LONDON – The U.K. government has signed a €1.4 billion (US$1.7 billion) advance purchase agreement with French biotech Valneva SE, for the supply of up to 190 million doses of its attenuated COVID-19 vaccine, VLA-2001.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA advises on getting back to business as usual; ICER evidence report targets ulcerative colitis treatments.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Cycle, Essa, Gan & Lee, Gannex, Kiadis, Mateon, Novartis, Pharmacyte, Regeneron, Reven, Sanofi, SK, Seneca, Supernus, Vaxart, Vertex, Ziopharm.
The volume of clinical data reported throughout the summer has continued to fall, with only 267 items collected in August, a drop of 10% from July and the lowest amount within the last five months.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Appili, Immupharma, Junshi, Seres, Sol-Gel.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amyris, Biocomo, Editas, Harbour, Hualan, Johnson & Johnson, Lavvan, Medicinova, VBL.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arch, Genmab, GSK, Halozyme, Sarepta, Terns, Zai Lab.
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