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FDA outlines rescission of Breakthrough Therapy Designation

USA - June 28 2022 Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Considerations for Rescinding Breakthrough Therapy Designation,”…

Robert Church, Lynn W. Mehler

FDA finalizes guidance on Orphan Drug “sameness” of gene therapies

USA - October 1 2021 Recently, the U.S. Food and Drug Administration’s (FDA’s) Office of Orphan Product Development published the four-page final guidance “Interpreting…

Jason F. Conaty, George A. O'Brien, Komal A. Karnik, Gary Veron

Federal Circuit affirms GSK labeling carve-out ruling in favor of innovator

USA - August 19 2021 Earlier this month, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC)…

Jason F. Conaty, Susan M. Cook, Philip Katz, Simon Roberts

Biden signs bill limiting new drug exclusivity awards to innovations in active moiety

USA - April 27 2021 On April 23, U.S. President Biden signed into law two bills meant to lower prescription drug prices by limiting new drug exclusivity awards and…

Jason F. Conaty, George A. O'Brien

New Orange & Purple Book laws increase transparency of patent information for drugs, biologics

USA - January 20 2021 On January 5, 2021, President Trump signed into law H.R. 1503, the "Orange Book Transparency Act of 2020," which amends provisions governing the types…

Jason F. Conaty, George A. O'Brien, Jason A Leonard, Gary Veron