National Institute of Health (NIH) funding for companies has changed more in the past year than in the previous decade. The Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) authorization lapsed on October 1, 2025, NIH closed its small
Duane Morris Life Sciences Law
Duane Morris Life Sciences Law, published by Duane Morris LLP, focuses on legal issues affecting the life sciences sector. The blog covers topics such as patent eligibility and intellectual property protection for emerging technologies like AI and diagnostics, regulatory compliance in financing and exit strategies, product liability concerns, and health economics related to personalized medicine. It also addresses legal challenges in wearable technology and provides insights on navigating complex intersections of scientific innovation, investment, and legal frameworks within the life sciences industry.
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Latest from Duane Morris Life Sciences Law
When Does Tissue Processing Cross the Regulatory Line and Require Pre-Market Review?
By Frederick R. Ball, Coleen W. Hill and Kelechi AnyatonwuFor developers of human cells, tissues, and cellular and tissue-based products, classification can determine the shape of an entire regulatory strategy and ultimately how to get that product to…
FDA Launches IND Pilot Program
By Frederick R. Ball, Coleen W. Hill and Kelechi AnyatonwuThe U.S. Food and Drug Administration (FDA) recently announced the final design of its much-anticipated Expedited Investigational New Drug Pilot Program. To participate in the program, sponsors and prospective…
U.S. Supreme Court Reverses Federal Circuit, Holding No Induced Infringement Plausibly Pled Based on Skinny Label and Related Statements
By Jiazhong (Jason) Luo, Ph.D. and Frederick R. Ball
Recently, the Supreme Court of the United States unanimously reversed the Federal Circuit in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., holding that Amarin failed to state a claim…
Federal Regulatory Response to New World Screwworm and Implications for the Agricultural and Animal Health Industries
By Driscoll R. Ugarte, Brandon A. Chan, Ph.D., Victoria (Tori) Hawekotte and Taylor Hertzler
The New World screwworm is a parasitic fly whose larvae burrow into the flesh of warm-blooded animals, feeding on healthy tissue and causing myiasis…
FDA Announces FY2026 Grant Funding for Animal and Veterinary Innovation Centers
By Duane Morris
By Driscoll R. Ugarte and Taylor Hertzler
On May 4, 2026, the U.S. Food and Drug Administration’s Center for Veterinary Medicine opened a new round of grant funding for its Animal and Veterinary Innovation Centers program via a notice of…
DOJ Proposes Antitrust Settlement with Data Consultant, Requiring Sweeping Changes to Meat Industry Data-Sharing Practices
By Duane Morris
By Driscoll R. Ugarte, Sean P. McConnell and Taylor Hertzler
On May 7, 2026, the U.S. Department of Justice’s Antitrust Division filed a proposed settlement in the U.S. District Court for the District of Minnesota to resolve claims…
Montana’s Draft Rules for Experimental Treatment Centers Under SB 535 – Key Highlights for Stakeholders
By Duane Morris
By Vicki G. Norton, Ph.D. and Brandon A. Chan, Ph.D.
Montana Senate Bill 535 established a framework for licensed experimental treatment centers to offer patients access to experimental treatments that have completed Phase I clinical trials but have not…
Ambiguity of Measurement Conditions for Relevant Chemical Property Leads to Federal Circuit Affirming Noninfringement of Epoprostenol Patents
By Duane Morris
By Thomas J. Kowalski, Ryan C. Smith, Ph.D. and Brandon A. Chan, Ph.D.
Numerical patent claim limitations can be helpful to both define the metes and bounds of the claimed subject matter to deter potential infringers as well as…
Highlights from the Food & Drug Law Institute’s Annual Conference 2026
By Duane Morris
By Frederick R. Ball and Victoria (Tori) Hawekotte
Attorneys from Duane Morris’ Life Sciences and Medical Technologies Industry Group attended the Food & Drug Law Institute’s Annual Conference, which featured participation from senior leadership at the Food and Drug Administration.…