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The FDA will maintain its policy on determining when an orphan drug product is entitled to market exclusivity, saying a recent federal court ruling that overruled the agency’s policy applied to just one drug and established no precedent. Read More
Hospira has submitted a BLA for anemia drug Retacrit, a proposed biosimilar to Amgen’s Epogen and Janssen’s Procrit — making it the fourth company to announce submission of a biosimilar application to the FDA. 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
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
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
Manufacturers that combine drugs with either medical devices or cellular or tissue-based products must determine which category the product falls under before filing a marketing application in Japan, the Pharmaceutical and Medical Devices Agency says. Read More