topics fda-approval 
LexBlog IP
JUNE 30, 2023
As we previously reported , the FDA first approved CYLTEZO in 2017, and in 2021 approved its supplemental Biologics License Application as the first and, at present, still only, HUMIRA® (adalimumab) biosimilar to receive interchangeable status. Stay tuned to Big Molecule Watch for continued updates on this topic.
LexBlog IP
APRIL 29, 2022
This week Patrizia Cavazzoni (Director, CDER), Peter Marks (Director, CBER), and Jeffrey Shuren (Director, CDRH) of the FDA testified before the committee on Health Education, Labor and Pensions of the U.S. The testimony spanned many topics, but notably the FDA discussed the progress of biosimilar approvals, including its impact on cost.
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Velocity of Content
APRIL 4, 2023
For example, a query for “rare disease drug approval” would include results for the Orphan Drug Act from the FDA. Google recognizes that “drug approval” relates to “government regulations.” This is where functionality beyond linking key terms evolves into topic-linking (or topic co-occurrence).
43(B)log
AUGUST 9, 2021
5, 2021) Scilex sells an FDA-approved, prescription-strength topical analgesic self-adhesive patch, ZTlido (lidocaine), which is allegedly often prescribed off-label, including for general neuropathic pain (e.g., FDA-approved.’ ” That was more than merely putting a product on the market. Sanofi-Aventis U.S.
43(B)log
MARCH 25, 2024
Under Central Hudson , the FDA lacked even “a shred of evidence. showing that the graphic warnings will ‘directly advance’ [FDA’s] interest in reducing the number of Americans who smoke.” What about the argument that the images might be subject to several different interpretations, and the FDA didn’t test for consumer takeaway? “[W]hen
Fish & Richardson Trademark & Copyright Thoughts
DECEMBER 2, 2020
For more information about any topic herein, please see our October 20, 2020 webinar, “ IP and Cannabis: The Current Landscape ,” or contact your Fish attorney. FDA Regulation. However, the bill did not eliminate the Food and Drug Administration’s (FDA) purview over products containing hemp, nor did it remove cannabis with over 0.3%
Patently-O
SEPTEMBER 26, 2022
Topics: Enablement / Written Description (All three are biotech / pharma): 3 Cases; Infringement (FDA Labeling): 1 Case; Anticipation (On Sale Bar): 1 Case; Double Patenting (Still the law?): This case delves deeply into the patent-FDA overlap and involves an increasingly common situation “skinny label” situation.
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