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Disc Medicine’s leadership tried to express optimism that its rare disease therapy bitopertin can be approved based on a Phase 3 trial set to begin shortly. However, analysts are worried that the protocol was developed with former FDA leaders.
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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.
The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
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The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
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Driven by growing market demand and an improving supply chain, the global weight-loss drug market is expected to hit $150 billion in value by the early 2030s, according to analysts cited by Reuters.
Amgen on Tuesday secured the FDA’s green light for the first interchangeable biosimilar to AstraZeneca’s Soliris to treat two rare diseases: paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Transitioning from team member to manager has its challenges, including managing ex-peers. There are a few ways you can make the change easier.
AstraZeneca last week set another ambitious goal, this time with plans to nearly double its total revenue by the end of the decade. However, it’s easier said than done, according to analysts.
The FDA currently does not recommend using changes in lean mass as an endpoint in clinical trials for weight loss drugs. Should it?
AstraZeneca targets $80 billion in revenue by 2030, layoffs at Bayer, BMS and Pfizer continue to generate attention across the biopharma industry, Takeda takes a deep dive into the molecular glue space and conference season is in full swing.
Johnson & Johnson’s deal for Numab Therapeutics’ bispecific antibody NM26, slated to enter Phase II studies, comes on the heels of J&J’s $850 million Proteologix bispecific antibody acquisition.
The potential purchase by the Japanese conglomerate could secure access to Calliditas’ IgA nephropathy therapy Tarpeyo, which won the FDA’s full approval in December 2023.
NS Pharma, a subsidiary of Nippon Shinyaku, announced Monday that its Duchenne muscular dystrophy candidate Viltepso failed a late-stage confirmatory trial, showing no significant motor function improvements over placebo.
Flagging a risk of hypoglycemia, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Friday did not recommend the approval of Novo Nordisk’s once-weekly insulin icodec for type 1 diabetes.