https://www.gilead.com/purpose/advancing-global-health/covid-19
https://www.gilead.com/purpose/advancing-global-health/covid-19
Farxiga (dapagliflozin)
KEYTRUDA® (pembrolizumab)
CALQUENCE® (acalabrutinib) capsules
Farxiga met all primary and secondary endpoints in groundbreaking Phase III DAPA-CKD trial for the treatment of patients with chronic kidney disease
PUBLISHED28 July 2020
This announcement contains inside information
28 July 2020 07:00 BST
Farxiga significantly reduced the worsening of renal function or risk of death in patients with chronic kidney disease with and without type-2 diabetes
AstraZeneca's Farxiga successful in late-stage kidney disease study
Jul. 28, 2020 6:50 AM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor
Phase 3 clinical trial, DAPA-CKD, evaluating the effect of Farxiga (dapagliflozin) on renal outcomes and cardiovascular mortality in chronic kidney disease (CKD) patients with and without type 2 diabetes (T2D).
https://seekingalpha.com/symbol/AZN
CALQUENCE® (acalabrutinib) capsules
IMBRUVICA® (ibrutinib) in Combination with Rituximab
CALQUENCE® (acalabrutinib) capsules
European advisory group backs AstraZeneca's Calquence for leukemia treatment
Jul. 24, 2020 10:54 AM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor
Calquence
acalabrutinib
On 23 July 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Calquence,1 intended for the treatment of chronic lymphocytic leukaemia (CLL). The applicant for this medicinal product is AstraZeneca AB.
https://www.ema.europa.eu/en/medicines/human/summaries-opinion/calquence
Please see full Prescribing Information, including Patient Information
https://seekingalpha.com/symbol/AZN
IMFINZI® (durvalumab)
IMBRUVICA® (ibrutinib) in Combination with Rituximab
IMBRUVICA® (ibrutinib) in Combination with Rituximab
European advisory group backs AstraZeneca's Imfinzi for first-line lung cancer
Jul. 24, 2020 11:51 AM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor
Imfinzi
durvalumab
On 23 July 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Imfinzi. The marketing authorisation holder for this medicinal product is AstraZeneca AB.
https://www.ema.europa.eu/en/medicines/human/summaries-opinion/imfinzi
https://seekingalpha.com/symbol/AZN
IMBRUVICA® (ibrutinib) in Combination with Rituximab
IMBRUVICA® (ibrutinib) in Combination with Rituximab
IMBRUVICA® (ibrutinib) in Combination with Rituximab
Janssen Receives CHMP Positive Opinion for Expanded Use of IMBRUVICA® (ibrutinib) in Combination with Rituximab for Previously Untreated Patients with Chronic Lymphocytic Leukaemia (CLL)
Fri July 24, 2020 9:13 AM|Business Wire|About: JNJ
Positive Opinion is supported by Phase 3 E1912 study evaluating ibrutinib-rituximab combination versus chemo-immunotherapy in first-line treatment of CLL
BEERSE, Belgium--(BUSINESS WIRE)-- The Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ)
For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200724005286/en/
https://seekingalpha.com/symbol/JNJ
https://seekingalpha.com/symbol/RHHBY
https://seekingalpha.com/symbol/ABBV
European advisory groups backs expanded use of Imbruvica
Jul. 24, 2020 9:43 AM ET|About: Johnson & Johnson (JNJ)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3594817-european-advisory-groups-backs-expanded-use-of-imbruvica
BIOTECNOVA™
FARXIGA® (dapagliflozin)
FARXIGA® (dapagliflozin)
FARXIGA® (dapagliflozin)
FARXIGA Granted Fast Track Designation in the US for Heart Failure Following Acute Myocardial Infarction Leveraging an Innovative Registry-Based Trial Design
Thu July 16, 2020 8:12 AM|Business Wire|About: AZN
Phase III DAPA-MI trial will evaluate FARXIGA as a treatment to reduce mortality and the risk of heart failure following a heart attack
WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca has been granted Fast Track Designation in the US for the development of FARXIGA® (dapagliflozin) to reduce the risk of hospitalization for heart failure (hHF) or cardiovascular (CV) death in adults following an acute myocardial infarction (MI) or heart attack.
FARXIGA Phase III DAPA-CKD trial will be stopped early after overwhelming efficacy in patients with chronic kidney disease
PUBLISHED30 March 2020
Please see accompanying US Full Prescribing Information and Medication Guide for FARXIGA.
