We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Sponsors of new drug applications in China must submit comprehensive data showing adherence to clinical trial requirements by Aug. 25 — in a surprise move that could prompt noncompliant or unprepared companies to withdraw their applications, reducing a pending backlog of more than 1,600. Read More
AstraZeneca is selling its rare cancer drug Caprelsa to Sanofi for up to $300 million, as the company continues to raise cash by divesting assets. Read More
The European Medicines Agency is seeking feedback on draft guidelines on conditional approval and accelerated assessment as it strives to fast track medicines for unmet medical needs. Read More
The Senate and House Appropriations Committees are calling on the FDA to issue guidance on biosimilars standards and work with industry to prevent drug shortages as part of their fiscal 2016 funding bills. Read More
UnitedHealth Group plans to use its market strength to negotiate prices to help consumers purchase expensive specialty drugs, adding to a growing press from doctors, patient advocates and lawmakers to rein in costs. Read More
The European Medicines Agency is recommending the first-ever malaria vaccine, GSK’s Mosquirix, as a protection for children ages six weeks to 17 months in sub-Saharan Africa. Read More
The FDA Friday gave the green light to Sanofi and Regeneron’s cholesterol-lowering drug Praluent, beating Amgen’s Repatha in a race to be the first PCSK9 inhibitor in the U.S. Read More
Drugmakers making changes to analytical validation methods over the lifecycle of a drug should retain samples to permit comparative studies of the new and old methods, the FDA says. Read More
Drug compounding groups are urging the FDA to revise a draft memorandum of understanding that outlines how states should regulate small compounders, saying a proposed cap on interstate shipments of compounded products would hinder patient access and unduly burden state enforcement agencies. Read More