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Sarepta’s Duchenne confirmatory trial fails — company to press FDA anyway
Sarepta Therapeutics reported that a confirmatory study of two exon‑skipping therapies for Duchenne muscular dystrophy missed its primary endpoint. Despite the negative result, Sarepta plans to...
Whole genome in under four hours: sequencing race accelerates newborn care
Researchers announced a new record for rapid whole‑genome sequencing, completing a human genome in under four hours. The speed milestone aims to shorten diagnostic timelines for critically ill...
Weill Cornell unveils non‑toxic gene‑switch — safer control for research and therapies
Investigators at Weill Cornell Medicine developed a versatile, non‑toxic gene‑switch tool that lets researchers turn target genes on or off using a benign small molecule. The platform—designed for...
Lilly to build $3B European plant for oral GLP‑1 pill
Eli Lilly announced plans to invest $3 billion to build a manufacturing facility in Katwijk, the Netherlands, to produce its oral GLP‑1 candidate orforglipron and other small‑molecule assets. The...
FDA drug regulator Tidmarsh resigns: HHS probe leaves CDER leaderless
George Tidmarsh resigned as director of the FDA’s Center for Drug Evaluation and Research after being placed on administrative leave while the Department of Health and Human Services investigates...
FDA signals no approval path: uniQure’s Huntington filing timeline stalls
uniQure said a recent pre‑BLA meeting with the U.S. Food and Drug Administration signaled the agency no longer views Phase I/II data using an external control as sufficient to support a biologics...
Pfizer sues to halt Novo’s Metsera bid — antitrust and breach claims filed
Pfizer filed multiple lawsuits in Delaware seeking to block Novo Nordisk’s attempt to acquire obesity biotech Metsera, alleging breach of contract and an anticompetitive plot to eliminate a U.S....
Thermo Fisher to buy Clario for $8.8B: expands trial data stack
Thermo Fisher Scientific agreed to acquire Clario for $8.8 billion to add clinical‑trial data capture, management and endpoint‑adjudication software to its Laboratory Products and Biopharma...
Roche bets on Manifold’s brain shuttles — pact could top $2B
Roche struck a research and license deal with Manifold Bio to develop next‑generation 'brain shuttles' aimed at improving delivery of biologics across the blood‑brain barrier. The agreement,...
Lilly to build $3B factory in Netherlands for oral GLP‑1 drug
Eli Lilly announced a $3 billion manufacturing site in Katwijk, the Netherlands, to produce its oral GLP‑1 candidate orforglipron and other medicines. The plant expands Lilly’s European production...
Myriad posts Q3 revenue dip — bets on upcoming MyRisk and MRD launches
Myriad Genetics reported a year‑over‑year revenue decline in Q3 but outlined product launches it expects to drive growth, including an expanded MyRisk hereditary cancer panel, a Polaris prostate...
California Medicaid adds MRD and whole‑genome sequencing to benefits
California’s Medi‑Cal expanded coverage effective Nov. 1 to include personalized plasma tumor‑informed MRD testing, whole‑genome sequencing for rare disease diagnosis and multiple genome‑wide...
Caribou’s off‑the‑shelf CAR‑T posts strong early responses — financing needed to scale
Caribou Biosciences disclosed early clinical evidence that its donor‑derived, matched off‑the‑shelf CAR‑T candidate produced high response rates in B‑cell lymphoma, including a 64% complete...
Sarepta’s Duchenne confirmatory trial fails — company to press FDA for approval anyway
Sarepta Therapeutics reported that a confirmatory study for two of its exon‑skipping therapies in Duchenne muscular dystrophy did not meet its primary endpoint. Despite the negative readout, the...
FDA drug chief resigns — CDER left without a leader
George Tidmarsh resigned as director of the FDA’s Center for Drug Evaluation and Research (CDER) after being placed on administrative leave amid an HHS investigation into his conduct. The...
UniQure’s Huntington’s gene therapy stalled — FDA questions sufficiency of Phase I/II data
UniQure disclosed that FDA officials indicated the company’s Phase I/II data for AMT‑130 may no longer be adequate to support a Biologics License Application (BLA), reversing earlier agency...
Thermo Fisher to buy Clario — major push into clinical trial software and data
Thermo Fisher Scientific agreed to acquire Clario, a clinical trial data management firm, in a deal that industry reports value at roughly $8.8–$9 billion. Thermo Fisher said the acquisition will...
California Medicaid adds MRD and whole‑genome sequencing to covered benefits
California’s Medi‑Cal expanded coverage effective Nov. 1 to include tumor‑informed minimal residual disease (MRD) testing, whole‑genome sequencing (WGS) for rare‑disease diagnosis, and additional...
Roche bets on brain shuttles — $55M upfront with Manifold; pact could top $2B
Roche signed a research and licensing pact with Manifold Bio to develop next‑generation brain‑shuttle technologies, paying an initial $55 million and structuring potential milestones that could...
Caribou’s off‑the‑shelf CAR‑T shows promise — funding needed to proceed
Caribou Biosciences reported early clinical results suggesting its allogeneic, donor‑matched CAR‑T approach can achieve efficacy benchmarks comparable to autologous products in lymphoma, renewing...