An alliance of pharmaceutical regulators has voiced concerns about European Commission draft guidelines relaxing some GMP requirements for advanced therapy medicinal products. Source: Drug Industry Daily
Two groups of senators have launched investigations into orphan drugs to examine whether drugmakers are misusing the designation and overcharging for treatments. Source: Drug Industry Daily
The FTC wants a federal court to dismiss a complaint from Watson and Allergan over the agency’s authority to pursue federal lawsuits alleging prior misconduct. Source: Drug Industry Daily
Twenty states have joined an antitrust lawsuit accusing six generics makers of colluding to fix the price of generic versions of antibiotic doxycycline hyclate and the diabetes drug glyburide. Source:…
The UK’s antitrust regulator alleges that Actavis and Concordia entered a pay-for-delay agreement to block the market entry of generic versions of hydrocortisone tablets and fix prices. Source: Drug Industry…
Regulations on off-label use are not harmonized across the European Union — only 10 out of 21 surveyed member states have specific policies, according to an European Commission report. Source:…
The GAO said that a lack of clarity on the role of FDA draft guidances on antibiotic drug development creates uncertainty for drug sponsors. Source: Drug Industry Daily
After almost three years of negotiations, the U.S. and the European Union have agreed to recognize each other’s drug GMP inspections. Source: Drug Industry Daily
The FDA officially unveiled its recommendations for the second generation of user fee agreements covering generics and biosimilars, with commitments to eight-month reviews of priority generics. Source: Drug Industry Daily
A U.S. district judge has dismissed a lawsuit alleging Amgen withheld manufacturing information from Genentech on an Avastin biosimilar. Source: Drug Industry Daily