Analysts were sounding pleased and the company intends to go ahead with a regulatory filing, but investors seem to have wanted more from Viridian Therapeutics Inc.’s top-line data from the elegrobart (formerly VRDN-003) Reveal-1 phase III trial in active thyroid eye disease (TED). Viridian shares (NASDAQ:VRDN) closed March 30 at $18.53, down $8.86, or 32%. Read More
United Therapeutics Corp. is eyeing a possible priority review in its anticipated supplemental NDA for Tyvaso (treprostinil) in idiopathic pulmonary fibrosis (IPF) after the second phase III trial hit its endpoints, even besting the impressive findings from the first phase III study reported last year, and positioning United for a substantial commercial launch in 2027. Read More
Boston Scientific Corp. revealed much-anticipated data from the Champion-AF trial which showed that its Watchman FLX device provides superior protection from bleeding compared to non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation (AF). The left atrial appendage closure device also proved noninferior to NOACs in reducing stroke, cardiovascular death, or systemic embolism. Read More
Eli Lilly and Co. is deepening its investment in artificial intelligence-driven drug discovery through a multibillion-dollar expansion of its collaboration with Hong-Kong listed Insilico Medicine Inc. in a move that could broaden its reach into next-generation metabolic therapies. Read More
Introduced last year as a pilot program, the U.S. FDA Commissioner’s National Priority Voucher (CNPV) could be here to stay – at least for the duration of Marty Makary’s tenure as FDA commissioner. Since the FDA unveiled the CNPV last June, it has welcomed 18 products from 16 companies into the “game-changer” program for patients, as Makary described it. The goal is to provide an “ultrafast review pathway,” one to two months instead of the standard 10 to 12 months, for drugs and biologics of strategic national importance while maintaining the FDA’s scientific and regulatory standards, according to the agency. Read More
Data presented at the 2026 American Academy of Dermatology (AAD) meeting have put the spotlight on the arrival of target-selective oral therapies that are set to challenge injected biologics in terms of efficacy, while offering greater convenience and improving access to treatment. Read More
Otsuka Pharmaceutical Co. Ltd. is taking a neuroplastogen approach to posttraumatic stress disorder (PTSD) through its planned $1.22 billion acquisition of Transcend Therapeutics Inc. The deal gives Tokyo-headquartered Otsuka access to Transcend’s lead asset, TSND-201, an oral neuroplastogen that has begun patient recruitment for a phase III study in the U.S. Read More
Biopharma and med-tech companies raising money in public or private financings, including: Apogee, Bioretec, Onkure, Precision Optics, Vor Bio, Zenas. Read More
Clinical updates for biopharma and med tech, including data readouts and publications: Abcuro, Astrazeneca, Dizal, Eli Lilly, Esobiotec, Organon, UCB. Read More
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Anaptysbio, Innate, Long Bridge Medical, Sensus, Skincure Oncology, Teleflex. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: ARS, Bavarian Nordic, Crinetics, Eisai, GSK, Johnson & Johnson, Medtronic, Novo Nordisk, Nuvation Bio, OS Therapies, Pharming, Rocket, Sanofi, Siga. Read More
