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Robust WGS from FFPE tissue unlocks clinical‑grade oncology sequencing
Researchers published a validated methodology that enables whole‑genome sequencing (WGS) from formalin‑fixed paraffin‑embedded (FFPE) tumor specimens, overcoming historical technical challenges...
Aspen raises $115M – scales iPSC Parkinson’s program
Aspen Neuroscience closed a $115 million Series C to accelerate clinical development and manufacturing of its autologous iPSC-derived cell therapy ANPD001 for Parkinson’s disease. The financing...
FDA clears Otsuka’s Voyxact: first APRIL inhibitor for IgAN
The U.S. Food and Drug Administration granted accelerated approval to Otsuka’s sibeprenlimab (Voyxact), a humanized monoclonal antibody targeting APRIL, for adults with primary immunoglobulin A...
Medicare price cuts land: CMS sets 2027 negotiated rates – semaglutide included
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...
FDA delays Ascendis decision – three‑month review on TransCon CNP
The FDA extended its review of Ascendis Pharma’s TransCon CNP for achondroplasia by three months, citing the need to evaluate recently submitted information related to the treatment’s...
Allogeneic iPSC‑derived iNKT cells tested in recurrent head‑and‑neck cancer
A phase 1 clinical trial tested allogeneic induced pluripotent stem cell (iPSC)‑derived invariant natural killer T (iNKT) cells in patients with recurrent head and neck cancer, reporting early...
Vigencell’s VT‑EBV‑N meets phase II endpoint – firm eyes conditional approval in South Korea
Vigencell announced 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...
In vivo gene editing pushes forward – delivery and timing remain the bottlenecks
Two complementary reports spotlight advances and challenges in translating gene editing to in vivo and prenatal settings. One review describes the field’s push from ex vivo to in vivo approaches...
mRNA peptibodies eradicate MDR pneumonia in mice – new delivery approach
A Nature Biotechnology paper reported that antimicrobial peptides encoded as mRNA 'peptibodies' and delivered to mouse lungs in anti‑inflammatory lipid formulations eradicated multidrug‑resistant...
FDA proposes reclassifying companion diagnostics to Class II – 510(k) route eyed
The FDA proposed reclassifying certain nucleic acid‑based companion diagnostics used with approved oncology therapeutics from Class III (PMA) to Class II (special controls), which would allow...
CSPC clears JMT‑206 to enter clinic in China for obesity trials
CSPC Pharmaceutical Group received clinical trial clearance from China’s National Medical Products Administration (NMPA) for JMT‑206, a weight‑management candidate intended for patients with...
FDA greenlights Otsuka’s Voyxact — first APRIL blocker for IgAN
The U.S. Food and Drug Administration granted accelerated approval to sibeprenlimab (Voyxact) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN). Otsuka’s approval...
CMS sets Medicare prices for Wegovy, Ozempic and 13 drugs — 2027 cuts unveiled
The Centers for Medicare & Medicaid Services released final negotiated maximum fair prices for 15 drugs under the Inflation Reduction Act that will apply in 2027, including semaglutide products...
Novo files high‑dose Wegovy — voucher speeds FDA review
Novo Nordisk submitted an application to the FDA for a higher‑dose formulation of Wegovy (semaglutide) for obesity and used an award voucher to expedite the agency’s review timeline. The filing...
Aspen raises $115M to scale personalized Parkinson’s iPSC therapy
Aspen Neuroscience closed a $115 million Series C to accelerate clinical development and scale manufacturing for its autologous iPSC‑derived cell therapy ANPD001 for Parkinson’s disease. Aspen...
Allogeneic iPSC‑derived iNKT cells show safety signals in head‑and‑neck phase 1
A first‑in‑human phase 1 study tested off‑the‑shelf iPSC‑derived invariant natural killer T (iNKT) cells in patients with recurrent head and neck cancer and reported initial safety and feasibility...
Tangram files CTA for TGM‑312 in MASH — phase I/II planned
Tangram Therapeutics submitted a clinical trial application to the U.K. Medicines and Healthcare products Regulatory Agency to start a phase I/II study of TGM‑312 for metabolic...
Vigencell’s antigen‑specific T‑cell therapy hits phase II endpoint in NKTCL
Vigencell reported positive top‑line results from a phase II trial of VT‑EBV‑N, an antigen‑specific killer T‑cell therapy targeting Epstein‑Barr virus (EBV) antigens in natural killer/T‑cell...
mRNA peptibodies eradicate multidrug‑resistant pneumonia in mice — lung delivery breakthrough
A Nature Biotechnology paper described delivery of antimicrobial peptides encoded as mRNA 'peptibodies' formulated in anti‑inflammatory lipid carriers to the mouse lung; investigators reported...
USP issues viral‑vector standards to steady gene‑therapy manufacturing
The United States Pharmacopeia launched new standards aimed at harmonizing quality attributes for viral vectors and plasmid DNA to support the growing cell and gene therapy field. USP collaborated...