As we previously reported, on January 11, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) moved to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation, and to transfer its case against Amgen, Inc. (“Amgen”) to the Northern District of West
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FDA Approves BMS and J&J CAR-T Cell Therapies for the Earlier Treatment of Multiple Myeloma
On April 4, 2024, Bristol Myers Squibb (“BMS”) and 2seventy bio, Inc. announced that the FDA has approved ABECMA (idecabtagene vicleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of…
Janssen v. Teva: Not an April Fool’s Day Joke for Life Sciences Companies
On April 1, 2024 the Federal Circuit released its opinion in Janssen Pharmaceuticals, Inc. et al v. Teva Pharmaceuticals USA, Inc. et al., affirming the district court’s finding that certain claims were not indefinite and remanding to the district court…
FDA Approves New Indication for AstraZeneca and Daiichi Sankyo’s Cancer Drug ENHERTU
On April 5, the FDA granted accelerated approval to AstraZeneca and Daiichi Sankyo’s ENHERTU (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.…
A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and regulations across pharmaceuticals, biologics,…
REGENXBIO and Sarepta Agree to Stay Litigation Pending Outcome of Sarepta’s IPR Petition
As we previously reported, REGENXBIO Inc. and the Trustees of the University of Pennsylvania filed suit in Delaware in June 2023 against Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC, and Catalent, Inc., alleging infringement of U.S. Patent No. 11,680,274…
USPTO Emphasizes Searches of FDA Databases for Pharmaceutical Patent Applications
In response to Biden Administration goals regarding increasing pharmaceutical competition and lowering drug prices, the USPTO recently released training provided to the USPTO examining corps on utilizing publicly available FDA and NIH databases for prior art searches. The goal of…
Interpretable Algorithms as a Potential Solution to CFPB’s Guidance on AI-driven Credit Denials
Fresenius Kabi and Formycon Reach Settlement Agreement for Ustekinumab Biosimilar Candidate in Europe and Canada
On March 18, 2024, Fresenius Kabi (“Fresenius”) and Formycon announced a settlement agreement with Johnson & Johnson regarding FYB202, a proposed ustekinumab biosimilar to STELARA in Europe and Canada. The terms of the settlement are confidential. According to the press…
FDA Approves First Gene Therapy to Treat Children with Metachromatic Leukodystrophy
On March 18, 2024, the FDA approved Orchard Therapeutics’ LENMELDY, the first approved gene therapy for the treatment of children with metachromatic leukodysrophy (MLD). MLD is a rare, fatal genetic disease affecting approximately one in every 40,000 individuals in the…