Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbisko, Atyr, Avidity, Briacell, Cyrano, Exegenesis, Hutchmed, Junshi, Krystal, Novavax, Orphagen, Paratek, Pharmather, Sanofi, Scisparc, Takeda.
The new year always brings with it a series of New Year’s resolutions, and the U.S. FDA has apparently resolved to catch up on its backlog of de novo notifications. The earlier of the two de novo regulatory announcements is for a digital product by Minneapolis-based Nightware Inc., and its namesake kit for reduction of sleep disturbances, a regulation that arrives more than two years after the product was granted market access.
Cytovale Inc. received U.S. FDA 510(k) clearance for its Intellisep sepsis test, which can aid in the diagnosis of the often fatal condition within 10 minutes. Cytovale is one of several companies and collaborations that aim to sharply reduce the time to diagnosis and the mortality rate for sepsis by providing quicker, more informative test results and standardizing protocols.
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.
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.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cytovale, Magstim, Orthogen, Vyspine.
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.
Nervtex Co. Ltd.’s diagnostic assessment software Modas for movement disorders such as Parkinson’s disease has been given NMPA approval in China. Using smart mobile devices, Modas can process video data collected from people with potential or existing movement disorders when they are in any specific motion state.
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