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Manufacturers are redesigning their processes to balance both better future emergency vaccine mobilization and the more demanding work of maintaining flexible, commercially viable manufacturing networks.
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In Thursday’s Senate committee meeting, FDA commissioner nominee Heidi Overton was repeatedly questioned about her ability to retain the FDA’s independence under President Donald Trump, as well as about her views on vaccines and abortion drugs.
Kyverna Therapeutics’ miv-cel showed improved mobility and a favorable safety profile at one year in patients with stiff person syndrome, further derisking an upcoming FDA application, William Blair said on Thursday. The biotech plans to file for priority review this year.
BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.
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Big Pharma needs more—not fewer—bold bets on rare and difficult diseases after Novartis’ efforts to invest in muscular dystrophy and ALS hit major roadblocks this month.
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Analysts were keen to see a new modality compete with Roche’s approved drug Lucentis in the late-stage trial but new safety issues could complicate the future for Merck’s candidate.
The weekly insulin Onswik will now be available to U.S. patients after initial approvals in Europe, Mexico and Japan.
Basecamp Research joins the growing group of AI-forward biotechs that in recent months have brought in notable sums from investors, including Isomorphic Labs and Enveda.
The new partnership follows Roche’s recent R&D expansion in Boston focused on development for cardiovascular, renal and metabolic diseases.
InnoCare Pharma is the latest addition to Eli Lilly’s dealmaking spree, which includes some of the biggest acquisitions this year: up to $7 billion for Kelonia Therapeutics in April and up to $7.8 billion for Centessa Pharmaceuticals in March.
In this episode of Denatured presented by Curium, Jennifer Smith-Parker speaks to Mike Patterson, CEO North America and Professor Sabine Brookman-May, vice president and head of Global Clinical Development. We look at the momentum behind radioligand therapy and how its diagnostic and therapeutic capabilities are improving care for more than 14 million patients worldwide.
After imeroprubart failed to demonstrate sufficient efficacy in lupus during a Phase 2b trial, Immunovant is moving on from the indication and looking to other high priority programs for the drug in neurology, endocrinology and rheumatology.
Tech darling Enveda has raised a total of $845 million in the past six years. The latest funding round is intended to pave the way for an IPO someday.
Amgen is awaiting another Phase 3 readout for the investigational Sjögren’s disease therapy, set for later this year. William Blair anticipates that at least two trials will be needed to support an FDA application.
A late-stage test of Roche and Ionis Pharmaceuticals’ sefaxersen showed that the drug reduced protein in the urine, which suggests the RNA-targeting therapy could improve kidney function and delay transplant.