Wyeth is reaping the benefits of its "learn and confirm" approach to clinical development, U.S. President Geno Germano tells analysts during a June 12 presentation at the Goldman Sachs Global Healthcare Conference. The firm announced last year it was replacing its three-phase development process with "learn and confirm" to better understand the medical value of a molecule up-front (1"The Pink Sheet" July 3, 2006, p. 19). Wyeth and other pharma companies have touted adaptive trial designs as a way to streamline the clinical development process and decrease the time and length of trials. That approach may eliminate agents that could fail on a larger scale later in development, Germano points out. For instance, "in one of our programs where we initiated an adaptive trial design, we were able to explore multiple dose ranges for a given product and determined that frankly it didn't have the activity that we thought it would have," he noted. "And while that's unfortunate, the good news is it's unfortunate at several million dollars less cost than it would be if we were to find out using a traditional approach to dose ranges and dose-finding studies"...
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
Highlights from day one of the BIO convention include advice for firms hoping to go public, a call for companies to push the US Congress on rare disease priority review vouchers, and updates on next-generation gene therapies.
Lupin became the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster.
The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.
