Search
Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.
News
05 January 2024
An already challenging financing market can seem especially daunting for innovative technologies that seek to go beyond merely treating a disease in order to promote healthy longevity....
News
17 October 2023
The U.S. Food and Drug Administration (FDA) recently issued new revised draft guidance on “Labeling for Biosimilar and Interchangeable Biosimilar Products,” which most notably...
News
03 October 2023
The U.S. Food and Drug Administration (FDA) published new draft guidance on “Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical...
News
26 June 2023
On Friday, the U.S. Food and Drug Administration (FDA) published the draft guidance “Psychedelic Drugs: Considerations for Clinical Investigations,” which outlines the...
News
28 June 2022
Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Considerations for Rescinding Breakthrough Therapy Designation,” which outlines how FDA will...
News
01 October 2021
Recently, the U.S. Food and Drug Administration’s (FDA’s) Office of Orphan Product Development published the four-page final guidance “Interpreting Sameness of Gene...
News
19 August 2021
Earlier this month, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed (2-1) upon rehearing its...
News
27 April 2021
On April 23, U.S. President Biden signed into law two bills meant to lower prescription drug prices by limiting new drug exclusivity awards and promoting biosimilars. The Ensuring...
News
23 February 2021
Companies in the life sciences and health care industry navigated unparalleled challenges in 2020. The pandemic forced the development and adoption of new technologies and innovations...
