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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...
Intellia’s in vivo CRISPR trial faces clinical hold after liver safety signal
Intellia Therapeutics disclosed voluntary pauses in dosing and screening across its Phase III MAGNITUDE trial and a second Phase III study after a patient experienced Grade 4 transaminase...
AAVantgarde raises $141M Series B to advance retinal gene therapies
AAVantgarde closed a $141 million Series B, led by Amgen Ventures, to advance gene‑therapy programs for inherited retinal diseases. The Milan‑based biotech will deploy the financing to accelerate...
Mass General Brigham researchers use tumor cells to kickstart antitumor immunity in models
Mass General Brigham researchers published preclinical data showing engineered tumor cells can be leveraged to restore innate immune sensing and trigger robust antitumor responses in animal...
TScan cuts workforce and halts solid‑tumor TCR program to focus on blood cancers
TScan Therapeutics announced a workforce reduction of roughly 30% and the discontinuation of a Phase I solid‑tumor T‑cell receptor (TCR) trial, shifting focus to hematologic indications. The...
UniQure’s Huntington Hopes Hit: FDA Signals Data Shortfall
UniQure said the FDA no longer agrees that its Phase I/II data for AMT-130—an experimental one-time gene therapy for Huntington’s disease—are adequate to support a Biologics License Application....
FDA Drug Office in Turmoil: CDER Director Resigns After Leave
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 probe into his conduct. The department said...
Pfizer Files Suit to Block Novo Nordisk–Metsera Deal — Antitrust Fight Starts
Pfizer sued Metsera and Novo Nordisk in Delaware court seeking to stop Novo’s counter-offer to acquire obesity biotech Metsera, alleging breach of contract and an anticompetitive conspiracy....
Thermo Fisher Expands Into Clinical-Trial Tech: Clario Deal Agreed
Thermo Fisher Scientific agreed to acquire clinical trial data firm Clario in a transaction reported at roughly $8.8–$9 billion to broaden its digital capabilities in clinical research. Clario...
Roche Taps Manifold Bio’s Platform: $55M Deal to Pilot Brain Shuttles
Roche struck a strategic collaboration and license deal with Manifold Bio to develop next-generation 'brain shuttle' technologies for neurological diseases. The pact includes an upfront payment...
Off‑the‑Shelf CAR‑T Shows Promise: Caribou Posts Early Efficacy Signals
Caribou Biosciences reported early data suggesting its allogeneic, off‑the‑shelf CAR‑T candidate can induce deep remissions in B‑cell lymphoma. The preliminary results showed high overall and...
Intellia Halts Dosing: CRISPR Heart Program Faces FDA Clinical Hold
Intellia Therapeutics paused dosing and screening in Phase III and Phase II trials of its in vivo CRISPR candidate nexiguran ziclumeran after a patient experienced severe liver injury. The FDA...
Clinical Program Cutbacks: TScan Lays Off Staff, Stops Solid‑Tumor Trial
TScan Therapeutics announced workforce reductions of roughly 30% and the termination of a Phase I solid‑tumor T‑cell receptor program as the company refocuses resources on blood‑cancer...