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Latest From Teva Pharmaceuticals USA Inc.
Prior Bad Conduct By Pharma Companies Could Be ‘Plus Factor’ In Merger Review
Experts suggest US FTC and DOJ retrospectively assess whether a merger gives companies increased leverage with PBMs and consider how it will impact vulnerable communities. Rutger’s Michael Carrier says there should be a presumption against mergers between two large firms.
Keeping Track: Pediatric Approvals, Seres Starts C Diff Submission, And BMS Pulls Reblozyl sBLA Before Possible CRL
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
US FDA Biosimilar Review Information Requests Should Come Earlier, With Longer Response Times
An FDA consultant and industry representatives recommend streamlining information requests during 351(k) application reviews and giving companies more than two days to respond; Eastern Research Group’s final assessment of the BsUFA II program finds positive views, but industry says more transparency is needed on timelines for delayed inspections.
US FDA Biosimilar Review Information Requests Should Come Earlier, With Longer Response Times
An FDA consultant and industry representatives recommend streamlining information requests during 351(k) application reviews and giving companies more than two days to respond; Eastern Research Group’s final assessment of the BsUFA II program finds positive views, but industry says more transparency is needed on timelines for delayed inspections.
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