Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amicus, Apellis, Biocorrx, Biogen, Boehringer, Eli Lilly, Grifols, Junshi, NLS, Ocuphire, Oramed, Palisade, Roche.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adagene, Aim Immunotech, Biontech, Brii, Iovance, Kaléo, Ossium Health, Pfizer, Shionogi, Sonnet, The AIDS Clinical Trials Group.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Foundation Medicine, Minute Molecular Diagnostics.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cellcarta, Cruinn, Eurofins, Healthy.io, Jogo Health, Medica, Physiq, Rivaara, Sense Biodetection, Sirona Dx, Sphingotec, Ultivue.
China’s NMPA has approved 12 antigen self-test kits between March 12 and 16 amid COVID-19 outbreaks in many parts of the country. The regulator claims that there will soon be more test kits approved. The number of COVID-19 infectious cases in China surged rapidly over the first half of March.
With global COVID-19 cases on the rise once again, the World Trade Organization (WTO) said it reached consensus among four WTO members – the U.S., European Union, India and South Africa – for an IP waiver regarding vaccines, a proposal to which biopharma reiterated its objections. Meanwhile, in the U.S., the White House appealed to Congress to provide adequate funding to continue the country’s pandemic response, and Pfizer Inc. and Biontech SE submitted an application to the FDA seeking emergency use authorization for a fourth shot of its COVID-19 vaccine.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allarity, Arrowhead, Beigene, Kairos, Maia, Medison, Myrtelle, Pepgen, Quoin, Wesana.
The bipartisan PREVENT Pandemics Act, which seeks to put into U.S. law many of the lessons learned from the COVID-19 pandemic, marked its first milestone March 15, with the Senate Health, Education, Labor and Pensions (HELP) Committee sending it to the full Senate with a do-pass recommendation on a 20-2 vote.
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