HeyJaredMichael Shriner
- Indexed articles, last 90 days
- 4
- Latest publication
- Aug 31, 2026
- Outlet visibility, for Mondaq
- Top 500K sites
- Earliest in this view
- Jul 27, 2026
Latest articles
Takeda Files BPCIA Suit Against Polpharma Biologics For Vedolizumab Biosimilar (opens the original)
Read excerpt
On August 26, 2026, Takeda Pharmaceuticals USA, Inc. and Takeda Pharmaceuticals International AG (collectively, “Takeda”) filed a BPCIA complaint in the U.S. District Court for the District of New Jersey against Polpharma Biologics S.A. (“Polpharma”), alleging that Polpharma’s vedolizumab biosimilar, PB016, will infringe six patents related to Takeda’s ENTYVIO (vedolizumab). This is the first BPCIA case involving a vedolizumab biosimilar. Takeda alleges infringement of U.S. Patent Nos. 9,663,579
Takeda Files BPCIA Suit Against Polpharma Biologics For Vedolizumab Biosimilar (opens the original)
Read excerpt
On August 26, 2026, Takeda Pharmaceuticals USA, Inc. and Takeda Pharmaceuticals International AG (collectively, “Takeda”) filed a BPCIA complaint in the U.S. District Court for the District of New Jersey against Polpharma Biologics S.A. (“Polpharma”), alleging that Polpharma’s vedolizumab biosimilar, PB016, will infringe six patents related to Takeda’s ENTYVIO (vedolizumab). This is the first BPCIA case involving a vedolizumab biosimilar. Takeda alleges infringement of U.S. Patent Nos. 9,663,579
FDA Addresses FAQs On Developing Potential Cellular And Gene Therapy Products (opens the original)
Read excerpt
On August 20, 2026, the FDA published guidance intended to provide answers to frequently asked questions about the development of cellular and gene therapy (“CGT”) products to help facilitate the development of safe, effective, and high-quality CGT products. The FDA’s guidance is in response to the Prescription Drug Use Fee Act VII commitment to increase the efficient development of CGT products. The frequently asked questions are grouped into four main categories: (1) submissions and FDA review
Formycon And OneSource Specialty Pharma Partner To Manufacture Biosimilars (opens the original)
Read excerpt
Formycon AG (“Formycon”) announced its partnership with OneSource Specialty Pharma Limited (“One Source”) on July 14, 2026. OneSource, located in Bangalore, India, will complement Formycon’s biosimilar development experience with its biologics manufacturing capabilities. OneSource has an integrated biologics platform that ranges from cell line development to commercial fill-finish and five manufacturing facilities. Currently, Formycon has three biosimilars on the U.S. market (FYB201/ranibizumab,
Publishing over time
Last 90 days. Choose a month to open its work.
Recurring subjects
Named in the text we hold. One piece can cover several.
Audience
Top 500K sites
For Mondaq, the outlet · Measured Aug 1, 2026
Website popularity band, not a count of readers or article views.
About this data
Counts cover the work we have indexed. Tone needs enough text and a confident classification. Excerpts and episode notes are not full articles or transcripts.
Identity or attribution wrong? Suggest a correction.