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In briefing documents published Monday ahead of an advisory committee meeting for deramiocel, the FDA disagreed with Capricor’s assertion that a Phase 3 trial met its primary outcome measures.
FEATURED STORIES
As drug hunting gets more complex, where and how data is generated in partnerships between Big Pharmas and AI biotechs is becoming a headache for dealmakers.
With a Phase 3 failure denting the rare disease drug’s prospects, AstraZeneca has little room for error as it plots a path toward its ambitious 2030 sales target.
The biopharma industry would do well to re-embrace the 505(b)(2) path, which allows sponsors to draw on previous findings around an existing drug even as they propose modifications to it.
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Jennifer Doudna–founded Scribe Therapeutics intends to use the proceeds from the public offering—the first for a gene editing outfit in over two years—to support development of its epigenetic silencing therapy for atherosclerotic cardiovascular disease.
Facing pressure around the world to withdraw the rare kidney disease drug Tavneos, Amgen has launched a robust defense with real-world evidence to support the product’s benefit-risk profile.
Eli Lilly’s $3.8 billion play for AtaiBeckley has fueled speculation that Big Pharma is ready to embrace psychedelics. But while the acquisition does validate the drug class, analysts say it is unlikely to trigger a broad wave of Big Pharma deals.
Summit’s star asset is the PD-1/VEGF bispecific ivonescimab, which this week produced promising survival data from a late-stage global trial in non-small cell lung cancer. The FDA review is ongoing with a decision expected by Nov. 14.
Acmopatide met the main goal of a Phase 2 study in type 1 diabetes, but Roche is axing the investigational drug to prioritize enicepatide for weight loss, type 2 diabetes and cardiovascular outcomes. Both assets come from the $2.7 billion buy of Carmot Therapeutics.
The addition of small molecule capacity at BeOne Medicines’ Hopewell site will support the company’s hematology efforts and bring total investment in the campus to more than $1 billion.
Roche has 19 investigational medicines that could launch by 2030—and even if not all of them make it to market, the company is “well set-up for growth into the next decade,” CEO Thomas Schinecker said on the pharma’s Q2 earnings call.
Summit Therapeutics and Akeso are answering questions raised about ivonescimab’s ability to translate to Western populations, though the partners have yet to share if the new findings are statistically significant.
Top-selling cell therapies from BMS, J&J and Gilead depend on a BioLife product, positioning Repligen to use the takeover to increase its exposure to the modality.
BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.