With one program in the clinic and another not far behind, Generate Biomedicines Inc. raised $273 million in a series C financing to advance its generative biology platform. It is one of the largest venture capital (VC) rounds for a U.S. company in 2023. Funds will go toward advancing the Somerville, Mass.-based company’s 17 pipeline programs, including the filing of multiple IND applications in 2024. Read More
Innovent Biologics Inc. announced a HKD$2.37 billion (US$306 million) placement on the Hong Kong Stock Exchange (HKEX) to advance its late-stage pipeline, including mazdutide, a GLP-1R/GCGR dual agonist for diabetes and obesity. The company plans to offer 68 million new shares priced at HKD$34.92, which represents an 8.8% discount to the previous closing price of HKD$38.30 per share, the company said in a filing on the HKEX. Morgan Stanley is the sole placing agent. Read More
A U.S. FDA advisory committee’s backing keeps Alnylam Pharmaceuticals Inc.’s Onpattro (patisiran) on the road to a supplemental approval in treating a rare heart disease, but it couldn’t stop the company stock from sliding. Shares (NASDAQ:ALNY) closed Sept. 14 down 8.8% at $193.06, the day after the Cardiovascular and Renal Drugs Advisory Committee voted 9-3 that patisiran’s benefits outweigh the risks in treating cardiomyopathy of transthyretin-mediated amyloidosis. Read More
Supporting their conclusions with data from the same phase III study, the EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for extending the use of Oncopeptides AB’s Pepaxti (melflufen) to earlier lines of treating relapsed, refractory multiple myeloma even as the FDA dug in its heels about withdrawing the drug from the U.S. market. Read More
Though data won’t be available for a few years, the disclosure in mid-July that Grifols SA completed enrollment in the phase III study called Sparta caused some ears to perk up in the alpha-1-antitrypsin deficiency (AATD) space, where a number of contenders are busy. Read More
Insilico Medicine Inc. struck an out-licensing deal with Exelixis Inc. for its small-molecule USP1-inhibitor candidate called ISM-3091, the company said on Sept. 12, standing to gain $80 million in up-front payments. Read More
The U.S. FTC put brand drug companies on notice Sept. 14 when the commissioners unanimously voted, 3-0, to issue a policy statement recognizing that improperly listed patents in the FDA’s Orange Book “may constitute an unfair method of competition.” Read More
Google’s Scott Penberthy joins the podcast for a visionary discussion that scans the horizon for startling changes artificial intelligence will bring to drug development in the relatively near future. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Aclipse, Apmonia, Beigene, Bionomics, Chong Kun Dang, First Wave, Genvion Harpoon, Landos, Merck & Co., Nona, Orchard, Pharmadrug, Pharmazz, Sun. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Aston, Bioray, Madrigal, Moderna, Morphosys, Nurexone, Rocket, Takeda. Read More
