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An April 15 U.S. FDA stakeholder call revisited several themes of interest in connection with diagnostics for the COVID-19 pandemic. However, Tim Stenzel, director of the agency’s Office of In Vitro Diagnostics and Radiological Health, said that while the agency has not yet authorized a home sample collection kit, “we do think it’s going to happen very soon.”
Within two weeks of a public challenge to design user-friendly, easily built ventilators, Montreal-based CAE Inc., formerly Canadian Aviation Electronics, began gearing up to distribute 10,000 units of its newly created ventilator over the next three months.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Behold.ai, Chembio, Nova Biomedical, Ortho.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advamed, Cardinal Health, Face Vital, Thermo Fisher Scientific.
Less than a year after backing Tscan Therapeutics Inc.'s $48 million series B round, Novartis AG is tapping the Waltham, Mass.-based company to discover and develop new T-cell receptor (TCR)-engineered T-cell therapies for up to three new solid tumor targets. The collaboration includes an up-front technology access fee and research funding totaling $30 million, as well as potential clinical, regulatory and sales-based milestone payments that could total hundreds of millions of dollars, Tscan said.
Two phase III studies in China testing Gilead Sciences Inc.’s antiviral drug, remdesivir, in patients with COVID-19 infection have been halted after Chinese authorities reported a lack of eligible patients. Other studies, including trials sponsored by the Foster City, Calif.-based company, remain ongoing.
The collection of nasal and throat swab samples to detect the presence or absence of the novel coronavirus SARS-CoV-2 has proven problematic on a few fronts, particularly in the U.S. The swabs themselves often have become scarce and difficult to obtain, while health care workers are routinely risking their own health commonly in the absence of proper protective equipment. In addition, sampling difficulties have largely been blamed for a very high false negative rate that could be as much as 25%.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Athersys, Forma, Gensight, Harbour, Humanigen, Pfenex, Remegen, Sinovac, Tetra, Urogen.
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