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Week in Review | AstraZeneca, Bristol Myers Squibb Weigh a $400B Merger
AstraZeneca and Bristol Myers Squibb held months of merger talks valuing the combined company near $400 billion, per the Financial Times — a deal tha…
1 month, 2 weeks ago
Daily Roundup | Novo Nordisk's ZEUS Failure: The Inflammation Thesis Just Got Repriced
Ziltivekimab missed its primary endpoint in the 6,300-patient Phase 3 ZEUS trial, sending Novo Nordisk down 10% and dragging BioAge Labs down 60% and…
1 month, 2 weeks ago
Daily Roundup | Replimune Wins 10-3 FDA Panel Vote for Melanoma Drug RP1
An FDA advisory panel backed Replimune's RP1 by 10 to 3, overriding agency reviewers, with an approval decision due August 2nd. Also: the same-day pa…
1 month, 2 weeks ago
Daily Roundup | Capricor's Duchenne Cell Therapy Voted Down — What It Means for the Field
FDA advisers recommended against Capricor's deramiocel — and the stock had already lost up to 60% before the vote. Also: Replimune falls nearly 40% a…
1 month, 2 weeks ago
Daily Roundup | Replimune RP1 on the Brink: FDA Calls Melanoma Data Uninterpretable
FDA reviewers say Replimune's IGNYTE overall survival analysis is "not interpretable" days before Thursday's advisory committee — shares fell more th…
1 month, 3 weeks ago
Daily Roundup | Capricor Craters 67% as FDA Questions Deramiocel Data
Capricor fell roughly 67% after FDA briefing documentsquestioned deramiocel's efficacy days before its advisory committee — and the company's rebutta…
1 month, 3 weeks ago
Week in Review | Amgen Refuses to Pull Tavneos: FDA Showdown Lands Wednesday
Amgen told the FDA no — a blinded Duke re-analysis of ADVOCATE met noninferiority at 68.1% versus 67.1% but lost superiority, and the deadline is Jul…
1 month, 3 weeks ago
Daily Roundup | Novo Seeks Injunction on Lilly Obesity Ads: The Comparative Claims Precedent
Novo Nordisk is asking a court to shut down Eli Lilly'scomparative obesity ads — an injunction bid that could reset the rules for GLP-1 promotion ind…
1 month, 3 weeks ago
Daily Roundup | J&J Bispecific Combo Cuts Myeloma Progression Risk 89%
J&J's Tecvayli–Talvey combo cut the risk of myeloma progression or death by 89% in earlier-line disease. Plus an FDA panel endorses wellness peptides…
1 month, 3 weeks ago
Daily Roundup | GSK Wins First Lung Cancer Approval — Jideytro Validates a $10.6B Bet
GSK's Jideytro cleared the FDA two months early — a week after the $10.6B Nuvalent deal closed — for GSK's first lung cancer approval. Plus Arrowhead…
1 month, 3 weeks ago