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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.
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.
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.
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.
- Contract Research, Toxicology Testing-CRO
- Drug Delivery
- Drug Discovery Tools
- Synthesis Technologies, Production Processes
- Other Names / Subsidiaries
- BliNK Biomedical SAS
- Crucell Sweden AB
- Iomai Corporation
- Intercell USA, Inc.
- Intercell AG, Vivalis
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