Just ahead of the Aug. 13 PDUFA date, Citius Pharmaceuticals Inc. won the U.S. FDA’s go-ahead for Lymphir (denileukin diftitox-cxdl), a new immunotherapy for relapsed/refractory (r/r) cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The drug is Cranford, N.J.-based Citius’ first approved therapy and the only CTCL treatment that targets the interleukin-2 receptor found on malignant T cells and regulatory T cells. It’s also the first green light given by the FDA for r/r CTCL since 2018. Read More
The U.S. FDA has granted accelerated approval to Novartis AG’s Fabhalta (iptacopan) for reducing proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. The approval strengthens the company’s renal disease presence as it puts two other IgAN treatments through clinical trials. Read More
Novo Nordisk A/S presented a mixed bag of R&D results for its cardiometabolic assets in the first half of 2024 as it axed three drug candidates but advanced one to a late-stage study. In the search for greener pastures beyond a crowding obesity market, Novo announced Aug. 7 that it advanced ziltivekimab into a phase III study to assess the subcutaneous therapy’s cardiovascular outcomes in acute myocardial infarction patients. Read More
China’s National Medical Products Administration has cleared Luye Pharma Group Ltd.’s new schizophrenia candidate LY-03020 to enter phase I trials in China. Independently developed by Shanghai-based Luye, the new chemical entity is a dual agonist that targets both the trace amine-associated receptor 1 and the 5-HT2C receptor and is intended to treat schizophrenia and Alzheimer’s disease psychosis. Read More
Infection or cure? Scientists from Tel Aviv University and the University of Glasgow genetically modified the Toxoplasma gondii to bring a protein inside neurons. The novelty of using a protozoan that can travel from the gut to parasitize the CNS contrasts with the possibility of causing a disease. The scientists are already working on how to avoid it. Read More
From no hope to viable treatments, BioWorld is there to cover the breakthroughs in medicine. Listen to Randy Osborne explain why the BioWorld team is ‘always on the lookout for what's next.’ Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aeterna Zentaris, Exelixis, Eyenovia, Formosa, G1, Kyowa, Newbridge, Poxel, Pharmacosmos, Precigen, Sumitomo, Voyager. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Neurogene, Ocular, Servier, Stoke, Takeda. Read More