https://www.astrazeneca-us.com/
businesswire.com: https://www.businesswire.com/news/home/20200716005568/en/
https://seekingalpha.com/symbol/AZN
remdesivir (GS-5734™)
FARXIGA® (dapagliflozin)
FARXIGA® (dapagliflozin)
HEALTH NEWSJULY 10, 2020 / 4:55 PM / (Reuters)
HHS allocates Gilead's COVID-19 drug remdesivir to four hardest hit states
https://www.gilead.com/
https://www.gilead.com/science-and-medicine/pipeline
July 10, 2020
Gilead Presents Additional Data on Investigational Antiviral Remdesivir for the Treatment of COVID-19
-- Data Presented Includes a Comparative Analysis of Clinical Recovery and Mortality Outcomes from the Phase 3 SIMPLE Trial Versus Real-World Cohort of Severe COVID-19 Patients Receiving Standard of Care --
-- Traditionally Marginalized Racial/Ethnic Groups Treated with Remdesivir Had Similar Clinical Outcomes as Overall Patient Population --
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD)
https://www.gilead.com/news-and-press/press-room/press-releases/2020/7/gilead-presents-additional-data-on-investigational-antiviral-remdesivir-for-the-treatment-of-covid-19
https://seekingalpha.com/symbol/GILD
Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)
https://clinicaltrials.gov/ct2/show/NCT04292899?cond=Covid19&intr=remdesivir&phase=2&draw=2&rank=2
LYNPARZA® (olaparib)
FARXIGA® (dapagliflozin)
KEYTRUDA® (pembrolizumab)
LYNPARZA® (olaparib) Approved by FDA as First-Line Maintenance Treatment with Bevacizumab for HRD-Positive Advanced Ovarian Cancer
Fri May 8, 2020 5:25 PM|Business Wire|About: MRK
Improved the Median Time to Disease Progression (37.2 months) vs. Bevacizumab Alone (17.7 months) Following Response to Platinum-Based Chemotherapy with Bevacizumab
Approximately One in Two Women with Advanced Ovarian Cancer Has an HRD-Positive Tumor
KENILWORTH, N.J.--(BUSINESS WIRE)-- AstraZeneca and Merck (MRK),
https://www.azpicentral.com/lynparza_tb/lynparza_tb.pdf#page=1
https://www.merck.com/clinical-trials/index.html
https://www.merck.com/index.html
https://www.businesswire.com/news/home/20200508005523/en/
https://seekingalpha.com/symbol/MRK
https://seekingalpha.com/symbol/AZN
KEYTRUDA® (pembrolizumab)
aducanumab for Alzheimer's disease (AD)
KEYTRUDA® (pembrolizumab)
FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) for Second-Line Treatment of Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
Thu July 9, 2020 6:45 AM|Business Wire|About: MRK
Application Based on Data Comparing KEYTRUDA to Standard of Care (Brentuximab Vedotin) From Pivotal Phase 3 KEYNOTE-204 Trial
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK)
Study of Pembrolizumab (MK-3475) vs. Brentuximab Vedotin in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-204/KEYNOTE-204)
https://clinicaltrials.gov/ct2/show/NCT02684292
https://www.businesswire.com/news/home/20200709005215/en/
https://www.merck.com/index.html
LYNPARZA® (olaparib)
aducanumab for Alzheimer's disease (AD)
aducanumab for Alzheimer's disease (AD)
Lynparza approved in the EU for BRCA-mutated metastatic pancreatic cancer
PUBLISHED8 July 2020
8 July 2020 07:00 BST
Only PARP inhibitor approved in this disease
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc
Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer
https://www.nejm.org/doi/full/10.1056/NEJMoa1903387
AstraZeneca's Lynparza OK'd in Europe for BRCA+ pancreatic cancer
Jul. 8, 2020 6:50 AM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3589368-astrazenecas-lynparza-okd-in-europe-for-brca-pancreatic-cancer
https://seekingalpha.com/symbol/AZN
https://seekingalpha.com/symbol/MRK
aducanumab for Alzheimer's disease (AD)
aducanumab for Alzheimer's disease (AD)
aducanumab for Alzheimer's disease (AD)
Biogen completes U.S. application for Alzheimer's drug aducanumab
Jul. 8, 2020 7:49 AM ET|About: Biogen Inc. (BIIB)|By: Douglas W. House, SA News Editor
221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease (EMERGE)
https://clinicaltrials.gov/ct2/show/NCT02484547?intr=BIIB-037&lead=biogen&phase=2&draw=2
BIOGEN COMPLETES SUBMISSION OF BIOLOGICS LICENSE APPLICATION TO FDA FOR ADUCANUMAB AS A TREATMENT FOR ALZHEIMER’S DISEASE
July 8, 2020 at 7:30 AM EDT
https://seekingalpha.com/symbol/BIIB
Veklury® (remdesivir)
IMBRUVICA® (ibrutinib)
IMBRUVICA® (ibrutinib)
European Commission Grants Conditional Marketing Authorization for Gilead’s Veklury® (remdesivir) for the Treatment of COVID-19
Fri July 3, 2020 7:56 AM|Business Wire|About: GILD
-- Veklury is the First Approved Treatment Option for COVID-19 in the European Union --
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD)
https://www.gilead.com/remdesivir
https://www.businesswire.com/news/home/20200703005116/en/
https://seekingalpha.com/symbol/GILD
July 10, 2020
Gilead Presents Additional Data on Investigational Antiviral Remdesivir for the Treatment of COVID-19
-- Data Presented Includes a Comparative Analysis of Clinical Recovery and Mortality Outcomes from the Phase 3 SIMPLE Trial Versus Real-World Cohort of Severe COVID-19 Patients Receiving Standard of Care --
-- Traditionally Marginalized Racial/Ethnic Groups Treated with Remdesivir Had Similar Clinical Outcomes as Overall Patient Population --
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD)
IMBRUVICA® (ibrutinib)
IMBRUVICA® (ibrutinib)
IMBRUVICA® (ibrutinib)
IMBRUVICA® (ibrutinib) Seeks to Expand U.S. Label with Long-Term Data in Waldenström's Macroglobulinemia (WM)
Tue June 23, 2020 7:30 AM|PR Newswire|About: ABBV
- The National Comprehensive Cancer Network® (NCCN®) recommends IMBRUVICA, with or without rituximab, for patients with WM, including Category 1, Preferred for Primary Therapy for WM
- IMBRUVICA has been used to treat nearly 200,000 patients worldwide across approved indications, including 5,300 patients with WM in the U.S.
