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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...
Bracco, Limula and Univ. of Fribourg team up to automate cell‑therapy manufacturing
Bracco Imaging and Limula launched an industry‑academia project with Prof. Nicola Vannini (University of Fribourg) funded by Innosuisse to develop a bead‑free, automated cell selection and...
FDA clears Voyxact: Otsuka’s anti‑APRIL antibody for IgA nephropathy
The U.S. Food and Drug Administration granted accelerated approval to sibeprenlimab (Voyxact) to reduce proteinuria in adults with primary IgA nephropathy (IgAN). Otsuka based the filing on...
CMS unveils IRA prices — Wegovy and Ozempic among high‑profile cuts
The Centers for Medicare & Medicaid Services released final negotiated prices from the Inflation Reduction Act’s second bargaining round, listing 15 drugs including semaglutide products used for...
Novartis expands gene‑therapy access: Itvisma approved for older SMA patients
The FDA approved Novartis’ intrathecal gene therapy Itvisma (onasemnogene abeparvovec) for patients aged two years and older with spinal muscular atrophy (SMA) due to biallelic SMN1 mutations....
Aspen raises $115M to scale autologous iPSC cell therapy for Parkinson’s
Clinical‑stage Aspen Neuroscience closed a $115 million Series C to advance ANPD001, its autologous iPSC‑derived cell therapy for Parkinson’s disease, and to scale manufacturing and pipeline...
Tangram seeks MHRA clearance to test TGM‑312 for metabolic‑associated steatohepatitis
Tangram Therapeutics filed a clinical trial application with the U.K. Medicines and Healthcare products Regulatory Agency to launch a Phase I/II study of TGM‑312 in metabolic...
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)...