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Latest From Valneva SE

Keeping Track: Pfizer And J&J’s Dueling Myeloma Bispecifics; Regeneron And Ipsen Nab Priority Vouchers

Shared REMS, diverse confirmatory trials and manufacturing delays are among the highlights in the latest US FDA drug approval news from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Approvals

Finance Watch: Novartis Sets October Separation Date For Sandoz Spin-Off

Novartis revealed detailed terms and a 4 October spin-off date for Sandoz’s standalone debut. Also, MIRA launched a small IPO, but two firms plan to go public in SPAC mergers. Also, Mirati’s $345m offering leads follow-ons offerings and Sangon Biotech raised $290m in venture capital.

Financing Growth

US FDA Frustrates Valneva With Chikungunya Vaccine Decision Delay

Valneva is sticking by its forecast of getting US approval, and getting hold of a lucrative priority review voucher before the end of the year, despite the Food and Drug Administration needing more time to evaluate the French vaccine specialist’s single shot for chikungunya.

Vaccines FDA

Bavarian Nordic Gets Chikungunya Vaccine Boost

Bavarian Nordic is planning regulatory submissions on both sides of the Atlantic next year for its vaccine against chikungunya virus, CHIKV VLP, after it demonstrated protection from the mosquito-borne disease in a second Phase III study.

Vaccines Clinical Trials
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Company Information

  • Industry
  • Contract Research, Toxicology Testing-CRO
  • Pharmaceuticals
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  • Biotechnology
    • Drug Discovery Tools
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  • Other Names / Subsidiaries
    • BliNK Biomedical SAS
    • Crucell Sweden AB
    • Iomai Corporation
    • Intercell USA, Inc.
    • Intercell AG, Vivalis
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