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M&A and corporate restructuring
Zymeworks has agreed to buy Theravance Biopharma for $929 million in cash, reshaping the royalty-focused biotech with immediate exposure to commercial respiratory revenue from Yupelri...
Clinical-stage failures in allergic and skin diseases
Evommune’s Phase 2b trial of EVO756 for chronic spontaneous urticaria (CSU) missed its primary endpoint, sending the stock down sharply and removing a potential challenger to Novartis in the CSU...
Regulatory guidance and AI integration in clinical trials
China’s National Medical Products Administration (NMPA) has issued updated Good Clinical Practice (GCP) regulations that take effect in September, tightening requirements around data governance,...
Companion diagnostics and MRD in Phase III oncology
Aveta Biomics will use Natera’s Signatera ctDNA test as a minimal residual disease (MRD) endpoint in its Phase III head and neck squamous cell carcinoma program, APG-157. The study will enroll up...
Oncology drug discovery deals
Antares has signed a discovery and commercialization collaboration with Novartis targeting small-molecule medicines across oncology targets described as long deemed undruggable. Antares will...
AI in drug discovery platforms
Insilico Medicine and SK Biopharmaceuticals have launched an AI-powered neuroimmune drug discovery collaboration that could generate up to $2.5 billion in value. Insilico will apply its Pharma.AI...
Technology and instrumentation commercialization
Roche has started shipping its Axelios 1 sequencer commercially after a year-long ramp-up, with an initial focus on North America, Europe, and Asia-Pacific. The company’s move signals a push to...
Lab automation and agentic AI for analytics
Tecan says it has integrated agentic AI into its Introspect lab analytics platform, leveraging NVIDIA’s BioNeMo Agent Toolkit. The update is designed to move beyond monitoring and reactive...
Diagnostics and corporate asset review risk
QuidelOrtho shares jumped after a report that the company may be exploring a sale of its point-of-care (POC) testing business. The Financial Times cited people familiar with the matter saying bids...
Targeted gene editing and DNA integration methods
Researchers reported new experiment-guided approaches to overcome limitations in AI-based protein and genome design workflows, including improved AlphaFold guidance with experimental data and new...
M&A and dealmaking
Zymeworks agreed to acquire Theravance Biopharma in a $929 million upfront transaction, pulling in commercial cash flow and late-stage momentum centered on Yupelri (revefenacin). The deal adds an...
Oncology discovery partnerships
Antares secured a major discovery and commercialization collaboration with Novartis aimed at small-molecule oncology targets considered historically undruggable. The Cambridge, Massachusetts-based...
Blood cancer MDM2 innovation
Ipsen moved to expand its myelofibrosis franchise with an agreement to acquire Kartos Therapeutics for $450 million upfront, alongside potential milestones up to $1.75 billion. The purchase...
Regulatory decision: CRL and manufacturing risk
Sobi received an FDA complete response letter for its gout combination treatment, citing concerns tied to third-party manufacturing sites. The agency’s action centers on production problems,...
Biotech pipeline setback and market repositioning
Evommune’s phase 2b trial of EVO756 failed to beat placebo in chronic spontaneous urticaria, ending the company’s attempt to challenge Novartis in the CSU market. The oral MRGPRX2 antagonist...
FDA approval: new targeted therapy for TED
Viridian Therapeutics won FDA approval for Lumvoa (veligrotug-vvze) to treat thyroid eye disease, including both chronic and active phases. The clearance positions Lumvoa as a competitor to...
AI regulation in early clinical trials
ACRO urged the FDA to include contract research organizations directly in the agency’s AI trial pilot for real-time clinical trials and AI-enabled optimization of early-phase studies. The...
Bioprocessing and lab automation: agentic AI tools
Tecan integrated agentic AI capabilities into its Introspect lab analytics platform, tying the upgrade to NVIDIA’s BioNeMo Agent Toolkit. The company says the goal is to move from monitoring and...
Neuroimmune AI drug discovery collaboration
Insilico Medicine and SK Biopharmaceuticals launched an AI-based collaboration focused on neuroimmune disorders in the central nervous system. The agreement assigns Insilico’s Pharma.AI platform...
Core science: AlphaFold ensemble improvements
Researchers at ISTA and international collaborators published methods to guide AlphaFold beyond its tendency to collapse heterogeneous structures into a single dominant conformation. The work,...