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.
COVID-19 undoubtedly will be the top U.S. health care priority for the 117th Congress and the incoming Biden administration, but that doesn’t mean prescription drug prices are no longer an issue. A raft of new-year price increases, many for already costly drugs, is ensuring drug pricing remains high on the congressional agenda.
Moncef Slaoui, chief advisor to Operation Warp Speed, the public-private partnership to hurry along a vaccine for COVID-19, cited tough going in the early days of development, as researchers met “a real challenge to engage the population.” During a panel discussion at the virtual 39th J.P. Morgan Healthcare Conference, he pointed to “a double-edged sword, to talk about what a vaccine can do, when we don’t know – and then once you know, you’re going to have to change your message.”
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.
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