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Bristol Myers Squibb Co. (BMY) Wednesday said the European Commission has approved its drug nivolumab in combination with cabozantinib as a treatment for patients with advanced renal cell carcinoma. The New York-based pharmaceutical company said the EC's decision was based on results from a late-stage...

fda jnj ema 041521 The European Medicines Agency Wednesday said that it believes the benefits of Johnson & Johnson's (JNJ) COVID-19 vaccine outweigh the risks of side effects. The regulator issued the statement following a temporary halt of the vaccine in the US after reports of extremely rare blood clotting. The other...

moderna 1104 14apr21 Moderna, Inc. announced that updated cases in its trial show its COVID-19 Vaccine (mRNA-1273) is greater than 90% effective against all cases of COVID-19, with around 6 months median follow-up post-dose 2. The new data from the Phase 3 COVE Study also shows that the vaccine is greater than 95% effective against severe cases of COVID-19.

Gilead Sciences Inc. (GILD) Tuesday announced that the U.S. Food and Drug Administration has granted accelerated approval of Trodelvy for use in patients with locally advanced or metastatic urothelial cancer. The accelerated approval was based on data from the international Phase 2, single-arm TROPHY...

fda jnj 041321 The U.S. Food and Drug Administration on Tuesday announced a temporarily halt on the usage of Johnson & Johnson's (JNJ) Covid-19 vaccine after six recipients developed a rare blood clotting disorder. "Right now, these adverse events appear to be extremely rare," the FDA said in a joint statement with...

Biotechnology company Rigel Pharmaceuticals, Inc. (RIGL) announced Tuesday positive topline results from a multi-center, Phase 2 clinical trial to evaluate the safety of fostamatinib, its oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of hospitalized patients with COVID-19. The trial,...

dreddys april13 Dr. Reddy's Laboratories Ltd. announced Tuesday that it has been authorized to import Russian-made Covid-19 vaccine Sputnik V into India for restricted emergency use. Sputnik V becomes the third coronavirus vaccine to be approved for use in India, after Covishield and Covaxin.

cvs heath 041221 CVS Health is now offering cost COVID-19 vaccines at select CVS Pharmacy locations in four more U.S. states as part of its ongoing effort to expand access to COVID-19 vaccines. It has now expanded the program to 51 more select locations in Arkansas, Nebraska, Iowa and Maine. It began in Washington, West Virginia, Delaware and New Mexico at 15 select locations from March 31.

colon Biotech company FibroGen Inc. (FGEN) announced Monday that the U.S. Food and Drug Administration has granted Fast Track designation for the company's anti-CTGF antibody, pamrevlumab, for the treatment of patients with Duchenne muscular dystrophy or DMD. In pre-market activity on Nasdaq, FibroGen shares...

GI Genius, developed by Cosmo Artificial Intelligence, Ltd., has become the first device that uses artificial intelligence or AI to help detect potential signs of colon cancer to get U.S. Food and Drug Administration's marketing approval. The new device uses AI based on machine learning to assist clinicians in detecting potential irregularities or lesions, such as polyps or suspected tumors.

Medical technology company Lucira Health, Inc. (LHDX) announced Monday that the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for over the counter (OTC) sale of the LUCIRA CHECK IT COVID-19 At-Home test kit that delivers PCR quality molecular accuracy in 30 minutes...

British drug major AstraZeneca Plc (AZN, AZN.L) Monday announced that its DARE-19 Phase III trial for Farxiga (dapagliflozin) in COVID-19 did not achieve statistical significance for the primary endpoint of prevention measuring organ dysfunction and all-cause mortality. The trial also failed to achieve...

New York-based pharmaceutical company Pfizer Inc (PFE) and its German partner BioNTech SE (BNTX) have requested the U.S. Food and Drug Administration to grant expanded Emergency Use Authorization of their COVID-19 vaccine in adolescents aged between 12 and 15. BNT162b2, the covid vaccine produced...

Merck & Co. Inc. (MRK), known as MSD outside the U.S. and Canada, announced Thursday that the pivotal Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, met its primary endpoint of disease-free survival (DFS) for the potential adjuvant treatment of patients with renal cell carcinoma...

astrazeneca covid19 040721 The European Medicines Agency said Wednesday blood clots are a "very rare" side effect of AstraZeneca's COVID vaccine. However, the EU drug regulator emphasized that the vaccine's benefits continue to outweigh its risks.

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