We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
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 equipment, and other shortcomings. Read More
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 GMPs, according to the European Medicines Agency. Read More