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- Eli Lilly Q1 profit more than doubles; Zepbound sales surge 80% to $4.2B, driven by weight-loss drug momentum
First major earnings report quantifying GLP-1 blockbuster impact; Lilly's obesity franchise now material to bottom line.
FDA Commissioner Marty Makary resigns after weeks of pressure over flavored vape approval decisionResignation creates leadership void with three top positions filled by temporary directors; future of recent FDA policies uncertain.
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- Novo Nordisk raises FY guidance on strong Wegovy pill demand, forecasts smaller-than-expected sales contraction
Oral GLP-1 momentum offsetting patent cliff pressures; FT reports Chinese generics to intensify pricing competition.
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- Regenxbio's Duchenne muscular dystrophy gene therapy meets pivotal study endpoint; FDA approval targeted for 2027
Two serious adverse events noted in trial; company claims FDA support for rare disease flexibility in approval pathway.
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Medicare launches pilot program expanding GLP-1 drug coverage to millions of beneficiaries for weight lossFederal government offering discounted semaglutide and tirzepatide specifically for obesity treatment.
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- CRISPR drug treats teenager with ultra-rare genetic mutation in first-of-kind case; regulators expected to revise rare-disease approval frameworks
Personalized gene-editing approach designed for single patient's unique variant signals pathway for future ultra-rare monogenic disorders.
- Neurocrine to acquire Soleno Therapeutics for ~$3B to gain first approved treatment for Prader-Willi syndrome
Deal values Soleno's commercialized extreme hunger therapy; expands Neurocrine's rare genetic disease footprint.
- Merck accelerates M&A activity as Keytruda patent cliff approaches, reshaping late-stage pipeline
Strategic acquisitions aim to offset revenue loss from imminent loss of exclusivity on top-selling cancer immunotherapy.
- Purdue Pharma to pay $8B+ to resolve US opioid litigation; settlement allows funds to flow to affected states and cities
Largest opioid settlement yet; distribution mechanism finally allows public health infrastructure funding across epidemic-hit regions.
- Bristol Myers Squibb and Hengrui Pharma form $15.2B strategic drug development collaboration across multiple indications
Landmark deal with top Chinese biopharma signals BMS's commitment to Asia-Pacific R&D partnerships for oncology and immunology.
Eli Lilly tirzepatide data show switching from injectable to oral formulation sustains weight loss long-termSURMOUNT-MAINTAIN and Foundayo results suggest maintenance dosing strategies for obesity.
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Biotech leaders campaign for Rick Pazdur as next FDA commissioner; Takeda to cut 4,500 jobsHundreds of executives back Pazdur amid agency leadership crisis; Takeda cuts 9% workforce under new CEO restructuring.
- Novartis Q1 profit falls 12% as blockbuster patents expire; generic competition erodes revenue base
Swiss pharma confronting patent cliff; DeepMind's Hassabis meanwhile pitches automated drug design to accelerate pipeline replacement.
Single-infusion cell therapy demonstrates multi-year HIV suppression in early patient cohort; study presented this weekApproach derives from CAR-T cancer technology; larger trials needed to confirm durability and safety profile.
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- Isomorphic Labs raises $2B as DeepMind AI drug-design spinoff advances first pipeline candidates toward human trials
Separately, Assertio accepts revised buyout offer at 31% premium over initial acquisition proposal.
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- Biogen advances tau-targeting drug BIIB080 to Phase 3 despite missing Phase 2 primary endpoint in Alzheimer's
Secondary efficacy signals and biomarker data justify late-stage development despite missed primary goal.
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Supreme Court maintains mifepristone mail access while litigation over FDA approval authority continuesJustice Alito paused a federal appeals court ruling that would restrict the abortion pill's distribution.
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FDA places full clinical hold on Aardvark Therapeutics' ARD-101 for Prader-Willi syndromeHalt due to safety concerns; Aardvark plans to unblind late-stage study, potentially forcing complete program restructuring.
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EU agrees Critical Medicines Act to boost domestic drug manufacturing capacity and prevent pandemic-era shortagesMember states will coordinate joint procurement and establish stockpiles of essential medicines.
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FDA's Center for Drug Evaluation and Research chief Tracy Beth Høeg departs as agency faces leadership turnover.Høeg's exit follows Commissioner Marty Makary's resignation days earlier; creates vacuum at top of drug review operations.
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Researchers expand CAR-T cell therapy beyond cancer to treat autoimmune diseases with immune system reset approachTherapy originally developed for oncology showing promise in reprogramming dysregulated immune responses.
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- Pig-kidney transplant recipient survives nine months; two U.S. biotech firms advancing xenotransplantation into human clinical trials
Extended graft survival post-transplant validates genetically modified porcine organs as potential solution for organ shortage.
UK's ARIA launches $1B research program to develop brain-rewiring therapies for epilepsy, Alzheimer's, and neurological disordersGovernment-backed moonshot aims to commercialize neurotech; billion-dollar commitment signals UK pivot toward neurotechnology innovation.
- BioNTech to cut 20% of workforce as Covid vaccine production winds down, pivots to oncology
German biotech reallocating resources away from saturated pandemic vaccine market toward cancer pipeline.
- GSK rebuilds oncology business via R&D and M&A after decade-long exit; targeting £40bn revenue milestone
Pharma giant re-entering cancer market through combination of internal pipeline and strategic acquisitions.
More: FT — Pharmaceuticals