Get the Daily Brief
Latest Biotech News
Gene therapy and manufacturing analytics partnership
NanoMosaic and Solid Biosciences moved to co-market and technically align their gene therapy workflow tools, targeting AAV vector development and manufacturing analytics. The deal pairs...
Large-scale oncology imaging and diagnosis
A portable bedside PET scanner technology was presented as a new option for real-time imaging during interventional procedures. Researchers at Washington University in St. Louis described a...
Diabetes and obesity pipeline and commercial momentum
A new licensing push highlighted Lilly’s continued expansion in GLP biology with a $75 million upfront deal for Hanmi’s long-acting GLP-2 analog sonefpeglutide. Lilly secured exclusive worldwide...
Big-cap clinical-stage signal with safety overhang
Abivax’s Phase 3 ulcerative colitis maintenance readout showed strong efficacy, but the stock moved sharply lower after malignancy cases emerged among treatment recipients. In the Abtect trial,...
Oncology companion diagnostics approval in prostate cancer
The FDA approved Foundation Medicine’s FoundationOne CDx assay as a companion diagnostic to identify patients for Pfizer’s Talzenna plus Xtandi regimen in HRR-mutated metastatic...
Biotech finance: major private anti-aging round
Anti-aging startup NewLimit raised $435 million at a valuation above $3 billion in a Series C financing led by Founders Fund. The company said it expects to start human testing next year for its...
Cell and gene therapy regulatory guidance
The FDA released additional CBER draft guidance detailing how cell and gene therapy developers can leverage prior knowledge. The agency outlined the types of information companies may reuse across...
Gene therapy manufacturing and partner standardization
Evosep and Molecular You announced a partnership intended to standardize high-throughput multiomic biomarker testing workflows. The collaboration integrates Evosep’s Eno liquid chromatography...
Gene therapy manufacturing and analytics
NanoMosaic and Solid Biosciences announced a comarketing agreement focused on improving AAV manufacturing analytics for gene therapy developers. NanoMosaic will promote its Tessie automated plate...
Large partnerships and deals in rare neuromuscular disease
Servier will acquire Edgewise Therapeutics’ muscular dystrophy business in a deal valued at up to $2.65 billion, including $1.55 billion upfront and as much as $1.1 billion tied to regulatory and...
Rare kidney disease pipeline expansion via licensing
Travere Therapeutics is stepping up its rare kidney disease pipeline by paying Everest Medicines $112.5 million upfront for a drug program targeting a broader set of rare kidney indications beyond...
Bipolar depression regulatory acceleration
Autobahn Therapeutics received FDA Fast Track designation for elunetirom (ABX-002) as an adjunctive treatment for depressive episodes in adults with bipolar I or bipolar II disorder. The...
Immunotherapy and oncology: PD-(L)1/VEGF bispecific overall survival win in China
Akeso’s ivonescimab delivered a statistically significant overall survival improvement in a Phase 3 lung cancer regimen presented at ASCO. In interim data from the Harmoni-6 trial in China,...
Diagnostics regulation: FDA clears FoundationOne CDx as CDx in prostate cancer
The FDA approved Foundation Medicine’s FoundationOne CDx assays as companion diagnostics for Pfizer’s Talzenna plus Xtandi regimen in metastatic castration-resistant prostate cancer with...
Cell and gene therapy innovation: IND clearance for tau-targeted Alzheimer’s gene therapy
Voyager Therapeutics received FDA IND clearance for VY-1706, an investigational gene therapy targeting intracellular and extracellular tau for Alzheimer’s disease. The company’s IND path indicates...
Clinical and regulatory: TIL therapy IND clearance for Iovance
Iovance Biotherapeutics received FDA IND clearance for IOV-5001, a next-generation tumor-infiltrating lymphocyte (TIL) therapy engineered with an interleukin-12 (IL-12) tethering component. The...
Microbial and antibiotic innovation: CRISPR therapy approach for Shiga toxin-producing E. coli
French researchers at Eligo Bioscience and collaborators published results on EB-003, a CRISPR-based antimicrobial approach targeting Shiga toxin-producing E. coli (STEC). The strategy comes amid...
Oncology diagnostics product launch: Veracyte begins Prosigna LDT in the US
Veracyte launched Prosigna Breast Risk of Recurrence as a laboratory-developed test (LDT) in the US after ASCO data suggested the assay can safely guide adjuvant treatment decisions for patients...
FDA approvals—new companion diagnostics and label expansions
The FDA approved new Foundation Medicine companion diagnostics tied to Pfizer’s prostate cancer regimen, extending the clinical footprint of FoundationOne CDx as a decision tool for specific...
Big pharma dealmaking—acquisitions and licensing that reshape pipelines
Servier agreed to acquire Edgewise Therapeutics’ muscular dystrophy business in a transaction valued at up to $2.65 billion, betting that neuromuscular franchise scale can accelerate its neurology...