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FDA setbacks and review pauses for pharma programs
The FDA delayed a decision on Exelixis’ colorectal cancer oral tyrosine kinase inhibitor in combination with Roche’s Tecentriq, extending the agency’s timeline following additional review steps....
Biotech financings and market moves
SELLAS Life Sciences shares fell sharply after a session with no publicly disclosed failed trial update or new filing in the record. Traders appear to be repricing the stock ahead of binary...
Clinical pipeline acceleration and trial design in immuno-oncology and beyond
A case report from Türkiye described sustained CNS remission in heavily pre-treated multiple myeloma after a BCMA-targeted bispecific antibody combined with intrathecal chemotherapy. The report,...
Carried therapeutic platforms and commercialization partnerships
Transcenta Therapeutics and WuXi Biologics announced a licensing and commercialization partnership aimed at scaling Transcenta’s HiCB platform and ExcelPro cell culture media. The collaboration...
Cell and gene therapy manufacturing capacity partnerships
Teijin, Teijin Regenet, and Shinshu University Hospital entered a joint research agreement focused on CAR T-cell manufacturing technologies. The collaboration aims to strengthen Japan’s...
Medical device and digital health adoption—FDA and reimbursement signals
Nutromics received FDA breakthrough device designation for its wearable patch designed to monitor vancomycin levels in real time. The monitoring approach targets a long-standing clinical...
New biotech platform building blocks—AI, imaging, and biosensing
Researchers proposed a new strategy for atomically thin sensors that could transform electronic biosensing by detecting disease markers in blood, identifying viral variants, and enabling...
Diabetes and metabolic disease pipeline—new real-world and preclinical bets
A real-world study, the T-BEAT program in Japan, is underway to track how tirzepatide performs when started early in type 2 diabetes care outside strictly controlled trials. The design is aimed at...
Biopharma dealmaking and manufacturing infrastructure expansion
Axogen agreed to acquire Biocircuit Technologies for $200 million in cash, a deal intended to deepen its position in the peripheral nerve market by bringing Nerve Tape—an FDA-approved device for...
FDA regulatory decisions – oncology/neurology
The FDA extended Exelixis’ review timeline for its metastatic colorectal cancer drug candidate after the company submitted new safety and efficacy data, according to the company’s filings....
FDA regulatory decisions – manufacturing quality
The FDA issued a second complete response letter (CRL) to Seikagaku for its resubmitted BLA for condoliase (SI-6603), a therapy aimed at radicular leg pain associated with lumbar disc herniation....
Cancer immunotherapy financing and scaling
Solstice Oncology exited stealth with a $225 million series A to advance porustobart, a next-generation CTLA-4 antibody intended to expand immunotherapy reach into microsatellite-stable colon...
Gene therapy funding momentum
Encoded Therapeutics raised $275 million in a Series F to push its lead gene therapy ETX101 into clinical trials for Dravet syndrome. The financing will also fund development work for a second...
Biopharma company moves – M&A and strategic partnerships
Revvity signed an agreement to acquire Human Cell Design (HCD), a France-based developer of human cell models used in preclinical research. Revvity said the deal is expected to add HCD’s human...
Cell therapy manufacturing – Japan infrastructure
Teijin, Teijin Regenet, and Shinshu University Hospital began a joint research agreement aimed at improving manufacturing technologies for cell and gene therapy products. The collaboration is...
Device innovation – antibiotic monitoring
Nutromics received an FDA breakthrough device designation for its wearable patch intended to monitor vancomycin levels in real time. The company’s system is designed to replace periodic blood...
Clinical-grade pipeline repricing after Phase 3 misses
Alzheon outlined plans for a major fundraising round even after missing the Phase 3 primary endpoint for its Alzheimer’s drug candidate. The company’s move indicates it is pursuing additional...
Diagnostics and digital clinical decision support – FDA clearance risk
Echo IQ said the FDA issued a not substantially equivalent determination for its initial 510(k) application for Echosolv HF, an AI-based heart failure clinical decision support software. The...
Business-to-biotech dealmaking – biopharma commercialization pressure
A new report warned that the lack of product development in the generics and biosimilars sector could imperil billions of dollars in potential savings. The trade group’s analysis points to a risk...
FDA device pathway for real-time antibiotic monitoring
Nutromics received FDA breakthrough device designation for its wearable patch designed to track vancomycin levels in real time. The company says the patch could reduce reliance on periodic blood...