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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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The layoffs, set to take effect in late November, will impact about a third of Reata’s headcount. The workforce reduction comes just weeks after Biogen completed its $7.3 billion Reata buy.
An increase in funding share and available lab space helps to keep the Bay State’s biotech and pharma sectors strong.
The MeiraGTx founder and CEO, now on her third career, didn’t take a typical path.
The subcutaneous version of its blockbuster multiple sclerosis drug notched a victory in a key late-stage study. Roche will submit the OCARINA II data to global health authorities in the coming months.
The next frontier in RNA therapies, RNA editing has the potential to treat both genetic and common disorders, and the technology is rapidly expanding beyond the liver.
The biotech is laying off about 29% of its employees and will focus its resources on the company’s hypoimmune platform. The latest downsizing follows a previous round of layoffs in August 2023.
The European Commission on Thursday ordered Illumina to divest Grail, opening the next chapter in the years-long regulatory saga. Illumina is reviewing the order, Reuters reported.
Following the recommendations of an independent Data Monitoring Committee, Novo Nordisk has halted a Phase III kidney outcomes study of semaglutide ahead of schedule due to strong efficacy signals.
Google and Microsoft are already making inroads into drug development, but smaller biotechs focused on AI may end up leading the charge.
The pharma giant’s anti-PD-1 therapy met its dual primary endpoint of overall survival as a treatment regimen for non-small cell lung cancer patients, as the FDA’s Oct. 16 PDUFA date looms.