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Latest From Legal Issues

Par Alleges 'Shocking' Trade Secret Theft By QuVa Pharma

Par says former employees who founded QuVa used Par's trade secrets to develop a vasopressin product, which FDA has added to its list of ingredients for drug compounding.

Intellectual Property Policy

Dr. Reddy’s Under Fire From German Regulator; Has Risk Of Class Action Suit

Dr. Reddy’s compliance woes hit a new low, with the German regulator stopping supplies to the EU from the firm’s Bachupally unit over significant GMP deviations. Worse still, some foreign investor rights law firms appear to be pressing for a class action suit against the company.

Legal Issues Manufacturing

AbbVie AndroGel Jury Verdict Targets 'Low T' Promotion

In first bellwether trial in testosterone replacement therapy litigation, jury issues $150m verdict against AbbVie for fraudulent misrepresentation of AndroGel.

BioPharmaceutical Policy

Enoxaparin Generic Saga Continues: Momenta's Manufacturing Patent Invalid

Jury verdict comes seven years after Momenta/Sandoz launched generic version of Lovenox; firms sought treble damages from Amphastar for willful infringement of manufacturing process patent.

Generic Drugs Legal Issues

US FDA Gets A New Lawyer: Rebecca Wood Named Chief Counsel

Former Sidley Austin partner brings a wealth of experience in drug product liability litigation and federal preemption. She replaces agency veteran Elizabeth Dickinson, who will stay on as senior deputy to the chief counsel.

FDA Leadership

German Isentress Case Could Mean More Compulsory Licensing In Europe

A German court’s decision to uphold a compulsory license allowing Merck & Co to keep on selling its HIV drug Isentress could pave the way for more compulsory licensing in Europe.

Europe Germany
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