The latest global regulatory news, changes and updates affecting biopharma, including: Pandemic not the time for trade restrictions; Longer-term vaccine follow-up crucial; Labeling update advised for chloroquines; FDA stands up new DDT path; FDA drafts DDI guidance; MHRA continues Brexit updates; FDA debars three.
Moderna Inc. and Covaxx Inc. are readying for delivery more than 220 million doses of their respective COVID-19 vaccines to Europe and emerging countries in newly cut deals. Moderna, of Cambridge, Mass., said it granted an option to the European Commission to buy up to 80 million additional doses of mRNA-1273 and is set to manufacture 500 million to 1 billion doses globally in 2021. The company said the vaccine, if approved, will ship to the EU beginning in December. The company’s shares (NASDAQ:MRNA) had a solid day Nov. 25, with shares closing 10.78% upward at $109.18.
CAJICA, Colombia – Cuba’s Finlay Institute of Vaccines is moving forward with Soberana 2, a domestically developed conjugate vaccine against SARS-CoV-2. This is the second vaccine under development in the small country of 12 million people.
The latest global regulatory news, changes and updates affecting biopharma, including: The other shoe drops for former Insys CEO; NICE gives nod to new myeloma regimen; MHRA prepares for January; FDA guidances finalized.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Altimmune, Basilea, Bio-Thera, Janssen, Liquidia, Pfizer, Polaryx, Reata, Revance, Rhovac, Sirtex.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arrowhead, Axon, Biontech, Centogene, Codexis, Instadeep, Neurolucent, Postera, Preveceutical, PTC, Redhill, Santhera, Takeda.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aim, Ascentage, Celltrion, Equillium, Inmed, Karyopharm, Medicinova, Urovant.
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