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Pioneering allogeneic iPSC‑derived iNKT cells enter clinic for head and neck cancer
A Phase I trial tested allogeneic iPSC‑derived invariant natural killer T (iNKT) cells in patients with recurrent head and neck cancer, reporting initial clinical findings from the first‑in‑human...
FDA proposes reclassifying companion diagnostics to speed market entry
The U.S. Food and Drug Administration proposed reclassifying certain nucleic acid‑based companion diagnostic assays from Class III (PMA) to Class II (special controls) and allowing a 510(k)...
BoltzGen debuts... MIT unveils generative AI model aimed at molecule design
Researchers at MIT introduced BoltzGen, a generative AI model designed to propose novel small molecules for hard‑to‑drug targets, presenting the work at the Abdul Latif Jameel Clinic for Machine...
mRNA‑encoded peptibody therapeutics eradicate multidrug‑resistant pneumonia in mice
A Nature Biotechnology study showed that delivering mRNA encoding antimicrobial peptibodies to the lung, packaged in anti‑inflammatory lipid formulations, eradicated multidrug‑resistant bacterial...
Cell‑type inference in cf‑nucleic acid liquid biopsies expands noninvasive diagnostics
A Nature Biotechnology paper described computational and experimental advances enabling inference of tissue‑ and cell‑type origins from cell‑free nucleic acids (cfDNA/cfRNA) in blood samples. The...
Otsuka wins FDA OK for Voyxact — first APRIL blocker for IgA nephropathy
The FDA granted accelerated approval to Otsuka Pharmaceutical’s sibeprenlimab (Voyxact) to reduce proteinuria in adults with primary IgA nephropathy (IgAN). The decision follows a multicenter,...
Novartis expands SMA gene therapy: Itvisma cleared for patients 2 and older
The U.S. Food and Drug Administration cleared Novartis’ Itvisma (onasemnogene abeparvovec) for children aged two and up, teens and adults with spinal muscular atrophy (SMA) caused by biallelic...
CMS names 2027 Medicare prices: Wegovy, Ozempic and 13 others hit by negotiated cuts
The Centers for Medicare & Medicaid Services released final negotiated maximum fair prices for 15 drugs under the Inflation Reduction Act, including semaglutide products Wegovy and Ozempic. CMS...
AstraZeneca doubles down on U.S. biologics: $2 billion Maryland expansion
AstraZeneca announced a $2 billion investment to expand biologics manufacturing in Maryland, nearly doubling commercial biologics capacity at its Frederick campus and building a new clinical...
Aspen raises $115m — scales autologous iPSC Parkinson’s program
Aspen Neuroscience closed a $115 million Series C to advance clinical development and scale manufacturing for ANPD001, its autologous iPSC‑derived cell therapy for Parkinson’s disease, and to...
Tangram files UK trial application for TGM‑312 in MASH
Tangram Therapeutics submitted a clinical trial application to the U.K. Medicines and Healthcare products Regulatory Agency to initiate a Phase I/II study of TGM‑312 for metabolic...
Toolgen, Geneditbio cross‑license to advance in‑vivo genome editing
Toolgen Inc. and Geneditbio Ltd. struck a strategic cross‑license agreement to jointly advance next‑generation in‑vivo genome‑editing therapeutics. The deal pools IP rights and aims to accelerate...
Gilead acquires Sprint’s TREX1 preclinical program — >$400m oncology buy
Gilead Sciences paid in excess of $400 million to acquire a preclinical oncology program from Sprint Bioscience that targets TREX1, an enzyme involved in nucleic acid sensing and tumor immune...
FDA proposes reclassifying companion diagnostics to Class II — 510(k) review pathway eyed
The FDA proposed reclassifying certain nucleic acid‑based companion diagnostic assays from Class III to Class II devices, which would allow manufacturers to seek clearance via the 510(k) pathway...
Phrontline raises $60m pre‑A+ to back bispecific ADC pipeline
Phrontline Biopharma Suzhou closed a $60 million pre‑A+ financing round led by Lapam Investment to support development of next‑generation bispecific antibody‑drug conjugates (ADCs) and dual‑linker...
Otsuka’s Voyxact cleared by FDA: first APRIL blocker for IgAN
The U.S. Food and Drug Administration granted accelerated approval to Otsuka Pharmaceutical’s sibeprenlimab (Voyxact) for adults with primary immunoglobulin A nephropathy (IgAN). The approval is...
CMS sets 2027 Medicare prices: Wegovy, Ozempic among cuts
The Centers for Medicare & Medicaid Services finalized negotiated Medicare prices for 15 drugs under the Inflation Reduction Act, including semaglutide — the active ingredient in Novo Nordisk’s...
Novo files high‑dose Wegovy voucher: regulator review accelerated
Novo Nordisk submitted a higher‑dose formulation of its GLP‑1 obesity drug Wegovy to the FDA and used a priority review voucher to expedite regulatory review. The filing indicates Novo’s push to...
iPSC‑derived iNKT cells show promise in recurrent head‑and‑neck trial
A first‑in‑human phase I trial tested allogeneic induced pluripotent stem cell–derived invariant natural killer T (iNKT) cells in patients with recurrent head and neck cancer. Investigators...
USP issues viral‑vector guidance: standards to steady gene‑therapy scale‑up
The U.S. Pharmacopeia (USP) released new standards aimed at viral vectors and plasmid DNA to improve quality and consistency for cell and gene therapy manufacturing. The guidance includes...