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Knobbe Martens
Mar 25, 2025
FDA Publishes Case Studies and User Guide for Rare Disease Drug Developers
Written by: Douglas W. Crandell, Ph.D. and Eric Furman, Ph.D. Drug development programs face unique challenges in demonstrating the safety and... Read More
Knobbe Martens
Mar 24, 2025
Two Bills Introduced to Target “Patent Thickets” and “Product Hopping”
Written by: Alistair J. McIntyre and Agnes Juang, Ph.D. On March 17, 2025, a bipartisan group of senators introduced two bills... Read More
Knobbe Martens
Mar 24, 2025
National Institutes of Health (NIH) Announces Plan to Centralize Peer Review Process
Written by: Susan M. Janicki, Ph.D. and Joseph Mallon, Ph.D. On March 6, 2025, the National Institutes of Health (NIH) announced... Read More
District Court Finds the FDA Reasonably De-listed Eli Lilly’s Weight Loss Drug From Drug Shortage List
Written by: Rhett D. Ramsey and Robert J. Hilton, Ph.D. Congress authorized the FDA to determine whether a drug is “in... Read More
Knobbe Martens
Mar 11, 2025
Suspension of the Climate Change Mitigation Pilot Program: What Happens Now?
Written by: Bailey R. Arenberg and Jason J. Jardine Effective January 28, 2025, the new administration suspended the Climate Change Mitigation... Read More
Knobbe Martens
Feb 4, 2025
Renewed Efforts in Congress for Pharmaceutical Patent Reform
Written by:Bailey R. Arenberg & Jason J. Jardine With the recent convocation of the 119th Congress, a change in administration,... Read More