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Opana ER Should Come Off The US Market, FDA Tells Endo

 
• By Sue Sutter

Agency seeks long-acting opioid’s withdrawal due to evidence the reformulated version increased intravenous abuse; FDA’s action, which Endo is weighing, portends a hard-line stance when it comes to opioid risks under new Commissioner Scott Gottlieb.

The US FDA’s request that Endo Pharmaceuticals Inc. withdraw Opana ER (oxymorphone extended-release) due to its intravenous abuse potential suggests the agency will take a tougher stand on currently marketed opioids under the leadership of newly installed Commissioner Scott Gottlieb.

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• By Sue Sutter

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Mysimba Passes EU Safety Probe, But Currax Must Explore Long-Term Heart Risks

 
• By Neena Brizmohun

The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.

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Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
• By Eliza Slawther

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
• By Eliza Slawther

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 
• By Joseph Haas and Nielsen Hobbs

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