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By Leroy Leo and Sriparna Roy (Reuters) -A panel of advisers to the U.S. Food and Drug Administration, wary of the safety of Intercept Pharmaceuticals’ oral drug for a type of fatty liver disease, recommended on Friday holding off on an accelerated approval of the medicine. The panel of outside experts voted 15-to-1 against the approval for obeticholic acid (OCA) based on surrogate biomarker data suggesting it was likely to benefit patients with NASH (non-alcoholic steatohepatitis) and fibrosis, or scarring, of the liver. The panel by a wide 12-to-2 margin voted that the benefits of Intercept’s drug did not outweigh the risks in NASH patients with fibrosis based on current data. Two members abstained. Responding to the FDA decision Intercept CEO Jerry Durso said in a statement, “We are disappointed in the outcome of today’s meeting.” “We continue to disagree with the FDA on certain characterizations of OCA’s efficacy and safety in pre-cirrhotic

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By Mike Stone WASHINGTON (Reuters) – The U.S. Department of State said on Thursday it wants to update internal processes for the tens of billions worth of foreign military sales it oversees each year to speed up approvals “for an age of heightened strategic competition.” The move comes as the war in Ukraine has shown the process of getting weapons in the hands of American allies is too slow, to counter potential threats from Russia and China. “The time has come to reassess and adapt security cooperation to meet new and emerging challenges” the State Department said in a fact sheet, adding that competition with China and Russia’s war in Ukraine were factors that led to the 10-point plan to re-tool the department’s oversight of foreign military sales. The plan, which followed an internal review at the State Department, involves “anticipatory policy decisions” for allies’ potential future purchases to begin the decision proce

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By Daniel Trotta (Reuters) – The writers’ group PEN America, authors and parents on Wednesday sued a Florida school district over its book bans, alleging educators violated the First Amendment right to free speech and their own policies in removing titles from school libraries. The Escambia County School District and School Board have targeted books dealing with race and LGBTQ issues for removal, depriving students of access to a wide range of viewpoints, according to the lawsuit filed in U.S. District Court for the Northern District of Florida. A spokesperson for the school district said officials were unable to comment on pending legislation. Book bans have been on the rise across the United States, PEN says, affecting 874 titles in the first half of the 2022-23 school year. The bans are most prevalent in Florida, Texas, Missouri, Utah and South Carolina and overwhelmingly target stories by and about minorities and LGBTQ people, PEN says. The Escambia County lawsuit s

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