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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 FDA has issued an import alert for an Australian manufacturing plant, barring it from shipping Eli Lilly’s erectile dysfunction drug Cialis into the U.S. Read More
Indian companies that export active pharmaceutical ingredients to the EU can use six months of long-term stability data to show conformity with good manufacturing practices, rather than the previously required 12 months of data. Read More
From now on, all NDAs will undergo a risk assessment by a team of FDA reviewers that will follow the drug from preapproval through manufacturing and into any eventual generic forms in an effort to ensure quality throughout a product’s lifecycle. 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
In a preview of how the FDA’s Office of Pharmaceutical Quality will speed approval of generic drugs, the office is rolling out a framework for ANDA filers to respond to minor agency queries involving chemistry, manufacturing and control issues early in the review cycle. 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