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Oncology diagnostics partnerships
Guardant Health and Nuvalent have struck a multi-year collaboration to build and commercialize oncology companion diagnostics. The deal will leverage Guardant’s tissue and liquid biopsy portfolio...
Late-stage manufacturing expansion
Novartis disclosed plans to build another factory in the US as part of its $23 billion expansion commitment, marking the final new build in the program. The company said it has allocated every...
Regulatory action: clinical trial acceleration via real-time data
The FDA announced a pilot effort to collect and review clinical trial data in real time, aiming to reduce delays between trial events and regulatory assessment. The initiative will build on...
Biopharma M&A: hereditary angioedema consolidation
Chiesi agreed to acquire KalVista Pharmaceuticals for about $1.9 billion, adding a commercialized hereditary angioedema (HAE) treatment to its rare-disease franchise. Under the deal structure...
Oncology drug development failure
GSK and Alector terminated a phase 2 Alzheimer’s disease program after an interim analysis indicated the trial would be unlikely to reach its primary endpoint. The decision followed the companies’...
Gene therapy / platform acquisition
Leo Pharma is paying $50 million for Replay, a US gene-writing biotech, and its preclinical gene therapy program for a rare skin disease. The purchase is focused on Replay’s high-payload...
CAR-T regulatory milestone
South Korea’s MFDS cleared Curocell’s Limcato (anbalcabtagene-autoleucel) as the first locally developed CAR T-cell therapy for advanced diffuse large B-cell lymphoma. The approval positions...
Clinical development readout in obesity
Boehringer Ingelheim reported that its dual-acting obesity drug survodutide succeeded in a phase 3 trial, producing significantly greater weight loss than placebo in a 76-week study. The company...
Precision oncology diagnostics acquisition
CareDx agreed to acquire Naveris for up to $260 million, expanding its precision oncology diagnostics footprint. The transaction gives CareDx access to NavDx, a liquid biopsy test for HPV-driven...
Biotech financing
Moleculent raised $20 million in an extended Series A to commercialize its spatial functional proteomics platform for profiling cell-cell communication. The round was led by Rubicon Healthcare...
Regulatory action and accelerated trials
The U.S. FDA moved toward faster decision-making by launching a pilot program to collect and review clinical trial data in real time. The agency said it will give reviewers access to information...
Alzheimer’s trial failure at GSK/Alector
GSK and Alector terminated a Phase 2 Alzheimer’s trial after an interim analysis indicated the study was unlikely to meet its primary endpoint. The stop reflects continued difficulty translating...
Gene editing manufacturing breakthrough for large DNA insertions
Researchers unveiled an improved genome-engineering technique, “prime assembly,” designed to enable efficient insertion of large DNA fragments into genomes. The approach targets a longstanding...
Biopharma partnerships: AstraZeneca adds preclinical EGFR degrader from Pinetree
AstraZeneca exercised an option to license a preclinical EGFR degrader from Pinetree Therapeutics, paying $25 million and setting up potential milestone payments totaling up to about $500 million...
Rare disease M&A: Chiesi acquires KalVista for hereditary angioedema franchise
Chiesi agreed to acquire KalVista Pharmaceuticals for about $1.9 billion in what it described as its biggest M&A deal yet, adding the FDA-approved hereditary angioedema therapy Ekterly...
Regulatory device milestone in psychiatry
Laguna Diagnostics received FDA Breakthrough Device designation for its mRNA Gene Biomarker blood test designed to differentiate schizophrenia from bipolar I disorder. The test generates an...
Obesity drug success in Phase 3: Boehringer’s survodutide
Boehringer Ingelheim reported Phase 3 success for its dual-acting obesity therapy survodutide, announcing significantly greater weight loss versus placebo in a trial of 725 participants. In...
Bioinformatics and early cancer detection: Mayo Clinic AI for pancreatic cancer on CT
Mayo Clinic investigators validated an AI model that can detect pancreatic cancer from routine abdominal CT scans up to three years before clinical diagnosis. The approach identifies subtle...
Diagnostics expansion via acquisition: CareDx to buy Naveris up to $260M
CareDx agreed to acquire Naveris for up to $260 million to expand its precision oncology diagnostics offering. The deal provides CareDx access to NavDx, a liquid biopsy test that detects viral DNA...
Immunology financing: Enterobiotix raises for Phase 2b IBS-C microbiome pill
Enterobiotix raised £19 million (about $25.7 million) to fund Phase 2b development of its lead microbiome program EBX-102-02 for irritable bowel syndrome with constipation (IBS-C). The company’s...