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.). Read More
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%. Read More
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. Read More
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. Read More
Metastatic solid tumors may be curable now. Among the most profound results presented over the weekend at the European Society for Medical Oncology (ESMO) 2024 Congress were the 10-year data from the Checkmate-067 and Keynote-006 trials, the phase III trials that tested Opdivo (nivolumab, Bristol Myers Squibb Co.) and Keytruda (pembrolizumab, Merck & Co. Inc.) as first-line agents in advanced or metastatic melanoma. Read More
Putting in writing what it’s been saying at advisory committee meetings, the U.S. FDA is issuing a draft guidance on multiregional clinical trials for cancer drugs that underscores the need for applicability to the U.S. population and medical practices. Read More
Immvira Group Co.’s oncolytic herpes simplex virus product, MVR-T3011, showed early efficacy via intravesical administration in patients with high-risk BCG-failure non-muscle invasive bladder cancer. Read More
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.” Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Atea, Curevac, Hotspot Therapeutics, Immuneering, Moberg, Neurocrine, Vico, Zambon. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cidara, Emergent Biosolutions, Nona, Omrx Oncology, OS Therapies, Umoja. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcturus, Bavarian Nordic, CSL Vifor, Halozyme, Nanoscope, Roche. Read More
