Keeping Track: Ticovac Is Latest Win For Pfizer’s Vaccine Business; Doors Open For BMS And GSK PD-1 Inhibitors
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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Oncologic Drugs Advisory Committee asked to weigh in on adequacy of GSK’s proposal for two single-arm trials to support accelerated approval in a curative setting, as well as the potential novel use of clinical complete response as an approval endpoint.
Advisory Committee on Immunization Practices unanimously supports recommendations for Pfizer tick-borne encephalitis vaccine and pediatric use of Emergent’s cholera vaccine in travelers at risk of exposure.
Boehringer Ingelheim and Eli Lilly have gained a US approval for their SGLT2 inhibitor empagliflozin in heart failure with reduced ejection fraction, which could be extended further in coming months to other types of heart failure, adding to the products competing in this previously neglected therapeutic area.