Lilly's Olumiant Resubmission Includes Safety Data From US FDA's Sentinel Network
Lilly used Reagan-Udall’s IMEDS to tap Sentinel for data on incidence of venous thromboembolism in patients with rheumatoid arthritis.
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Agency is paying “enormous sums” to access postmarket information from payers, Commissioner Gottlieb says, suggesting public-private partnerships to enhance access.
Accelerated approval would help agency monitor gene therapies for durability and off-target effects, US FDA commissioner says.
Investors await news from Lilly on whether it will use repatriated cash for M&A; from Biogen on its Spinraza and gene therapy strategies in light of Novartis' AveXis deal; and from Amgen on pipeline programs and acquisitions as major products face new competition. Immuno-oncology combination updates are anticipated from Roche, plus guidance on how GSK will cope with Advair generics, HIV competition from Gilead and the cost of new drug launches is expected.