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Johnson and Johnson’s guilty plea and $2.2 billion settlement with the U.S. government to resolve off-label marketing claims for its anti-psychotic Risperdal leaves the company with more legal fights ahead of it. Read More
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
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
Drugmakers looking to access FDA-related guidance and regulations via the federal website Regulations.gov were hampered by technical glitches that took the site down for several days earlier this month. Read More
Despite a recent ruling by the White House Office of Management and Budget (OMB) that $85 million in already collected fiscal 2013 FDA user fees remain impounded and unavailable for the agency to use, no plans have yet emerged in Congress to free up the funds. Read More
The FDA is expected to approve 34 new drugs this year, down from a record 43 approved in 2012. That drop is expected to be temporary, though, as more drugmakers adjust their pipelines to take advantage of the agency’s breakthrough therapy pathway. 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
Baxter International and Cell Therapeutics (CT) on Friday joined together in a strategic partnership to develop and market pacritinib, CT’s investigational JAK2/FLT3 inhibitor for genetic mutations connected to myelofibrosis, leukemia and other types of solid tumors. Read More
Senior European Medicines Agency (EMA) officials are cautioning their peers that when it comes to making regulatory decisions, high levels of risk aversion may do more harm than good. Read More
The FDA has handed Daiichi Sankyo an untitled letter for making claims in a brochure that two of its hypertension treatments helped lower blood pressure in patients with severe hypertension, despite a lack of substantial supportive evidence. Read More
The FDA has handed specialty drugmaker US WorldMeds an untitled letter for omitting key risk information and making unproven claims on its website about its drug Revonto. Read More
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