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FDA’s ‘plausible mechanism pathway’: experts split on bespoke rare‑disease route
FDA officials Vinay Prasad and Martin Makary published a ‘plausible mechanism pathway’ proposing expedited approval routes for bespoke medicines in rare diseases, drawing praise and criticism from...
Aspen raises $115m – scales autologous Parkinson’s iPSC program
Aspen Neuroscience announced a $115 million Series C to accelerate clinical development and manufacturing scale-up for ANPD001, its autologous iPSC-derived cell therapy for Parkinson’s disease....
CSPC cleared to test JMT‑206 in China: obesity clinic entry granted
China’s NMPA granted clinical trial clearance for CSPC Pharmaceutical Group’s JMT‑206, a candidate for weight management in people with obesity or overweight plus comorbidity. CSPC will start...
Novo files high‑dose Wegovy – voucher expedites FDA review
Novo Nordisk submitted a higher‑dose formulation of its obesity drug Wegovy to the FDA and is using a regulatory voucher to accelerate review. The company seeks approval to expand dosing options...
CMS posts second drug‑price list… biopharma braces for deeper cuts
The U.S. Centers for Medicare & Medicaid Services released its second list of negotiated drug prices under the Inflation Reduction Act, laying out adjusted maximum fair prices for 15 medicines and...
Cell therapy momentum... iPSC‑iNKT and VT‑EBV‑N hit clinical milestones
Two cell‑therapy programs reported meaningful clinical progress this week. A phase 1 trial of allogeneic iPSC‑derived invariant natural killer T (iNKT) cells demonstrated early safety signals and...
SK Biopharma inks WARF license for WT‑7695 radiopharmaceutical
SK Biopharmaceuticals signed an exclusive worldwide license with the Wisconsin Alumni Research Foundation (WARF) for WT‑7695, a preclinical radiopharmaceutical developed with the University of...
Drug‑degradation race: Blueprint patents CDK4 PROTACs; Gluetacs shows molecular glues
Blueprint Medicines disclosed new PROTAC compounds targeting CDK4, claiming proteolysis‑based degradation as a route to overcome resistance to classical kinase inhibitors. Separately, Gluetacs...
Early‑stage biotech funding: CrisprBits raises $3m; Myrio touts novel binder tech
Indian CRISPR diagnostics startup CrisprBits closed a $3 million pre‑Series A round led by Spectrum Impact to expand CRISPR‑based diagnostics and R&D capabilities. The financing aims to accelerate...
FDA policy shifts: 'Plausible mechanism' for bespoke drugs and companion diagnostics reclassification
US regulatory policy is shifting on two fronts. FDA officials and agency authors proposed a 'plausible mechanism pathway' to expedite approval of bespoke therapies for very rare diseases that...
Next‑gen PRMT5 inhibitor shows preclinical brain tumor activity; PRMT5 linked to cardiac risk
Tango Therapeutics presented preclinical data on TNG‑456, a selective MTA‑cooperative PRMT5 inhibitor that produced strong antitumor activity in glioma models and tumors that metastasize to the...
Otsuka wins accelerated FDA nod for IgA nephropathy: Voyxact clears 9-month endpoint
The FDA granted accelerated approval to Otsuka Pharmaceutical’s sibeprenlimab (Voyxact) for adults with primary immunoglobulin A nephropathy (IgAN), based on a phase III Visionary trial interim...
CMS sets deep Medicare cuts: 15 drugs to see 2027 price caps
The Centers for Medicare & Medicaid Services released final negotiated Medicare prices for 15 high‑expenditure drugs, saying the measures would have cut aggregate net spending by roughly 44% had...
Aspen raises $115M to scale autologous iPSC Parkinson’s program
Aspen Neuroscience closed a $115 million Series C to accelerate clinical development and manufacturing for ANPD001, its autologous iPSC‑derived cell therapy for Parkinson’s disease, and to expand...
Novo files high‑dose Wegovy with FDA using voucher: fast track to higher semaglutide dose
Novo Nordisk submitted a supplemental New Drug Application for a higher‑dose formulation of Wegovy (semaglutide) to the FDA and invoked an awarded voucher to expedite review. The filing aims to...
FDA proposes reclassifying companion diagnostics to Class II: 510(k) pathway eyed
The FDA proposed reclassifying certain nucleic acid‑based companion diagnostic assays from Class III (PMA) to Class II with special controls, allowing submission via the 510(k) pathway. The...
Allogeneic iPSC‑iNKT cell therapy posts Phase 1 data in recurrent head and neck cancer
Investigators reported Phase 1 clinical results for an allogeneic iPSC‑derived invariant natural killer T (iNKT) cell therapy in recurrent head and neck cancer, showing tolerability and early...
Tangram seeks UK clearance to test TGM‑312 in MASH — phase I/II CTA filed
Tangram Therapeutics submitted a clinical trial application to the UK’s MHRA to initiate a Phase I/II study of TGM‑312 for metabolic dysfunction‑associated steatohepatitis (MASH). The CTA covers...
Epigenetic editing proposed to remove prion protein — Sonia Vallabh shows data
At an American Society of Gene & Cell Therapy meeting, Sonia Vallabh presented preclinical data on AAV‑mediated epigenetic editing designed to silence the prion protein gene as a potential...
Vigencell’s antigen‑specific T‑cell therapy hits phase II endpoint in NKT lymphoma
Vigencell reported positive top‑line results from a Phase II study of VT‑EBV‑N, an antigen‑specific killer T‑cell therapy targeting Epstein‑Barr virus–associated natural killer T‑cell lymphoma...