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Earlier withdrawals of Purdue’s Palladone and original OxyContin create precedent for request that Endo’s Opana ER come off market due to risk of abuse; former chief counsel sees agency's move as ‘tip of the iceberg’ on opioid safety actions.
US FDA commissioner nominee clears procedural hurdle as agency's opioid policy remains a charged political issue.
‘Dramatic action’ needed to curb opioid epidemic, commissioner-nominee says, including potentially a cross-center approach to evaluating drugs and devices for pain, and new nomenclature for formulations currently labeled as abuse deterrent.
Takeda is continuing apace with smaller targeted alliances despite its big Ariad acquisition, this time linking with a private US venture for the global development of a novel drug for serious pediatric epilepsies, in a move that aligns with the Japanese firm's pursuit of R&D externalization.
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