Testing Vivus' Staying Power
Executive Summary
Vivus' first-year sales of its impotence drug surpassed even its most optimistic projections. But that very success led to problems, most notably manufacturing capacity shortfalls, that threaten not just future US growth, but the drug's European launch, just when Vivus is bracing for Pfizer's market entry.
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.