Despite the U.S. FDA’s approval of Sage Therapeutics Inc.’s priority NDA for postpartum depression, the accompanying complete response letter (CRL) for major depressive disorder has undercut the company’s plans. Withholding the approval for MDD slices away a huge amount of the potential market for Sage and its collaborator, Biogen Inc. Read More
Wall Street cheered Vistagen Therapeutics Inc.’s first positive phase III trial with a drug for social anxiety disorder (SAD) in 15 years and sent the South San Francisco-based firm’s shares (NASDAQ:VTGN) on a rocket ride to close Aug. 7 at $13.05, up $11.37, or 677%. Vistagen unveiled top-line data from the phase III study called Palisade-2 testing the efficacy, safety, and tolerability of lead asset fasedienol (PH-94B) nasal spray in adults with SAD. Read More
When Nektar Therapeutics Inc. decided to push ahead with development of Treg stimulator rezpegaldesleukin (rezpeg) in atopic dermatitis despite what appeared to be middling early stage data, investors weren’t exactly jumping up and down. But it turns out those data are more promising than originally thought. Read More
Iveric Bio Inc. is now the second biotech to gain U.S. clearance for geographic atrophy – snagging U.S. FDA approval on Aug. 4 for Izervay (avacincaptad pegol intravitreal solution) to treat GA secondary to age-related macular degeneration. The once-monthly Izervay 2-mg injection is anticipated to be available in the U.S. in two to four weeks, said Tokyo-based Astellas Pharma Inc., which recently acquired Iveric in May 2023. Read More
The dent made in Bavarian Nordic A/S’ future revenues after it dropped development of late-stage respiratory syncytial virus (RSV) contender MVA-BN-RSV could be offset by potential sales of its chikungunya virus vaccine, PXVX-0317, if recent phase III immunogenicity data manage to persuade the U.S. FDA that it’s as worthy as Valneva SA’s VLA-1553, the other chikungunya vaccine racing to be first to market. Read More
Even as biopharma challenges to the constitutionality of the “excise tax” included in the Inflation Reduction Act await action in the U.S. federal court system, the Treasury Department and the Internal Revenue Service (IRS) said they intend to issue proposed regulations to implement the tax. Read More
U.S. federal government agency recoveries under the False Claims Act (FCA) are down slightly in the first half of 2023 relative to the first half of 2022, but that doesn’t mean companies in the life sciences can afford to let their guard down. The Senate is examining two pieces of legislation that would significantly amplify the risk for device and drug makers, including a Senate bill that would eviscerate the materiality standard as set by the U.S. Supreme Court in Escobar. Read More
New hires and promotions in the biopharma industry, including: Ankyra, Arbor, Avalyn, Oncopeptides, Serimmune, Viracta, Vivoryon, Voyager, Xortx. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Affimed, Altrubio, Amgen, Cullinan, Eli Lilly, Neurobo, Theracosbio. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aceragen, Arcus, Astellas, Biontech, Duality, Ikena, Pionyr, Poseida. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Basilea, Mesoblast, Sanofi. Read More
