The latest global regulatory news, changes and updates affecting biopharma, including: CDER lays out public speech rules for staff; Health Canada opens quicker path for COVID-19 drugs; EMA OKs COVID-19 use of dexamethasone.
Next-generation sequencing may help provide clinicians with a speedier answer as to the identity of the second pathogen, a service that may prove critical to suppressing the fatality rate in this and in future pandemics, according to Robert Schlaberg, chief medical officer of IDbyDNA Inc., of Salt Lake City.
While COVID-19 is responsible for about 14% of the regulatory data collected by BioWorld in 2020 and even though numerous clinical trials have suffered delays, the pandemic does not appear to have slowed the pace of the FDA’s approval process.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott, Aeye Health, Bond Digital Health, Cmr Surgical, Foundation Medicine, Fujifilm, HSS, Naval Research Laboratory, National Center for Advancing Translational Sciences, Optomed, Renalytix AI, Siemens Healthineers, Takeda.
CAJICA, Colombia - The Cuban government announced the successful development of a COVID-19 vaccine, but little is known about it beyond announcements that it has already started phase I trials.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aikido, Axon, Bintai, Equillium, Foundation, Generex, Om, Oncologie, Springworks, Summit, Takeda, Ufovax, Vifor.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Achieve, AKL, Astellas, Direct Biologics, Kezar, Lilly, Merck, Merck KGaA, Oncologie, Roche.
The diagnostic industry in the U.S. and elsewhere has scrambled to keep up with the COVID-19 pandemic, and one of the key developments will be a test that can be used at home without medical supervision. However, Tim Stenzel, director of the U.S. FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the Sept. 16 diagnostic town hall that the agency is keen on authorizing such a test, but has yet to receive any emergency use authorization filings. “We want to see a home test submission, and we’re willing to be very flexible here,” Stenzel said.
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