Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbsiko, Alys, Gilead, Innoviva, Jazz, Merck, Outlook, Renibus, Unicycive, Vivavision, X4.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bioduro-Sundia, Curadev, Deepcure, Grifols, Medicovestor, Recursion, Sanyou, Silicogenix, Synaptixbio, XL-protein.
New hires and promotions in the biopharma industry, including: Biorestorative, Cervomed, Cristcot, Day One, Devonian, Enhanced Genomics, Fibrobiologics, Fibrogen, Idorsia, Lyell, Microbiotica, Neurocrine, Tevard.
The U.K. government has doubled the rate that pharmaceutical companies must repay on sales of branded drugs, under the statutory rebate scheme, to a record 31.3%. Only 1-2% of total sales of branded drugs fall under the statutory scheme, but the increase is seen as a sign that an ongoing review of the voluntary scheme is not going well.
Mosanna Therapeutics secured $80 million in a series A round to develop MOS-118 as a treatment for the nearly 1 billion people globally with obstructive sleep apnea (OSA). The company has completed the formulation work to make the drug into a nasal spray and the initial proof-of-concept animal studies and is now ready to enter clinical trials in patients with OSA.
When it comes to the U.S. biopharma market, pricing seems to be the driving focus of most congressional conversations – and government contracts. Rep. Cliff Bentz, R-Ore., hit pause on that conversation at a June 11 House subcommittee hearing on the drug supply chain, when he asked if the U.S. is sacrificing security for price.
Philochem AG’s ligand-targeting approach drew to the table Bristol Myers Squibb Co. in a potential $1.35 billion agreement granting BMS subsidiary Rayzebio Inc. exclusive worldwide rights to OncoACP3, a diagnostic and therapeutic candidate targeting prostate cancer.
Deep Apple Therapeutics Inc. could bring in as much as $812 million in a new collaboration and license deal with Novo Nordisk A/S. The total includes an unspecified up-front payment, research costs and milestones. The two plan to develop and commercialize oral small molecules for non-incretin G-protein coupled receptor targets for treating cardiometabolic diseases, including obesity, a core specialty for Novo Nordisk.
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