PERTH, Australia – Australian digital health company Resapp Health Ltd. was down nearly 52% following news that the U.S. FDA rejected its de novo request for its smartphone application for the diagnosis and management of respiratory disease. The agency rejected the application, citing the need for additional information to demonstrate that the “clinical benefits of the device outweigh the risks,” CEO Tony Keating told analysts during a March 12 conference call on the news.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acer, Astrazeneca, Applied DNA, Cansino, Cytodyn, Dicerna, Gilead, Hansoh, Janssen, Merck, Novartis, Oramed, Takis and Virpax
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Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aqualung, Arecor, Cyclica, Entos, Forma, Generex, Hoth, Lilly, Mateon, Nascent, Neurotheryx, Rocket, Roivant, Stabilitech.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Algernon, Bellus, Biondvax, Bioxcel, Cellphire, Genentech, GT Biopharma, ISA, Nantkwest, Novartis, Oramed, Pfizer, Phathom, Soligenix, TFF.
The first attempt at using existing drugs to treat patients infected with SARS-CoV-2 has yielded disappointing results. In 200 hospitalized patients with severe COVID-19, a 14-day regimen of twice-daily treatment with Kaletra/Aluvia (lopinavir/ritonavir, Abbvie Inc.) did not hasten recovery when added to the standard of care.
The U.S. capacity for SARS-CoV-2 testing is limited by several items, including the swabs used to collect patient specimens, but the supply of reagents has been front and center recently. Despite those concerns, several private test makers said they are quickly ramping up production, including Thermo Fisher Scientific Inc., of Waltham, Mass., which said it has enough supplies of all types on hand to provide 2 million reactions per week, a volume that should increase to 5 million per week in April.
LONDON – In the rush to test drugs against COVID-19, clinical trials in other indications are starting to be interrupted by the strains on health care systems and the fact that many potential patients are those most at risk from the effects of the novel coronavirus.
With medical researchers across the globe adjusting to the far-reaching impacts of COVID-19, commercial and academic trialists are taking action to protect essential studies. Regulators, too, are now joining the effort in a more concerted way, with the FDA issuing new guidance for industry, investigators and institutional review boards on conducting clinical trials during the pandemic.
As the world goes to war with COVID-19, the U.S. is ripping open the purse strings to fund mobilization against both the coronavirus and the economic devastation it’s causing.
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