Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Algernon, Biontech, Clarity, Janssen, Mallinckrodt, Novartis, Pfizer, Vitro.
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.
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.