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GlaxoSmithKline’s experimental coronary heart disease drug darapladib failed to reduce heart attacks, strokes and major cardiovascular events in a closely watched Phase III clinical trial, deflating some expectations for GSK’s Phase III pipeline. Read More
A bill that will require drugmakers to establish a pedigree system for pharmaceuticals within one year is expected to reach President Obama’s desk this Friday. Read More
The FDA says someone hacked into CBER’s online submission system last month and may have put users in danger of having their online personal identity stolen. Read More
The UK’s National Institute for Health and Care Excellence (NICE) has asked Janssen for more information on its multiple myeloma treatment Velcade before an appraisal committee can make final recommendations on its use in patients untreatable with high-dose chemotherapy and haematopoietic stem cell transplant. Read More
To demonstrate value in the age of personalized medicine, drugmakers must adjust their marketing campaigns around patients’ real-world experiences, a new PricewaterhouseCoopers (PwC) report says. Read More
Sanofi’s bid to expand the indication for its biologic Lemtrada to treat relapsing multiple sclerosis (MS) faces tough scrutiny by FDA advisors as agency reviewers say data supporting the application point to “serious and potentially fatal safety issues.” Read More
Aegerion Pharmaceuticals CEO Marc Beer’s televised comments about the company’s heart drug Juxtapid have drawn a warning letter from the FDA for failing to mention drug risks and promoting an off-label use. Read More
The Department of Justice is investigating a Phase III study of AstraZeneca’s (AZ) heart drug Brilinta, which analysts and experts say could revolve around allegations of data falsification. Read More