Clinical updates, including trial initiations, enrollment status and data readouts and publications: Arrowhead, Biocryst, Centessa, Innovent, Insilico, Jacobio, Lysogene, Point, Regulus, Sarepta, Simcere, TFF, Trevi, Vaxcyte.
The deadly SARS-CoV-2 virus that has cost nearly 6 million lives worldwide and disrupted global economies has brought the biopharma industry $82 billion in sales revenue since the start of the pandemic, with guidance for another $88 billion this year.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, Atamyo, Conserv, Endpoint, Grifols.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Glaxosmithkline, Hightide, Sanofi.
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.
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