Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's and Parkinson’s with Neal Goodwin and Pawel Krysiak of Jaya Bio
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Daily Compliance News: June 23, 2025, The Is Walmart Cool Edition
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Unexpected Paths to IP Law with Dan Young and Colin White
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Compliance Program Effectiveness: Keep it Streamlined and Strategic
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
Earlier this month, a Patent Trial and Appeal Board (“PTAB”) panel denied institution of two petitions that were filed separately by Samsung Bioepis (IPR2025-00176) and Formycon (IPR2025-00233) for inter partes review (“IPR”)...more
On January 29, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entries of preliminary injunction preventing Samsung Bioepis Co., Ltd....more
On January 29, 2025, the CAFC issued opinions affirming the preliminary injunctions issued against biosimilars of Regeneron’s EYLEA® (aflibercept): Samsung Bioepis’s Opuviz™ (aflibercept-yszy) (CAFC Case Nos. 24-1965,...more
On August 30, 2024, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) and Samsung Bioepis Co. Ltd. (“Samsung Bioepis”) settled their BPCIA dispute related to...more
On August 12, 2024, Amgen filed Case No. 1:24-cv-08417 (D.N.J.) against Samsung Bioepis, alleging SB16 (denosumab), its proposed Prolia® / Xgeva® (denosumab) biosimilar, would infringe 34 of Amgen’s patents....more
As we previously reported, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) sued Samsung Bioepis Co. Ltd. (“Samsung”) in January 2024 in the U.S. District Court...more
Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) filed a complaint on January 3, 2024, against Samsung Bioepis Co. Ltd. (“Samsung”) in the U.S. District Court for the...more
On January 3, 2024, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) filed a BPCIA litigation in the District of Delaware (Case No. 1-24-cv-00005 (D. Del.)) against...more
Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint on November 22 against Samsung Bioepis Co., Ltd. (“Bioepis”) in the U.S. District Court for the Northern District of West Virginia, alleging infringement...more
Last week Pfizer filed a lawsuit in a federal court of Australia against respondents Samsung Bioepis, Merck, Sharp & Dohme, Organon, and Arrow, to halt sales of their biosimilar BRENZYS (etanercept). Pfizer alleges that the...more
The New Jersey district court in the Immunex v. Samsung Bioepis BPCIA litigation entered a Final Judgment and Order of Permanent Injunction on November 3, 2021. As we previously reported, the litigation pertains to ETICOVO...more
Yesterday, September 4, 2018, Genentech filed a complaint against Samsung Bioepis in the District of Delaware alleging infringement under the BPCIA of 21 patents based on Bioepis’s filing of an aBLA for SB3, a biosimilar...more
As we previously reported, Janssen and Samsung Bioepis jointly filed a stipulation of voluntary dismissal requesting that the District of New Jersey dismiss with prejudice Janssen’s patent infringement claims against Samsung...more
On May 17, 2017, Janssen sued Samsung Bioepis in the District of New Jersey for patent infringement under the BPCIA based on Samsung Bioepis’s filing of its aBLA for Renflexis® (infliximab-abda), a biosimilar of Remicade®...more
This morning, the district court in Janssen v. Samsung Bioepis, which concerns Samsung Bioepis’ Renflexis® (infliximab-abda) biosimilar product, entered a pretrial scheduling order. The scheduling order calls for, among other...more
On May 17, 2017, Janssen filed a complaint under the BPCIA in the District of New Jersey against Samsung Bioepis Co., Ltd. regarding Renflexis® (infliximab-abda), Samsung Bioepis’s recently approved biosimilar of Remicade®....more