Publicly disgraced after cardiologist Steven Nissen and his colleagues unveiled data on its cardiovascular risks in 2007, Avandia was withdrawn in Europe and put under tight rein in the U.S. Now, the FDA is revisiting the issue, and Nissen himself has issues with that.
In the first collaboration of its kind, the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority has brought on GlaxoSmithKline to help the federal agency develop new antibiotics to combat bioterrorism and growing resistance to the drugs.
Any medication involves a balancing of risk and benefit. In areas where there is an unmet need, a little more risk might be acceptable. But the waters get muddy when two treatments, one offering better results but greater risks, are available for patients.
India has started the countdown on new price controls for a vastly expanded list of drugs, a move that is expected to cut deeply into the profits of drugmakers for hundreds of drugs.
GlaxoSmithKline CFO Simon Dingemans has found one of the mainstays of retail works just fine for drugs, particularly in emerging markets where GSK wants to build its foothold. You just put them on sale.
New data has been published analyzing one year's worth of media reports--more than 10,000 pieces from 144 countries--to get a sense of where negative vaccine views were most prevalent.
The FDA granted approval to GlaxoSmithKline's new respiratory drug Breo Ellipta. By itself, that's a solid victory for GSK, which needs to build up its respiratory franchise before Advair copycats finally make their way to market. Analysts figure Breo for a blockbuster in the U.S., with peak sales at around $1.3 billion.
GlaxoSmithKline is turning to market-expansion contractors DKSH to push its antibiotic products in Hong Kong, part of the drugmaker's efforts to cash in on booming Asian demand.
GlaxoSmithKline and Theravance have won FDA approval for their drug Breo Ellipta for treating chronic obstructive pulmonary disease, the third-biggest killer of Americans, the agency announced. The approval comes with an undesirable boxed warning from the agency that LABA therapies boost risk of asthma-related deaths.
GlaxoSmithKline turned on a website that serves as a conduit for authorized researchers to tap clinical study data on certain GSK drugs, placing the pharma giant on the forefront of transparency in pharma and spurring skepticism about the process for releasing anonymous patient-level data from its vaults.