The U.K.’s drugs regulator has approved the COVID-19 vaccine from Valneva SE – although the shot is likely only to be offered to health workers in Scotland after the Westminster government rejected it because rivals beat it to market.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affamed, Atyr, Biogen, Boehringer, Briacell, Direct, Eli Lilly, Novavax, Recbio.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biontech, Dyadic, Epygen, Emergex, Excellthera, Hookipa, Inotrem, Insilico, Gain, Geneuro, ICER, Longeveron, Magenta, Matinas, Micros, Oncolytics.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adiso, Addex, Amryt, Imcyse, Lineage, Medicinova, Oncternal, Phosplatin, Recce, Sonnet, Syneurx, Turning Point.
Pharma CEOs have pushed back strongly against intellectual property (IP) waivers for COVID-19 vaccines and therapies, saying that pricing is not the reason why middle- and low-income countries have not received pharmaceutical countermeasures against the pandemic. Senior execs from Pfizer Inc., Eli Lilly and Co., and Roche Holding AG, also expressed concerns about the latest funding package from the U.S. government, which at $10 billion is less than half that originally requested by the White House.
Shionogi & Co. Ltd.’s plan to make ensitrelvir, an oral antiviral for COVID-19, the first domestically approved COVID-19 treatment has hit a snag. Animal studies showed the drug, also known as S-217622, disturbed fetal development, according to media reports.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aeglea, Affamed, Bharat Biotech, Biocardia, Blue Earth, Fera, Gilead, Henlius, Medilink, Myovant, Ocugen, Paradigm, Poxel, Secura, Vistagen, Xortx.
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