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REMS For Qsymia Limits Distribution, But Vivus To Explore Expanding Access

 
• By Cathy Dombrowski

Qsymia will launch through certified mail-order pharmacies, but FDA has asked the sponsor to look for ways to expand into the retail space with pharmacies that can meet requirements for distributing patient risk information and keeping track of prescribers.

Vivus Inc. will distribute its obesity drug Qsymia only through select mail-order pharmacies at launch, but, at FDA’s request, will expand to retail pharmacies as soon as the company can develop a plan to do so.

FDA approved Qsymia, a combination of phentermine and extended-release topiramate and formerly known as Qnexa, July 17 with a Risk...

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

 
• By Mandy Jackson

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

 
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The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

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EU CHMP Opinions And MAA Updates

 
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AI In Clinical Research: Benefits Across The Board, But ‘Nirvana’ Still Out Of Reach

 
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