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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. Read More
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. Read More
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. Read More
Over four years after adopting an ICH guideline on manufacturing processes, the FDA has responded to industry questions on justifying starting materials for chemical entity drug substances. Read More