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Vertex submits NDA to FDA for triple combination CF drug pharmaceutical-technology
July 24, 2019
Boston-based Vertex Pharmaceuticals has announced it has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for its triple combination therapy for cystic fibrosis (CF), VX-445 (elexacaftor), tezacaftor and ivacaftor.
Vertex’s CF drug gets label extension as pricing row continues pharmaphorum
January 24, 2019
While UK cystic fibrosis patients continue their long wait for access to Vertex’s Orkambi, the drug has received a label extension from the European Commission allowing it to be used in younger children.
Amid pricing spat with U.K. government, Vertex declines to submit data on new CF drug to NICE fiercepharma
August 13, 2018
The battle between Vertex Pharmaceuticals and U.K. health officials over cystic fibrosis drug pricing has reached an impasse after NHS England’s “final” offer in July. Now, Vertex is withholding data on new drug Symkevi that patients are anxiously awaitin