National Institute of Allergy and Infectious Diseases Director Anthony Fauci spoke on recent developments regarding potential COVID-19 vaccines and various drugs being tested to treat the disease as America tops the list of global infections with 7.7 million cases and more than 214,000 deaths. "There's never a guarantee for a vaccine, but we are cautiously optimistic that we will have a vaccine that would be safe and effective by the end of this year, and we'll be able to distribute doses at the end of this year and throughout the beginning and middle of 2021," Fauci said.
The FDA has given 510(k) clearance to Scopio Labs for its Full Field Peripheral Blood Smear application and X100 hematology imaging and analysis system.
Purdue Pharma has reached a settlement agreement under which it will enter guilty pleas to three federal criminal charges stemming from the US opioid crisis. The OxyContin maker also said it will pay more than $8 billion and dissolve itself, which will lead to the formation of a public-benefit company that will produce overdose-rescue drugs in addition to painkillers.
The CMS has proposed a guideline for still-in-development blood-based colorectal cancer screening tests to obtain approval, and it has declined to cover Epigenomics's FDA-approved Epi proColon blood-based screening test.
European regulators have given CE mark approval to CerTest Biotec's VIASURE SARS-CoV-2 PCR detection kit that can detect COVID-19, respiratory syncytial virus and influenza.
Singapore-based Breathonix has created a breathalyzer-style test for COVID-19 that can deliver results within one minute.
The FDA has given clearance to Tyber Medical for its new line of foot and ankle plating systems. "Our plates feature geometry to reduce overall prominence, especially in areas with minimal soft tissue coverage," said senior engineer Melissa Coale.
- Page 1