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Vitruvias Therapeutics has “ceased operations” after voluntarily recalling a batch recall of generic thyroid tablets due to possible superpotency that could cause a range of adverse events.
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Twenty-five biotechs have used the IPO route to go public this year—with five of those debuts occurring this month alone. It’s the most IPOs since 2021, when the industry recorded 78 during the height of the COVID-19 pandemic.
While Novartis’ Pluvicto is a blockbuster, Curium heads into talks with the FDA about the review of its rival drug candidate believing a competing product can make the supply chain more resilient.
Following a tumultuous stretch under ex-Commissioner Marty Makary, current FDA leadership is working to restore reliability, integrity and transparency to the agency—but experts say that doesn’t necessarily mean an easier regulatory road for drugmakers.
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The FDA has been trying to mend fences with rare disease drug developers and patient groups since the departure of former Commissioner Marty Makary three months ago. But advisory committee meetings last week for Replimune and Capricor Therapeutics only created more confusion and frustration.
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Though the potential change is unconfirmed, media outlets reported Wednesday that one deputy commissioner would focus on the intersection between health and AI, while another will be dedicated to drugs.
FDA extends its review of Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy as an unhappy shareholder advocates for change; Merck and Moderna tout positive data for their mRNA-based cancer vaccine; Trump nominates White House aide Heidi Overton as FDA commissioner; and the oral obesity market heats up with rivals Eli Lilly and Novo Nordisk going head-to-head.
Haisco Pharmaceutical Group has been on a deal hot streak this year, inking major deals with Eli Lilly, AbbVie and more. The new company will take on one of Haisco’s core immunology assets.
While Bausch + Lomb’s dual-action eye drops failed to outperform active comparators at day 29, the investigational asset showed significant superiority at day 15.
Eli Lilly’s best play for Foundayo is to bring it overseas, a more price-sensitive market where the pharma can more readily outcompete Novo Nordisk “given the high margins of a small-molecule therapy,” Truist analyst Srikripa Devarakonda told BioSpace.
The FDA has granted a three-month extension for Capricor Therapeutics’ Duchenne muscular dystrophy hopeful deramiocel in order to review additional data and consider a refined indication. The new target action date for the therapy is November 22.
The FDA has placed a clinical hold on RGX-121 after small nodules or cystic masses were detected in the spines of five patients enrolled in REGENXBIO’s registrational trial. The biotech no longer plans to resubmit the candidate—which was rejected in February—in the near term.
Roche, through its subsidiary Genentech, will gain access to the investigational asset HM17321, which is designed to not only elicit weight loss but also improve lean mass.
The current classifications of vaccine recommendations could imply that not all shots require the consent of patients or their parents, according to Health Secretary Robert F. Kennedy Jr.
Not much is known about Boehringer Ingelheim’s drug candidate, dubbed BI 3031185, though the asset has completed at least two other Phase 1 studies this year.