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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)...
BoltzGen debuts... MIT unveils generative AI model aimed at molecule design
Researchers at MIT introduced BoltzGen, a generative AI model designed to propose novel small molecules for hard‑to‑drug targets, presenting the work at the Abdul Latif Jameel Clinic for Machine...
mRNA‑encoded peptibody therapeutics eradicate multidrug‑resistant pneumonia in mice
A Nature Biotechnology study showed that delivering mRNA encoding antimicrobial peptibodies to the lung, packaged in anti‑inflammatory lipid formulations, eradicated multidrug‑resistant bacterial...
Cell‑type inference in cf‑nucleic acid liquid biopsies expands noninvasive diagnostics
A Nature Biotechnology paper described computational and experimental advances enabling inference of tissue‑ and cell‑type origins from cell‑free nucleic acids (cfDNA/cfRNA) in blood samples. The...
Otsuka wins FDA OK for Voyxact — first APRIL blocker for IgA nephropathy
The FDA granted accelerated approval to Otsuka Pharmaceutical’s sibeprenlimab (Voyxact) to reduce proteinuria in adults with primary IgA nephropathy (IgAN). The decision follows a multicenter,...
Novartis expands SMA gene therapy: Itvisma cleared for patients 2 and older
The U.S. Food and Drug Administration cleared Novartis’ Itvisma (onasemnogene abeparvovec) for children aged two and up, teens and adults with spinal muscular atrophy (SMA) caused by biallelic...
CMS names 2027 Medicare prices: Wegovy, Ozempic and 13 others hit by negotiated cuts
The Centers for Medicare & Medicaid Services released final negotiated maximum fair prices for 15 drugs under the Inflation Reduction Act, including semaglutide products Wegovy and Ozempic. CMS...
AstraZeneca doubles down on U.S. biologics: $2 billion Maryland expansion
AstraZeneca announced a $2 billion investment to expand biologics manufacturing in Maryland, nearly doubling commercial biologics capacity at its Frederick campus and building a new clinical...
Aspen raises $115m — scales autologous iPSC Parkinson’s program
Aspen Neuroscience closed a $115 million Series C to advance clinical development and scale manufacturing for ANPD001, its autologous iPSC‑derived cell therapy for Parkinson’s disease, and to...
Tangram files UK trial application for TGM‑312 in 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...
Toolgen, Geneditbio cross‑license to advance in‑vivo genome editing
Toolgen Inc. and Geneditbio Ltd. struck a strategic cross‑license agreement to jointly advance next‑generation in‑vivo genome‑editing therapeutics. The deal pools IP rights and aims to accelerate...