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The European Medicines Agency is recommending halting sales of 700 drugs that were approved based on testing data provided by CRO GVK Biosciences, following an inspection that found the Hyderabad, India, firm manipulated echocardiogram data. Read More
The Supreme Court wasted no time in acting on the precedent it set last month in its Copaxone ruling, sending several patent cases, including one Hatch-Waxman dispute, back to the appellate level just a week later. Read More
The U.S. Supreme Court on Jan. 20 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
GPhA President and CEO Ralph Neas is stepping down in the fall, the trade group said last month. A search for his replacement got underway immediately. 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 House Energy and Commerce Committee’s newly released legislative wish-list for overhauling the FDA and incentivizing new drug development includes few generics-friendly proposals, possibly because the generics industry had little input into the 21st Century Cures initiative that developed the proposals. Read More
The FDA slapped Canadian generics maker Apotex with a warning letter for serious lapses in current good manufacturing practices at its Bangalore, India, finished product plant. Read More
The number of new drug shortages in 2014 remained at 44 for the second year in a row, with the FDA making full use of new tools to prevent shortages that reached a critical mass three years ago at 251. Read More
Nearly half of all serious adverse event reports submitted to the FDA by drugmakers don’t include basic information such as the patient’s age and gender and the event date, a new analysis of adverse event reports shows. Read More
Teva is asking a federal court to bar any generic versions of Copaxone from entering the market until the last of the blockbuster MS drug’s patents expires in September. Read More
Japanese regulators have notified Novartis Pharma K.K., the Japanese arm of the Swiss drug giant, that they are planning to temporarily suspend the firm from doing business in the country. Read More