CATIE: Learning to Live With large Comparative Trials
• By Cole Werble
Pharma has come a long way in the last three years in developing tactics to respond to large, government-funded comparative clinical trials. Aggressive and well-prepared responses by the antipsychotic manufacturers to the CATIE comparison of four atypical brands to perphenazine changed what could have been a threatening study into an event for publicizing the strengths of individual brands.
By Cole Werble
The media grabbed its message quickly.
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
After three months on the job, FDA Commissioner Martin Makary is sounding much more effusive about the quality of the agency staff. Better late than never?
Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.
The FDA will take a hard line on trial design and site selection to ensure applicability to the US, Oncology Center of Excellence Director Richard Pazdur said during a meeting on GSK's Blenrep.
The plan was announced as the White House Office of Management and Budget discusses with stakeholders a widely anticipated guidance about the 340B rebate model, which is being advanced by manufacturers to enhance transparency and control ballooning discounts in the program.
After three months on the job, FDA Commissioner Martin Makary is sounding much more effusive about the quality of the agency staff. Better late than never?