The U.S. Supreme Court has paved the way for Pfizer’s Hospira to develop a generic version of a Merck unit’s skin infection therapy after denying an appeal to uphold several…

European regulators are proposing a series of indirect methods for driving down prescription drug costs without stepping outside the science-focused parameters of their roles. Source: Generic Line

Industry groups are worried that a section of the proposed FDA and NIH Workforce Authorities Modernization Act would exempt biologics from adhering to U.S. Pharmacopeial standards for quality. Source: Generic…

Democrats and Republicans of the House Oversight Committee took executives of Valeant Pharmaceuticals and Turing Pharmaceuticals to task Feb. 4 over what members called a strategy of buying old drugs…

CDER is tightening up its protocols for companies submitting data about active pharmaceutical ingredients used in generic drugs. Source: Generic Line

European officials are pushing for greater synchronicity between the U.S. and EU regulators on generic approval processes as part of broader trade negotiations. Source: Generic Line

House members are growing impatient with the FDA over a lack of guidance on biosimilars, with several venting their frustrations during a hearing last month. Source: Generic Line

An FDA advisory committee gave Celltrion’s biosimilar candidate for Remicade a strong show of support Feb. 9, backing its approval for six different indications. Source: Generic Line

In a case with broad implications for medical patent litigation, the U.S. Supreme Court showed little enthusiasm for lowering a strict appellate standard for enhanced damages during oral arguments Feb.…

Pay-for-delay deals don’t have to be in cash form for them to be at risk of an antitrust suit, according to a recent federal appellate panel ruling. Source: Generic Line