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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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Life science companies can protect intellectual property in multiple ways, including leveraging IP rights.
Bayer on Thursday provided additional data on late-stage studies of its rival drug to Astellas’ Veozah, which met all primary endpoints.
A European Medicines Agency panel on Friday cited a possible but unconfirmed risk of cancer and recommended that hydroxyprogesterone caproate drugs be suspended from the European Union market.
Bolstered by promising response data from its Phase II study, Amgen announced Thursday it got the FDA’s green light for its first-in-class bi-specific T-cell engager Imdelltra for extensive-stage small lung cancer.
Disappointed with Phase I/II results for two Ionis-partnered programs, one for amyotrophic lateral sclerosis and another for Angelman syndrome, Biogen has opted to not proceed with their development.
Since taking the helm in 2023, Anderson has embarked on a radical departure from the traditional structure of large pharma companies. Will getting rid of management layers fix Bayer?
A Senate health committee report published Wednesday forecasts spending on prescription drugs to hit $1 trillion a year in 2031, unless the prices of GLP-1 medicines such as Novo Nordisk’s Wegovy are cut.
Eli Lilly’s efsitora alfa, which is meant to be taken weekly instead of multiple times a day, demonstrated non-inferior A1C reduction in a Phase III trial compared to Novo Nordisk’s daily insulin.
Johnson & Johnson announced Thursday it is paying $850 million in cash, plus a potential milestone payment, for privately held biotech Proteologix and its atopic dermatitis-focused bispecific antibody candidates.
Roche’s $2.7 billion acquisition of Carmot Therapeutics in December 2023 appears to be paying off as its investigational GLP-1/GIP receptor agonist induced strong weight loss in a Phase Ib study.