LONDON – DNA damage repair (DDR) specialist Artios Pharma Ltd. has sealed a $860 million per target deal with Merck KGaA, around a series of small-molecule DNA nuclease inhibitors. The deal, for up to eight targets, will see Artios get $30 million in up-front and near-term milestones to take programs to the point at which Merck will decide on its option to take them in-house. For any products that make it to market, the $860 million in milestones along the way will be followed by double-digit royalties on sales. Subject to certain conditions, Cambridge-based Artios has rights to do joint development with Darmstadt, Germany-based Merck. Read More
The extraordinary speed with which mRNA technology has delivered what appear to be safe and highly efficacious vaccines for preventing COVID-19 herald the start of a “golden age of vaccinology,” according to C. Buddy Creech, director of the vaccine research program at Vanderbilt University in Nashville and principal investigator on the phase III trial of Moderna Inc.’s mRNA-1273 COVID-19 vaccine. Read More
Shares of immunotherapy developer Enlivex Therapeutics Ltd. (NASDAQ:ENLV) climbed as much as 69% Dec. 3 after interim data showed the apparent benefits of its lead candidate, Allocetra, for severe and critical COVID-19 patients. Read More
The phase III study of Zepzelca (lurbinectedin) as combination therapy from Jazz Pharmaceuticals plc and Pharmamar SA was a stumble, but the companies said they found plenty of encouraging data prompting them to continue development. Read More
HONG KONG – Takeda Pharmaceutical Co. Ltd. received approval from Japan’s Ministry of Health, Labor and Welfare (MHLW) for an additional indication for its tyrosine kinase inhibitor, Cabometyx (cabozantinib), clearing the firm to manufacture and market 20-mg and 60-mg tablets for patients with unresectable hepatocellular carcinoma that has progressed after prior systemic therapy. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: DEA gets on board with partial Rx fills; USPTO touts early results of amendment pilot; FDA posts combo product feedback final guidance. Read More
Biopharmas raising money in public or private financings, including: Bioage, Codexis, I2o, Kinnate, Neuroglee, Ortho Regenerative, Rubedo, Silverback. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agenus, Antengene, Emmaus, Engene, Eyenovia, Genmab, Janssen, Neurogene, Ose, Realta, Rezolute. Read More
