Drug ManufacturingInfectious Disease November 27, 2024 Valneva submits application seeking FDA approval for IXCHIQ for adolescent use By PBR Staff Writer The vaccine, which is approved for adults currently, may soon be available for use in adolescents aged 12 to 17 years if the extension is granted. This move
CardiovascularDrug Manufacturing November 26, 2024 FDA accepts Alnylam’s vutrisiran sNDA to treat ATTR-CM By PBR Staff Writer This investigational ribonucleic acid interference (RNAi) therapeutic is aimed at treating transthyretin amyloidosis with cardiomyopathy (ATTR-CM). The FDA has set a prescription drug user fee act (PDUFA) action
Cell TherapyDrug Manufacturing November 25, 2024 FDA approves StemCyte’s cord blood stem cell therapy BLA By PBR Staff Writer The approval makes the company the first commercial biotech to receive such a license for this cell therapy type. Derived from the umbilical cord blood of humans, the
RespiratoryDrug Manufacturing November 22, 2024 Dyadic receives grant from Gates Foundation for RSV antibody development By PBR Staff Writer The funding is set to enhance the company’s C1 protein production platform to enable rapid, cost-effective production of mAbs. This initiative focuses on diseases like RSV and malaria,
Drug ManufacturingMetabolic Disorders November 21, 2024 Laekna partners with Lilly to develop obesity therapy By PBR Staff Writer This partnership aims to address the global obesity epidemic by fast-tracking an innovative therapy that could improve the lives of millions. It includes the progression of LAE102 through
Drug ManufacturingNeurology November 20, 2024 FDA grants ODD to Ractigen Therapeutics’ RAG-21 for ALS treatment By PBR Staff Writer This small interfering ribonucleic acid (RNA)[siRNA] therapy is designed to combat one of the ALS subtypes, FUS-ALS, by reducing FUS protein levels. RAG-21 leverages RNA interference (RNAi) technology
Drug Manufacturing November 19, 2024 Arrowhead Pharmaceuticals submits plozasiran NDA to treat FCS By PBR Staff Writer This rare genetic disease currently lacks FDA-approved treatments, making the submission a significant milestone. Plozasiran, also known as ARO-APOC3, is an investigational RNA interference (RNAi) therapeutic. It aims
Oncology November 18, 2024 Numab Therapeutics and Kaken Pharmaceutical collaborate to develop ND081 By PBR Staff Writer Under the agreement, Kaken has secured an option to acquire commercial rights to the antibody in select Asian territories. In return, the company will fund the preclinical and
DermatologyDrug Manufacturing November 15, 2024 FDA to review Sanofi, Regeneron’s Dupixent sBLA for CSU By PBR Staff Writer The FDA has set a target action date of 18 April 2025 for its decision. If approved, Dupixent is expected to become the first targeted CSU therapy in
Drug ManufacturingNeurology November 14, 2024 Asha Therapeutics secures grant for ALS therapeutic development By PBR Staff Writer This grant will aid the progression of ASHA-624 towards first-in-human clinical trials. Designed using the company’s PRISM drug design technology, it is a brain-penetrant intra-molecular glue inhibitor of