Pfizer’s Lyrica: DEA Proposes Schedule V Designation, Comments Due June 13

The pregabalin launch is at least a month away following the Drug Enforcement Administration’s proposed rule on controlled substance scheduling for the neuropathic pain agent. Lyrica has a “low potential for abuse” relative to Schedule IV substances, DEA says.

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

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Brazil Pilots Digital Drug Pack Inserts

 

A new pilot aims to take Brazil closer to ‘digital transformation.’

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Opuni Appointed Acting CEO Of Ghana’s FDA As Darko Leaves To Lead African Medicines Agency

 

Kwabena Frimpong-Manso Opuni has been appointed as the new acting CEO of the Ghana Food and Drugs Authority, succeeding Delese Darko, who is now head of the Africa’s pan-continental medicines agency.

UK HRA Working On ‘Trusted’ Path Forward To Support Simplified Informed Consent

 
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The Health Research Authority is working on a streamlined model for informed consent that maintains people’s trust.

EU Ups Ante On Stockpiling For Crises

 

The European Commission has published two new strategies on stockpiling that will improve the availability of critical medicines in times of crisis and reduce the EU’s dependance on suppliers outside the bloc.