Get the Daily Brief
Latest Biotech News
Regulatory modernization and real-time clinical trial oversight
The FDA moved to shrink clinical trial reporting lags by launching a pilot approach to review data in real time as it is accrued. The agency said it will start with oncology studies run by...
Oncology pipeline and advisory committee focus for AstraZeneca
The FDA is set to convene an oncology advisory committee meeting after a long hiatus, with AstraZeneca drugs among the primary topics. The agenda centers on applications spanning HR+/HER2- locally...
FDA action over Tavneos—withdrawal proposal raises compliance scrutiny
The FDA proposed withdrawing Amgen’s Tavneos, alleging “untrue statements of material fact” in the approval application for avacopan. The action would target a C5aR antagonist approved in 2021...
Biopharma M&A and portfolio expansion in rare disease
Chiesi agreed to buy KalVista Pharmaceuticals for about $1.9 billion, adding Ekterly (sebetralstat) to its rare-disease portfolio. Ekterly is the first FDA-approved oral on-demand treatment for...
Cell therapy regulation—South Korea clears first homegrown CAR T
South Korea’s Ministry of Food and Drug Safety (MFDS) approved Curocell’s Limcato (anbalcabtagene-autoleucel; anbal-cel), marking the first MFDS-cleared homegrown CAR T therapy. The treatment is...
Vaccine and immunotherapy science—mRNA delivery engineering
Mount Sinai researchers reported a design principle for mRNA vaccine potency: detargeting mRNA expression away from hepatocytes can strengthen T-cell immunity in a lymphoma model. The work,...
Gene editing and precision therapeutics—AI-enabled target and platform advances
Insilico Medicine said it advanced its AI drug target discovery framework by integrating Target Identification Pro (TargetPro) with Target Identification Benchmark (TargetBench 1.0) into a...
Diagnostics expansion—China registration for GeneMind’s SURFSeq Dx sequencer
GeneMind Biosciences received NMPA registration for its SURFSeq 5000 Dx high-throughput sequencer as a Category III medical device in China. The registration allows deployment for DNA and RNA...
Oncology data and biomarkers—Pancreatic cancer AI detection signals
Mayo Clinic researchers validated an AI model that can detect pancreatic cancer up to three years before diagnosis using routine abdominal CT scans. The approach, described as identifying subtle...
Biotech funding—Microbiome drug enters late development for IBS-C
Enterobiotix raised about £19 million (US$25.7 million) to fund phase IIb development of EBX-102-02, a microbiome-based pill for irritable bowel syndrome with constipation (IBS-C). The company...
Regulatory push to speed clinical development
The FDA has launched a real-time review pilot aimed at making clinical-trial oversight faster and more data-driven, starting with oncology studies conducted by AstraZeneca and Amgen. The agency...
Big Pharma dealmaking: Chiesi buying KalVista
Chiesi has agreed to acquire KalVista Therapeutics in a $1.9 billion deal that adds an approved oral therapy for hereditary angioedema to its rare-disease portfolio. Analysts cited the transaction...
Big Pharma exits: AstraZeneca pauses multiple programs and scraps an asthma FLAP inhibitor
AstraZeneca said it is cutting several late-stage and mid-stage programs after disappointing efficacy, including discontinuing a Phase 2 asthma trial of atuliflapon, a FLAP inhibitor. The company...
Oncology data and regulatory pressure: FDA proposes withdrawing Tavneos
The FDA has proposed withdrawing Amgen’s Tavneos (avacopan), alleging “untrue statements” were included in the approval application for the C5a receptor antagonist. The notice would unwind the...
Clinical trial momentum in rare neurology: Teva buys Emalex
Teva has struck a $700 million upfront deal to acquire Emalex Biosciences, aiming to move a Tourette syndrome candidate closer to near-approval. The buyout is positioned as Teva’s largest deal in...
Immuno-oncology financing: Coultreon’s $125M Series A for SIK3 oral therapy
Coultreon Biopharma has raised $125 million in a Series A led by Sofinnova Investments to advance COL-5671, an oral salt-inducible kinase 3 (SIK3) inhibitor in Phase 1 for autoimmune diseases. The...
RNA vaccine design principle: hepatocyte detargeting boosts immunity
A Mount Sinai team reported a key design principle for next-generation mRNA therapeutics: detargeting mRNA expression away from hepatocytes can strengthen T-cell immunity in preclinical lymphoma...
AstraZeneca and Amgen real-time trial platform details
As part of the FDA’s real-time trial review effort, the agency says the pilot will rely on a real-time data platform built by Paradigm Health for the AstraZeneca and Amgen studies. The FDA’s...
Biopharma M&A: CareDx to acquire Naveris for HPV liquid biopsy MRD
CareDx agreed to acquire Naveris for up to $260 million, seeking expanded access to liquid biopsy monitoring in HPV-driven cancers. The deal provides $160 million upfront, with as much as $100...
FDA clearance via breakthrough designation: Laguna Diagnostics psychiatric mRNA biomarker test
Laguna Diagnostics received FDA Breakthrough Device designation for its mRNA Gene Biomarker test intended to help differentiate schizophrenia from bipolar I disorder in symptomatic patients. The...