Category Archives: FDA

Things to be Thankful for in IP Wonderland

Apart from the carnage wrought by the ever-expanding scope of s. 101 rejections and the tightening of the written description requirement, there were still a number of events/trends in 2017 to applaud or at least to note as “worthwhile.” I … Continue reading

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Why Did the Chicken Cross the Road? To Get New Genes!

Jay Cormier has a new post on the FDA Law Blog called “Tastes Like Chicken: Second ‘BioPharm’ Animal Approved to Produce Biological to Treat Orphan Disease Includes 6th Rare Pediatric Disease Priority Review Voucher.” He writes: On December 8, 2015, … Continue reading

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FDA Publishes “Purple Book” for Biologicals/Biosimilars

In a major move to get organized for the oncoming wave of biosimilar applications, the FDA has published a “Purple Book” listing licensed (e.g., approved) biologicals and licensed interchangeable biosimilars. Rather than summarize the contents table of the book, linked … Continue reading

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FDA Accepts First Biosimilar Application for Review

In an important step forward for the introduction of “generic biological,” the FDA announced that it has accepted Sandoz’s application to market a generic version of Amgen’s Neupogen®, which stimulates white blood cell production. As you may recall, about two years … Continue reading

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