Reuters USA

US FDA to take steps to help gene therapies get accelerated approval

(Reuters) -The U.S. Food and Drug Administration is moving to optimize the development of gene therapies, including encouraging the use of biomarkers to help get accelerated approval of therapies for serious conditions, an agency official said. Biomarkers, such as pulse and blood pressure, are characteristics of the body that you can measure. The FDA will …

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Moderna expects to price its COVID vaccine at about $130 in the US

By Patrick Wingrove (Reuters) -Moderna Inc expects to price its COVID-19 vaccine at around $130 per dose in the U.S. going forward as purchases move to the private sector from the government, the company’s president Stephen Hoge said in an interview on Monday. “There are different customers negotiating different prices right now, which is why …

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Biden signs bill requiring declassification of COVID origins information

By Patricia Zengerle WASHINGTON (Reuters) -U.S. President Joe Biden on Monday signed a bill that requires declassification of information related to the origins of the coronavirus that causes COVID-19, the White House said. Biden said he shared Congress’ goal of releasing as much information as possible about the origin of COVID-19. “In implementing this legislation, …

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FDA staff says safety issues with Biogen’s ALS drug to not prevent approval

By Bhanvi Satija (Reuters) -The U.S. health regulator’s staff said on Monday safety issues with Biogen Inc’s drug to treat an ultra-rare form of amyotrophic lateral sclerosis or ALS, also known as Lou Gehrig’s disease, should not prevent its accelerated approval. A panel of outside advisers to the U.S. Food and Drug Administration on Wednesday …

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Fox, Dominion pursue pretrial wins in $1.6 billion defamation case

By Jack Queen and Helen Coster WILMINGTON, Delaware (Reuters) – Lawyers for Dominion Voting Systems on Tuesday were asking a Delaware judge to find Fox Corp liable for defamation over airing debunked vote-rigging claims, while Fox lawyers fighting a $1.6 billion lawsuit counter that the network’s 2020 election coverage was constitutionally protected speech. Delaware Superior …

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US Sen Scott pushes for new Fed inspector general, slams Fed over bank regulation

By David Morgan WASHINGTON (Reuters) – Republican U.S. Senator Rick Scott said on Monday he will introduce legislation to create an independent inspector general to oversee the Federal Reserve, as he called the U.S. central bank “unable or unwilling to properly regulate” banks in a letter to Fed Chair Jerome Powell. Scott, a Republican known …

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