Get the Daily Brief
Latest Biotech News
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...
Roche buys into brain‑shuttle tech: Manifold pact blends AI and BBB expertise
Roche struck multi‑hundred‑million‑dollar research terms with Manifold Bio to develop new ‘brain‑shuttle’ platforms and paid an initial $55 million to access Manifold’s AI‑driven discovery stack....
Thermo Fisher to buy Clario for $9B — software joins the lab stack
Thermo Fisher Scientific agreed to acquire Clario for about $9 billion, bringing clinical‑trial endpoint capture and clinical data management software into Thermo Fisher’s biopharma services...
Pfizer sues to block Metsera‑Novo deal — obesity M&A turns litigious
Pfizer filed litigation seeking to enforce its merger agreement with Metsera and to block a competing offer tied to Novo Nordisk, accusing Novo and Metsera’s board of breaching contractual terms...
TScan cuts 30% of staff, halts solid‑tumor TCR program
TScan Therapeutics laid off roughly 30% of its workforce and stopped its Phase 1 solid‑tumor T‑cell receptor (TCR) trial to concentrate resources on blood‑cancer programs. The company cited a...
FDA leadership in flux: CDER director George Tidmarsh placed on leave
Reports indicate George Tidmarsh, director of the FDA’s Center for Drug Evaluation and Research (CDER), has been placed on administrative leave. Multiple outlets reported the move and cited...
Intellia clinical hold–dosing paused after severe liver injury
Intellia Therapeutics halted dosing and screening across its Phase III MAGNITUDE program and a second Phase III trial after a participant developed severe liver injury that met Hy’s law criteria....
Thermo Fisher shells out $9 billion: buys Clario to plug clinical‑data gap
Thermo Fisher Scientific agreed to acquire Clario in a deal valued at about $9 billion, expanding its clinical‑trial software and data-management capabilities. Clario provides endpoint data...
FDA turmoil...CDER director placed on leave as agency faces leadership strain
Reports indicate George Tidmarsh, director of the FDA’s Center for Drug Evaluation and Research (CDER), has been placed on administrative leave amid internal controversies. The moves were reported...
Amgen Ventures backs AAVantgarde: $141 million to accelerate retinal gene therapies
AAVantgarde closed a $141 million Series B led by Amgen Ventures to advance gene therapies for inherited retinal diseases that cause blindness. The Milan‑based company said the financing will fund...
Moderna unravels: vaccine success fails to translate into broader pipeline wins
Moderna is undergoing deep restructuring after Covid‑era revenue declines and unmet expectations for next‑generation mRNA programs. The company has cut costs, faced canceled government contracts...
Optical genome mapping augments CLL workup: pilot shows broader structural variant capture
Researchers piloted optical genome mapping (OGM) alongside FISH analysis to improve diagnostic resolution in chronic lymphocytic leukemia (CLL). The study showed OGM can detect structural variants...
Plasma pTau217 test: Fujirebio aims to speed Alzheimer’s diagnosis with blood assay
Fujirebio presented data on its Lumipulse G pTau217/β‑Amyloid 1‑42 plasma ratio test, positioning the assay to shorten diagnostic timelines for Alzheimer’s disease by providing accessible...
Phage tech moves from farms to clinics: virus‑loaded patches and bird‑flu phage research advance
Researchers developed microneedle patches that deliver bacteriophages into food to kill pathogens like E. coli and Salmonella, offering a potential on‑product safety measure for ready‑to‑eat...