Replimune Group Inc. received another complete response letter (CRL) from the U.S. FDA for immunotherapy vusolimogene oderparepvec to treat advanced melanoma, sending shares plunging by more than 19% on the April 10 PDUFA date.
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Duality, Glenmark, Macrogenics, Modular Medical, Novo Nordisk.
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: 23andMe, Assertio, Ataraxis, Biomérieux, BMS, Cartherics, Cartography, Catalent, Cosette, Daiichi, Deck Bio, Eli Lilly, Garda, Gilead, GE, Imagene, Kymera, Medical Microinstruments, Myndtec, Nxera, Oxford, Paindrainer.
Realta Life Sciences Inc. raised an additional $40 million in the final tranche of its series A investment, bringing the total the company has raised to more than $150 million through mission-driven investors and a family-office model.
Amending his previous two-year-renewal of the standard charter for the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP), Health and Human Services Secretary Robert Kennedy made monitoring adverse vaccine events a primary function of the committee and expanded its liaison membership to include organizations that have challenged vaccine safety.>
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