Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Celltrion, Evaxion, Intercept, Linnaeus, Mitsubishi, Nrx, Panbela, Viracta.
Just as the U.S. mpox public health emergency declaration is about to end, the FDA is releasing a draft guidance on developing drugs and biologics to treat infections caused by the virus.
In the absence of a European framework, industry is stepping up with an initiative to help EU patients cross borders to participate in clinical trials.
The U.S. Department of Health and Human Services received low marks on its latest Government Accountability Office (GAO) report card for its oversight of high-risk research involving potential pandemic pathogens, but legislative fixes might be necessary to ensure that all the gaps are closed.
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.
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 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.
After years of negotiations, the U.S. FDA and Swissmedic are one step away from recognizing each other’s good manufacturing practice (GMP) inspections of biopharma facilities.
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