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Article content “We will continue to work toward securing Emergency Use Authorization in the United States for drug substance manufactured at Emergent Bayview as quickly as possible,” J&J said in an email. The FDA did not immediately respond to a Reuters request for comment. The Wall Street Journal, which first reported the news, cited a letter from the FDA saying the agency had no objections with the plant resuming manufacturing. (https://on.wsj.com/3iXSAfg) The facility could make as many as 120 million doses a month at full capacity, but the finished doses might not be available until ...

Reuters 2 minute read A box of Johnson & Johnson's coronavirus disease (COVID-19) vaccines is seen at the Forem vaccination centre in Pamplona, Spain, April 22, 2021. REUTERS/Vincent West/File Photo July 28 (Reuters) - Emergent BioSolutions (EBS.N) said on Wednesday it will resume production of Johnson & Johnson's (JNJ.N) COVID-19 vaccine at its troubled Baltimore facility, where operations were stopped in April after millions of doses were found to be contaminated. The development comes after J&J last week slashed 2021 production target of its single-dose vaccine to between 500 million and ...

Listen to this article WEST LAFAYETTE — The Purdue Research Foundation Office of Technology Commercialization has awarded more than $130,000 to four projects led by researchers in Purdue University’s College of Engineering and its College of Science, and Purdue University Northwest’s College of Engineering and Sciences. The Trask Innovation Fund supports short-term projects that enhance the commercial value of Purdue’s intellectual property. Brooke Beier, vice president of the Office of Technology Commercialization, explained how the Trask Innovation Fund complements acti...

Johnson & Johnson to destroy millions of vaccines spoiled at factory 15 Jun 2021, 05:56 GMT+10 WASHINGTON D.C.: The U.S. Food and Drug Administration said Friday that Johnson & Johnson must destroy millions of doses of its COVID-19 vaccine that were manufactured at a Baltimore factory. At the same time, millions of other doses were cleared for use. While some 10 million doses have been approved for use, an additional 60 million doses must be destroyed, said the FDA. In April, the Emergent BioSolutions plant in Baltimore was ordered to stop manufacturing the Johnson and Johnson vaccine due to ...

Emergent BioSolutions Inc. is promising the Food and Drug Administration a series of fixes in response to an inspection that led to a halt in production at a company facility that had been making Johnson & Johnson’s Covid-19 vaccine. The contract manufacturer said in a letter to the FDA dated April 30 that it would strengthen its biowaste handling processes, put in place new requirements for wearing protective gowns and deliver training to facility personnel, among other steps to ensure the quality of the vaccine, after agency inspectors cited myriad problems in a report earlier that mont...