The Trump administration is urging the FDA to grant emergency authorization to flu drug Avigan as a potential COVID-19 treatment despite limited evidence of its effectiveness and questions about safety, according to people with knowledge of the matter. The FDA, HHS and Avigan manufacturer Fujifilm have been discussing possible clinical trials of the drug in the US, internal documents showed, and trials are underway in Japan.
The novel coronavirus has now infected more than 1 million and killed almost 53,000 people worldwide as cases continue to surge in the US, according to figures from Johns Hopkins University. The US accounted for more than 245,000 infections and more than 6,000 deaths, while Italy and Spain reported 13,915 and 10,935 deaths, respectively.
Priority review status was granted to Mesoblast's allogeneic cell therapy Ryoncil, or remestemcel-L, as a treatment for pediatric patients with steroid-refractory acute graft-versus-host disease. The FDA could issue a decision on the drug's approval by Sept. 30.
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 NDMA levels increase over time and when the drugs are exposed to higher-than-normal temperatures.
An updated list of medications in shortage was released by the FDA on Thursday, and the list now includes the sedation drug midazolam, which is used for patients who require mechanical ventilation. Five manufacturers noted that the shortage was due to a higher demand for the drug.
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.
Countries including the UK and Germany are considering invoking long-held laws that let them suspend manufacturers' patents rights so they can quickly obtain medications to treat the coronavirus. Drugmakers likely would resist the move, lawyer James Tumbridge says.
Neurimmune of Switzerland and German biotech Ethris have partnered to create messenger RNA antibodies that can be inhaled and delivered directly into a patient's lungs to neutralize SARS-CoV-2, which causes COVID-19.
The second closing of its Series B funding round brought in $125 million for immunotherapy startup iTeos Therapeutics. The new capital will be used to continue work on two cancer treatments it is developing.
Operator Stena Bulk's MR tanker will be on a test run using 100% MR1-100, a second-generation biofuel made from used cooking oil. The use of the biofuel, produced by GoodFuels, is touted as the company's contribution "to push the industry and pave way towards more sustainable shipping," said Stena Bulk President and CEO Erik Hanell.
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Francis of Assisi, patron saint of Italy, animals, ecology
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