Well ahead of the assigned Aug. 16 PDUFA date, Amgen Inc. bagged accelerated clearance from the FDA for Lumakras (sotorasib), the first targeted therapy for adults with KRAS G12C-mutated locally advanced or metastatic non-small-cell lung cancer (NSCLC), as determined by an FDA-approved test.
HONG KONG – In the midst of a COVID-19 crisis, India has waived the need for “well-established” foreign vaccines to undergo local trials. That could open doors for vaccines by Pfizer Inc., Johnson & Johnson and Moderna Inc.
The second oral CGRP antagonist to win FDA approval for acute migraine care is now the first to add preventive treatment to its label, marking a valuable win for Biohaven Pharmaceutical Holding Co. Ltd. and its oral dissolving tablet, Nurtec (rimegepant). The U.S. approval, for preventive treatment of episodic migraine, officially blesses a use for the medicine already adopted by many doctors, Piper Sandler analyst Christopher Raymond wrote, while opening up a potentially rich new stream of revenue for Biohaven.
Bristol Myers Squibb Co. said the FDA has approved Zeposia (ozanimod) as the first and only oral sphingosine 1-phosphate (S1P) receptor modulator for the treatment of ulcerative colitis (UC). The medicine, first FDA-approved in March 2020 for certain adults with multiple sclerosis, can now be used to treat patients with moderately to severely active UC.
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.
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