Latest From Indivior PLC
Institute for Clinical and Economic Review's cost effectiveness reports usually don't change much following input from drug sponsors, researchers at Tufts conclude.
Pink Sheet Podcast: The Upcoming US FDA Commissioner Confirmation Hearing, Sublocade Loses Orphan Designation, Project Orbis Politics
In first-of-its-kind decision, agency concludes it relied on unreasonable assumptions regarding total market size, and failed to consider information about other dosage formulations, in granting designation for buprenorphine under the cost recovery provision; however, the FDA reaffirms that scope of Sublocade’s three-year exclusivity will keep Braeburn’s Brixadi off the market for another year.
US FDA's focus on areas such as REMS abuse may have prompted certain brand sponsors to shift their focus to the commercial space to keep generic competition off the market, former commissioner Scott Gottlieb tells the Association for Accessible Medicines.
- Drug Delivery
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- Reckitt Benckiser Pharmaceuticals Inc.
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Mark Crossley, CFO
Ponni Subbiah, MD, CMO
Christian Heidbreder, PhD, CSO
Richard Simkin, Chief Commercial Officer
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