On March 1, Eli Lilly was the first to announce U.S. list price reductions of 70% for its most commonly prescribed insulins and an expansion of its Insulin Value Program that caps patient out-of-pocket costs at $35 or less...more
The U.S. Court of Appeals for the Third Circuit is currently hearing arguments from pharmaceutical manufacturers Novo Nordisk, Sanofi and AstraZeneca and the Department of Health and Human Services (HHS) on whether the 340B...more
The Paris Court has ruled against Sanofi in the Depakine case on the class action initiated by an association. According to a parliamentary report dated 11 June 2020, only twenty-one class actions have been brought to court...more
As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district...more
Recently, JHL Biotech co-founders Racho Jordanov and Rose Lin pled guilty and were convicted of conspiring to steal trade secrets related to Genentech’s cystic fibrosis drug Pulmozyme, and cancer drugs Rituxan, Herceptin, and...more
On May 24, 2021, Zydus Cadila launched the world’s first antibody drug conjugate (ADC) biosimilar. The drug is a trastuzumab emtansine biosimilar - using Genentech’s Kadcyla as the reference product - that will be marketed...more
On April 30, 2020, Sanofi received a positive opinion from the European Medicines Agency (EMA)’s Committee for Medical Products for Human Use (CHMP), recommending the granting of marketing authorization for its biosimilar of...more
Litigation Update - On January 30, 2020, class action, consumer protection and pharmaceutical lawyers from around the country will be in federal court in Tampa, Florida to argue before a panel of federal judges whether...more
Some remembrances upon the passing of influential former Fed Chair Paul Volcker, a force in American economic policy for nearly 60 years who led “the Federal Reserve’s brute-force campaign to subdue inflation in the late...more
Over the past few weeks, numerous biologics and biosimilar companies released their quarterly earnings for Q1 2018 and held related earnings calls. Below are some highlights...more
Case Name: Sanofi v. Lupin Atl. Holdings S.A., Civ. No. 15-415-RGA (consol.), 2017 U.S. Dist. LEXIS 174931 (D. Del. Oct. 23, 2017) (Andrews, J.)....more
Case Name: Sanofi v. Watson Labs. Inc., Nos. 875 F.3d 636, Nos. 2016-2722, 2016-2726, 2017 U.S. App. LEXIS 22438 (Fed. Cir. Nov. 9, 2017) (Circuit Judges Prost, Wallach, and Taranto presiding; Opinion by Taranto, J.) (Appeal...more
On January 10, 2018, in In re Lantus Direct Purchaser Antitrust Litig., the District Court for the District of Massachusetts dismissed the antitrust case against Sanofi-Aventis U.S. LLC (“Sanofi”), the manufacturer of Lantus...more
The FDA granted final approval of Sanofi’s 505(b)(2) application for Admelog yesterday. According to the FDA, Admelog is a follow-on product that, for approval, relied in part on FDA’s finding of safety and effectiveness of...more
Case Name: Sanofi v. Lupin Atlantis Holdings SA, Civ. No. 15-415-RGA, 2017 U.S. Dist. LEXIS 10653 (D. Del. Jan. 26, 2017) (Andrews, J.). Drug Product and U.S. Patent: Multaq® (dronedarone tablets); U.S. Patent No....more
2016 was an active year in securities litigation. In the first half of 2016 alone, plaintiffs filed 119 new federal class action securities cases. It was also a busy year for SEC enforcement proceedings, with a record 868...more
Case Name: Sanofi v. Glenmark Pharms. Inc., Civ. No. 14-264-RGA (Consolidated), 2016 U.S. Dist. LEXIS 116950 (D. Del. August 31, 2016) (Andrews, J.) - Drug Product and Patent(s)-in-Suit: Multaq® (dronedarone); U.S....more