Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affamed, Amgen, Astrazeneca, Biohaven, BMS, Calliditas, Diurnal, Eton, Fennec, Humanigen, Iterum, Lantheus, Novo, PCI, Provention, Ryvu, Verrica.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioinvent, Dicerna, Eli Lilly, Emmaus, Foresee, Gannex, GSK, Hightide, Intercept, J&J, Legend, Myovant, Ocugen, Pfizer, Seelos, Tarus, Transgene, Vir.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 10-7 May 27 that the benefits of Provention Bio Inc.’s teplizumab outweighed its risks, but the vote was not a ringing endorsement of the anti-CD3 monoclonal antibody biologic that could be the first disease-modifying treatment for people at risk of developing type 1 diabetes (T1D).
There are now two FDA-backed monoclonal antibody COVID-19 treatments after the agency granted Glaxosmithkline plc (GSK) emergency use authorization (EUA) for single-dose sotrovimab to treat mild to moderate COVID-19 in adults and children as young as 12. Vir Biotechnology Inc. collaborated on the program.
Originally intended as a way to help provide health care to uninsured and underinsured Americans, the 340B program has mutated into a revenue stream that’s benefiting large U.S. hospital systems, contract pharmacies and even pharmacy benefit managers (PBMs) while contributing to higher drug prices for patients, according to stakeholders speaking at a May 26 Air 340B summit on the federal program.
Bad regulatory news didn’t quash hopes for Travere Therapeutics Inc. with sparsentan, its dual-acting antagonist of the endothelin type A and angiotensin II type 1 receptors for focal segmental glomerulosclerosis (FSGS), a disease of kidney scarring.
The brakes have now been pumped twice at Larimar Therapeutics Inc. as the FDA placed a clinical hold on its CTI-1601 Friedreich’s ataxia (FA) clinical program, and the company won’t close on a planned $95 million private placement financing. Larimar’s stock (NASDAQ:LRMR) took a battering May 26 as shares slumped 33.46% to close at $8.99.
With the global COVID-19 pandemic and variants raising expectations about the need for booster shots, more companies are jumping into the vaccine space. But unless those sponsors have been engaging “in an ongoing manner” with the U.S. FDA on developing the manufacturing process and clinical trial program for their vaccine candidates, their emergency use authorization (EUA) requests may be denied, according to a new FDA guidance on EUAs for COVID-19 vaccines.
LONDON – New guidelines for stem cell research open the door to extending the legal limit on human embryo research beyond the current 14-day maximum set down 40 years ago. In revised guidelines, the International Society for Stem Cell Research (ISSCR) has moved research on human embryos from category 3, which explicitly bans their study in culture post 14 days in any circumstances, to category 2B, in which research post 14 days would be permissible if there is a clear scientific rationale – and after a thorough specialized review.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Immunitybio, Larimar, Mezzion, PTC, Revance, Travere.
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