LONDON – New figures underline the devastating effect the pandemic is having on cancer clinical research, with recruitment to U.K. studies falling by 60%. A total of 27,734 patients were recruited in 2020/21, compared to an average of 67,057 in the three years previously. Over those three years, recruitment had been on the rise, going from 61,810 in 2017/18 to 71,709 in 2019/20, according to figures compiled by the Institute of Cancer Research in London.
As Omicron spreads throughout Europe there’s a pressing need for new therapies that could reduce the burden on hospitals by preventing COVID-19 symptoms from escalating to a critical point. Apogenix GmbH, of Heidelberg, Germany, is pushing a potential new therapy into phase III that could be added to the armamentarium against COVID-19 with €20.7 million (US$23.4 million) government funding.
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.
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