In its first report on device application processing times since it completed most of its medical device reforms, Australia’s Therapeutic Goods Administration (TGA) met all the legislated time frames for processing medical device applications during the six-month period from July 31 to December 2021.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amneal, Astellas, Coherus, Innovent, Inxmed, Merck, PTC, Regeneron.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agios, Biontech Calcimedica, Evelo, Exelixis, Genmab, Inmune, ISA, Lexaria, Marinus, Pfizer, Sanofi, Sciwind, Surface, Taurx, Vendanta.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fosun Diagnostics.
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.
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