Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Eli Lilly, Genentech, Halozyme, Medexus, Poseida, Regeneron, Roche, Simcere, Somite, Zentalis.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akeso, Bristol Myers Squibb, Equillium, Immatics, Immuneonco, Intercept, Korro, Merck, Novo Nordisk, Quine, Roche, Sama, Summit, Tonix, Vivtex.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ascendis, Bioinvent, BMS, Boehringer, Evaxion, Gan & Lee, GSK, Immvira, Immutep, Ipsen, Iteos, Nuvalent, Scorpion, Transgene.
While it’s called the FDA Modernization Act (FDAMA) 3.0, the short bipartisan bill introduced in the U.S. Senate Sept. 15 is basically a message to the FDA: “The move away from animal testing in FDAMA 2.0 wasn’t a congressional suggestion. It’s a mandate, so get it done.”
Putting in writing what it’s been saying at advisory committee meetings, the U.S. FDA is issuing a draft guidance on multiregional clinical trials for cancer drugs that underscores the need for applicability to the U.S. population and medical practices.
Predictably, weekly vs. daily subcutaneous injections made a big difference in the achondroplasia space, where shares of Copenhagen, Denmark-based Ascendis Pharma A/S (NASDAQ:ASND) closed Sept. 16 at $139.57, up $20.35, or 17%, on favorable, pivotal top-line data with Transcon CNP (navepegritide), as competitor Biomarin Pharmaceutical Inc.’s stock (NASDAQ:BMRN) ended the day at $69.86, down $15.04, or 17.7%.
Genentech’s newly approved multiple sclerosis (MS) injection takes about 10 minutes to administer, dramatically reducing the four to six hours required by its intravenous predecessor. The U.S. FDA approved the humanized monoclonal antibody Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for relapsing MS and primary progressive MS on Sept. 13.
Eli Lilly and Co.’s Ebglyss (lebrikizumab) becomes the latest U.S. entrant in the increasingly competitive atopic dermatitis space, following FDA approval of the IL-13-targeting antibody, which will now go up against other biologics such as established blockbuster Dupixent (dupilumab, Regeneron Pharmaceuticals Inc.), as well as more recently approved Adbry (tralokinumab, Leo Pharma Inc.).
Biocom California’s most recent edition of its Let's Talk About series covered the future of women’s health. The panel of executives from companies and investors in women’s health were frustrated about the state of funding for the space. “Only about 1% of health care R&D dollars go [specifically] to women’s health outside of oncology,” Jenn Kiang, director of corporate affairs and development at Daré Bioscience Inc. told the audience. But the opportunity is huge, she said.
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