Get the Daily Brief
Latest Biotech News
Moderna’s mRNA seasonal flu vaccine gets fresh FDA scrutiny before advisory panel
Ahead of a June advisory committee hearing, the FDA and external documents indicate regulators are broadly open to Moderna Inc.’s mRNA-1010 seasonal flu vaccine, after a prior refusal-to-file...
FDA extends comment window for real-time, AI-enabled clinical trial pilot
The U.S. FDA extended the comment period for its AI-powered real-time clinical trial (RTCT) pilot program to June 29, responding to requests from sponsors and CROs seeking additional time. The...
Clinical update: dual-checkpoint immunotherapy plus chemo in HARMONi-A for EGFR-variant NSCLC
A randomized HARMONi-A analysis published in JAMA reports that ivonescimab, a bispecific antibody, added to chemotherapy improved outcomes in EGFR-variant non–small cell lung cancer. The JAMA...
Immune-oncology: dual IL-23/IL-23R strategy gains momentum in ulcerative colitis pipeline
Spyre Therapeutics reported two sets of data described as “two for two” for ulcerative colitis candidates SPY-001 and SPY-002, prompting analyst interest ahead of top-line readouts for the...
Company funding: HMNC raises $50M Series B to advance depression drugs into Phase III
HMNC Brain Health GmbH raised $50 million in the first close of a Series B financing to move its depression pipeline toward Phase III studies. The capital will enable the company to prepare for...
Partnerships for AI drug discovery: Merck expands Protillion collaboration to up to $510M
Merck & Co. launched an AI drug discovery collaboration with Protillion Biosciences that could pay up to $510 million in milestone payments, anchored on Protillion’s “lab-in-the-loop” antibody...
Dealmaking: Lilly buys 4E Therapeutics in non-opioid pain M&A push
Eli Lilly agreed to acquire 4E Therapeutics as it continues its non-opioid pain strategy through acquisitions. The deal gives Lilly early-stage, non-addictive pain programs built around MNK...
Diagnostic innovation: Volition and Sysmex optimize circulating nucleosome and NETosis assay on Sysmex platforms
Volition announced a collaboration with Sysmex to optimize its Nu.Q NETs H3.1 circulating nucleosome-based assay on Sysmex analyzers. The assay quantifies H3.1-nucleosomes associated with...
China regulatory shift: new “tech track” for advanced biomedical technologies effective May 1
China introduced a regulatory pathway known as “Order 818,” establishing an alternative approval track for certain advanced biomedical technologies designed to speed access for patients. The...
Gene therapy FDA pathway
FDA reversed course again for uniQure’s Huntington’s disease gene therapy, clearing the company to seek accelerated approval after previously objecting to the evidence base. Per uniQure...
AI drug discovery dealmaking
Merck entered a new AI-enabled biologics discovery collaboration with Protillion Biosciences, expanding use of Protillion’s “lab-in-the-loop” on-chip antibody platform. Under the multi-target...
T-cell engager expansion via AbCellera
Jazz Pharmaceuticals and AbCellera announced a preclinical research collaboration to discover next-generation T-cell engaging (TCE) multispecific antibodies aimed at GI cancers and other solid...
UK access demand for Wegovy pill
Demand for Novo Nordisk’s Wegovy pill surged immediately after UK approval, with a major online pharmacy reporting a waiting list of about 30,000 people per week. The report highlights how access...
Biopharma cyber threat hits Novo AI models
Hackers claimed they stole Novo Nordisk AI models and manufacturing recipes, escalating cyber risk around drug development and production know-how. The group’s claim describes attempted extortion...
Oncology partnership for spatial biomarkers in bladder cancer
10x Genomics and Cleveland Clinic began a multiyear collaboration to identify spatial biomarkers predicting response to antibody-drug conjugates in advanced bladder cancer. The work will analyze...
Clinical trial readout: pumitamig plus chemo in frontline NSCLC
At the 2026 ASCO Annual Meeting, results from ROSETTA Lung-02 showed that pumitamig (BNT327/BMS986545) plus chemotherapy produced high response rates in first-line NSCLC across histologies and...
Regulatory evidence and pricing pressures in Europe
Germany backed away from a variable discount pricing plan for branded drugs after industry pushback, Reuters reported—switching instead to a fixed approach. The original proposal was designed to...
Protein production platform: E. coli collaboration
NorthX Biologics and enGenes Biotech launched an integrated collaboration to build an E. coli-based protein production platform covering strain design through GMP manufacturing. The companies...
Gene therapy bioprocessing: move toward continuous manufacturing
CGT Catapult unveiled a continuous bioprocessing platform for advanced therapy medicinal products (ATMPs), aiming to raise yields and productivity to expand gene therapy manufacturing...
Huntington’s gene therapy regulatory shift in the US
FDA has reversed course on uniQure’s Huntington’s disease gene therapy, clearing the way for the company to file for US accelerated approval. After a dispute that included scrutiny of the...