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Heightened diligence standards and longer decision timelines for early-stage startups slowed venture activity last year, J.P. Morgan found in a report published ahead of the bank’s annual healthcare conference in San Francisco.
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With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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Analysts at BMO Capital Markets said Centessa’s orexin receptor agonist has “best-in-class” potential for narcolepsy, putting the company in a strong position in the $15 billion market.
Eli Lilly says Indianapolis-based Premier Weight Loss is cracking open auto-injector pens containing its blockbuster drug and repackaging them into separate doses.
Akero Therapeutics, 89bio, Boston Pharmaceuticals and more are working to bring novel treatment options for metabolic dysfunction-associated steatohepatitis to a market that could reach $16 billion by 2033.
Researchers in pharma and beyond have historically glommed onto a limited number of disease targets, limiting innovation. AI could change that.
One day after the European Medicines Agency requested that three clinical trials of Elevidys be placed on hold after the death of a U.S. teenager, a data monitoring committee concluded that they should continue unchanged.
Roche’s reorganization of Spark Therapeutics is coming more into focus, with nearly 300 employees being let go by the end of this year. Spark also trimmed its staff in 2024.
While it’s not unusual for certain positions to turn over with a new administration, the number of senior-level FDA staffers who have recently left the agency is unprecedented. The lack of communication, transparency and human decency is as well.
The FDA has asked for another well-controlled trial to establish the efficacy of reproxalap in dry eye disease.
The FDA derives just under half of its yearly funding from pharma user fees, which help support its operations and fund employee salaries. An analysis from AgencyIQ suggests that the agency is dangerously close to losing it all.
In the Phase III MITIGATE trial, Uplizna cut IgG4-related disease flares by 87% versus placebo.