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Latest From AbbVie Inc.

RSV Vaccine May Be On Market In 2023, CDC’s ACIP Anticipates

Panel expects to review five respiratory syncytial virus vaccines and vote on one or two of them in June 2023 and others four months later. Sanofi presents results of three clinical trials of its monoclonal antibody nirsevimab, which is on track to be the second RSV prophylaxis for infants.

Advisory Committees Vaccines

BioMarin Rolls Up Sleeves To Prepare For Roctavian’s EU Debut

The company plans to start in Germany with an outcomes-based payment model. But while a US FDA nod seems likely, analysts have been more cautious about calling US approval a done deal.

Gene Therapy Market Access

For Second Time This Month, Medtronic Announces Class I FDA Recall Related To HeartWare System Component

Medtronic, Baxter and BD are all facing recalls, with Medtronic finding yet another issue with HeartWare HVAD systems. Separately, the FDA put a Baxter respiratory device recall into Class I, and BD announced a recall on intraosseous devices.

FDA Enforcement

Sarepta’s Exondys 51 Successor On Clinical Hold, But Quick Resolution Expected

The FDA placed a hold on the Phase II study of SRP-5051, which uses the company’s next-generation peptide conjugation technology, but Sarepta thinks it can address safety questions in short order.

Drug Safety Clinical Trials
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  • Other Names / Subsidiaries
    • Luminera
    • Mavupharma
    • Pharmacyclics, Inc.
    • Stemcentrx, Inc.
    • Syndesi Therapeutics SA
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