This article was originally published in RAJ Devices
European environment committee reaffirms tough stance on Reach
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Janet Woodcock’s 2019 prediction that record ANDA approval volumes would not continue is confirmed with the FY 2020 approval total down 21% from the previous year.
Deal snapshot: Resolving a loose end from its 2014 buyout of Auxilium, Endo acquires all rights to Xiaflex, along with approved cellulite therapy Qwo.
One pilot target domestic manufacturers of finished drugs and another foreign manufacturers of APIs. As an incentive to participate, companies assigned high scores will be accorded regulatory flexibility. Also, participants that disclose facility ratings could “benefit from a competitive advantage.”