With Alhemo (concizumab-mtci) from Novo Nordisk A/S, a third hemophilia drug in the past eight months has been approved by the U.S. FDA. The once-daily injectable prophylaxis is to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or B with inhibitors. Read More
Vertex Pharmaceuticals Inc.’s chief operating officer Stuart Arbuckle said during the Stifel Healthcare Conference in November that his firm’s launch last year of Casgevy (exagamglogene autotemcel) for sickle cell disease and transfusion-dependent beta-thalassemia “was the beginning of diversifying on top of our cystic fibrosis [CF] base” – a base that itself continues to grow. Read More
As recently as last month, Lexicon Pharmaceuticals Inc. was holding out hope regarding the NDA for Zynquista (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD), with analysts mulling the potential label. Read More
China's National Medical Products Administration (NMPA) approved Innovent Biologics Inc.’s NDA for Dovbleron (taletrectinib), a next-generation ROS1 tyrosine kinase inhibitor (TKI), for treating adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs. Read More
As if the uncertainties surrounding an incoming administration weren’t enough, a landmark U.S. Supreme Court decision and a potential new avenue of liability for drug and device manufacturers could bring an added level of unpredictability to the sector for 2025. Read More
SK Bioscience Co. Ltd. won €50 million (₩75.5 billion, US$52.03 million) up front from Sanofi SA to expand an earlier agreement to develop and commercialize novel pneumococcal conjugate vaccines (PCVs). The first deal resulted in GBP-410 (SP-0202), its pediatric 21-valent PCV candidate that moved into phase III study last week. Read More
The acquisition of Karuna Therapeutics Inc. by Bristol Myers Squibb Co. (BMS) was announced in December 2023, and closed as the BioEurope Spring meeting was convening in March. Along with the acquisition of Cerevel Therapeutics Inc. by Abbvie Inc., the deal signaled that big pharma companies were ready to get back into the brain diseases space. Read More
The U.S. FDA approved 10 drugs in November, down from 15 in October, 24 in September and 22 in August. Four new molecular entities were approved by the agency in the month, bringing the year-to-date total to 42. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apollomics, GSK, Novo Nordisk, Stemcyte, TC Biopharm. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aadi, Aridis, Corxel, Cytokinetics, Dac Bio, Epitopea, Eton, Genevant, HLB Innovation, Idordia, Ipsen, Merck, Pyxis, Sanofi, Verismo, Wuxi Biologics. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fennec, Humacyte, Innovent, Ionis, Santhera, Zealand Pharma. Read More
