Dismissed as undruggable in the early 2000s, Src homology 2 domains are now viable and at the heart of Recludix Pharma Inc.’s new deal with Sanofi SA’s U.S. unit. The two will collaborate on developing and commercializing treatments for immunological and inflammatory diseases. In the near term, Recludix will get $125 million, but long term it could add up to $1.2 billion in milestones. Recludix could also bring in up to double-digit royalties on possible future product sales. Read More
Vir Biotechnology Inc. said it won’t be discussing further the phase II data from the influenza A prevention study called Peninsula until the company’s second-quarter earnings update Aug. 3, and a closer look at the results has yet to decide the fate of monoclonal antibody VIR-2482, which missed its primary and secondary endpoints. Read More
Sosei Heptares is fulfilling its ambition for growth in the Asia-Pacific region by buying the Japanese and South Korea businesses of Swiss biotech Idorsia Ltd. for ¥65 billion (US$463 million), potentially freeing Idorsia from its struggle to prove its stroke drug, Pivlaz (clazosentan), is effective enough to warrant approval in key Western markets. Read More
A day after a U.S. House committee, on a party-line vote, advanced two bills to reauthorize emergency preparedness programs, the Senate Health, Education, Labor and Pensions (HELP) Committee voted 17-3 July 20 to send its bipartisan reauthorization of the Pandemic and All Hazards Preparedness Act to the Senate floor with a do-pass recommendation. Read More
Artificial intelligence (AI) drug discovery specialist Insilico Medicine Inc. is progressing INS018-055, its lead compound to phase II trials for idiopathic pulmonary fibrosis, a chronic lung disease that results in progressive and irreversible decline in lung function. Read More
A lot of biosimilar sponsors and wannabes are watching as the biosimilar competition in the U.S. unfolds to challenge the all-time biggest-selling drug, Humira from Abbvie Inc. In this episode, BioWorld Regulatory Editor Mari Serebrov and Tom Newcomer, vice president and head of U.S. market access at Samsung Bioepis, discuss the biosimilars landscape. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Armgo, Emergex, Faron, Hansa, Kintor, Merck & Co., Recce, Telix, Zai, Zambon. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biontech, Biotheus, CASI, Circle, Cleave, Elgan, Eliem, Vitrivax. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ambrx, Aqualung, Bloomsbury, Fosun, Hoth, Mabwell, Qihan, Sensorion. Read More