The FDA is asking manufacturers of over-the-counter and prescription ranitidine drugs, sold under the Zantac brand, to immediately remove their products from the market because of concerns over levels of N-nitrosodimethylamine, a probable carcinogen. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said the many samples tested did not contain unacceptable levels of NDMA, but an agency investigation found that NMDA levels increase over time and when the drugs are exposed to higher-than-normal temperatures.
AdvaMed has reported a quick rise in ventilator production by member companies due to the novel coronavirus outbreak. "Across the board, our ventilator members have boosted production by more than 285% to meet the demands of this global crisis," said AdvaMed President and CEO Scott Whitaker.
The UK government has contracted Smith & Nephew to produce OxVent ventilators, currently being reviewed by the Medicines and Healthcare products Regulatory Authority, in response to the COVID-19 outbreak. Production of the ventilators will begin immediately after the company receives design authorization.
The Biomedical Advanced Research and Development Authority has given Luminex a second contract worth $642,450 to support the development of its Aries SARS-CoV-2 Assay, which can deliver results within two hours.
A COVID-19 point-of-care test that can deliver results within 15 minutes was launched by Becton Dickinson. The test confirms previous or current exposure to the novel coronavirus by checking for antibodies present in the blood.
European regulators have given CE mark approval to Genetic Signatures' SARS-CoV-2 test kit.
The FDA has given 510(k) clearance to ABM Respiratory Care's Biwaze Cough system, which helps people who are unable to cough remove secretions.
The FDA said the antimalarial drugs hydroxychloroquine and chloroquine, which have been allowed for emergency use in certain patients with COVID-19, are in shortage as demand surges. The agency said manufacturers of the drugs are increasing production.
The European Medicines Agency recommends being cautious about the use of hydroxychloroquine and chloroquine, drugs being used to treat malaria, rheumatoid arthritis and lupus, due to the uncertain efficacy and potential side effects these could have on patients diagnosed with COVID-19. The agency said the drugs should only be utilized for national emergency use programs or trials.
Vir Biotechnology and Alnylam Pharmaceuticals have increased their collaboration in a quest to advance investigational RNAi therapies that target host factors in treating COVID-19. The companies will evaluate the RNAi therapeutics targeting three host factors that the SARS-COV-2 infection requires.
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