PR Newswire
NORTH CHICAGO, Ill., June 23, 2020 /PRNewswire/ -- AbbVie (ABBV)
June 23, 2020
IMBRUVICA® (ibrutinib) Seeks to Expand U.S. Label with Long-Term Data in Waldenström's Macroglobulinemia (WM)
Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia
https://clinicaltrials.gov/ct2/show/NCT02165397?term=innovate&draw=2&rank=12
https://seekingalpha.com/symbol/ABBV
https://seekingalpha.com/symbol/JNJ
remdesivir (GS-5734™)
IMBRUVICA® (ibrutinib)
Keytruda (pembrolizumab)
JUNE 25, 2020 / 8:41 AM / 5 DAYS AGO
Gilead's remdesivir set to become Europe's first COVID-19 therapy
(Reuters)
European advisory backs Gilead's remdesivir for COVID-19
Jun. 25, 2020 9:15 AM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3586118-european-advisory-backs-gileads-remdesivir-for-covidminus-19
https://seekingalpha.com/symbol/GILD
https://www.gilead.com/
https://www.gilead.com/purpose/advancing-global-health/covid-19
Gilead's remdesivir OK'd in Australia for COVID-19
Jul. 10, 2020 7:26 AM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3590149-gileads-remdesivir-okd-in-australia-for-covidminus-19
https://seekingalpha.com/symbol/GILD
Gilead inks deals to sell remdesivir in 127 countries
May 12, 2020 2:14 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3573501-gilead-inks-deals-to-sell-remdesivir-in-127-countries
https://www.gilead.com/purpose/advancing-global-health/covid-19
Remdesivir Emergency Use
https://www.gilead.com/remdesivir
Australia's first COVID treatment approved
https://www.tga.gov.au/media-release/australias-first-covid-treatment-approved
About Remdesivir
https://www.gilead.com/purpose/advancing-global-health/covid-19/about-remdesivir
July 10, 2020
Gilead Presents Additional Data on Investigational Antiviral Remdesivir for the Treatment of COVID-19
-- Data Presented Includes a Comparative Analysis of Clinical Recovery and Mortality Outcomes from the Phase 3 SIMPLE Trial Versus Real-World Cohort of Severe COVID-19 Patients Receiving Standard of Care --
-- Traditionally Marginalized Racial/Ethnic Groups Treated with Remdesivir Had Similar Clinical Outcomes as Overall Patient Population --
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD)
Keytruda (pembrolizumab)
Tecentriq in Combination With Chemotherapy (including Abraxane)
Keytruda (pembrolizumab)
FDA Approves First-Line Immunotherapy for Patients with MSI-H/dMMR Metastatic Colorectal Cancer
Mon June 29, 2020 3:33 PM|PR Newswire
SILVER SPRING, Md., June 29, 2020 /PRNewswire/ --
FDA OKs Merck's Keytruda for highly mutating forms of colorectal cancer
Jun. 29, 2020 3:57 PM ET|About: Merck & Co., Inc. (MRK)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/symbol/MRK
https://seekingalpha.com/symbol/MRK
Tecentriq in Combination With Chemotherapy (including Abraxane)
Tecentriq in Combination With Chemotherapy (including Abraxane)
Tecentriq in Combination With Chemotherapy (including Abraxane)
Genentech’s Tecentriq in Combination With Chemotherapy (including Abraxane) Meets Primary Endpoint of Improved Pathological Complete Response, Regardless of PD-L1 Status, as Initial Treatment for People With Early Triple-negative Breast Cancer
Thu June 18, 2020 1:00 AM|Business Wire|About: RHHBY
— IMpassion031 data will be discussed with health authorities globally, including the U.S. Food and Drug Administration and the European Medicines Agency —
— Tecentriq is the only approved cancer immunotherapy for the treatment of metastatic triple-negative breast cancer, a very aggressive and difficult-to-treat form of breast cancer —
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)
https://www.gene.com/topics/cancer-immunotherapy
https://www.businesswire.com/news/home/20200617005876/en/
A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer (IMpassion031)
https://clinicaltrials.gov/ct2/show/NCT03197935?term=IMpassion031&draw=2&rank=1
https://seekingalpha.com/symbol/RHHBY
https://www.gene.com/media/press-releases/14860/2020-06-17/genentechs-tecentriq-in-combination-with
Venclexta (venetoclax) and chemo agent azacitidine
Tecentriq in Combination With Chemotherapy (including Abraxane)
Tecentriq in Combination With Chemotherapy (including Abraxane)
Roche and AbbVie's Venclexta extends survival in first-line AML
Mar. 23, 2020 8:47 AM ET|About: Roche Holding Ltd ADR (RHHBY)|By: Douglas W. House, SA News Editor
A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy
https://clinicaltrials.gov/ct2/show/NCT02993523?term=NCT02993523&draw=2&rank=1
https://seekingalpha.com/symbol/ABBV
https://seekingalpha.com/symbol/RHHBY
https://www.venclextahcp.com/cll.html
https://www.gene.com/media/press-releases/14858/2020-06-12/positive-phase-iii-results-for-venclexta
BIOTECNOVA™
OPDIVO® (nivolumab)
Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab)
CALQUENCE® (acalabrutinib)
U.S. Food and Drug Administration Approves Opdivo® (nivolumab) for the Treatment of Patients with Advanced Esophageal Squamous Cell Carcinoma (ESCC) After Prior Fluoropyrimidine- and Platinum-based Chemotherapy
Opdivo demonstrated superior overall survival benefit compared to docetaxel or paclitaxel 1
First approved immunotherapy in this patient population regardless of tumor PD-L1 expression level
CORPORATE/FINANCIAL NEWS WEDNESDAY, JUNE 10, 2020 7:52 PM EDT
PRINCETON, N.J.--(BUSINESS WIRE)--
Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo ® (nivolumab)
https://seekingalpha.com/symbol/BMY
OPDIVO® Immunotherapy: Giving People a Choice and a Chance Against Their Cancer
ADVANCED LUNG CANCER
NON-SMALL CELL LUNG CANCER
