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FDA flexibility for gene therapy approvals
The FDA signaled renewed flexibility for uniQure’s Huntington’s disease gene therapy. After earlier concerns about acceptable evidence, the regulator agreed that three-year analysis data from...
Clinical oncology trial readouts and biomarker strategy
A growing set of late-stage oncology updates highlighted shifting treatment strategies across lung and prostate cancer. In metastatic urothelial cancer, data explored combining tremelimumab and...
AI regulation for real-time clinical trials
The U.S. FDA extended the comment period for its AI-powered real-time clinical trial (RTCT) pilot. The agency pushed feedback timing to June 29, responding to requests from sponsors and CROs...
Takeda’s TYK2 win in Phase 3 psoriasis
Takeda reported top-line Phase 3 results for zasocitinib (TAK-279), positioning the oral TYK2 inhibitor as statistically superior to Bristol Myers Squibb’s Sotyktu (deucravacitinib) in a...
Large biotech IPO fundraising
Biotech IPO momentum continued as Kardigan raised $400 million for its Nasdaq debut, joining a run of large 2026 biotech offerings. The company said it will use the proceeds to support three...
AI drug discovery deal between Merck and Protillion
Merck and Protillion launched an AI drug discovery collaboration that can generate up to $510 million in milestone payments, combining Merck’s therapeutic discovery capabilities with Protillion’s...
Early-stage funding for inflammatory disease and pipeline expansion
HMNC Brain Health raised $50 million in a series B to move its depression programs toward Phase 3 readiness. The funding supports two lead programs as the company advances...
Regenerative medicine for pediatric airway narrowing
Researchers at Children’s Hospital of Philadelphia (CHOP) developed a patient-specific approach to enlarge pediatric airways narrowed by severe subglottic stenosis. The method uses decellularized...
T-cell engager R&D deal between Jazz and AbCellera
Jazz Pharmaceuticals and AbCellera announced a preclinical research collaboration to discover next-generation T-cell engaging multispecific antibodies for gastrointestinal cancers and other solid...
FDA shifts on gene-therapy evidence for uniQure’s Huntington’s program
The FDA reversed course again on uniQure NV’s Huntington’s disease gene therapy, clearing the company to submit an accelerated BLA for its AMT-130 treatment. Under the latest agreement, the agency...
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...