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Richard Pazdur named CDER director — veteran regulator returns
The FDA appointed long‑time oncology regulator Richard Pazdur as director of the Center for Drug Evaluation and Research (CDER), a move framed by agency leaders as restoring experienced,...
CMS covers Personalis MRD assay for breast cancer surveillance
The Centers for Medicare & Medicaid Services granted Medicare coverage for Personalis’ NeXT Personal minimal residual disease (MRD) assay for stage II and III breast cancer recurrence monitoring....
Lilly bets $1.2B on RNAi: Sanegene partnership targets obesity
Eli Lilly entered a $1.2 billion collaboration with Suzhou Sanegene Bio to advance tissue‑selective RNA interference (RNAi) therapeutics for metabolic diseases, aiming to accelerate development of...
Pfizer clinches Metsera for $10 billion – Novo bows out
Pfizer reached a binding agreement to acquire obesity drug developer Metsera for roughly $10 billion after a week-long bidding war that saw Novo Nordisk drop out. The amended deal secures...
FDA moves to strip HRT black-box labels – access to menopause drugs widens
The U.S. Food and Drug Administration announced it will work with manufacturers to remove or narrow boxed warnings on hormone replacement therapies for menopause, reversing long-standing labeling...
CRISPR field endures mixed week – trial fatality and promising lipid data
CRISPR therapeutics companies reported conflicting developments this week: Intellia disclosed a patient fatality tied to an investigational in vivo CRISPR program and awaited FDA clinical-hold...
Merck’s oral PCSK9 pill posts near-injectable LDL cuts – data land at AHA
Merck released late-stage results showing its oral PCSK9 inhibitor produced LDL-cholesterol reductions similar to injectable PCSK9 biologics in phase 3 trials, positioning the pill as the first...
Cogent’s bezuclastinib clears phase 3 hurdles – NDA planned for 2026
Cogent Biosciences announced pivotal phase 3 results for bezuclastinib in imatinib-resistant gastrointestinal stromal tumors, meeting the primary endpoint with a 50% reduction in risk of...
Engene posts pivotal bladder gene-therapy data – stock surges
Engene (EnGene/Engene Holdings) released additional pivotal-cohort data from its Legend phase II trial of detalimogene voraplasmid for high-risk, BCG-unresponsive non–muscle-invasive bladder...
Lilly inks gene-therapy, RNAi pacts—expands genetic-medicine footprint
Eli Lilly announced a flurry of genetic-medicine deals: a licensing agreement for MeiraGTx’s AAV-AIPL1 retinal gene therapy and a major collaboration with Sanegene worth up to $1.2 billion to...
MGI to sequence 110,000 genomes in South Africa – national reference aims launched
MGI Tech signed an MoU with South Africa’s SAMRC and DSTI to launch a 110,000-genome program that will establish the country’s first national genomic reference database. The initiative installs...
Iambic raises $100M-plus to advance AI-discovered therapeutics
Iambic Therapeutics closed an oversubscribed financing of over $100 million to accelerate its AI-discovered drug portfolio and platform work, citing new collaborations and clinical advances. The...
FDA taps Richard Pazdur to lead CDER – regulator returns to center stage
The U.S. Food and Drug Administration named veteran regulator Richard Pazdur as director of the Center for Drug Evaluation and Research (CDER) following the sudden resignation of his predecessor....
FDA taps veteran Richard Pazdur—names him CDER director
The FDA appointed long‑time cancer regulator Richard Pazdur as director of the Center for Drug Evaluation and Research (CDER). The agency announced the move after George Tidmarsh's abrupt...
Pfizer clinches Metsera for $10 billion — bidding war ends
Pfizer reached a definitive agreement to acquire obesity developer Metsera for roughly $10 billion after a week‑long auction in which Novo Nordisk declined to increase its bid. Company statements...
CRISPR’s mixed week... breakthrough readouts and a trial fatality
The CRISPR field produced divergent headlines this week: CRISPR Therapeutics reported early clinical data showing substantial reductions in cholesterol and triglycerides with an investigational in...
Neurocrine’s Takeda‑licensed depression drug flunks mid‑stage tests
Neurocrine Biosciences confirmed that NBI‑1070770, an oral NR2B negative allosteric modulator licensed from Takeda, failed to meet the primary endpoint in a Phase 2 trial for major depressive...
Merck’s oral PCSK9 pill posts injectable‑like LDL cuts in phase studies
Merck disclosed late‑stage data showing its oral PCSK9 inhibitor produced LDL cholesterol reductions comparable to current injectable biologics in Phase 3 trials. The company’s CORALreef program...
Engene posts more pivotal bladder‑gene therapy data — stock jumps
Engene (EnGene/Engene Holdings) released additional preliminary results from its pivotal Legend Phase II cohort testing detalimogene voraplasmid in high‑risk, BCG‑unresponsive non‑muscle invasive...
Iambic raises $100M+—AI‑discovered pipeline advances
Iambic Therapeutics closed an oversubscribed financing of more than $100 million to accelerate development of AI‑discovered therapeutics and platform advances. The round drew strategic investors...