- OPDIVO + YERVOY for certain adults with newly diagnosed advanced non-small cell lung cancer that tests positive for PD-L1
- OPDIVO + YERVOY, in combination with chemotherapy, for adults with newly diagnosed advanced non-small cell lung cancer
- OPDIVO for people who have had prior treatments for non-small cell lung cancer
SMALL CELL LUNG CANCER
Choose your condition:
- Advanced Lung Cancer
- Advanced Kidney Cancer
- Advanced Liver Cancer
- Colorectal Cancer (MSI-H/dMMR)
- Melanoma
- Head and Neck Squamous Cell Cancer
- Advanced Bladder Cancer
- Classical Hodgkin Lymphoma
CALQUENCE® (acalabrutinib)
Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab)
CALQUENCE® (acalabrutinib)
Calquence showed promising clinical improvement in majority of 19 hospitalised COVID-19 patients
PUBLISHED5 June 2020
Improved laboratory markers of inflammation and decreased oxygen requirements observed in most patients
Ongoing global trials aim to confirm findings
Results published in Science Immunology showed that Calquence (acalabrutinib), a Bruton’s tyrosine kinase (BTK) inhibitor, reduced markers of inflammation and improved clinical outcomes of patients with severe COVID-19 disease.1
AstraZeneca's Calquence shows positive effect in hospitalized COVID patients
Jun. 8, 2020 8:02 AM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/symbol/AZN
Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab)
Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab)
Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab)
FDA approves Roche’s Tecentriq in combination with Avastin for people with the most common form of liver cancer
- Tecentriq in combination with Avastin is the first and only cancer immunotherapy regimen approved for the treatment of unresectable or metastatic hepatocellular carcinoma
- Tecentriq combination improved overall survival and progression-free survival compared to the previous standard of care
- Application approved under FDA’s Project Orbis initiative and Real-Time Oncology Review pilot programme
Basel, 2 June 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY)
Cancer immunotherapy
Avastin is approved to treat metastatic colorectal cancer (mCRC) for:
- First- or second-line treatment in combination with intravenous fluorouracil–based chemotherapy
- Second-line treatment when used with fluoropyrimidine-based (combined with irinotecan or oxaliplatin) chemotherapy after cancer progresses following a first-line treatment that includes Avastin
https://seekingalpha.com/symbol/RHHBY
Libtayo® (cemiplimab-rwlc)
KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib)
Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab)
Libtayo® (cemiplimab-rwlc) longer-term results in advanced cutaneous squamous cell carcinoma presented at ASCO 2020 show durable responses that deepen over time
Fri May 29, 2020 8:00 AM|GlobeNewswire|About: SNY
Libtayo® (cemiplimab-rwlc) longer-term results in advanced cutaneous squamous cell carcinoma presented at ASCO 2020 show durable responses that deepen over time
*Across all groups combined, complete responses (CR) are now 16%; in the metastatic group with the longest follow-up, CRs are 20% representing a 200% increase over two years
PARIS and TARRYTOWN, N.Y. – May 29, 2020 –
Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma
https://seekingalpha.com/symbol/SNY
https://seekingalpha.com/symbol/REGN
IMFINZI® (durvalumab) plus tremelimumab
KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib)
KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib)
IMFINZI plus tremelimumab Demonstrated Promising Clinical Activity and Tolerability in Patients With Advanced Liver Cancer
Fri May 29, 2020 8:01 AM|Business Wire|About: AZN
Data presented at ASCO showed patients treated with a single, priming dose of tremelimumab plus IMFINZI achieved longest median survival among regimens tested
WILMINGTON, Del.--(BUSINESS WIRE)-- Results from the global Phase II Study 22 trial testing AstraZeneca’s tremelimumab, an anti-CTLA4 antibody and potential new medicine, added to IMFINZI® (durvalumab)
IMFINZI and tremelimumab were granted Orphan Drug Designation in the US for the treatment of HCC
IMFINZI® (durvalumab) Showed a Sustained Overall Survival Benefit in 1st-Line Extensive-Stage Small Cell Lung Cancer in the Phase III CASPIAN Trial
Fri May 29, 2020 8:01 AM|Business Wire|About: AZN
ASCO data show more than 10% of patients on IMFINZI plus chemotherapy had not progressed and remained on treatment at two years vs. 2.9% on chemotherapy alone
WILMINGTON, Del.--(BUSINESS WIRE)
Please see complete Prescribing Information, including Medication Guide.
https://www.businesswire.com/news/home/20200529005123/en/
https://seekingalpha.com/symbol/AZN
KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib)
KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib)
KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib)
KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib) Combination Demonstrated Clinically Meaningful Tumor Response Rates in Unresectable Hepatocellular Carcinoma and Advanced Renal Cell Carcinoma
Thu May 28, 2020 6:37 PM|Business Wire|About: MRK
Analyses from KEYTRUDA Plus LENVIMA Trials to be Presented at 2020 ASCO Annual Meeting
KENILWORTH, N.J. & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside the United States and Canada, and Eisai today
KEYNOTE-146/Study 111 (ClinicalTrials.gov, NCT02501096) is a Phase 1b/2, open-label, single-arm trial evaluating the KEYTRUDA plus LENVIMA combination in patients with selected solid tumors.
