Incivek Sales Continue To Crater, CF Program Takes The Stage At Vertex
This article was originally published in The Pink Sheet Daily
Executive Summary
Vertex’s longer-term strategy in hepatitis C centers on combination trials of Phase II nucleoside VX-135 with three other companies’ candidates. In cystic fibrosis, Kalydeco sales continue to grow as the firm advances other candidates for combination therapy.
You may also be interested in...
US FDA Drugs Center Ready To Break Down Silos On Regulatory Innovation
CDER Director Cavazzoni is promising to increase coordination and collaboration to accelerate broader adoption of innovative clinical trial designs and other approaches to speed drug development. A new "Quantitative Medicine Center of Excellence" illustrates the approach.
New OSP Director To Guide CDER-Wide IT Upgrades; System Enhancements Speed ANDA Assessments
Generic Drug Structured Assessment for Bioequivalence launched in 2023 and has been used in 40 ANDA reviews so far.
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.