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Rigel’s Veppanu commercialization rights clarified
Rigel Pharmaceuticals’ newly approved breast cancer drug Veppanu got deal clarity as Rigel and its partners finalized commercialization arrangements. Arvinas and Pfizer agreed to find a new...
DOJ escalates pharma fraud enforcement
The U.S. Department of Justice told industry audiences it is expanding enforcement under the False Claims Act, with drug pricing, cybersecurity, and fraud detection now central priorities. In a...
Parexel acquires Vitrana for AI pharmacovigilance
Parexel acquired Vitrana, an AI pharmacovigilance technology developer, to automate high-volume drug safety workflows and reduce manual bottlenecks in clinical trials. The CRO said the platform...
Digital pathology M&A: Roche to acquire PathAI
Roche agreed to buy PathAI in a deal valued at $750 million upfront to expand AI-powered digital pathology capabilities. PathAI’s technology supports pathology laboratories and biopharma partners...
Gene therapy safety investigation stalls at hospital over tissue access
Capsida Biotherapeutics said it still cannot determine the cause behind a child’s death in its CAP-002 gene therapy trial, citing continued obstacles in accessing autopsy tissue samples. The...
AAV redosing and immunity debates surface at ASGCT
ASGCT highlighted growing clinical and regulatory focus on solving AAV’s “one-and-done” limitation by enabling redosing and addressing pre-existing immunity. BioCentury’s coverage pointed to...
Genewiz upgrades gene synthesis workflow
Genewiz launched Gene Synthesis 2.0, upgrading how researchers design and order genes with faster workflows and improved codon optimization. The platform introduces three ordering packages—Sprint,...
Alamar begins analyst coverage after IPO
Leerink and JPMorgan initiated coverage of Alamar Biosciences following the company’s public debut, with both banks issuing positive ratings based on NULISA assay sensitivity and automation....
Major CRO deal expands AI pharmacovigilance automation
Parexel said it has acquired Vitrana, an AI pharmacovigilance technology developer, as part of an effort to reduce the operational burden of drug safety reporting for clinical studies. The...
Bayer signals return to pharma M&A after pause
Bayer’s CEO Bill Anderson told investors the company is preparing to re-enter pharma M&A, saying it will be “careful, but also aggressive.” The statement comes as Bayer moves to refresh its...
BMS expands China partnership with Hengrui in large biobucks deal
Bristol Myers Squibb joined Hengrui in a broad alliance that covers 13 drug programs, with deal value up to $15.2 billion. The pact reflects the deepening relationship between China-based large...
Roche to acquire PathAI to deepen digital pathology footprint
Roche agreed to acquire PathAI for $750 million upfront to expand AI-powered digital pathology capabilities for pathology laboratories and biopharma customers. PathAI’s technology is used to...
Partner acquisition: Fractyl’s GLP-1 gene therapy clears European clinical test
European regulators cleared Fractyl Health for a clinical trial of its GLP-1 gene therapy candidate, positioning the company in the race to replace chronic GLP-1 injections and pills with a...
Gene therapy safety investigation still unresolved at Capsida
Capsida Biotherapeutics said it still has no answers after investigating the death of a child in its gene therapy trial of CAP-002 last September. The company said progress has been stymied...
A major therapy approval: Partner’s Bizengri wins FDA nod for NRG1-driven cholangiocarcinoma
Partner Therapeutics said its bispecific antibody Bizengri received FDA approval for advanced cases of cholangiocarcinoma driven by NRG1 gene fusions. The therapy was acquired as U.S. rights from...
Clinical and IP signal: enGene share crash after updated bladder cancer readouts
enGene’s stock plunged after updated Phase II results for its nonviral gene therapy candidate detalimogene voraplasmid in high-risk, BCG-unresponsive non-muscle invasive bladder cancer. The update...
AI-enabled biotech operations: Knit Health raises seed for healthcare AI workflow agent
Knit Health, a UC Berkeley spinout, raised $11.6 million in seed funding to pursue an AI-driven approach to healthcare operations described as thinking “like a doctor.” The company’s strategy...
Antibody discovery acceleration: Nuclera launches antibody triage service
Nuclera launched an antibody screening service to streamline the transition from antibody hit generation to lead selection, aiming to reduce the experimental bottleneck that slows AI-driven...
Regulatory approval in rare, genomically defined cancer
Partner Therapeutics’ Bizengri (bispecific antibody targeting NRG1 fusions) received FDA approval for advanced cholangiocarcinoma driven by NRG1 gene fusions. The approval makes Bizengri the first...
Big pharma partnership unlocking China pipeline assets
Bristol Myers Squibb struck a broad, multi-asset partnership with China’s Hengrui Pharma, paying $600 million upfront to advance 13 early-stage programs spanning the two companies’ pipelines. The...