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AstraZeneca unveils semi‑automated dual LC‑MS screen to rescue oligo candidates
AstraZeneca published a semi‑automated liquid chromatography‑mass spectrometry (LC‑MS) workflow designed to accelerate and standardize oligonucleotide analytical characterization, aiming to reduce...
Aspen raises $115m: scales iPSC Parkinson’s program
Aspen Neuroscience closed a $115 million Series C to accelerate clinical and manufacturing work for its autologous iPSC-derived Parkinson’s program, ANPD001. The company said proceeds will support...
Otsuka’s Voyxact cleared: first APRIL blocker for IgAN
The U.S. FDA granted accelerated approval to Otsuka’s sibeprenlimab (Voyxact) for adults with primary IgA nephropathy (IgAN), marking the first approval of an APRIL‑blocking monoclonal antibody in...
CMS sets 2027 prices – major drugs face steep negotiated cuts
The Centers for Medicare & Medicaid Services announced final 2027 Medicare negotiated prices for 15 high‑expenditure drugs, including major oncology, respiratory and metabolic therapies. CMS...
Novo submits high‑dose Wegovy: uses voucher to speed FDA review
Novo Nordisk submitted a high‑dose formulation of its GLP‑1 obesity drug Wegovy to the FDA and invoked an awarded priority review voucher to accelerate the agency’s clock. The submission aims to...
FDA proposes reclassifying companion diagnostics: 510(k) pathway eyed
The U.S. Food and Drug Administration proposed reclassifying certain nucleic acid‑based companion diagnostic (CDx) assays from Class III (PMA) to Class II with special controls, effectively...
Allogeneic iPSC‑iNKT cells enter clinic: phase 1 head‑and‑neck study reported
A phase 1 trial tested allogeneic induced pluripotent stem cell (iPSC)‑derived invariant natural killer T (iNKT) cells in patients with recurrent head and neck cancer. The study represents an...
TNG‑456 shows brain‑tumor activity: next‑gen PRMT5 inhibitor emerges
Tango Therapeutics presented preclinical data on TNG‑456, a selective MTA‑cooperative PRMT5 inhibitor engineered to exploit methylthioadenosine (MTA) biology in tumors such as glioma and...
AstraZeneca’s semi‑automated LC‑MS: gives oligo candidates a second chance
AstraZeneca described a semi‑automated liquid chromatography–mass spectrometry (LC–MS) screening platform to streamline oligonucleotide analytical characterization across early discovery and CMC...
CrisprBits nets $3m: funds CRISPR diagnostics, R&D expansion
Indian CRISPR startup CrisprBits closed a $3 million pre‑Series A round led by Spectrum Impact to expand CRISPR‑based diagnostics and gene‑editing R&D. The financing will support product...
Tangram seeks MHRA clearance: TGM‑312 head‑to‑head for 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...
Aspen raises $115m—scales iPSC Parkinson’s program
Aspen Neuroscience closed a $115 million Series C to accelerate clinical development and manufacturing scale-up of ANPD001, its autologous iPSC-derived cell therapy for Parkinson’s disease. The...
FDA approves Voyxact: first APRIL blocker for IgA nephropathy
The U.S. FDA granted accelerated approval to Otsuka’s sibeprenlimab (Voyxact) for adults with primary IgA nephropathy to reduce proteinuria. Approval was supported by interim results from the...
CMS sets 2027 Medicare prices—semaglutide among steep cuts
CMS published final negotiated Medicare prices for the second round under the Inflation Reduction Act, cutting prices on 15 high‑expenditure drugs slated to take effect in 2027. The list includes...
FDA proposes reclassifying companion diagnostics: 510(k) route suggested
The FDA issued a proposal to reclassify certain nucleic acid‑based companion diagnostic devices from Class III (PMA) to Class II with special controls, opening the 510(k) pathway for tests tied to...
Tangram seeks MHRA clearance for TGM‑312 in MASH trials
Tangram Therapeutics submitted a clinical trial application to the U.K. MHRA to initiate a Phase I/II study of TGM‑312 for metabolic dysfunction‑associated steatohepatitis (MASH). The CTA filing...
China clears CSPC’s JMT‑206 to enter obesity trials
China’s NMPA granted clinical trial clearance to CSPC Pharmaceutical Group for JMT‑206, a weight‑management candidate for people with obesity or overweight and at least one weight‑related...
SK Biopharma licenses preclinical radiopharmaceutical WT‑7695 from WARF
SK Biopharmaceuticals acquired exclusive worldwide rights from the Wisconsin Alumni Research Foundation (WARF) to develop, manufacture and commercialize WT‑7695, a preclinical radiopharmaceutical...
Vigencell’s antigen‑specific T cells hit phase II endpoint—Korea filing planned
Vigencell reported positive top‑line phase II results for VT‑EBV‑N, an antigen‑specific cytotoxic T‑cell therapy for natural killer T‑cell lymphoma (NKTCL), and intends to seek conditional...
Allogeneic iPSC‑derived iNKT cells enter clinic for recurrent head and neck cancer
A phase I trial tested allogeneic induced pluripotent stem cell (iPSC)‑derived invariant natural killer T (iNKT) cells in patients with recurrent head and neck cancer, marking a translational step...