Developers of tests for the SARS-CoV-2 virus have gained a tremendous amount of experience in a very small amount of time, and of all the media for sampling, saliva offers the easiest route for test administration. The U.S. FDA’s Tim Stenzel said on the Aug. 5 testing town hall, however, that the FDA and developers have discovered that this is an extremely difficult medium to work with.
PARIS – France’s Medical Device and Health Technology Evaluation Committee (CNEDiMTS), has published it latest annual activity report. This committee of the French National Authority for Health (HAS) evaluates medical devices with a view to their coverage by L’Assurance Maladie, the body which manages health care in France.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Endologix, Eyenuk, Life Spine, Neumodx, Roche, Sentinel Diagnostics, Siemens Healthineers.
Citing the limited supplies and the pricing of the COVID-19 therapy, nearly three dozen U.S. states and territories are clamoring for the federal government to march in on Gilead Sciences Inc.’s patents for remdesivir. And if the feds won’t, then states should be given that authority, according to a letter sent Tuesday to the Department of Health and Human Services, the NIH and the FDA.
HONG KONG – The recent approval of all-oral hepatitis C virus (HCV) drug RDV/DNV, a combination of Asclevir (ravidasvir) and Ganovo (danoprevir), helped boost shares of Ascletis Pharma Inc. (HK:1672), which ended July with a 10% jump to HK$3.36 (US43 cents), as the Hangzhou, China-based company continues to push its pipeline of treatments forward and improve its outlook.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axsome, Diurnal, Pharmacyte, Revive.
The latest global regulatory news, changes and updates affecting biopharma, including: Medicines and Healthcare Products Agency, Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria.
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