Teva Launches First-Ever CREATES Act Suit
Seeks Help With Fabry Disease Generic Development
Amicus should to be forced to sell samples of Galafold (migalastat) for bioequivalence and other testing, Teva argues in what appears to be the initial case brought under the 2019 law intended to smooth the development of ANDAs.
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US FDA says COVID disruptions may be having an impact; complete response letters have also dropped significantly.
US President Joe Biden has signed an executive order asking the FTC to ban so-called “pay-for-delay” reverse-payment settlements. According to the order, this could help curb high prices that are in part the result of lack of competition among drug manufacturers. However, talking exclusively to Generics Bulletin, AAM senior vice president Jeff Francer insists on a balance, explaining that such settlements result in earlier access to biosimilars and generics.
The policies have long been Democratic priorities, but of the three, the order’s implicit support for march-in rights might lead to the biggest change.