The U.S. FDA has cleared the way for Abbott Laboratories sixth COVID-19 test, a near-patient, point-of-care antigen test that gives results in 15 minutes and can be run without laboratory equipment. The company has priced the Binaxnow COVID-19 Ag Card rapid test at $5 and is offering a complementary mobile app that allows people to display their test results when asked by organizations for verification.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Centers for Medicare & Medicaid Services, FDA, HHS, NICE, Stericycle Expert Solutions.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Carl Zeiss Meditech, Eurofins, Tandem Diabetes Care.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomark, Cassiopea, Galecto, Glaxosmithkline, Laurent, Rocket, Sirtex, Taysha Gene Therapies.
A number of controversies have swirled around the U.S. FDA’s handling of the COVID-19 pandemic, including the question of the emergency use authorization (EUA) program for testing. The FDA’s Tim Stenzel said on an Aug. 26 testing town hall that he would not answer questions about the rescission order for FDA regulation of lab-developed tests (LDTs), but also said, “we are simply overwhelmed” with EUA filings for testing.
HONG KONG – Telangana, India-based Dr. Reddy’s Laboratories Ltd. has launched Avigan (favipiravir), Fujifilm Holdings Corp.’s potential COVID-19 treatment, in India.
After a steady upward trend since the beginning of the year, the BioWorld Infectious Diseases index has hit a speed bump for the first time and dropped almost 8% so far in August. Companies in the group focusing on treatments for COVID-19 took the brunt of the valuation decline as investors became notably anxious about other drug developers making it to market sooner with their COVID-19 therapies.
RSS
