The latest global regulatory news, changes and updates affecting biopharma, including: HHS posts rule for agency enforcement action; Guidance to help with COVID-19 Mabs; Chinese pharma exec sentenced on U.S. drug charges.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Innovation, Lexicon, Novartis, Orchard, Theratechnologies, Vor.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alexion, Ampio, Atyr, Bicycle, Knopp, Kyorin, Mirum, Nantkwest, Organogenesis, United, Verona.
Reports of multiple new variants of the SARS-CoV-2 virus have emerged, raising questions about the efficacy of vaccines, but also regarding the utility of diagnostic and other tests. The U.S. FDA’s Tim Stenzel said single-target tests are thus at a greater risk of returning a false negative result, adding that these developers “should consider this carefully” in surveillance of their tests.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: New test beats biopsy for transplant rejection; NICE eyes digital health HTAs; MHRA moves on the hazards of bedrails; TGA zeroes in on tests for COVID-19; HHS posts rule for agency enforcement action.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Excalibur Healthcare Services, Siemens Healthineers, Vestibular First.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acarix, Exact Sciences, Glaukos, Nexstim, Lumiradx.
CAJICA, Colombia – Authorities in Brazil released new efficacy data for Sinovac Biotech Ltd.'s COVID-19 vaccine Coronavac that surprised on the downside, suggesting the vaccine could be much less effective than initially indicated for preventing symptomatic infections.
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