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GenScript | June 03, 2020
GenScript Biotech Corp., the world's leading research reagent provider, announced today that the company has filed for Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) to market its cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit. This is the first test submitted for regulatory approval that specifically detects neutralizing antibodies to SARS-CoV-2, the virus that causes COV-19, without the use of live virus. Current serological antibody tests...
FUJIFILM Diosynth Biotechnologies | July 28, 2020
FUJIFILM Diosynth Biotechnologies, a world leading contract development and manufacturing organization (CDMO) for biologics, viral vaccines and gene therapies, announced today that its College Station, Texas, site will support COVID-19 vaccine candidate manufacturing, as part of Operation Warp Speed, a U.S. government program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 to the U.S. population.The Biomedical Advanced Research and Development Auth...
Acorda Therapeutics, Inc. | October 17, 2022
Acorda Therapeutics, Inc. announced that a three-judge arbitration panel has issued a final decision in a dispute with Alkermes PLC regarding licensing royalties relating to AMPYRA. Acorda was awarded $15 million plus prejudgment interest of $1.5 million from Alkermes. In addition, as a result of the panel’s ruling, Acorda will no longer have to pay Alkermes any royalties on net sales for license and supply of AMPYRA, and Acorda is now free to use alternative sources for supply of AMPYRA, ...
Cilta-cel | November 01, 2021
Legend Biotech Corporation (Legend Biotech), a global, clinical-stage biotechnology company developing and manufacturing novel therapies, today announced that the U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act (PDUFA) target date for ciltacabtagene autoleucel (cilta-cel) to February 28, 2022. Cilta-cel is a BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy being investigated for the treatment of adults with relapsed and/or refractory multiple myelo...
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