Rep. Rosa DeLauro's recent letter to the FDA criticizing expedited approval pathways designed to accelerate the commercialization of innovative treatments does not capture the role of FDA's expedited approval programs in speeding therapies to patients suffering from unmet medical needs and faced with few or no medical alternatives.
By David Grainger Clinical trial results are seldom reported in a form that is accessible to the public. To many people that is unacceptable for several reasons: it allows drug companies to...
By David Grainger Late-stage attrition kills returns on pharma R&D investment. One way to reduce attrition is to take less risk-- incremental innovation reduces the risk of failing in development...
By Michelle Rohrer, Vice President, U.S. Regulatory Affairs, Genentech In August I had the pleasure of participating in Fierce's "Understanding Major Regulatory Change" webinar. This...
While just about any new treatment option for migraine would be welcomed by patients and physicians, there is clearly a need to pursue new disease targets in order to develop improved therapeutics for this debilitating disorder.
Spending on platforms prevents big pharma from properly addressing the cost problem in drug discovery and development and unless it is addressed such platforms may ultimately prove their nemesis rather than their saviour.
Disraeli supposedly said "The only two certainties in life are death and taxes," but if a team of Croatian scientists, led by Professor Miroslav Radman, is correct, death need be no certainty.
In recent years, it has become dramatically easier and quicker to create a virtual drug-development company. Today it is even possible to take virtual to its logical extreme: a zero-person biotech company.
Payers have become increasingly unwilling to pay for incremental drug innovation, meaning that the industry would have to instead seek bigger improvements in clinical performance. But the market for late-stage products that show little, if any, differentiation remains as frothy as ever.
The biggest winners in the Supreme Court's ruling on the Myriad gene-patent case are the genetics, diagnostics and medical device industry, and especially patients, specifically women across the country.