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Latest Biotech News

Braveheart raises $185M to advance HCM candidate

November 05, 2025

Braveheart Bio closed a $185 million financing to launch registration‑enabling studies of a hypertrophic cardiomyopathy candidate licensed from Jiangsu Hengrui. The Series A attracted top biotech...

Qiagen to buy Parse Biosciences for single‑cell push

November 05, 2025

Qiagen agreed to acquire Parse Biosciences for $225 million in cash plus up to $55 million in milestones, folding an instrument‑free single‑cell sample prep technology into Qiagen’s sample and...

Merck sells ADC risk, pays to regain an asset – two‑check deal

November 05, 2025

Merck struck a pair of financial deals this week tied to its Trop2‑targeting antibody‑drug conjugate program: Blackstone Life Sciences agreed to provide $700 million in a risk‑sharing financing,...

Thermo Fisher to buy Clario for $8.8B to expand clinical‑trial tech

November 05, 2025

Thermo Fisher Scientific agreed to acquire Clario, a clinical‑trial data and eClinical solutions provider, for $8.8 billion to accelerate its digital footprint in clinical research. The purchase...

Azalea Therapeutics launches with $82M to pursue in‑vivo CAR‑T

November 05, 2025

Azalea Therapeutics, a Jennifer Doudna‑linked spinout, announced an $82 million raise to develop in‑vivo CAR‑T approaches intended to convert patients’ immune cells directly inside the body. The...

Metsera M&A melee: Novo and Pfizer raise the ante

November 05, 2025

Novo Nordisk and Pfizer escalated a high‑stakes auction for obesity biotech Metsera this week, with Novo increasing its offer to roughly $10 billion and Pfizer improving a competing bid to about...

CDER leadership split: Top FDA drug regulator exits

November 05, 2025

George Tidmarsh resigned as director of the FDA’s Center for Drug Evaluation and Research after being placed on administrative leave amid an HHS probe into his conduct. The departure leaves CDER...

UniQure data reversal: Huntington’s gene therapy timeline murky

November 05, 2025

UniQure said a recent FDA meeting signaled the agency no longer supports relying on its Phase I/II AMT‑130 data against an external control as sufficient for a BLA submission, casting the timing...

FDA rejects Biohaven’s troriluzole bid: RWE route blocked

November 05, 2025

The FDA has rejected Biohaven’s approval request for troriluzole in spinocerebellar ataxia, delivering a complete response letter that questioned the real‑world evidence (RWE) and externally...

Sarepta’s confirmatory miss: Duchenne approval path in flux

November 05, 2025

Sarepta Therapeutics reported that its long‑awaited ESSENCE confirmatory trial of Vyondys 53 and Amondys 45 failed to meet the primary endpoint, though management signaled it will press the FDA...

Arena BioWorks shutters: billionaire‑backed research hub folds

November 05, 2025

Arena BioWorks, launched with roughly $500 million from billionaire backers to accelerate AI‑driven drug discovery, is abruptly closing and laying off staff after investors decided to cease...

Qiagen scoops Parse Biosciences to bulk up single‑cell toolkit

November 05, 2025

Qiagen agreed to acquire Parse Biosciences for $225 million in cash plus up to $55 million in milestones, aiming to expand into high‑throughput single‑cell sample prep and scale its presence in...

Colossal buys Viagen to add cloning, biobank muscle

November 05, 2025

Colossal Biosciences acquired Viagen Pets & Equine, a cloning and biobanking specialist, integrating Viagen’s reproductive and preservation capabilities into Colossal’s broader...

Nautilus installs single‑molecule proteomics platform at Buck Institute

November 05, 2025

Nautilus Biotechnology placed its single‑molecule protein analysis system at the Buck Institute for Research on Aging—the first external installation—so Buck researchers can profile tau...

Exact Sciences posts strong quarter as screening climbs

November 05, 2025

Exact Sciences reported third‑quarter revenues of $850.7 million, a 20% increase year‑over‑year, driven by growth in its Cologuard screening business and rising precision oncology...

UniQure’s Huntington bid stalls: FDA backs away from external‑control path

November 05, 2025

UniQure said the U.S. Food and Drug Administration signaled that data from its phase I/II AMT‑130 program compared with an external control group may not be adequate to support a biologics license...

FDA drug leadership in turmoil: CDER left helmless after Tidmarsh exit

November 05, 2025

George Tidmarsh resigned as director of the FDA’s Center for Drug Evaluation and Research after being placed on administrative leave amid an HHS probe into his conduct. The departure leaves CDER...

Sarepta’s Duchenne confirmatory miss: company vows to press FDA for full approvals

November 05, 2025

Sarepta reported that its long‑awaited confirmatory ESSENCE Phase III trial of exon‑skipping antisense oligonucleotides failed to meet the primary endpoint, sending its shares sharply lower. The...

Metsera takeover melee: Novo ups bid to $10B as Pfizer pushes back

November 05, 2025

Novo Nordisk raised its offer for obesity biotech Metsera to as much as $10 billion, topping Pfizer’s competing bid and escalating a weeks‑long acquisition battle. Metsera’s board has declared...

Merck taps Blackstone for $700M ADC push; pays $150M to regain asset

November 05, 2025

Merck struck parallel transactions that shift financing risk and consolidate control of an ADC program: Blackstone Life Sciences will provide roughly $700 million to underwrite pivotal development...