The U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee voted 17-4 to recommend Pfizer and BioNTech’s Covid-19 vaccine for Emergency Use Authorization (EUA) for individuals ages 16 years and older.
Airlines Gear Up to Fly Covid-19 Vaccines to U.S. Distribution Sites
"Operation Warp Speed" Initiative, Advisory Committees, Airlines, Belgium, BioNTech, Business, COVID-19 Vaccines, Distribution, Emergency Use Authorization, FDA, Federal Aviation Administration (FAA), Michigan, Pfizer, U.S. Department of Transportation (USDOT)With both Pfizer-BioNTech and Moderna’s Covid-19 vaccines at the U.S. Food and Drug Administration awaiting potential Emergency Use Authorization (EUA), airlines are preparing their cargo operations to ship the vaccines.
A panel of outside advisers to the U.S. Food and Drug Administration voted that a potential Alzheimer’s treatment from Biogen Inc. has not been proven to slow progression of the disease, a sharp rebuke to agency staff who had praised the drug.
Pfizer Enters Final Stretch of Late-Stage Covid-19 Vaccine Trial
Analysts, AstraZeneca, BioNTech, Biotechnology Companies, Biotechnology Companies, Clinical Trials, COVID-19 Vaccines, Emergency Use Authorization, Oxford University, Pfizer, R&D, United Kingdom, United States, Vaccines and Related Biological Products Advisory CommitteePfizer indicated that the company’s Phase III clinical trial of 44,000 volunteers with partner BioNTech needed less than 2,000 people to be fully enrolled.
The U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention presented details about Covid-19 and the requirements for a vaccine in a nine-hour virtual meeting.
Shares of Alkermes were up in trading after the Ireland-based company announced the experimental schizophrenia drug ALKS 3831 was overwhelmingly supported by an advisory committee for the U.S. Food and Drug Administration.
The U.S.Food and Drug Administration issued a Complete Response Letter for Mesoblast’s Biologics License Application for Ryoncil (remestemcel-L).
FDA Action Alert: Aquestive, Eton and Mesoblast
Adrenal Glands, Adrenal Insufficiency, Business, Clinical Trials, Congenital Adrenal Hyperplasia (CAH), Epilepsy, FDA/Regulatory, Glands, New Drug Application (NDA), Oncologic Drugs Advisory Committee (ODAC), PDUFA, Pediatric, Quarterly results, R&D, Seizure ClustersThe U.S. Food and Drug Administration is wrapping up the month of September with a few PDUFA dates, including an approval review of Aquestive’s Libervant for the management of seizure clusters in epilepsy.
A physician who heads the influential U.S. Food and Drug Administration vaccine advisory committee recused herself from the panel’s review of Covid-19 vaccines because of her role overseeing a clinical trial for Moderna Inc.’s candidate, her spokeswoman told Reuters.
Shares of Reata Pharmaceuticals plunged more than 33 percent after the company announced a potential delay in plans to seek approval of omaveloxolone, an investigational treatment of Friedreich’s ataxia (FA).