Tag Archives: Regulatory Affairs Professionals Society

Novartis gets FDA nod for breakthrough leukemia treatment Kymriah; with a cost of $450,000, who’s going to get it?

The News: Novartis AG (Basel CHE) has obtained approval from the US Food and Drug Administration (FDA) for its Kymriah (tisagenlecleucel or CTL019) to treat children and young adults with… Read more »

Alexion on a roll as Soliris gets label expansion in EU; although flying under the radar, analysts, investors still bullish.

The News: Alexion Pharmaceuticals Inc. (New Haven CT) got another shot in the arm this week with the EU approving its key revenue driver Soliris for an additional indication. EU approval… Read more »

FDA chief Gottlieb makes good on promise to increase drug price competition; will expedite review of generics

The Food and Drug Administration on Tuesday (June 27, 2017) moved to try to spur more competition in the market for generic drugs, an effort aimed at driving down prices. In… Read more »