Rates of adverse events (AEs) gave pause to some on Wall Street, and shares of Viking Therapeutics Inc. (NASDAQ:VKTX) fell 42%, or $17.73, to close Aug. 19 at $24.36 after the firm reported 13-week data from the phase II trial with the oral tablet form of VK-2735, the company's dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. Read More
It looks like Biogen Inc.’s Nrf2 activator, Skyclarys (omaveloxolone), will maintain its status as the sole therapy approved for treating patients with Friedreich’s ataxia (FA), at least for now. The U.S. FDA asked for another “adequate and well-controlled study” in the complete response letter (CRL) issued to PTC Therapeutics Inc. for 15-lipoxygenase inhibitor vatiquinone. The agency said “substantial evidence of efficacy was not demonstrated.” Read More
CSL Ltd.’s stock tumbled 16.88% on the news that it plans to cut 3,000 jobs and to hive off its Seqirus vaccine unit in a cost-cutting measure to save more than $500 million per year over the next three years. Read More
Avixgen Co. Ltd., a subsidiary of Dx&Vx Co. Ltd., inked a $360 million license agreement with an unidentified U.S.-based biotechnology company, granting the latter rights to its advanced cell penetrating (ACP) peptide drug delivery platform. Read More
Singapore-based Immortal Dragons has launched with $40 million under management, mostly from its founder Boyang Wang, with a focus on investing in early stage companies developing treatments to extend life. Read More
For more than 30 years, the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) worked together to harmonize their evidence-based vaccine schedules. Not anymore. Read More
Biopharma happenings, including deals and partnerships, and other news in brief: Astrazeneca, Boehringer, Fibrogen, Huadong, Lakeshore, Palatin, Vcare. Read More
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: BMS, Merck, Newamsterdam, Novo Nordisk, Soligenix, Springworks, Stealth, Systimmune, Tonix, Valneva. Read More
