Irlab Therapeutics AB’s phase IIb exploration of the dopamine D3-receptor with the Ipsen SA-partnered oral antagonist mesdopetam in Parkinson’s disease (PD) levodopa-induced dyskinesia (LID) fell short in terms of the primary endpoint, but the company is holding out hope. Mesdopetam missed the primary endpoint of change in daily hours of “on” time – periods of adequate PD control – without troublesome dyskinesia as shown in patient diaries, the company said. Read More
Now there are three. Moderna Inc. has posted strong phase III study data on its mRNA respiratory syncytial virus (RSV) vaccine, keeping pace with Pfizer Inc. and GSK plc’s candidates, which have May PDUFA dates. Moderna’s top-line results of the ConquerRSV pivotal efficacy study of mRNA-1345 show the vaccine hit its primary efficacy endpoints of 83.7% against RSV-associated lower respiratory tract disease in older adults. Read More
Looking ahead to potential commercialization of its late-stage tau PET imaging agent, Aprinoia Therapeutics Inc. has chosen to go public via a merger with special purpose acquisition company (SPAC) Ross Acquisition Corp. II in a deal that has an equity value of $280 million. The funding is aimed at getting candidate 18F-APN-1607 to the market in China. Read More
Bio-Thera Solutions Ltd. has obtained NMPA approval for BAT-1806 to treat rheumatoid arthritis, systemic juvenile idiopathic arthritis and cytokine release syndrome. BAT-1806 is the world’s first tocilizumab biosimilar approved for marketing, according to Guangzhou, China-based Bio-Thera. Read More
Shanghai Henlius Biotech Inc. scored NMPA approval for its self-developed anti-PD-1 monoclonal antibody Hansizhuang (serplulimab). It can be used for the first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC) in combination with carboplatin and etoposide. Read More
If the U.S. FTC has its way in banning all noncompete employment agreements, a lot of biopharma and med-tech companies are going to have to rethink how they protect sensitive information and business strategies. Read More
New hires and promotions in the biopharma industry, including: Adolore, Asieris, Biosenic, Capsida, Hinge, Neurobo, Nikang, Sanotize, Sensorium, Structure, Tune. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abionyx, Arcutis, Ascletis, Avacta, Avalo, Biomea Fusion, Cardiol, Clinuvel, Everimmune, GPCR, IGM, Kancera, Newamsterdam, Reneo, Theriva. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 4SR, Amgen, Evoq, Gero, Hc, Launch, Palatin, Pathalys, Pfizer, Phasebio, Sab, SFJ, Merck & Co., Teon and Vaxxas. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alkermes, Astrazeneca, Eisai, First Wave, Forge, Henlius, Immunos, Luye, Relief, Stada Arzneimittel, Umecrine Cognition, Xbrane. Read More
