Par Pharmaceutical filed a civil complaint against QuVa Pharma saying the company’s two founders poached key employees and stole trade secrets. Source: Drug Industry Daily

Coherus BioSciences filed a petition with the PTO for an inter partes review of a patent on production methods for Amgen’s Enbrel (etanercept), saying the claims are obvious and unpatentable.…

Two compounders forfeited their exemptions as compounding pharmacies from certain FDA rules because they made products that were not formulated in response to prescriptions for individual patients, the agency said.…

In anticipation of the passage of PDUFA VI, the FDA called on drug companies to notify agency officials of any PDUFA eligible products and Orange Book changes involving their products…

More than 120 questions and answers were added to the European Medicines Agency’s FAQs on the launch of the new EudraVigilance reporting system, set to go live Nov. 22. Source:…

German health officials called for a ban on imports to the European Union from a plant operated by Dr. Reddy’s Laboratories in India, following inspections finding poor quality controls, dirty…

Mylan disclosed it is part of the Justice Department’s probe into opioid marketing despite its minimal footprint in the opioid business. Source: Drug Industry Daily

Drugmakers need to provide adequate details — and include narratives — in describing manufacturing processes in their applications, but can leave out elements such as machinery serial numbers and general…

China’s high court called for severe criminal punishments for deliberately falsifying drug clinical trial reports and other related documents, issuing a judicial interpretation that takes effect Sept. 1. Source: Drug…

View the entire issue. Source: Drug Industry Daily