Without commenting on the patent dance laid out in the Biologic Price Competition and Innovation Act (BPCIA), the Federal Circuit made it clear that biosimilar makers can't jump onto the dance floor before the music starts.
Diversity in clinical trials is a common refrain at advisory committee meetings these days, with panelists often recommending postmarket trials or subgroup analyses for minorities or patients with specific co-morbidities.
When it comes to diversity in clinical trials, most discussions revolve around gender, race and ethnicity. If age comes up, the conversation tends to focus on pediatrics. But as the baby boomers age and life spans lengthen globally, some experts are recognizing a greater need to test investigational drugs and devices in the elderly.
While most of the companies developing Ebola vaccines and therapies are getting considerable government support, several lawmakers are proposing another incentive – transferable priority review vouchers.
As government agencies partner with industry in a race to save countless lives in a growing Ebola outbreak, two hurdles loom large for companies lining up for the run, the FDA's Luciana Borio told a House subcommittee Wednesday.
Ever since Gilead Sciences Inc. unveiled its $84,000 price tag for Solvaldi, a breakthrough hepatitis C drug, many lawmakers, patient groups and payers have been throwing warning flags about the escalating price of drugs.
In the first hearing of the lame duck session of Congress, the Senate Appropriations Committee looked at the government's response to the Ebola crisis and considered the president's request for $6.2 billion in emergency funding to help contain the outbreak.
