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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...
Regulatory push toward continuous, real-time clinical trial oversight
The U.S. FDA moved toward real-time clinical-trial review, announcing it will pilot a program that lets agency scientists access trial data as it is generated. The effort builds on...
Big pharma M&A reshapes rare-disease and oncology portfolios
Chiesi Group agreed to acquire KalVista Pharmaceuticals for about $1.9 billion, adding the already-approved hereditary angioedema therapy Ekterly (sebetralstat) to its rare-disease lineup. The...
AstraZeneca steps back after late-stage efficacy disappointments
AstraZeneca said it has ended several mid- and late-stage trials as part of portfolio prioritization after disappointing efficacy signals. The company’s first-quarter updates pointed to...
Teva bets $700M on near-approval Tourette therapy via Emalex
Teva agreed to buy Emalex Biosciences for $700 million upfront, aiming to bring an NDA-near Tourette syndrome candidate into its neurology pipeline. The acquisition positions the deal as Teva’s...
Oncology: PTC reports 24-month interim signals in Huntington’s disease extension study
PTC Therapeutics reported top-line results from a 24-month interim analysis of votoplam in the long-term extension portion of the Phase II Pivot-HD program. The company said the results showed...
AAV2 trafficking and clearance mechanisms in the central nervous system
New research in Gene Therapy mapped AAV2 capsid clearance and neuronal trafficking dynamics within the central nervous system, highlighting processes that can constrain both safety and efficacy...
Gene editing and genome engineering breakthrough: prime assembly enables large DNA insertions
Researchers unveiled a technique called prime assembly (PA) that improves the insertion of large DNA fragments into genomes, targeting a bottleneck that has limited efficient integration of...
mRNA vaccine design: detargeting expression from hepatocytes reshapes immunity
New Nature Biotechnology research showed that where mRNA is expressed after administration can strongly affect immune potency. In preclinical lymphoma models, hepatocyte detargeting strengthened...
Diagnostics: FDA breakthrough designation for a mRNA gene biomarker test in psychiatry
Laguna Diagnostics said the FDA granted breakthrough device designation to its mRNA Gene Biomarker test aimed at differentiating schizophrenia from bipolar I disorder in symptomatic patients. The...
Precision oncology diagnostics deal: CareDx to acquire Naveris for up to $260M
CareDx agreed to acquire Naveris for up to $260 million in a move to expand its oncology diagnostics footprint. The deal structure includes $160 million upfront plus up to $100 million in...
Regulatory action and clinical development acceleration
The FDA is moving toward real-time, continuous clinical trial oversight, starting with oncology studies run by AstraZeneca and Amgen. The agency says reviewers will access trial data as it...
Big pharma M&A and rare-disease consolidation
Chiesi Group agreed to buy KalVista Pharmaceuticals for about $1.9 billion, adding an oral hereditary angioedema (HAE) franchise to its portfolio. The deal values KalVista at $27 per share,...