Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cardiowise, Locate Bio, Siemens Healthineers.
LONDON – The U.K. is to make treatment with interleukin-6 (IL-6) inhibitors standard of care for critically ill COVID-19 patients after a randomized trial found the arthritis drugs significantly improve survival.
CAJICA, Colombia – Brazil's Butantan Institute and the government of the state of Sao Paulo released efficacy results on Jan. 7 for Coronavac, developed by China’s Sinovac Biotech Ltd., that suggest the COVID-19 vaccine is more than 78% effective.
DUBLIN – Curevac AG has entered a global alliance with Bayer AG to accelerate its efforts to bring a third, desperately needed mRNA-based COVID-19 vaccine to market. The vaccine in question, CVnCoV, began a pivotal phase IIb/III trial on Dec. 14.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Aldeyra, Alnylam, AM-Pharma, Basilea, Pfizer, Pharmaessentia.
Nextgen Biomed Ltd. has begun a clinical trial of a breath test to monitor antibody levels in individuals vaccinated against COVID-19. Be'er Ya'akov, Israel-based Shamir Medical Center authorized the trial for test developer Scent Medical Technologies Ltd. (Scentech Medical), which is in the midst of merging with Nextgen. The merged company will be called Scentech Medical.
The U.S. FDA is actively working on guidance for conversion of emergency use authorizations (EUAs) to conventional premarket review programs, but the FDA’s Tim Stenzel said he does “not perceive a need to rush to convert EUAs” because of the volume of EUA applications, and because he does not expect the public health emergency “to end anytime soon.”
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA grants EUA to Quanterix for Simoa test; EC investing in startups; Alternatives to animal testing a challenge; USPTO seeks more uniformity between PTAB, courts; NICE nods to Olympus Plasma for BPH.
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