With the first global approval by Health Canada in hand, Medicago Inc. aims to provide 20 million doses this year of Covifenz – which itself represents another first, as a plant-originated, virus-like particle, recombinant, adjuvanted COVID-19 vaccine. “Hopefully, if all goes well, we’ll be able to do it faster than the last day of the last month” of the year, said Brian Ward, medical officer of Quebec City-based Medicago, a unit of Mitsubishi Tanabe Pharma Corp., which partnered on Covifenz with Glaxosmithkline plc (GSK).
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chromacode, Dyad Medical, Medtronic.
A sense of normalcy is returning to the U.K., at least from a regulatory perspective. The U.K.’s Medicines and Healthcare Products Regulatory Agency will continue to support COVID-19 clinical trials with ongoing regulatory and scientific input, but all further applications and meeting requests for COVID-19 products will be considered according to usual timelines rather than on an emergency basis, the agency said Feb. 23.
In the quest for regulatory approval for their COVID-19 vaccine, Sanofi SA and Glaxosmithkline plc (GSK) said they plan to submit their phase III and booster efficacy study data showing it induced a significant increase in neutralizing antibodies after a primary series of mRNA or adenovirus vaccines.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D Pharma, AB Science, Abbvie, Armata, Bharat Biotech, Beigene, Cansino, Homology, Ocugen, Provention, RDIF.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ariana, Atma Journey, Aulos, Cyclerion, Filament, Foresee, Jnana, Synaptogenix, Trpharm and Vicore.
LONDON – Oxford University spinout Oxdx Ltd. has raised £2.6 million (US$3.6 million) in pre-seed funding to advance development of a technology for directly identifying infectious pathogens without the need to purify, culture or amplify samples first. The instant testing method uses a mixture of a single universal reagent, high resolution microscopy and machine learning, to identify specific species and strains of bacteria, viruses and other pathogens within minutes.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Foundation Medicine, Gramercy Extremity Orthopedics, Lumiradx, Olympus, Precisis.
Shares in Synairgen plc have cratered after a phase III trial of its inhaled COVID-19 therapy SNG-001 failed to produce conclusive results, with the company blaming improvements in standard care for the disappointing findings in patients hospitalized with the disease. The Southampton, U.K.-based biotech’s shares (LSE:SNG) touched lows of 10 pence, down 94%, and stabilized around 85% below their previous closing price of £25.36 after the announcement on Monday.
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