Ever since Teva Pharmaceutical Industries Ltd. sued Eli Lilly and Co. several years ago, claiming Lilly’s migraine drug, Emgality (galcanezumab), infringed its headache treatment patents, the two companies have been on a litigation rollercoaster.
Fosun Pharmaceutical (Group) Co. Ltd. has received the approval from China’s National Medical Products Administration (NMPA) to initiate a clinical trial of FXB-0871 (TEV-56278) for the treatment of locally advanced or metastatic solid tumors.
Biolojic Design Ltd. has earned an additional milestone payment from its collaboration partner, Teva Pharmaceutical Industries Ltd., for TEV‘325 (TEV-56308, formerly BD-9), a multibody targeting IL-13 and thymic stromal lymphopoietin (TSLP) for autoimmune disease
The structurally similar cytokines IL-2 and IL-15, and their shared beta subunit CD122, are keeping developers busy across a range of indications. Though some scientific confusion has plagued the space historically, drug candidates have drawn deals and Wall Street interest aplenty. Amgen Inc., Novartis AG, and Incyte Corp. are among those who’ve made their interest known.
CD122 – shared beta subunit of the IL-15 and IL-2 receptors, two targets for the figurative price of one – has drawn the eyes of many drug developers, among them Anaptysbio Inc., which will roll out phase Ib results in celiac disease during the fourth quarter of this year with ANB-033. The San Diego-based firm intends to weigh the candidate in a second inflammatory disease. A phase Ib study with ANB-033 in eosinophilic esophagitis will begin this quarter.
After passing on one skinny label case a few years ago, the U.S. Supreme Court agreed to delve into the dark hole the Federal Circuit has dug for drug label carveouts that allow generic drugs and biosimilars to come to market even though some indications of the reference drug may still be protected by exclusivities or patents. The high court granted cert Jan. 16 to Hikma Pharmaceuticals v. Amarin Pharma Inc., which revolves around Hikma’s marketing of its generic version of Amarin’s blockbuster drug, Vascepa (icosapent ethyl).
The U.S. FTC is taking a bow after Teva Pharmaceutical Industries Ltd. asked the FDA to remove more than 200 patent listings from the agency’s Orange Book.
Drug companies and organizations challenging the Medicare drug negotiations have yet to convince a U.S. court that the process, mandated by the 2022 Inflation Reduction Act, violates the Constitution. The most recent decisions came this week when the U.S. Court of Appeals for the Second Circuit ruled Aug. 7 against Boehringer Ingelheim GmbH and the Sixth Circuit ruled Aug. 6 against a challenge filed by the Dayton, Ohio, Chamber of Commerce, the U.S. Chamber, and the Ohio and Michigan Chambers.