Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biocon Biologics, Biomarin, Janssen, Johnson & Johnson, Repare.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: GSK, Janssen, Nuvectis, Scilex.
Although last year’s massive U.S. launch of Humira biosimilars captured headlines, the market adoption of those competitors has been nothing to write home about, even with discounts as low as 85% off the innovator price.
During a webinar arranged by Demy-Colton, panelists discussed a wide range of potential outcomes that might occur depending on which political party ends up in power next year. From tweaks to the Inflation Reduction Act to new laws to the Federal Trade Commission's regulation of M&As, there’s potential for the government to have substantial effects on the drug development industry.
Cumulus Oncology Ltd. is in the thick of raising a $50 million series A round as its model of sourcing novel drug targets emerging from academia, shaping them up for clinical development, and spinning them into startups, gathers pace. At the same time, Nodus Oncology Ltd., the first spinout created around an acquired asset, has just reached in vivo proof of concept with its lead DNA damage response inhibitor, and it, too, is looking to raise a series A to take the program through to the end of phase I.
Yoltech Therapeutics Co. Ltd. licensed its PCSK9-targeting gene editing therapeutic, YOLT-101, to Shenzhen Salubris Pharmaceuticals Co. Ltd. for mainland China rights in a deal worth ¥1.035 billion (US$145 million).