The NIH announced the launch of a national clinical trials network, dubbed the COVID-19 Prevention Trials Network, to help perform late-stage clinical trials of COVID-19 vaccines and other treatments. A vaccine co-developed by Moderna and the National Institute of Allergy and Infectious Diseases is expected to be tested in the first late-stage trial conducted through COVPN this summer.
India-based Lupin Pharmaceuticals and Granules Pharmaceuticals have recalled their metformin products after the FDA warned that it discovered higher-than-acceptable levels of N-nitrosodimethylamine, a probable human carcinogen, in the drugs. Lupin is pulling all lots of its metformin extended-release tablets, while Granules is recalling 12 lots after discovering higher than allowed levels of NDMA in some batches.
Mylan is recalling a single lot of injectable daptomycin after particulate matter was found in a single-dose sample vial manufactured at the firm's specialty formulation center in India. The affected lot was distributed to wholesalers and retail pharmacies across the US from April to May, the FDA said.
The FDA has given emergency use authorization to Assure Tech for its Assure COVID-19 IgG/IgM Rapid Test Device, which can deliver results within 15 minutes, and to Laboratorio Clinico Toledo for its Laboratorio Clinico Toledo SARS-CoV-2 Assay.
The FDA has given 510(k) clearance to Getinge for its Servo-air mechanical ventilator, a critical care ventilator for adult and pediatric patients that has invasive and noninvasive options for ventilation.
The recently introduced Requiring Assistance to Meat Processors for Upgrading Plants Act -- the RAMP-UP Act -- could provide incentives for facilities to improve their meat processing capacity and focus on a more diversified processing model. The bipartisan bill would provide $100,000 grants to meat processors to become federally inspected and compliant with the USDA's Food Safety & Inspection Service.
China has two COVID-19 vaccines slated to begin late-stage trials later this month, putting the country ahead of others in vaccine development. Eight of the 19 vaccines under development originate from China.
European regulators have given CE mark approval to DiaSorin Molecular for its Simplexa Flu A/B & RSV Direct Gen II assay, which can be used in combination with the firm's Simplexa COVID-19 Direct assay or by itself to test for influenza and respiratory syncytial virus.
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