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Manufacturers of influenza vaccine in the EU must file strain variation applications for next year’s flu season by June 16, the European Medicines Agency says. Read More
Actavis and Pfizer say they have settled all patent litigation over the generic version of painkiller Celebrex, which may clear the way for Actavis to start marketing its version of the drug before the end of the year. Read More
Massachusetts doctors who want to prescribe the painkiller Zohydro will need to complete a risk-assessment and pain management treatment agreement with their patients, under sweeping restrictions announced Tuesday by Gov. Deval Patrick (D). Read More
Pfizer Monday reached an agreement to settle a class action lawsuit alleging that the drugmaker attempted to improperly delay the launch of generics of its epilepsy drug Neurontin. Read More
Israeli drugmaker Teva announced April 17 that it has reached a settlement with Pfizer to hold back marketing generic Celebrex (celecoxib) in the U.S. until December. Read More
U.S. lawmakers are asking the Office of the United States Trade Representative to put Canada back on its priority watch list after the country withdrew a number of patents for drugs sold by American drugmakers. Read More
U.S. Supreme Court Chief Justice John Roberts on April 18 denied Teva’s attempt to recall and stay a lower court’s ruling that invalidated a patent on Copaxone, opening the gate for generic versions of the blockbuster multiple sclerosis drug to reach the market as early as next month. Read More
Pfizer Monday reached an agreement to settle a class action lawsuit, alleging the drugmaker attempted to improperly delay generics of its epilepsy drug Neurontin from reaching the market. Read More
Drugmakers and distributors are asking the FDA to delay strict enforcement of federal track-and-trace requirements, since most companies won’t be able to meet the first deadlines for exchanging transaction data. Read More
Indian Cabinet Secretary Ajit Seth and other top Indian officials today are laying a framework to begin discussions about intellectual property rights with U.S. drugmakers, a number of whom have lost patent protection in India in recent months. Read More