Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alexion, Ampio, Arca, Astrazeneca, Crinetics, I-Mab, Merck, Otsuka, Harbour and Liminal.
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.
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