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Opana Withdrawal Request Builds On US FDA Actions On Palladone, OxyContin

 
• By Sue Sutter

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.

The US FDA’s decision to seek market withdrawal of Endo Pharmaceuticals Inc.’s Opana ER (oxymorphone extended-release) due to intravenous abuse liability builds upon earlier regulatory actions on two Purdue Pharma LP opioid products and may be the beginning a new level of scrutiny for opioid product formulations with high risk of abuse.

The agency’s 2005 request that Purdue withdraw Palladone (hydromorphone extended-release) due to the risk of dose-dumping in the presence of...

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• By Vibha Sharma

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EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
• By Eliza Slawther and Neena Brizmohun

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Expedited Reviews For China-Originated Drugs Shift Back Home

 
• By Xu Hu

The proportion of China-originated drugs granted expedited reviews in China doubled in the first half of this year, Pharmaprojects data show, surpassing those receiving similar treatment in the US and likely driven by multiple factors.

Sarepta Will Resume US Elevidys Shipments For Ambulatory DMD Patients After FDA Reverses Course

 
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The FDA recommended removal of a voluntary hold on shipments of the gene therapy to younger patients after finding that the death of an 8-year-old boy in Brazil was unrelated to Elevidys. Discussions on safety of DMD treatment for non-ambulatory patients is ongoing.

EU 15% Tariff Deal Still Leaves Questions For Pharma On Possible Grace Period, Generic Exemption

 
• By Jessica Merrill

While the 15% rate is a substantial blow for pharmaceutical firms, the US-EU deal provides a framework for trade agreements with other countries that could see the industry avoiding higher tariffs elsewhere.