Please see Prescribing Information for LENVIMA (lenvatinib) at http://www.lenvima.com/pdfs/prescribing-information.pdf.
https://www.merck.com/index.html
https://www.eisai.com/index.html
https://www.businesswire.com/news/home/20200528005868/en/
LENVIMA® (lenvatinib) is a prescription medicine that is used to treat certain kinds of cancer.
https://seekingalpha.com/symbol/ESALY
https://seekingalpha.com/symbol/MRK
XTANDI® (enzalutamide)
OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab)
OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab)
XTANDI® (enzalutamide) Approved by Japan MHLW for the Treatment of Prostate Cancer with Distant Metastasis
Fri May 29, 2020 2:30 AM|PR Newswire|About: ALPMY, PFEPR Newswire
TOKYO, May 29, 2020 /PRNewswire/ -- Astellas Pharma Inc. (ALPMF) (TSE: 4503,
Additional details about ENZAMET (NCT02446405) are available on www.clinicaltrials.gov.4
Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer (ENZAMET)
https://clinicaltrials.gov/ct2/show/NCT02446405
https://seekingalpha.com/symbol/ALPMY
https://seekingalpha.com/symbol/PFE
OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab)
OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab)
OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab)
U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) Combined with Limited Chemotherapy as First-Line Treatment of Metastatic or Recurrent Non-Small Cell Lung Cancer
Tue May 26, 2020 5:48 PM|Business Wire|About: BMY
In CheckMate -9LA, Opdivo + Yervoy combined with two cycles of chemotherapy demonstrated superior overall survival versus chemotherapy, regardless of PD-L1 expression or tumor histology1
Approval marks sixth indication for Opdivo + Yervoy-based combinations across five types of cancer
Two Opdivo + Yervoy-based combinations are now approved in first-line lung cancer
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)
Please see U.S. Full Prescribing Information for OPDIVO and YERVOY, including Boxed WARNING regarding immune-mediated adverse reactions for YERVOY.
https://www.businesswire.com/news/home/20200526005870/en/
https://seekingalpha.com/symbol/BMY
https://www.opdivo.com/advanced-nsclc-combination
Farxiga (dapagliflozin)
OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab)
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
Farxiga approved in the US for the treatment of heart failure in patients with heart failure with reduced ejection fraction
PUBLISHED6 May 2020
6 May 2020 07:00 BST
Farxiga is the first SGLT2 inhibitor proven to significantly reduce
the risk of cardiovascular death and hospitalisation for heart failure
AstraZeneca’s Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death and hospitalisation for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without type-2 diabetes (T2D).
FDA OKs AstraZeneca's Farxiga for type of heart failure
May 6, 2020 6:44 AM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3569858-fda-oks-astrazenecas-farxiga-for-type-of-heart-failure
https://www.nejm.org/doi/full/10.1056/NEJMoa1911303?query=main_nav_lg
FDA approves new treatment for a type of heart failure
May 05, 2020
https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-type-heart-failure
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) as First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer Whose Tumors Express PD-L1≥1%
Fri May 15, 2020 3:56 PM|Business Wire|About: BMY
In CheckMate -227 Part 1a, Opdivo + Yervoy showed superior and durable long-term overall survival versus chemotherapy1,2,3
Fifth indication for Opdivo + Yervoy, the first and only FDA-approved dual immunotherapy
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)
https://www.yervoy.com/metastatic
https://www.businesswire.com/news/home/20200515005557/en/
OPDIVO® Immunotherapy: Giving People a Choice and a Chance Against Their Cancer
BACK
ADVANCED LUNG CANCER
- OPDIVO for people who have had prior treatments for non-small cell lung cancer
- OPDIVO for people who have had prior treatments for small cell lung cancer
- Advanced Lung Cancer
- Advanced Kidney Cancer
- Advanced Liver Cancer
- Colorectal Cancer (MSI-H/dMMR)
- Melanoma
- Head and Neck Squamous Cell Cancer
- Advanced Bladder Cancer
- Classical Hodgkin Lymphoma
Tecentriq® (atezolizumab)
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
Tecentriq® (atezolizumab)
Monday, May 18, 2020
FDA Approves Genentech’s Tecentriq as a First-Line Monotherapy for Certain People With Metastatic Non-Small Cell Lung Cancer
Tecentriq’s fourth indication in metastatic non-small cell lung cancer and fifth indication in lung cancer overall
Approval based on the Phase III IMpower110 study showing Tecentriq demonstrated a significant overall survival benefit in people with high PD-L1 expression compared with chemotherapy
South San Francisco, CA -- May 18, 2020 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)
https://www.businesswire.com/news/home/20200518005690/en/
https://www.gene.com/topics/cancer-immunotherapy
FDA Approves Genentech’s Tecentriq as a First-Line Monotherapy for Certain People With Metastatic Non-Small Cell Lung Cancer
Mon May 18, 2020 3:30 PM|Business Wire|About: RHHBY
– Tecentriq’s fourth indication in metastatic non-small cell lung cancer and fifth indication in lung cancer overall –
– Approval based on the Phase III IMpower110 study showing Tecentriq demonstrated a significant overall survival benefit in people with high PD-L1 expression compared with chemotherapy –
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)
https://seekingalpha.com/symbol/RHHBY
LYNPARZA® (olaparib)
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
Tecentriq® (atezolizumab)
LYNPARZA® (Olaparib) Approved in the US for HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer
Wed May 20, 2020 7:00 AM|Business Wire|About: AZN
Only PARP inhibitor to improve overall survival vs enzalutamide or abiraterone in the biomarker-based subset of prostate cancer patients with BRCA1/2 or ATM mutations
Approximately 20-30% of men with mCRPC have an HRR gene-mutation
WILMINGTON, Del.--(BUSINESS WIRE)--
AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (Merck: known as MSD outside the US and Canada)
Please click here for complete Prescribing Information, including Patient Information (Medication Guide).
https://www.astrazeneca-us.com/
https://www.businesswire.com/news/home/20200520005224/en/
https://seekingalpha.com/symbol/AZN
https://seekingalpha.com/symbol/MRK
https://seekingalpha.com/symbol/AZN
BIOTECNOVA™
VENCLEXTA® (venetoclax) with Obinutuzumab
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
AbbVie Receives Health Canada Approval for the Combination of VENCLEXTA® (venetoclax) with Obinutuzumab for Patients with Previously Untreated Chronic Lymphocytic Leukemia
Tue May 5, 2020 7:01 AM|Canada Newswire|About: ABBV
- VENCLEXTA® (venetoclax) plus obinutuzumab is the first chemotherapy-free, fixed-duration combination regimen approved by Health Canada for patients with previously untreated chronic lymphocytic leukemia (CLL).
