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A federal court has ruled that any payment from a brand drugmaker to settle a patent infringement case that results in delay of a competitive generic product is enough to support a pay-for-delay claim, potentially lowering the bar for such lawsuits. Read More
Australian authorities have suspended a biosimilars naming initiative, pending review, in the wake of a recent World Health Organization proposal on how biosimilars should be named. Read More
The FDA has given a Teva subsidiary the first greenlight for a generic Nexium in a snub to Ranbaxy, which is suing the agency after having its ANDA first-filer status on the therapy revoked over GMP violations at its India plants. Read More
Astellas Pharma will pay $98 million to settle 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
Gilead has expanded its licensing agreements with eight India-based generic drugmakers to market cheaper copies of its pricey blockbuster hepatitis C therapy Sovaldi in 91 developing countries. Read More
The White House released a joint statement by President Barack Obama and Indian Prime Minister Narenda Modi pledging to negotiate a harmonized approach to intellectual property protections and establish standard definitions for what is patentable. Read More
As negotiators continue to shape the Trans-Pacific Partnership trade deal, the length of patent protection for biologics remains a sticking point, with the U.S. continuing to push for 12 years of protection before a biologic drug can be copied. Read More
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