Citing "known and potential benefits" of using Gilead Sciences Inc.'s remdesivir for the treatment of COVID-19 that "outweigh the known and potential risks of the drug's use," the FDA has issued an emergency use authorization (EUA) for the antiviral, currently in limited supply, according to the company. Gilead CEO Daniel O’Day, who said the company is working with partners across the globe to ramp up supply, said his team is working with "urgency and responsibility" to meet global needs for the medicine.
PARIS – April 2020 was a milestone month for the key players in interventional cardiology in France. The reimbursement system in France is finally opening its doors to the drug-eluting balloon (DEB), following years in the wilderness.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bio-Rad, Quotient, Scibase.
The EMA's Committee for Medicinal Products for Human Use said Friday it has started a rolling review of Gilead Sciences Inc.'s antiviral, remdesivir, for the potential treatment of COVID-19. The move put into play one of multiple regulatory tools it has deployed "to speed up the assessment of a promising investigational medicine during a public health emergency."
Bio-Rad Laboratories Inc. has launched its SARS-CoV-2 Total Ab test, which is a blood-based assay to identify all the antibodies that are developed by the human body in response to the novel coronavirus SARS-CoV-2. Companies have been racing to offer serological tests that work to detect the antibodies developed during a COVID-19 infection that remain present in the blood after the initial infection clears.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acceleron, Alexion, BMS, Essa, Galectin, Genmab, Novan, Novartis, Pierre Fabre, PTC, Sosei, Telix, Vertex.
The COVID-19 pandemic has gripped the conversation regarding diagnostic and surveillance testing, but stakeholders nonetheless saw fit to populate the docket for the FDA’s proposal to down-classify tests for the human immunodeficiency virus (HIV) to class II. One of the themes of the feedback was that the proposal excludes a few key items, such as quantitative nucleic acid tests and testing for viral load monitoring, leaving the FDA with some difficult decisions to make.
TORONTO – Within a week of completing clinical trials the chest radiography AI tool developed by Vancouver, B.C.-based 1Qbit Inc. has been given the all-clear from Health Canada for deployment across the country. The XrAI was originally developed to better identify patients with respiratory illness including SARS, pneumonia and tuberculosis (TB), but then in February was tested on a publicly available data set of COVID-19 X-ray images.
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