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The CDC’s changes threaten to cut vaccine sales for makers including Pfizer, Moderna, Merck and more, but a legal expert suspects affected manufacturers will stay on the sidelines rather than back a push to declare the revised schedule unlawful.
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After a rocky 2025, Sarepta Therapeutics’ executives admit they have work to do to bring patients back into the fold as sales of Duchenne muscular dystrophy gene therapy Elevidys continue to decline.
Last week, the FDA made its one pivotal trial policy official, sparking myriad questions from industry leaders, including around specific evidence required for the single study and why it hasn’t been implemented across all therapeutic areas before now.
Alternatives to opioids are desperately needed to better treat moderate to severe acute pain, but to date, we’ve seen few novel analgesics hit the market.
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Eli Lilly’s win in a head-to-head trial drove Novo Nordisk’s market cap to pre-Wegovy levels not long after the victor became the first pharma company to top a $1 trillion valuation. It seems one company can do no right, while the other can do no wrong.
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As Sarepta Therapeutics moves closer to full approval and an expanded label for its gene therapy, some experts push back on clinical efficacy and cost while others note the hope it provides patients with Duchenne muscular dystrophy.
The biotech touted its prime editing technology at ASGCT on Tuesday after receiving FDA clearance last week for a clinical study of a drug candidate based on the platform.
Tuesday afternoon’s session was standing room only as representatives from various biopharma companies presented on their work to improve the efficiency and quality of AAV production.
AAVs and accelerated approval are just two of the topics being discussed at ASGCT. Meanwhile, the race between Vertex and bluebird bio’s gene therapies Casgevy and Lyfgenia is heating up.
With appeals and additional cases still pending, it remains to be seen if any of the arguments being brought by biopharma companies against the U.S. government will hold up in court.
The FDA is looking at four decision deadlines in the coming three weeks, including two for a CAR-T therapy and another for a hepatitis B vaccine.
The newest company by the life sciences venture capital firm, Prologue Medicines will search through the vast viral proteome to identify proteins with therapeutic potential.
With a total revenue of nearly $2.7 billion, Vertex exceeded analyst estimates in the first quarter, bolstered by strong uptake of its cystic fibrosis products.
ADC Therapeutics is positioning Zynlonta for a label expansion with new Phase II data showing that the treatment can elicit high rates of complete response in patients with relapsed or refractory marginal zone lymphoma.
In a joint conference event on Monday, cell therapy pioneer Carl June revealed unpublished results showing that in around 1,500 patients treated with CAR-T therapies, no cases of secondary malignancy could be definitively linked to the treatment.