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Qiagen buys Parse Biosciences — push into single‑cell market
Qiagen agreed to acquire Parse Biosciences for $225 million in cash plus up to $55 million in milestones, a move to bring instrument‑free single‑cell sample‑prep into its portfolio. The...
Tempus AI readies for MRD reimbursement — Q3 revenue jumps 85%
Tempus reported an 85% year‑over‑year revenue jump in Q3 as the company positions its MRD (minimal residual disease) tests for reimbursement and seeks FDA submissions for multiple assays....
FDA turmoil: CDER chief resigns amid probe, critics warn credibility erodes
George Tidmarsh resigned as director of FDA’s Center for Drug Evaluation and Research after being placed on administrative leave amid an internal probe into his conduct, according to reporting in...
Metsera M&A melee: Novo raises bid to $10 billion
Novo Nordisk and Pfizer escalated a takeover duel for obesity biotech Metsera this week, with Novo increasing its proposal to as much as $10 billion and Pfizer responding with a raised...
FDA turmoil: CDER chief exits amid probe
The FDA’s drug review center lost its director after George Tidmarsh was placed on administrative leave and then resigned as the Department of Health and Human Services opened a probe into his...
UniQure stumble: FDA shifts on Huntington’s gene therapy
UniQure disclosed that the FDA no longer appears to view its Phase I/II AMT‑130 data as sufficient to support a Biologics License Application, reversing earlier signals that had encouraged the...
Sarepta confirmatory miss – Duchenne trial fails primary endpoint
Sarepta Therapeutics reported that its long‑awaited ESSENCE confirmatory trial of two exon‑skipping drugs missed the primary endpoint, producing results that the company described as influenced by...
FDA rejects Biohaven’s RWE bid for troriluzole
The FDA issued a complete response letter to Biohaven's submission for troriluzole in a neurological indication, ruling that the real‑world evidence (RWE) and externally controlled analyses failed...
Braveheart raises $185M to advance HCM candidate
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
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
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
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
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
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
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
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
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
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
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
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...