Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antengene, Aquavit, Arrowhead, Aviceda, Boan, Diamond, Enlivex, Fore, Ichnos, Intellia, Jiangsu Recbio, Luye, Mereo, Prestige, Sanofi, Sensei.
Citing “serious breaches” of its code of practice, the Association of the British Pharmaceutical Industry (ABPI) suspended the membership of Novo Nordisk A/S in the trade organization for two years. The suspension marks the eighth time in 40 years that the association has invoked such sanctions.
Despite a failed phase III study, the U.S. FDA suggests in briefing documents that tofersen (BIIB-067) is effective for treating the rare, genetic disease superoxide dismutase 1 amyotrophic lateral sclerosis (ALS). The intrathecally injected therapy is being developing by Biogen Inc. and Ionis Pharmaceuticals Inc. and is at the heart of a March 22 meeting of the agency’s Peripheral and Central Nervous System Drugs Advisory Committee (adcom).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ipsen, Kuria, Likang, Novartis, Pfizer, Sarepta.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbisko, Clearmind, Everest, Glenmark.
Sarepta Therapeutics Inc. CEO Doug Ingram said the U.S. FDA has promised to schedule “expeditiously” an advisory committee meeting on the BLA related to SRP-9001 (delandistrogene moxeparvovec) for Duchenne muscular dystrophy (DMD).
Citing clinical trial data backed by real-world data, members of the U.S. FDA’s Antimicrobial Drugs Advisory Committee voted overwhelmingly, 16-1, March 16 that the overall benefit-risk assessment is favorable for the use of Pfizer Inc.’s Paxlovid to treat mild to moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Argenx, Biontech, Bioprojet, Cognition, Deciphera, Edesa, Pfizer, Skye.
Pfizer Inc.’s Paxlovid has become such a part of the COVID-19 treatment scene in the U.S. that it’s easy to forget it’s only authorized for emergency use. That could soon change. The FDA is convening its Antimicrobial Drugs Advisory Committee March 16 to consider Pfizer’s NDA for the co-packaged nirmatrelvir and ritonavir treatment.
Despite the new Medicare inflation rebate, the U.S. price of 27 Part B drugs grew faster than inflation in the last quarter of 2022, triggering the new rebate provision in the Inflation Reduction Act. The manufacturers of those single-source drugs will be billed for the rebates in 2025, but Medicare beneficiaries should see a drop in their coinsurance for those drugs, for the next quarter at least. According to the Biden administration, the decrease in out-of-pocket costs for those drugs will range from $2 to as much as $390 per average dose from April 1 through June 30.
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