RegulationGastrointestinal March 12, 2024 Johnson & Johnson files sBLA for ulcerative colitis treatment By PBR Staff Writer A dual-acting IL-23 inhibitor, TREMFYA acts on both IL-23 and CD64 to potentially provide relief for patients. The sBLA is based on the data from the Phase III
Drug DiscoveryCardiovascular March 11, 2024 FDA approves Novo Nordisk’s Wegovy for cardiovascular risk reduction By PBR Staff Writer This label expansion follows a supplemental New Drug Application (sNDA) submitted by the company. As per the latest approval, the treatment is indicated for reducing risks of major
RegulationDrug DiscoveryOncology March 8, 2024 iOnctura receives orphan drug status for pancreatic cancer therapy By PBR Staff Writer Following the analysis of cambritaxestat’s chemical and biological properties, including a promising non-clinical safety and efficacy profile, the US regulator granted the ODD status. This designation provides benefits
Drug Discovery March 7, 2024 Sionna Therapeutics secures $182m for cystic fibrosis drug development By PBR Staff Writer The fundraising was spearheaded by Enavate Sciences, with Viking Global Investors and Perceptive Advisors joining as new investors. The financing round also saw contributions from all current stakeholders,
OncologyRegulationWomen's Health March 6, 2024 UK NICE recommends GSK’s Dostarlimab regimen for womb cancer By PBR Staff Writer This recommendation, part of NICE’s final draft guidance, could potentially benefit nearly 540 adults. A monoclonal antibody, Dostarlimab works by aiding the immune system in combating cancer. Administered
RegulationOphthalmology March 5, 2024 FDA approves Formosa-AimMax’s post-surgery eye care treatment By PBR Staff Writer This marks a significant advancement in ophthalmic care, introducing the first FDA-approved ophthalmic formulation of clobetasol propionate, a corticosteroid and the first new steroid in the ophthalmic market
Drug DiscoveryRegulationOncology March 4, 2024 EMA validates Daiichi Sankyo-AstraZeneca’s cancer therapy applications By PBR Staff Writer This marks a significant step in the potential approval of the medication for use in the European Union. One application pertains to the treatment of adults with locally
Drug DiscoveryNeurology March 1, 2024 Kenai secures funds for neurological cell therapy development By PBR Staff Writer The financing round was led jointly by Alaska Permanent Fund Corporation, Cure Ventures, and The Column Group, with additional contributions from Euclidean Capital and Saisei Ventures. Previously operating
Drug DiscoveryOncology February 29, 2024 SN Bioscience’s SNB-101 received FDA orphan drug designation By PBR Staff Writer This development is based on pre-clinical findings of the drug in treating pancreatic cancer, a condition with a notably low five-year survival rate and limited treatment options. SNB-101
Manufacturing February 28, 2024 Merck to open new distribution centre in Brazil for Life Science sector By PBR Staff Writer The facility, which will be operational this month, is designed to meet the increasing demand for life science products in the region. Spanning 13,000m2, the centre is twice