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DoJ and GMPs: A Prosecutor’s Take on Enforcing Product Quality

 
• By Maame Ewusi-Mensah Frimpong

The wave of marketing promotions undertaken by the Department of Justice over the past decade may be abating, but prosecutors are looking at manufacturing violations as fertile new territory for cases. One prosecutor shares her thoughts on how companies can protect themselves.

We do not see our work as a list of statutes to enforce or collection of areas of law in which we practice. Rather, our focus is on the mission of protecting consumers, and our highest priority is to protect consumers where they are most vulnerable—where the harm to consumers is widespread and substantial or where consumers are at greatest risk of harm.

We are very concerned any time it appears that a company is gambling with patient health for monetary gain, and...

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Aurobindo, MSN Fail To Beat US Nuplazid Patent Expiring In August 2038

 
• By Dean Rudge

Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis appears safe from generic competition until well into the next decade, following a favorable infringement and validity decision by a US district court.

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

US FDA’s ‘Good Reputation’ For Science May Mean Loper Bright Not ‘Cataclysmic,’ Attorney Says

 
• By Malcolm Spicer

Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.

Europe’s UPC Issues Landmark Ruling On Second Medical Use Claims

 
• By Neena Brizmohun

The verdict by the Unified Patent Court in the dispute between Sanofi/Regeneron Pharmaceuticals and Amgen explains what companies should look out for when deciding whether infringement has taken place when it comes to second medical use patents.

More from Pink Sheet

Aurobindo, MSN Fail To Beat US Nuplazid Patent Expiring In August 2038

 
• By Dean Rudge

Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis appears safe from generic competition until well into the next decade, following a favorable infringement and validity decision by a US district court.

LDT Final Act? US FDA Will Not Appeal District Court Decision Vacating Final Rule

 
• By Brian Bossetta

The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.

New Pricing Agreements And Greater Transparency: What A US MFN Policy Could Mean For France

 
• By Francesca Bruce

A potential MFN drug pricing policy in the US could also lead to a greater push for collaborative action in the EU, such as joint procurement among the member states, says one European industry expert.