- Approval is based on data from the Phase 3 CLL14 trial, which showed that patients treated with obinutuzumab plus one year of treatment with VENCLEXTA had clinically meaningful and statistically significant progression-free survival (PFS) and higher rates of undetectable minimal residual disease compared to patients receiving a standard of care chemoimmunotherapy regimen of obinutuzumab and chlorambucil.1
MONTREAL, May 5, 2020 /CNW/ - AbbVie (ABBV), a research-based global biopharmaceutical company, announced today that Health Canada has approved VENCLEXTA® (venetoclax) in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL).
https://seekingalpha.com/symbol/ABBV
https://seekingalpha.com/news/3568997-abbvies-venclexta-okd-in-canada-for-first-line-cll
https://seekingalpha.com/symbol/RHHBY
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
Bristol Myers Squibb Announces Acceptance of U.S. and EU Regulatory Filings for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy in First-Line Lung Cancer
FDA application granted Priority Review designation with PDUFA date of August 6, 2020
Submissions based on results from Phase 3 CheckMate -9LA trial
CATEGORY:
CORPORATE/FINANCIAL NEWSWEDNESDAY, APRIL 8, 2020 6:59 AM EDT
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE:BMY)
Remdesivir (GS-5734, Nuc inhibitor
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
Remdesivir (GS-5734, Nuc inhibitor
An Open Letter from our Chairman and CEO
Daniel O’Day - March 28, 2020
Gilead Generates Street Skepticism Ahead of Covid-19 Results
By Cristin FlanaganApril 7, 2020, 7:34 AM EDT Updated on April 7, 2020, 10:03 AM EDT
- Remdesivir China data expected this month, U.S. results in May
- Barclays sees 20% chance that Chinese studies will succeed
Bottles of Remdesivir at a hospital in Wuhan, China, in Feb. Photographer: Yuan Zheng
— With assistance by Gregory Calderone
Bloomberg
Working to Supply Remdesivir for COVID-19
Army signs agreement with drug giant Gilead on experimental COVID-19 treatment
Patricia KimeMarch 10
https://mp.weixin.qq.com/s/CMSi5JhG1T0kZb0DNgzAhw
https://www.nasdaq.com/market-activity/stocks/gild/dividend-history
Data for Gilead’s potential coronavirus therapy are coming soon. Here’s what you need to know
By ANDREW JOSEPH @DrewQJoseph, ADAM FEUERSTEIN @adamfeuerstein, DAMIAN GARDE @damiangarde, and MATTHEW HERPER @matthewherper
APRIL 6, 2020
https://www.statnews.com/2020/04/06/gilead-remdesivir-data-coming-soon/
Science 14:56, 06-Mar-2020
Translate
Interview with Chinese respiratory disease expert: Clinical drug trials for COVID-19 going smoothly
Updated 18:49, 06-Mar-2020
By Xu Zhaoqun and Dai Piaoyi
FARXIGA® (dapagliflozin)
BRAFTOVI® (Encorafenib) in Combination w/ Cetuximab = BRAFV600E-Mutant Metastatic Colorectal Cancer
Remdesivir (GS-5734, Nuc inhibitor
Farxiga Phase III DAPA-CKD trial will be stopped early after overwhelming efficacy in patients with chronic kidney disease
PUBLISHED30 March 2020
30 March 2020 07:00 BST
Farxiga is the first SGLT2 inhibitor to show meaningful benefit in patients with chronic kidney disease in a trial including both type-2 diabetics and non-diabetics
Farxiga reduced the incidence of heart failure worsening or cardiovascular death in a sub-analysis from landmark Phase III DAPA-HF trial
https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/farxiga-reduced-the-incidence-of-heart-failure-worsening-or-cardiovascular-death-in-a-sub-analysis-from-landmark-phase-iii-dapa-hf-trial.html
https://seekingalpha.com/pr/17821565-farxiga-reduced-incidence-of-heart-failure-worsening-cardiovascular-death-in-sub-analysis
https://seekingalpha.com/symbol/AZN
https://www.astrazeneca.com/
BRAFTOVI® (Encorafenib) in Combination w/ Cetuximab = BRAFV600E-Mutant Metastatic Colorectal Cancer
BRAFTOVI® (Encorafenib) in Combination w/ Cetuximab = BRAFV600E-Mutant Metastatic Colorectal Cancer
BRAFTOVI® (Encorafenib) in Combination w/ Cetuximab = BRAFV600E-Mutant Metastatic Colorectal Cancer
U.S. FDA Approves BRAFTOVI® (Encorafenib) in Combination with Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer (CRC) After Prior Therapy
Wed April 8, 2020 6:27 PM|Business Wire|About: PFE
BRAFTOVI plus cetuximab is the first-and-only FDA-approved targeted regimen specifically for adults with previously treated metastatic CRC with a BRAFV600E mutation
NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®)
https://www.businesswire.com/news/home/20200408005791/en/
https://seekingalpha.com/symbol/PFE
ERBITUX® (cetuximab)
Libtayo® (cemiplimab)
BRAFTOVI® (Encorafenib) in Combination w/ Cetuximab = BRAFV600E-Mutant Metastatic Colorectal Cancer
BRAFTOVI® (Encorafenib) in Combination w/ Cetuximab = BRAFV600E-Mutant Metastatic Colorectal Cancer
