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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,...
Clinical trial setbacks and FDA enforcement
AstraZeneca scrapped multiple late-stage pipeline programs after disappointing efficacy, including shutting down atuliflapon, a FLAP inhibitor tested in a phase 2 asthma study. The company said it...
Precision oncology diagnostics: liquid biopsy expansion
CareDx agreed to acquire Naveris for up to $260 million, extending its precision oncology footprint with viral-driven liquid biopsy monitoring. The acquisition targets NavDx, a test designed to...
Commercial-stage expansion in genetic medicine
GeneMind Biosciences said China’s NMPA registered its SURFSeq 5000 Dx high-throughput sequencer as a Category III medical device. With registration, the company can deploy the diagnostic version...
Health-tech funding and investment for microbiome therapeutics
Enterobiotix raised £19 million (about $25.7 million) to fund phase IIb development of its microbiome-based therapy for IBS-C. The company’s lead program, EBX-102-02, targets irritable bowel...
Pivotal regulatory milestone in cell therapy
South Korea’s MFDS cleared Curocell’s Limcato (anbalcabtagene-autoleucel; anbal-cel) as the first homegrown CAR T therapy for advanced diffuse large B-cell lymphoma. The approval marks a domestic...
AI-enabled clinical operations and trial execution
Suvoda launched an updated agentic AI-powered system for randomization and trial supply management (RTSM), aiming to accelerate study startup and reduce manual workload for sponsors. The company...
New clinical evidence for mRNA vaccine design
Mount Sinai researchers reported that detargeting mRNA expression away from hepatocytes can strengthen T-cell immunity in preclinical lymphoma models. Published in Nature Biotechnology, the work...
Preclinical obesity and metabolic pipeline momentum
Boehringer Ingelheim reported phase 3 results for survodutide, a dual-acting obesity shot licensed from Zealand Pharma. In the Synchronize-1 trial, the company said participants on survodutide...