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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
An FDA advisory committee may have given its unanimous approval for a biosimilar application this month, but industry and patient groups contend the regulatory pathway still has many potholes and unanswered questions. Read More
Unauthorized knock-offs of Gilead’s pricey blockbuster hepatitis C therapy, Sovaldi, may soon hit the market in India after the government refused to grant it patent protection. Read More
Mylan and Abbott have submitted proposed commitments to the European Commission’s competition oversight body to allay anti-competitive concerns over a proposed merger that would reincorporate Mylan in the Netherlands. Read More
Actavis must keep its Alzheimer’s drug Namenda on the market for now, but a recent agreement with the New York Attorney General will let the company avoid notifying more than half a million people of that fact. Read More
A federal appeals court is expected to rule next month in a dispute over Actavis’ plan to pull an older formulation of its blockbuster Alzheimer’s drug Namenda from the market and replace it with a newer version. Read More