https://clinicaltrials.gov/ct2/show/NCT03132636?cond=Basal+Cell+Carcinoma&lead=regeneron&draw=2&rank=1 May 5, 2020 at 12:59 AM EDT
LIBTAYO® (CEMIPLIMAB) SHOWS CLINICALLY-MEANINGFUL AND DURABLE RESPONSES IN SECOND-LINE ADVANCED BASAL CELL CARCINOMA
TARRYTOWN, N.Y. and PARIS, May 5, 2020 /PRNewswire/ --
Objective responses seen in approximately 29% of patients with locally advanced basal cell carcinoma (BCC)
In a preliminary analysis, objective responses seen in 21% of patients with metastatic BCC
Approximately 85% of patients who responded to Libtayo maintained their response for at least one year
Regeneron and Sanofi plan regulatory submissions in 2020
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
Libtayo® (cemiplimab) shows clinically meaningful and durable responses in second-line advanced basal cell carcinoma
Tue May 5, 2020 1:00 AM|GlobeNewswire|About: SNY
Libtayo® (cemiplimab) shows clinically meaningful and durable responses in second-line advanced basal cell carcinoma
- Objective responses seen in 29% of patients with locally advanced basal cell carcinoma (BCC)
- In a preliminary analysis, objective responses seen in 21% of patients with metastatic BCC
- Approximately 85% of patients who responded to Libtayo maintained their response for at least one year
- Sanofi (SNY) and Regeneron plan regulatory submissions in 2020
Paris and Tarrytown, NY – May 5, 2020 - Topline data for a pivotal, single-arm, open-label trial for Sanofi and Regeneron’s PD-1 inhibitor Libtayo® (cemiplimab)
https://seekingalpha.com/symbol/SNY
https://seekingalpha.com/symbol/REGN
PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy
Regeneron and Sanofi's Libtayo shows benefit in skin cancer
May 5, 2020 6:42 AM ET|About: Regeneron Pharmaceutic... (REGN)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3568922-regeneron-and-sanofis-libtayo-shows-benefit-in-skin-cancer
Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib)
Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib)
Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib)
Bristol Myers Squibb and Exelixis Announce Positive Topline Results from Pivotal Phase 3 CheckMate -9ER Trial Evaluating Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) in Previously Untreated Advanced Renal Cell Carcinoma
Mon April 20, 2020 6:59 AM|Business Wire|About: BMY, EXEL
Study met primary endpoint of significantly improving progression-free survival, and secondary endpoints of overall survival and objective response rate vs. sunitinib
Opdivo in combination with CABOMETYX demonstrates clinically meaningful efficacy results across all endpoints and preliminary assessment showing a favorable safety profile
PRINCETON, N.J. & ALAMEDA, Calif.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) and Exelixis, Inc. (EXEL) (NASDAQ: EXEL)
A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 9ER)
https://clinicaltrials.gov/ct2/show/NCT03141177?term=checkmate-9er&draw=2&rank=1
https://www.businesswire.com/news/home/20200420005248/en/
https://seekingalpha.com/symbol/EXEL
https://seekingalpha.com/symbol/BMY
Opdivo/Cabometyx combo successful in first-line kidney cancer
Apr. 20, 2020 7:19 AM ET|About: Bristol-Myers Squibb C... (BMY)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3561978-opdivo-cabometyx-combo-successful-in-first-line-kidney-cancer
IMBRUVICA® (ibrutinib) Receives 11th FDA Approval
Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib)
Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib)
IMBRUVICA® (ibrutinib) Receives 11th FDA Approval
Tue April 21, 2020 3:22 PM|PR Newswire|About: ABBV
- This milestone marks the fifth study for IMBRUVICA to bring a chemo-free treatment option to patients with CLL and the sixth approval for IMBRUVICA in CLL
- Granted under FDA's Real-Time Oncology Review pilot program, Project Orbis and priority review
- IMBRUVICA has been used to treat more than 195,000 patients worldwide across approved indications
PR Newswire
NORTH CHICAGO, Ill., April 21, 2020 /PRNewswire/ -- AbbVie (ABBV)
https://seekingalpha.com/symbol/ABBV
https://seekingalpha.com/symbol/RHHBY
Farxiga (dapagliflozin)
Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib)
Farxiga (dapagliflozin)
Farxiga approved in the US for the treatment of heart failure in patients with heart failure with reduced ejection fraction
PUBLISHED6 May 2020
6 May 2020 07:00 BST
Farxiga is the first SGLT2 inhibitor proven to significantly reduce
the risk of cardiovascular death and hospitalisation for heart failure
AstraZeneca’s Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death and hospitalisation for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without type-2 diabetes (T2D).
