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The FDA finalized guidance on assessing user fees under PDUFA VI — covering fiscal years 2018 through 2022 — describing the new fee structure and the types of fees organizations are responsible for under the act. Read More
The agency noted that Health Canada-implemented ICH guidances take precedence over its existing guidances and said it is working to remove any inconsistencies. Read More
The U.S. Patent Trial and Appeal Board ruled in February 2017 that CRISPR patents granted to the Broad Institute for use in eukaryotic cells would stand. Read More
In the latest tussle over lucrative patents covering the revolutionary gene-editing technology CRISPR-Cas9, an appeals judge for the U.S. Court of Appeals for the Federal Circuit said she would likely side with the Broad Institute. Read More
In what Regeneron CEO Len Schleifer called a “paradigm-shifting agreement,” Sanofi and Regeneron sealed a deal with the pharmacy benefit manager Express Scripts cutting the price of their cholesterol drug Praulent (alirocumab) by up to $10,000 a year in exchange for easier access for Express Scripts patients. Read More
The medication-assisted treatments will be compared to a tentative list of medications commonly used in MAT, such as methadone, Vivitrol and Suboxone. Read More
A Massachusetts judge ruled that Biogen must face a False Claims Act lawsuit brought by former employees alleging the company paid healthcare providers kickbacks to prescribe Biogen’s multiple sclerosis products, including Avonex, Tecfidera and Tysabri. Read More