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
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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…
Biden Administration Proposes Biosimilar Substitution Without Interchangeability
The Biden Administration recently released a 2025 Budget Proposal which includes permitting biosimilar substitution without the Food and Drug Administration’s (“FDA”) separate determination of interchangeability. Specifically, the U.S. Department of Health & Human Services (HHS)’s 2025 proposed budget includes a…
2023-2024 Key Trends and Updates: Securities Litigation Against Life Sciences Companies Webinar
In this webinar, Caroline Bullerjahn, Tucker DeVoe, and Justin Ward from Goodwin, and Frank Schneider from Cornerstone Research will discuss key updates and recent trends concerning securities class actions filed against publicly traded pharmaceutical, biotechnology, medical device and…
Women’s History Month Spotlight: Emmanuelle Charpentier and Jennifer Doudna
In honor of Women’s History Month, Big Molecule Watch recognizes Emmanuelle Charpentier and Jennifer Doudna, who won the Nobel Prize for a method for genome editing, commonly called CRISPR or “molecular scissors”. By sharing the 2020 Nobel Prize in Chemistry, Charpentier…
Celltrion Announces Commercial Availability of ZYMFENTRA™ (infliximab-dyyb)
Celltrion USA announced on March 18, 2024, the availability of ZYMFENTRA (infliximab-dyyb), a subcutaneous (SC) formulation of infliximab. ZYMFENTRA, approved by the FDA in October 2023, is the first FDA-approved SC infliximab for the treatment of moderately to severely active…
Celltrion Submits BLA for Omalizumab Biosimilar
Last week, Celltrion USA announced it had submitted a BLA for CT-P39, a biosimilar to XOLAIR (omalizumab). Phase 3 studies demonstrated that in patients with chronic spontaneous urticaria, CT-P39 and reference product XOLAIR (omalizumab) had comparable efficacy and safety. XOLAIR…
Chamber of Commerce Sues CFPB To Eliminate or Enjoin $8 Late Fee Cap
Last week, the U.S. Chamber of Commerce (Chamber) joined five other trade associations to sue the Consumer Financial Protection Bureau (CFPB) and its director Rohit Chopra in Texas Federal District Court, seeking a court order declaring a recent CFPB rule…