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Astellas Pharma has settled a class action lawsuit that accuses the brandmaker of filing a frivolous citizen petition and subsequent lawsuit solely to delay generic competition to its transplant drug Prograf. Read More
Baxter plans to roll out two of its Phoxillum solutions for continuous renal replacement therapy in the second quarter of this year, following FDA approval earlier this month. Read More
Indian officials are accusing FDA investigators of inspecting drug manufacturers in the country without Indian inspectors present, violating an agreement between the two countries that calls for Indian regulators to tag along on FDA drug manufacturing inspections as observers. Read More
GPhA President and CEO Ralph Neas is stepping down in the fall, the trade group said Tuesday. A search for his replacement will begin immediately, the group added. Read More
Colorado lawmakers have introduced a biosimilar substitution bill that closely mirrors at least one aspect of compromise language unveiled by industry leaders last month — elimination of prescriber notification in favor of entering a switch into an electronic database. Read More
The U.S. Supreme Court Tuesday upheld Teva Pharmaceuticals’ patent on its multiple sclerosis drug Copaxone, overturning an appeals court ruling and preventing Sandoz from launching a generic of the drug. Read More
The European Medicines Agency has extended its pilot program for coordinating international generic drug applications. Under the pilot, drugmakers can make joint submissions through the EU’s centralized procedure and the regulatory authorities of Australia, Canada, Taiwan and Switzerland. Read More
The European Medicines Agency on Monday approved Novartis’ Cosentyx as the first front-line biologic for moderate-to-severe plaque psoriasis. Read More
The FDA has upgraded its rating on Fresenius’ APP Pharmaceuticals New York plant, clearing the facility, which had been troubled by pest problems, to produce new drugs for Fresenius’ Kabi arm. Read More
The UK’s health cost-benefit watchdog is recommending coverage of Janssen’s drug Olysio as a treatment option for people with both genotype 1 and genotype 4 hepatitis C. Read More