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Drugmakers have 13 months to revamp how they track drugs after the Senate voted Monday to send to President Barack Obama’s desk a measure that would establish a nationwide track-and-trace requirement for prescription drugs. Read More
A North Carolina pharmacy is recalling all of its sterile compounded drugs distributed within the Tar Heel State and ceasing production of sterile products altogether after an FDA site inspection. Read More
AbbVie on Monday released the first of six SAPPHIRE Phase III trial results for its hepatitis C candidate, M11-646. The rosy results set the drugmaker up for regulatory filings in early 2014. 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
A panel of FDA advisors Nov. 14 overwhelmingly voted against approval of Sanofi’s Lemtrada for an expanded indication to treat relapsing multiple sclerosis (MS). Read More
FDA advisers overwhelmingly voted Nov. 14 to recommend approval of Vanda’s sleep drug tasimelteon for the visually impaired despite some concern over a clinical trial’s primary endpoint. Read More
GlaxoSmithKline is close to designating several new chemicals ready for clinical research as a result of successful collaborations with academia, the drugmaker said Nov. 6. Read More
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