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Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
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Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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Attendance at the Biotech CEO Sisterhood’s annual photo of women leaders and allies in Union Square doubled this year. There’s still more work to do.
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Thursday’s announcement comes after the insurance giant last week said it would remove AbbVie’s Humira from its major formularies starting in 2025, replacing the blockbuster with more affordable biosimilars.
BioMarin executives sought to calm an anxious investor base Wednesday with a public address and pledge to achieve a nearly 50% bump in annual revenue by 2027. But analysts were left wanting.
Facing financial challenges, IN8bio is looking to preserve cash resources through a pipeline prioritization and layoffs at its New York City and Birmingham, Alabama, sites.
Eli Lilly’s weekly insulin injection efsitora alfa secured two late-stage victories on Thursday in a potential blow to rival Novo Nordisk, which in July failed to secure the FDA’s approval for its basal insulin icodec.
A broad indication for MariTide could help Amgen secure Medicare coverage for the treatment following FDA approval, CEO Robert Bradway said at Wednesday’s Morgan Stanley Global Healthcare Conference.
Like its U.S. and European counterparts, Britain’s Medicines and Healthcare Products Regulatory Agency found no conclusive link between the use of GLP-1s and a heightened risk of suicidal and self-injury thoughts.
The company is building a new facility in California, its third U.S.-based radioligand therapy production site, and expanding an Indianapolis site for producing isotopes for cancer treatment.
Proceeds from the oversubscribed financing will be used to advance ArsenalBio’s lead programs, which include a handful of solid tumor cell therapy candidates.
ImmunityBio will lay off 16 employees in California and said it expects to need more funding to commercialize Anktiva, approved in April for non-muscle invasive bladder cancer.
Under a multi-year agreement announced Wednesday, Eli Lilly will leverage Haya Therapeutics’ proprietary RNA-guided genome platform to identify drug targets to address the chronic conditions.