Get the Daily Brief
Latest Biotech News
Biopharma dealmaking and fundraising surge
Biopharma deal value hit a record first half as megadeals pushed total M&A proceeds to $170.11 billion through June 2026, according to BioWorld’s records. The haul surpassed prior yearly highs,...
Precision oncology diagnostics: Tempus to buy Personalis
Tempus AI agreed to acquire Personalis for $1.5 billion, extending its minimal residual disease (MRD) diagnostics footprint. Under the deal, Personalis shareholders will receive $16.25 per share...
Spatial and single-cell tools move deeper into clinical workflows
10x Genomics advanced its push from research platforms into clinical diagnostics by detailing plans for a CLIA-certified laboratory at its Pleasanton, California headquarters. The lab is expected...
Rare disease gene therapy: Broad launches Center for Therapeutic Genetics with ARPA-H funding
The Broad Institute, Boston Children’s Hospital, and The Jackson Laboratory launched a Center for Therapeutic Genetics aimed at developing gene therapies for rare diseases while standardizing...
Sickle cell setbacks reshape commercial positioning at Agios
Agios Pharmaceuticals said it is discontinuing tebapivat, its next-generation oral pyruvate kinase activator, after Phase 2 data in sickle cell disease failed to demonstrate the differentiated...
AI infrastructure builds at scale: BMS and Nvidia partnership expands
Bristol Myers Squibb expanded its partnership with Nvidia to build a large AI “factory” for life sciences, including planned deployment of NVIDIA DGX SuperPOD infrastructure. BMS said the effort...
Diagnostics regulation: FDA authorization for multiplex PCR HSV/VZV/MPXV assay
Seegene received Emergency Use Authorization from the FDA for its Allplex HSV-1&2/VZV/MPXV multiplex real-time PCR assay, designed to detect and differentiate viruses associated with ulcerative...
Regulatory and policy: FDA plans permanent CBER and CDER leadership slate with new commissioner
The FDA is planning to announce permanent senior center heads alongside the appointment of a new commissioner, including leadership for CBER and CDER, according to three sources familiar with the...
FDA enforcement: Alembic Pharmaceuticals warned over clinical study consent failures
Alembic Pharmaceuticals received an FDA warning letter after failing to obtain informed consent from patients for a clinical study, according to the company’s notice. The FDA cited a consent lapse...
Big pharma competitive battle in obesity: Novo sues Lilly over GLP-1 advertising
Novo Nordisk sued Eli Lilly alleging the companies’ obesity-drug ads are misleading, according to the complaint. Novo is challenging marketing claims that it says compare doses and efficacy in a...
Sickle cell setbacks at Agios and a broader re-risking in the field
Agios Pharmaceuticals said it is ending development of tebapivat, its next-generation pyruvate kinase (PK) activator for sickle cell disease, after a Phase 2 study failed to show a differentiated...
AI-guided precision oncology expands through Tempus-Personalis buyout
Tempus AI agreed to acquire Personalis for $1.5 billion, extending its reach in minimal residual disease (MRD) testing and precision oncology. Under the terms, Personalis shareholders will receive...
IPO momentum in liquid biopsy and cancer detection: Freenome goes public
Freenome completed a SPAC merger with Perceptive Capital Solutions to go public, raising total gross proceeds of $310 million. The company will begin trading on Nasdaq under the ticker FRNM, with...
New FDA clearance for multiplex viral diagnostics with public health utility
Seegene received Emergency Use Authorization from the FDA for a multiplex real-time PCR assay designed to detect and differentiate HSV-1, HSV-2, VZV, and mpox (MPXV) from ulcerative skin lesions....
Europe diagnostic expansion: Bioneer secures CE-IVDR Class D for HBV and HCV PCR
Bioneer said its real-time quantitative hepatitis B and hepatitis C PCR assays received CE-IVDR Class D certification in Europe for use with the company’s ExiStation FA 96 fully automated system....
Cancer radioligand pipeline trimming at Novartis
Novartis discontinued a Phase 2 radioligand therapy program after early clinical data did not support advancing it to the next stage. The company ended studies of Lutetium-NeoB (Lu-NeoB), a...
New gene-therapy delivery model takes aim at rare-disease regulation and scaling
The Broad Institute, Boston Children’s Hospital, and The Jackson Laboratory launched a new Center for Therapeutic Genetics to build gene therapies for people with rare diseases and standardize...
Clinical differentiation still drives capital: Jasper merges with Kira with $132M backing
Jasper Pharmaceuticals completed its merger with Kira Pharmaceuticals following an investment structure that included $132 million of syndicate funding. The combined organization will retain the...
FDA transparency policy for rejections meets legal uncertainty
A FDA policy to increase transparency around complete response letters (CRLs) is running into legal uncertainty, according to reporting that points to evolving agency actions and concerns that the...
Capital allocation remains selective as biotech IPO and funding paths diverge
Investment coverage described capital as remaining selective in a “barbell” biotech market, with funding increasingly directed toward companies showing clinical differentiation, strong management...