As the world begins to emerge from a horrific pandemic, armed with high-efficacy vaccines and a roadmap of lessons learned, it has become abundantly clear that dangerous infections are here to stay, and it is up to health care leaders and citizens to remain prepared and vigilant in preventing another deadly and disruptive COVID-19. During the last day of the virtual 39th Annual J.P. Morgan Healthcare Conference, two health care leaders discussed the efforts and mistakes experienced, as well as the path forward toward herd immunity and the unknown outbreaks to come.
LONDON – A new national consortium of virologists has been set up to systematically assess how mutations in SARS-CoV-2 affect key outcomes such as effectiveness of vaccines and therapies, transmissibility of the virus and the severity of COVID-19 infections. Now is the critical time to do this, as the level of both natural and vaccine-conferred immunity that might drive natural selection is increasing, said Wendy Barclay, head of the department of infectious disease at Imperial College London, who is leading the G2P-UK (Genotype to Phenotype-UK) project.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, DBV, Gracell, Pfizer, RDIF, Steba.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS examines device classification process at FDA; NIH offers NGS system for SARS-CoV-2; FDA issues pandemic policy for coagulation systems.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hyperfine Research, Novaerus, Perkinelmer, Perspectum.
Keeping you up to date on recent developments in diagnostics, including: Improving diagnosis of brain diseases; Predicting survival of COVID-19 patients; New causal gene for chronic kidney disease.
Citing a lack of efficacy from adding its complement inhibitor Ultomiris (ravulizumab) to best supportive care for patients hospitalized with severe COVID-19, Alexion Pharmaceuticals Inc. paused further enrollment in a global phase III study of the drug. The move, recommended by the trial's independent data monitoring committee, suggested Ultomiris may soon join the list of other therapeutics once tested against COVID-19 but now no longer.
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