The U.S. FDA’s efficacy bar for COVID-19 vaccines for the youngest children may be lower than the 50% required for the adult vaccines, according to Peter Marks, director of the agency’s Center for Biologics Evaluation and Research.<
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Johnson & Johnson, Myovant, Pfizer.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aqilion, Aracari, Brii, Compass, Cumberland, Gain, IGM, Insilico, Jemincare, Neurelis, Orion, Psybio, Verity, Virpax.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acer, Amylyx, Anthos, Citius, Evofem, KVK-Tech, Relief, Scilex, Sen-Jam, Sorrento.
In response to the COVID-19 pandemic, health systems around the world are looking to digital technologies to support health delivery but where exactly can these technologies have the most impact? At the Medtech Forum in Barcelona, European leaders gathered to discuss practical examples of how digital tools can help make health systems more efficient.
A risk of rare but potentially life-threatening blood clots in combination with low platelet levels after a jab of Johnson & Johnson's Janssen COVID-19 vaccine has convinced the U.S. FDA to limit its use. The vaccine is now authorized in the U.S. only for adults who wouldn't otherwise be vaccinated and those who can't or shouldn't, for medical reasons, get another approved vaccine. Through March 18, 2022, the FDA and CDC have identified 60 confirmed cases, including nine fatal cases of the condition, called thrombosis with thrombocytopenia syndrome – a rate of 3.23 cases per million doses of vaccine administered.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bio Products, Daiichi, Incyte, Jiangsu Recbio, Kempharm, Moleculin, Newsoara, Palisade, Vistagen, Xortx.
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