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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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Read our takes on the biggest stories happening in the industry.
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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NuCana’s chemotherapy replacement has failed to improve progression-free survival in a Phase II test, sending the biotech’s shares down by 50%.
Despite the added survival benefit for its drug, Alnylam still faces steep competition from Pfizer, whose ATTR-CM therapies have become established treatment options.
Eli Lilly this week announced plans to sell single-dose vials of its weight loss drug Zepbound directly to consumers. Novo Nordisk could adopt a similar strategy for Wegovy as its CEO is set to testify Sept. 24 before the Senate health committee.
J&J gained rights to the FcRn blocker nipocalimab when it acquired Momenta Pharmaceuticals in August 2020 for $6.5 billion.
Siding With Novo and Lilly, Court Agrees to First Tackle ‘Cross Cutting Issues’ in GLP-1 Litigations
In agreeing with Novo Nordisk and Eli Lilly, Pennsylvania judge Karen Spencer Marston said the court should first settle questions of gastroparesis diagnosis and sufficient warnings for side effects.
Emergent BioSolutions joins Bavarian Nordic on pharma’s frontline in the fight against the ongoing mpox emergency.
In Texas, the Plano City Council approved a development agreement that supports a planned project that would bring over 3 million square feet of life sciences space to the area.
Last week, BioMarin revealed changes to its C-suite; now, the company has announced its second round of layoffs this year, following the termination of 170 employees in May.
In this episode, the third and final conversation of our mini-series on diversity in clinical trials, Lori and guests discuss framing strategies designed to protect DEI initiatives from legal challenges.
The pharma continued its clinical losing streak on Thursday with the announcement that it is discontinuing late-stage studies of the anti-PD-1 therapy in non-small cell lung cancer and cutaneous squamous cell carcinoma.