FDA Approvals, In Brief
Agency clears Amylin’s metreleptin, expands the use of Vertex’s Kalydeco and approves a novel formulation of indomethacin from Iroko, and Pfizer’s Prevnar 13 moves closer to getting a CDC recommendation to match its FDA approval for use in older adults.
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AstraZeneca will acquire all of Bristol’s interests in their current diabetes alliance. In doing so, AZ believes its geographic reach and scale in assets and capabilities position it to succeed, while Bristol retreats from diabetes to focus on specialty biologics, notably its PD-1 franchise.
The Dec. 11 Endocrinologic and Metabolic Drugs Advisory Committee also will consider whether a proposed Risk Evaluation and Mitigation Strategy would address the possible risk for lymphoma and immunogenicity with Bristol-Myers Squibb/AstraZeneca’s drug.
Pfizer and Moderna’s ‘endemic’ COVID vaccine market scenarios anticipate much higher booster rates than have been achieved so far, but performance for 2023 may be aided by the Biden Administration campaign to increase shots this winter.