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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...
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...