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Thermo Fisher expands clinical stack: Clario deal to scale trials
Thermo Fisher Scientific agreed to acquire clinical trial data firm Clario for about $8.8 billion, folding a major electronic data capture and endpoint‑management platform into its Laboratory...
Azalea launches: $82M raise to enable single‑shot in vivo CAR‑T
A Jennifer Doudna‑linked spinout, Azalea Therapeutics, closed a notable funding round — reported at $82 million total — to pursue in vivo CAR‑T approaches designed to convert patients’ immune...
Celltrion gambit: $744M deal for Kaigene autoimmune antibodies
Celltrion struck a licensing and distribution agreement with Kaigene that could deliver up to $744 million in payments tied to two preclinical autoimmune antibody programs—KG006 and KG002. The...
Sarepta stumbles: Duchenne confirmatory trial misses endpoint
Sarepta Therapeutics reported that a long‑awaited confirmatory trial of two exon‑skipping therapies for Duchenne muscular dystrophy did not meet its primary endpoint. Company leadership said it...
Off‑the‑shelf CAR‑T shows promise — Caribou posts durable remissions
Caribou reported preliminary clinical data indicating that its off‑the‑shelf CAR‑T candidate produced complete and durable remissions in a cohort of patients with advanced B‑cell lymphoma. The...
Astellas unveils KRAS G12D degrader with tumor activity preclinically
Astellas Pharma disclosed preclinical data showing tumor growth inhibition for ASP‑4396, a CRBN‑based proteolysis targeting chimera (PROTAC) designed to degrade KRAS G12D. The preclinical package...
Cas12l nucleases emerge as compact CRISPR tools for therapeutics
Caszyme and industry partners unveiled Cas12l nucleases, a family of compact CRISPR enzymes (~850 amino acids) reported to deliver high editing efficiency with different PAM requirements and...
uniQure’s Huntington’s therapy hits FDA roadblock — shares tumble
UniQure disclosed that the FDA has signaled the company’s Phase I/II data for AMT‑130 may not be adequate to support a Biologics License Application, marking a reversal from prior agency...
FDA leadership crisis deepens after CDER director resigns
George Tidmarsh resigned as director of the FDA’s Center for Drug Evaluation and Research two days after being placed on administrative leave while the Department of Health and Human Services...
Pfizer sues to block Novo‑Metsera deal — legal battle escalates
Pfizer filed lawsuits alleging Novo Nordisk’s counter‑offer for obesity biotech Metsera is anticompetitive and breaches Pfizer’s merger agreement, asking courts to block Metsera from terminating...
Doudna‑linked Azalea raises $82M to chase in vivo CAR‑T single‑dose therapy
Azalea Therapeutics, a spinout from Jennifer Doudna’s lab, closed an $82 million financing to develop in vivo CAR‑T approaches that aim to reprogram patients’ immune cells with a single infusion....
Roche pumps billions into brain‑shuttle technology with Manifold pact
Roche signed a strategic collaboration and large financial commitment to pilot Manifold Bio’s blood‑brain barrier shuttle technology, paying an upfront amount and potential milestone payments to...
Thermo Fisher to buy clinical‑trial data firm Clario — $8.8B deal expands digital reach
Thermo Fisher Scientific agreed to acquire Clario, a clinical trials software and data management company, in a transaction valued at roughly $8.8–9 billion. The move integrates Clario’s endpoint...
AAVantgarde raises $141M Series B to push retinal gene therapies forward
Milan‑based AAVantgarde closed a $141 million Series B backed by investors including Amgen Ventures to advance gene therapies for inherited retinal diseases. The funds will accelerate IND‑enabling...
Caribou’s allogeneic CAR‑T shows early promise — off‑the‑shelf story revives
Caribou released data suggesting its off‑the‑shelf cell therapy platform produced complete and durable responses in advanced B‑cell lymphoma patients, supporting continued development of...
TScan cuts workforce, halts solid‑tumor TCR program amid refocus
TScan Therapeutics is laying off about 30% of staff and stopping a Phase I solid‑tumor T‑cell receptor trial to prioritize blood‑cancer programs and preserve runway. The company told investors it...
CDER chief resigns: FDA left leaderless after conduct probe
George Tidmarsh resigned as director of the FDA’s Center for Drug Evaluation and Research after being placed on administrative leave amid an HHS investigation into his conduct. The departure...
UniQure stumbles: FDA signals AMT‑130 data now inadequate
UniQure said the FDA has signaled that data from its Phase I/II studies of AMT‑130, a gene therapy for Huntington’s disease, may no longer be sufficient to support a Biologics License Application....
Pfizer sues to block Novo’s Metsera counter‑offer — takeover fight turns legal
Pfizer filed lawsuits seeking to stop Metsera from terminating its merger agreement and from accepting Novo Nordisk’s counter‑offer, alleging breach of contract and antitrust harms. The legal...
Thermo Fisher shelled out for Clario: $8.8B bet on digital trials
Thermo Fisher Scientific agreed to acquire Clario, a clinical‑trial data and endpoint technology firm, for about $8.8–$9 billion to expand its digital capabilities in clinical research. The...