The in vitro diagnostics industry has turned in an impressive response to the COVID-19 pandemic, but a few problems are bound to surface. The U.S. FDA reported May 10 that the Accula test by San Diego-based Mesa Biotech Inc. has been recalled due to contamination of test materials at the manufacturing site, a problem that could lead to false negative findings with the test.
A congressional investigation into COVID-19 vaccine manufacturing failures at Emergent Biosolutions Inc. unveiled more troubling issues at the company’s Bayview facility in Baltimore, which had been awarded a lucrative U.S. government contract to produce vaccines for Johnson & Johnson.
First results from the U.K. Cov-Boost trial, looking at responses to a fourth dose of an mRNA COVID-19 vaccine, show that antibody levels increase more than after the third dose, confirming the precautionary move to give the most vulnerable a second COVID-19 booster in advance of immune response data being available.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acer, Elpiscience, Logicbio, Resverlogix, Selection, Teva, Therapeutics Solutions.
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.
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