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The U.S. FDA reported that it has expanded the emergency use authorization for the Labcorp polymerase chain reaction (PCR) test for SARS-CoV-2 to include the company’s Pixel self-collection kit, a development that may presage a wider testing paradigm that is needed to restore the U.S. economy to normalcy.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainlab, Inspire Medical Systems, Labcorp, Roche.
LONDON – The search for modulators of the immune cascade that is the cause of the most severe respiratory symptoms of COVID-19 is intensifying, with Cyclacel Pharmaceuticals Inc. and Pharming Group NV adding their drugs to the list of repurposing projects.
Privately held Memgen LLC and the H. Lee Moffitt Cancer Center agreed to technology licensing agreements covering intellectual property the two jointly developed. The deal includes MEM-288, Memgen’s lead candidate, which the company said exhibits significantly enhanced selectivity and activity against a range of tumor types.
The urgent need to have at least a few proven COVID-19 therapies approved in the U.S. before the pandemic’s expected resurgence in the fall has become biopharma’s Manhattan Project – a coming together of industry, researchers and government agencies to take on a single global enemy.
DUBLIN – The Swiss biotech sector raised about CHF1.2 billion ($$1.2 billion) in equity investment in 2019, a significant downward dip on the last two years, but well ahead of its average annual raise of CHF800 million over the past decade, according to the newly published Swiss Biotech Report 2020.
PERTH, Australia – The Australian Government is providing AU$13 million (US$8 million) to fast-track research into treatments for COVID-19, and a number of promising candidates are about to enter the clinic.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alk-Abello, Bayer, Beigene, Boehringer Ingelheim, Hope, Myovant, Passage.
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