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Par Pharmaceutical filed a civil complaint against QuVa Pharma saying the company’s two founders poached key employees and stole trade secrets. Read More
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. Read More
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. Read More
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 by the end of August. Read More
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. Read More