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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...
Cyclin A2 Reboots Human Heart Cells: New Gene Therapy Drives Division
Researchers at Mount Sinai demonstrated that delivering the gene Cyclin A2 (CCNA2) via a human‑compatible viral vector can induce cytokinesis in adult human cardiomyocytes and promote cardiac...
Non‑toxic gene‑switch 'Cyclone' Debuts: Precise, Safer Control of Gene Activity
Weill Cornell Medicine investigators introduced a versatile gene‑switch system that uses a non‑toxic, clinically used antiviral molecule to control expression of target genes in cells. The...
uniQure’s Huntington therapy — FDA flags data shortfall
uniQure told investors that the FDA indicated data from its Phase I/II AMT‑130 program—benchmarked against an external historical control—may no longer be sufficient to support a Biologics License...
Roche bets on brain shuttles: $55M Manifold tie‑up to speed BBB delivery
Roche struck a discovery and licence collaboration with Manifold Bio to develop next‑generation brain shuttles, paying roughly $55 million upfront and structuring potential payments that could...
Italian gene‑therapy startup raises $141M — Amgen joins Series B
Milan‑based AAVantgarde closed a $141 million Series B round led by investors including Amgen Ventures to advance gene therapies for inherited retinal diseases. The company said proceeds will...
Intellia’s CRISPR program paused — FDA places clinical hold after liver signal
Intellia voluntarily paused dosing and screening in its Phase III MAGNITUDE program and a companion Phase III trial after a patient experienced Grade‑4 liver transaminase elevations and...
TScan slashes staff, abandons solid‑tumor trial — refocus on blood cancers
TScan announced workforce reductions of roughly 30% and confirmed it will stop a Phase I solid tumor T‑cell receptor (TCR) program to concentrate resources on hematologic indications. The...
Caribou’s off‑the‑shelf CAR‑T posts competitive lymphoma results — needs cash
Caribou Biosciences reported that its allogeneic CAR‑T candidate vespa‑cel produced high complete response (CR) and overall response rates in advanced B‑cell lymphoma, outcomes the company says...
Thermo Fisher to buy Clario for $9B — bet on clinical‑trial software
Thermo Fisher Scientific agreed to acquire Clario, a provider of clinical‑trial software for collecting, managing and analyzing endpoint data, for approximately $9 billion. The deal is positioned...
BioNTech lifts guidance after Bristol Myers bispecific payment
BioNTech raised its full‑year sales guidance after receiving a milestone payment from Bristol Myers Squibb tied to their PD‑1xVEGF bispecific collaboration. The company cited the payment and...
CDER shakeup: George Tidmarsh placed on leave — regulatory leadership in flux
Reports indicated that George Tidmarsh, director of the FDA’s Center for Drug Evaluation and Research (CDER), has been placed on leave amid internal inquiries. Multiple outlets reported the move...
Moderna unravels: Covid windfall fades, pipeline and contracts under strain
Moderna is confronting a sharp strategic reset as Covid vaccine sales recede, government contract cancellations hit revenue projections and the company executes layoffs and restructurings....
UniQure’s Huntington’s filing timeline clouds: FDA signals more data needed
UniQure said the timetable to submit AMT‑130, its in vivo gene therapy for Huntington’s disease, is now unclear after a recent FDA meeting. Regulators signaled that existing Phase 1/2 data using...
Intellia’s in vivo CRISPR program halted: FDA clinical hold after liver safety event
Intellia Therapeutics announced voluntary pauses to dosing and screening in two Phase 3 programs for nexiguran ziclumeran (nex‑z), and the FDA imposed clinical holds on the INDs after a treated...
Caribou’s off‑the‑shelf CAR‑T shows clinical promise — cash crunch looms
Caribou Biosciences reported that its allogeneic CAR‑T candidate induced high remission rates in advanced B‑cell lymphoma, claiming outcomes comparable to autologous CAR‑T benchmarks. In a small...
AAVantgarde raises $141M: Amgen backs retinal gene therapy push
Milan‑based AAVantgarde closed a $141 million Series B round led in part by Amgen Ventures to advance gene therapies targeting inherited retinal diseases. The financing will support two lead...