Makers of vitro diagnostics (IVDs) are facing several significant challenges in the next few years, thanks to existing and impending revisions to a number of regulatory frameworks. There are other considerations that are adding to the headwinds, such as a poor patent protection environment in the U.S., the net effect of which is to make life unusually miserable for developers of these tests.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aytu, Bioinvent, Biontech, Cybin, Cytodyn, Daré, Moderna, Neurop, Nuvation, Pfizer, Saol, Supernus.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abpro, Ascentage, Betterlife, Canbridge, Clover, Prestige, Redx and Smart Immune.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Achiko, Foundation Medicine, Philips.
There is now more clarity on the Omicron variant of SARS-CoV-2, as serum antibodies produced by three doses of the Pfizer Inc.-Biontech SE COVID-19 vaccine have been shown to neutralize it. The data arrived a day after Glaxosmithkline plc and Vir Biotechnology Inc. said the monoclonal antibody sotrovimab retains activity against key mutations of the Omicron variant, including those found in sotrovimab’s binding site.
Due to COVID-19, diagnostics are in the limelight, and public and private investors are watching how the pandemic may impact the in vitro diagnostics (IVD) market in the future. As the sector receives an influx of investment, companies will be in strong positions to expand their portfolios. So, with 2022 around the corner – what are the investment trends to watch?
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amra Medical, Audere, Cosara, Foldax, Linus Biotechnology, Medtronic.
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