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EU moves to secure critical medicine supplies
The European Parliament and Council provisionally approved the Critical Medicines Act, advancing an EU-wide framework intended to strengthen supply chains for medicines deemed critical. The...
Oncology diagnostics push into end-to-end workflow
Roche outlined a strategy to become an end-to-end oncology solutions provider by combining diagnostic instruments, testing workflows and new capabilities via acquisitions. At its diagnostics day,...
AI drug discovery funding surge
Isomorphic Labs, the Alphabet-backed AI biotech focused on drug design, closed a $2.1 billion Series B round to scale its unified drug discovery engine. Thrive Capital led the round with...
Immunotherapy biomarker strategy via liquid biopsy
LiquidCell Dx began building an evidence base for LiquidTME, a cell-free DNA methylation profiling assay designed to predict response to immune checkpoint inhibitors by characterizing tumor...
CRISPR-edited stem cell transplant in AML/MDS
Researchers at Washington University School of Medicine reported Phase I/II multicenter results in Nature Medicine showing that CRISPR-Cas9 deletion of CD33 from donor cells can help reduce...
Precision oncology trial signal in ovarian cancer
Data presented from the MYTHIC trial showed activity for lunresertib plus zedoresertib in platinum-resistant ovarian cancer, with response rates highest in a biomarker-defined subgroup. For...
Manufacturing and supply-side scrutiny: onshoring timelines
The U.S. Department of Commerce issued procedures giving companies 30 days to submit company-specific onshoring plans to qualify for agreements tied to Section 232 biopharma tariffs. The notice...
AAV gene therapy trial oversight concern
Capsida Biotherapeutics said it still has no answers in its investigation into the death of a child in a gene therapy trial last September. The company reported that efforts were blocked because...
AI drug discovery funding
Isomorphic Labs closed a $2.1 billion Series B, underlining how quickly Alphabet-linked assets are moving from model-building to clinical execution. The London-based AI biotech said Thrive Capital...
Deal: western pharma expands Hengrui partnership in China
Bristol Myers Squibb and Hengrui Pharma expanded their China-centric collaboration, agreeing to a broad deal covering 13 early-stage programs. The pact, structured as a “biobucks” arrangement,...
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...