https://www.nejm.org/doi/full/10.1056/NEJMoa1911303?query=main_nav_lg
https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-type-heart-failure
https://seekingalpha.com/symbol/AZN
LYNPARZA® (olaparib)
Retevmo™ (selpercatinib)
Farxiga (dapagliflozin)
LYNPARZA® (olaparib) Approved by FDA as First-Line Maintenance Treatment with Bevacizumab for HRD-Positive Advanced Ovarian Cancer
Fri May 8, 2020 5:25 PM|Business Wire|About: MRK
Improved the Median Time to Disease Progression (37.2 months) vs. Bevacizumab Alone (17.7 months) Following Response to Platinum-Based Chemotherapy with Bevacizumab
Approximately One in Two Women with Advanced Ovarian Cancer Has an HRD-Positive Tumor
KENILWORTH, N.J.--(BUSINESS WIRE)-- AstraZeneca and Merck (MRK)
https://www.businesswire.com/news/home/20200508005523/en/
https://www.merck.com/index.html
https://www.merck.com/clinical-trials/index.html
https://www.azpicentral.com/lynparza_tb/lynparza_tb.pdf#page=1
LYNPARZA® (olaparib) Approved by FDA as First-Line Maintenance Treatment with Bevacizumab for HRD-Positive Advanced Ovarian Cancer
Improved the Median Time to Disease Progression (37.2 months) vs. Bevacizumab Alone (17.7 months) Following Response to Platinum-Based Chemotherapy with Bevacizumab
Approximately One in Two Women with Advanced Ovarian Cancer Has an HRD-Positive Tumor
Friday, May 8, 2020 5:25 pm EDT
https://seekingalpha.com/symbol/MRK
https://seekingalpha.com/symbol/AZN
Retevmo™ (selpercatinib)
Retevmo™ (selpercatinib)
Retevmo™ (selpercatinib)
Lilly Receives U.S. FDA Approval for Retevmo™ (selpercatinib), the First Therapy Specifically for Patients with Advanced RET-Driven Lung and Thyroid Cancers
05/08/2020Download PDF- Approved for metastatic RET fusion-positive NSCLC, advanced or metastatic RET-mutant MTC and advanced or metastatic RET fusion-positive thyroid cancer
- Accelerated approval based on data from LIBRETTO-001 Phase 1/2, largest trial ever reported in patients with RET-driven cancers
- Registrational data demonstrated durable objective responses and showed high intracranial response rate in patients with NSCLC that has spread to the brain
INDIANAPOLIS, May 8, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)
FDA Approves First Therapy for Patients with Lung and Thyroid Cancers with a Certain Genetic Mutation or Fusion
May 08, 2020
FDA approves Eli Lilly drug to treat three types of tumors
May 8, 2020 6:57 PM ET|About: Eli Lilly and Company (LLY)|By: Carl Surran, SA News Editor
https://seekingalpha.com/news/3572368-fda-approves-eli-lilly-drug-to-treat-three-types-of-tumors
https://seekingalpha.com/symbol/LLY
Rubraca® (Rucaparib)
Retevmo™ (selpercatinib)
Retevmo™ (selpercatinib)
Rubraca® (Rucaparib) Approved in the U.S. as Monotherapy Treatment for Patients with BRCA1/2-Mutant, Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Been Treated with Androgen Receptor-Directed Therapy and a Taxane-Based Chemotherapy
Fri May 15, 2020 2:30 PM|Business Wire|About: CLVS
Rubraca is the first PARP inhibitor approved in a prostate cancer setting
Accelerated approval based on objective response rate (ORR) and duration of response (DOR) data from the TRITON2 clinical triali
44% ORR (95% CI 31, 57) and median DOR not evaluable (95% CI 6.4, NE, range in months at data cutoff 1.7-24.0+) by blinded independent radiologic review (IRR)i
Most common Grade 3-4 adverse reaction was anemia; most common Grade 3-4 lab abnormality was decrease in hemoglobini
BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (CLVS),
https://rubracaconnections.com/
https://www.clovisoncology.com/
Opdivo (nivolumab) Plus Yervoy (ipilimumab) w/ Chemo
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
Bristol Myers Squibb Announces Acceptance of U.S. and EU Regulatory Filings for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy in First-Line Lung Cancer
Wed April 8, 2020 6:59 AM|Business Wire|About: BMY
FDA application granted Priority Review designation with PDUFA date of August 6, 2020
Submissions based on results from Phase 3 CheckMate -9LA trial
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY)
https://seekingalpha.com/symbol/BMY
https://www.nasdaq.com/market-activity/stocks/azn/dividend-history
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FARXIGA® (dapagliflozin)
FARXIGA® (dapagliflozin)
Farxiga Phase III DAPA-CKD trial will be stopped early after overwhelming efficacy in patients with chronic kidney disease
PUBLISHED30 March 2020
30 March 2020 07:00 BST
Farxiga is the first SGLT2 inhibitor to show meaningful benefit in patients with chronic kidney disease in a trial including both type-2 diabetics and non-diabetics
Farxiga reduced the incidence of heart failure worsening or cardiovascular death in a sub-analysis from landmark Phase III DAPA-HF trial
https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/farxiga-reduced-the-incidence-of-heart-failure-worsening-or-cardiovascular-death-in-a-sub-analysis-from-landmark-phase-iii-dapa-hf-trial.html
https://seekingalpha.com/pr/17821565-farxiga-reduced-incidence-of-heart-failure-worsening-cardiovascular-death-in-sub-analysis
https://seekingalpha.com/symbol/AZN
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BRAFTOVI® (Encorafenib) in Combination with Cetuximab
BRAFTOVI® (Encorafenib) in Combination with Cetuximab
U.S. FDA Approves BRAFTOVI® (Encorafenib) in Combination with Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer (CRC) After Prior Therapy
Wed April 8, 2020 6:27 PM|Business Wire|About: PFEBRAFTOVI plus cetuximab is the first-and-only FDA-approved targeted regimen specifically for adults with previously treated metastatic CRC with a BRAFV600E mutationNEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®)
https://www.businesswire.com/news/home/20200408005791/en/
https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_braftovi_encorafenib_in_combination_with_cetuximab_for_the_treatment_of_brafv600e_mutant_metastatic_colorectal_cancer_crc_after_prior_therapy
https://seekingalpha.com/symbol/PFE
INDICATIONS AND USAGE
BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib) are kinase inhibitors indicated for use in combination for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation as detected by an FDA-approved test.
https://www.braftovimektovi.com/hcp/