Vertex
In Brief This Week: UniQure, WHO, Vertex, Lonza, Elixirgen, Eli Lilly, ClearNote Health, Penn State
News items for the week of Sept. 23, 2024.
HHS OIG Issues Unfavorable Opinion on Gene Therapy Developer's Fertility Preservation Program
Without more data on the risk of abuse associated with these programs, the agency won't provide immunity to drugmakers offering to pay for fertility services.
Vertex Pharmaceuticals Sues HHS, OIG Over Legality of Fertility Preservation Program
The firm is asking a court to determine that its program to pay for fertility treatments for patients on Casgevy doesn't violate anti-kickback and inducement laws.
FDA to Review Vertex Pharma's NDA for 'Vanza Triple' Cystic Fibrosis Regimen
Vertex's regulatory application for the triplet combination has priority review from the agency and has been validated by the European Medicines Agency.
EC Approves Vertex's Kalydeco for Cystic Fibrosis Patients as Young as 1 Month
Kalydeco, already approved for patients as young as 1 month old in the US and UK, is now available to babies that young throughout the European Union.
Nov 1, 2023