To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...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
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
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
On July 20, 2017, Merck & Co. announced that the FDA granted tentative approval of its 505(b)(2) application for Lusduna™ Nexvue™ (insulin glargine injection), its follow-on version of Sanofi SA’s Lantus. Merck’s product...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
In In re Sanofi Securities Litigation, No. 15-588-cv, 2016 U.S. App. LEXIS 4107 (2d Cir. Mar. 4, 2016), the United States Court of Appeals for the Second Circuit affirmed the dismissal of class action complaints alleging that...more