Real World Evidence: ‘Hot Topic’ At US FDA, But Not On Front Burner
Executive Summary
Officials are enthusiastic about the possibility of ‘real world evidence’ supporting the regulatory process – but are also eager to tamp down expectations (or fears) that it will make a big difference any time soon.
You may also be interested in...
An Ex-Commissioner’s Bleak Take On The State Of Biopharma Innovation
Former US FDA Commissioner Robert Califf remains eager to encourage broader use of real-world evidence – but his blunt, pessimistic read on the state of biopharma innovation is remarkable coming from a former FDA head.
Real World Evidence Is Critical To Pharma’s Future: Can We Agree On What It Is?
Urgent calls for industry to generate and apply real world evidence were matched at a recent conference only by complaints about challenges faced by this growing, ill-defined evidence category.
J.P. Morgan Notebook Day 1: PCSK9 Face-Off, Teva’s Slowed Growth, Merck’s Keytruda Wins, Lilly’s CDK4/6 Hopes And More
Daily round-up of news and notes from the 2017 J.P. Morgan Healthcare conference in San Francisco. Regeneron CEO rebuffs Amgen’s patent battle strategy; Teva CEO apologizes for reduced financial guidance; Merck looks for more Keytruda wins, combos; Lilly awaits potentially differentiating Phase III CDK4/6 data; Alkermes readies ALKS 5461 depression submission; Biden discusses cancer moonshot, FDA’s real world evidence views; and UniQure turns a corner.