The COVID-19 pandemic has not run its course, but the U.S. FDA is already working on a plan for handling devices in the period after the public health emergency ends. Bill Maisel, chief medical officer at the FDA’s Center for Device and Radiological Health (CDRH), said the agency is thinking through what would have to appear in a guidance for a transition that may span a number of months, providing industry with some much-needed breathing room.
More than 62% of the volume and 63% of the projected values of med-tech deals completed in 2020 are for one of two things: COVID-19 diagnostics and devices or digital health technologies that fall outside of the pandemic efforts. As of late September, BioWorld has tracked 1,012 deals this year – including licensings, collaborations and joint ventures – valued at $3.67 billion, as well as 272 completed mergers and acquisitions valued at $8.53 billion.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Genetron, Ka Imaging, Perkinelmer, Sentiar, Vexos.
As his firm unveiled early data with its spike protein-targeting COVID-19 therapy, Regeneron Pharmaceuticals Inc.’s chief scientific officer, George Yancopoulos, said that, even if researchers come up with a drug that works, coming up with efficient point-of-care diagnostics remains “a major societal imperative.”
CAJICA, Colombia – Privately held Inosan Biopharma SA De Cv, of Mexico City, is racing to develop a biological treatment to cure COVID-19 patients. Inosan has mastered the technique of using horses to produce antibodies to heal patients bitten by poisonous creatures, such as snakes, spiders and scorpions.
PERTH, Australia – Starpharma Holdings Ltd. completed a AU$45 million (US$32 million) placement to domestic and international investors that will see it advance its COVID-19 antiviral nasal spray. The treatment is based on the company’s antiviral dendrimer, SPL-7013, which inactivates viruses by blocking the interaction between viral surface proteins and the human cell receptor proteins.
LONDON – Oxford Immunotec plc is aiming to plug a significant gap in the COVID-19 diagnostics landscape, with the development of a commercial clinical grade test for quantifying T cell responses to the SARS-CoV-2 virus. T-Spot Discovery SARS-CoV-2, currently available for research use only, is based on the same automated technology as the company’s tuberculosis diagnostic, which is approved for use in more than 60 countries.
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