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The European Medicines Agency is urging manufacturers of biosimilar insulin-containing products to demonstrate similar pharmacokinetic and pharmacodynamic profiles as the gold standard in proving efficacy similarity to their reference products. Read More
The European Medicines Agency is recommending that clinical trial sponsors evaluate local tolerance of medicinal products at contact sites on the body as part of a trial’s general toxicity studies. Read More
With generic competition on the horizon, Sanofi and Eli Lilly are collaborating to turn the popular erectile dysfunction drug Cialis into an OTC product. Read More
Drugmakers should evaluate potential names for new drugs and weed out candidates that include elements such as medical abbreviations, inactive ingredients and partial lists of active ingredients, the FDA says. Read More
Novartis wants the FDA to back off plans that would require drugmakers to include details of clinical trials data in labeling for drugs brought to market under accelerated approval pathways. Read More
The FDA is moving to withdraw ANDAs for four generic versions of the laxative MiraLAX, nearly six years after the agency issued a notice of opportunity for a hearing (NOOH) threatening to take away the marketing clearance because the reference product had turned OTC while the generics remained prescription-based. Read More
Chicago-based Durata Therapeutics won FDA approval for Dalvance, an antibacterial for skin infections that is the first drug approved under the Qualified Infections Disease Product designation, the agency said Friday. Read More