Purdue Pharma, tax cases headline December argument session

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The Supreme Court will hear oral argument on Dec. 4 in the challenge to the legality of the bankruptcy plan for Purdue Pharma, the manufacturer of the highly addictive opioid painkiller OxyContin. The argument in the Purdue Pharma case is one of eight cases scheduled for seven hours of oral argument in the court’s December argument calendar, which was released on Thursday morning.

The justices had indicated in August that the Purdue Pharma case would be slated for argument … Read the rest

Justices put Purdue Pharma bankruptcy plan on hold

Justices put Purdue Pharma bankruptcy plan on hold

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The Supreme Court on Thursday put a bankruptcy plan for Purdue Pharma, the manufacturer of the highly addictive opioid painkiller OxyContin, on hold while it reviews a challenge to the legality of the plan, which would shield the Sackler family, the owners of the drug company, from lawsuits. In the brief order the justices agreed to hear oral arguments this December in the Biden administration’s appeal of a lower-court ruling approving the plan. There were no recorded dissents.

U.S. … Read the rest

EU Pharma Legislation Review Series: National MA Procedures Including the Mutual Recognition Procedure and Decentralized Procedure

The European Commission (the “Commission”) wants to “avoid unnecessary administrative and financial burdens for applicants and competent authorities.”  As such, the Commission’s proposal for a revised Directive on the Union Code Relating to Medicinal Products for Human Use (the “Directive”) retains the Decentralized Procedure (“DCP”) and Mutual Recognition Procedure (“MRP”).  Chapter III of the Directive sets out the new procedures for national marketing authorizations (“MAs”).  This includes a purely national MA procedure granted in a single Member State … Read the rest