HeyJaredHarrison Gunn
- Indexed articles, last 90 days
- 3
- Latest publication
- Sep 23, 2026
- Outlet visibility, for Mondaq
- Top 500K sites
- Earliest in this view
- Jul 9, 2026
Latest articles
Parties Dispute Intent Standard In STELARA® Antitrust Appeal (opens the original)
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As we previously reported, portions of CareFirst’s antitrust claims concerning STELARA® (ustekinumab) survived summary judgment in December 2025. On January 14, 2026, the U.S. District Court for the Eastern District of Virginia reconsidered that decision and granted summary judgment to Johnson & Johnson and Janssen Biotech, Inc. (collectively, “J&J”) on CareFirst’s theory that J&J’s acquisition of four Momenta Pharmaceuticals manufacturing patents violated Section 2 of the Sherman Act. The court
FDA Revises Draft Guidance On Substantial Evidence Of Effectiveness To Clarify Confirmatory Evidence Requirements For A Single Clinical Investigation (opens the original)
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On June 25, 2026, the U.S. Food and Drug Administration (FDA) announced the availability of revised draft guidance titled “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products.” The original draft guidance was issued in December 2019. When finalized, the revised draft guidance will replace the FDA’s 1998 guidance titled “Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products.” The revised draft guidance provides recommendations t
FDA Expands Indication For Vertex’s CASGEVY To Children Aged Two Years And Older (opens the original)
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On July 1, 2026, Vertex Pharmaceuticals announced that the FDA approved an expanded indication for CASGEVY (exagamglogene autotemcel) to treat children aged two years and older with sickle cell disease (SCD) experiencing recurrent vaso-occlusive crises or who have transfusion-dependent beta thalassemia (TDT). The approval makes CASGEVY the first CRISPR-based gene-editing therapy approved for children aged two years and older with SCD or TDT. CASGEVY is a non-viral, ex vivo CRISPR/Cas9 gene-edite
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Top 500K sites
For Mondaq, the outlet · Measured Aug 1, 2026
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