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.
LONDON – Efficacy data for Russia’s Sputnik V COVID-19 vaccine held steady at 91.4% in the second interim analysis, conducted after 39 confirmed cases of COVID-19 infection in 18,794 volunteers, seven days after they received the second dose.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA lists entities recognized under ASCA program.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apyx Medical, Braid Health, Cardiawave, Cepheid, Fluidigm, Neuronetics, Zymo Research.
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