U.S. physicians say skepticism over the North American results in the pivotal PLATO study is one of many factors that’s been slowing adoption. Competition with low-cost generics is another.
AstraZeneca PLC’s plan to turn around performance of Brilinta/Brilique (ticagrelor) in the U.S. is likely to be an uphill battle, considering competition from low cost clopidogrel generics and skepticism in the cardiology community about the North American results in the PLATO pivotal trial, among many other factors.
Approved in the U.S. in July 2011 and Europe in December 2010 for patients with acute coronary syndromes, the drug has launched in more than 80 countries worldwide and yet...
The Clinical Trials Access Collaborative (CTAC) will build on a pilot program's work to bolster community-based clinical research infrastructure so "anyone who wants to participate in clinical trials can and do it closer to home,” CEO Tesheia Harris said in an interview.
CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.
The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.
