A new $1.33 billion oncology deal between Roche Holding AG and Repare Therapeutics Inc. is poised to give the Swiss multinational access to what it hopes will be a best-in-class program targeting DNA damage repair for the treatment of solid tumors. The global licensing agreement, for Repare's midstage camonsertib, gives Roche entrée to a developing race to lead the class alongside other big players, such as Merck KGaA, Bayer AG and Astrazeneca plc. Read More
Poor phase II top-line data for Immunic Inc.’s lead candidate, vidofludimus calcium (IMU-838) hammered the stock June 2 as the study of the selective oral DHODH inhibitor missed its primary endpoint of clinical remission in treating moderate to severe ulcerative colitis. The failure means Immunic won’t pursue a phase III study on its own in the indication, but it won’t affect the company’s planned phase III studies of IMU-838 in treating relapsing multiple sclerosis (MS) and a phase II in treating progressive MS. Read More
Although the death toll in the U.S. is nearing 1 million lives lost, signs continue to suggest that an end is in sight for the COVID-19 pandemic, the most disruptive global health crisis in a century. Read More
Suzhou, China-based Cstone Pharmaceuticals Co. Ltd. has begun trading again on the Hong Kong exchange (HKEX:02616) after trading was halted on April 1 following investigations over questionable investments during the company’s year-end audit for 2021. Read More
Four scientists have shared the 2022 Kavli Prize in neuroscience, "for pioneering the discovery of genes underlying a range of serious brain disorders," together and separately. Read More
Shares of Aeglea Biotherapeutics Inc. tumbled 51% June 2 on news that it received a refusal to file (RTF) letter from the U.S. FDA regarding the BLA for pegzilarginase for the treatment of arginase 1 deficiency, with the agency requesting additional efficacy data. Read More
Following an investigation into Leadiant Group’s pricing of a rare disease drug, the Italian Competition Authority fined the privately held company about €3.5 million (US$3.76 million) May 31 for charging the Italian National Health Service excessive prices since 2017 for Chenodeoxycholic Acid Leadiant. Read More
New hires and promotions in the biopharma industry, including: Fibrobiologics, Gradalis, Intrommune, Neurophth, Regulus, Renibus, Terns, Transition, Zealand. Read More
New and updated preclinical and clinical data to be presented by biopharma firms at American Society of Clinical Oncology annual meeting, including: Alkermes, Antengene, AVM, Harbour, Iterion, Jubilant, Lava, Lindis, Polypid, Seres, Sorrento. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Codagenix, Eagle, Foresee, Hutchmed, Kashiv, Kymera, Mezzion, Midatech, Neuronascent, Roche, Sanofi, Swedish Orphan, Teon, TG, UCB, VBI. Read More
