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Latest Biotech News

Thermo Fisher shells out $8.8B for Clario to bolster clinical‑trial tech stack

November 04, 2025

Thermo Fisher Scientific agreed to acquire clinical trial data firm Clario for $8.8 billion, a deal that will expand Thermo Fisher’s digital offerings across trial operations and data management....

Roche bets on Manifold brain‑shuttle tech with multi‑hundred‑million pact

November 04, 2025

Roche signed a strategic collaboration and license deal with Manifold Bio to develop next‑generation brain shuttles, paying an upfront $55 million and structuring a partnership that could exceed...

Private capital backs Merck oncology push: Blackstone buys into ADC royalties

November 04, 2025

Blackstone Life Sciences agreed to purchase a stake in Merck’s Trop‑2 antibody‑drug conjugate program, paying roughly $700 million to underwrite development and share future royalty streams....

Metsera M&A melee: Novo pushes $10B bid, Pfizer strikes back

November 04, 2025

Novo Nordisk increased its takeover proposal for obesity biotech Metsera, lifting its offer to as much as $10 billion and reshaping the competitive auction for a leading obesity-platform company....

FDA turbulence: CDER boss resigns amid probe

November 04, 2025

George Tidmarsh, the director of the FDA’s Center for Drug Evaluation and Research (CDER), resigned following reports of administrative leave and a Health and Human Services probe into his...

UniQure setback: FDA questions AMT‑130 data — filing timeline unclear

November 04, 2025

UniQure disclosed that the FDA now signals it may no longer accept AMT‑130’s Phase I/II data — based on comparisons to an external control — as sufficient evidence to support a Biologics License...

Thermo Fisher expands clinical stack: Clario deal to scale trials

November 04, 2025

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

November 04, 2025

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

November 04, 2025

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

November 04, 2025

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

November 04, 2025

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

November 04, 2025

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

November 04, 2025

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

November 04, 2025

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

November 04, 2025

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

November 04, 2025

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

November 04, 2025

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

November 04, 2025

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

November 04, 2025

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

November 04, 2025

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...