Pharma's Innovation Bar and the Need for Less Impersonal Medicine
Executive Summary
Key to Pharma's future success will be the ability to identify subpopulations and develop drugs for them. This is not quite the one-drug-for-one-patient fantasy of "personalized medicine," but a significant departure from the one-size-fits-all therapy represented by blockbuster drugs like Lipitor is necessary. This change is driven by increasing costs of large studies, growing demand for more than drug-versus-placebo evidence when a new product wants to take on the standard of care, and more intense attention to safety.
You may also be interested in...
Shadow FDA? Researchers Are Taking Approval Matters into their Own Hands
Drug and biotech companies will face an emerging trend of outside interference on pending drug reviews at FDA. The events surrounding the final outcome of FDA's review of Bristol-Myers Squibb and Merck's diabetes drug muraglitazar (Pargluva) signal that outside medical centers and prominent researchers will voluntarily play a larger role in drug safety oversight in the future.
Positioning Acomplia: Has the Drug Arrived Before the Disease?
Sanofi-Aventis is the envy of many as it awaits approval for fat-busting metabolic syndrome drug, Acomplia. But obesity is rarely reimbursed; metabolic syndrome still undefined.
NitroMed's BiDil Pricing: Test for a Whole Class of New Companies
After putting two generics together and then getting the product approved for a new indication, NitroMed priced its new drug above expectations. But will the old-style pricing strategy hold up in a managed care world?