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EU Updates Guidance On Safety Features For Drugs Under Falsified Medicines Directive

 
• By Vibha Sharma

The EU has issued updated guidance on the Falsified Medicines Directive, which gives drug manufacturers until February 2019 to affix 2D barcodes on their products to allow the identification and authentication of individual packs.

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EU Has Issued Revised Q&As On Safety Features Needed On Drug Packaging • Source: Shutterstock

The European Commission has issued updated guidance to help drug manufacturers comply with new rules on fixing unique identifiers on the packs of almost all prescription medicines, as required under the EU Falsified Medicines Directive. The new rules will apply as of Feb. 9, 2019, although Belgium, Greece and Italy have the option of deferring their implementation application for up to six additional years.

The guidance, issued in the form of a revised question and answer document, contains new information on: some...

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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.

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GLP-1s In Crosshairs As Employers Worry About Health Costs – And Their Own Reliance On Rebates

 
• By Cathy Kelly

Business Group on Health annual employer survey highlights fast-growing Rx costs, led by the GLP-1 drugs, and payer strategies for controlling them. Policy prescriptions are unclear, though, since employers are loath to leave PBMs and nervous about pending changes to Medicare and Medicaid.