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.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aspen Surgical, Baxter, Babybe, Blue Earth Diagnostics, Bodycad, Canon Medical Systems, Cloudbreak, Cohealo, Curtis Mathes, DarwinAI, Emphysys, Exactech, Flirtey, Fluidx, Glassbeam, Gigcapital2, Harpak-Ulma, Insightec, Ixlayer, Lockheed Martin, Median Technologies, Natus Medical, Nucleis Radiopharmaceuticals, Pack Health, Paramit, Premier, Protek Medical Products, Storm ID, Todos Medical, Uphealth, Vault Health, Zebra Medical Vision.
More than a third of the money raised through biopharma financings in 2020 was raised by companies developing either a therapeutic or a vaccine for COVID-19, yet completely wiping away those totals still leaves the year with $76.8 billion, a full 12% more than the next highest year.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Appili, BMS, F-star, Mustang, Obseva, Polypid, Viatris.
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