Results 1 to 5 of 13

Eleventh Circuit decision could significantly expand scope of orphan exclusivity

USA - February 1 2022 With the issuance of its mandate on January 28, 2022, in Catalyst Pharmaceuticals, Inc. v. Becerra, the U.S. Court of Appeals for the Eleventh…

Susan M. Cook, Philip Katz, Komal Nigam

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, David M. Fox, Komal A. Karnik, Gary Veron

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, David M. Fox

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, David M. Fox, Jason A Leonard, Gary Veron

FDA publishes final guidance on ANDA/505(b)(2) NDA pathways

USA - May 10 2019 On Thursday, FDA published the final guidance document, “Determining Whether to Submit an ANDA or a 505(b)(2) Application” that contains minor…

Philip Katz