The ruling not only opens GSK to the Humana suit, which applies to its Medicare Advantage plans, but also to potential lawsuits from other insurers.
Once Avandia's heart risks were fully understood, the former blockbuster from GlaxoSmithKline, was tightly restricted in the U.S. and pulled from the European market. The diabetes drug was at the heart of the company's $3 billion settlement with federal authorities last year. Now, the FDA will take another hard look at the research on its side effects to see if there is something more the agency should do to limit its use.
After previous attempts elsewhere, researchers at the University of Texas Medical Branch at Galveston say that the treatment appeared to improve memory in preclinical testing, and they have a theory as to why.
GlaxoSmithKline has shaken off more litigation tied to the safety of its Avandia diabetes drug by agreeing to pay $90 million in a settlement with 38 states. It did so without contrition.
Stung with heart safety problems of previous drugs, GlaxoSmithKline has been on the forefront of using an acclaimed discovery in stem cell science to catch cardiovascular risks of compounds prior to human testing, Bloomberg reported. And the London-based drug giant's use of the technology helps the company tackle safety hazards that trigger costly failures in clinical trials.
Does FDA have a special obligation to patients who sign up for post-marketing safety studies? An article in the latest New England Journal of Medicine suggests it does. And with new legislation setting up the prospect of more fast-track approvals, the authors point out, post-marketing studies will be more common--and more important--than ever.
Last week, when we unveiled our Top 10 Pharma Settlements report, we promised to update it as new deals hit the news. We didn't realize we'd need to fulfill that promise so quickly. Today, GlaxoSmithKline officially announced its $3 billion settlement, which puts it squarely on top of that list.
It's official: GlaxoSmithKline ($GSK) will pay a whopping $3 billion to wrap up longstanding Justice Department probes. It's the largest healthcare fraud settlement in history, topping Pfizer's ($PFE) $2.3 billion deal from 2009. GSK will plead guilty to three counts and pay a $1 billion criminal penalty, plus another $2 billion to wrap up civil claims.
Did Takeda Pharmaceutical downplay reports of heart failure in Actos patients?
GlaxoSmithKline has settled almost 25,000 more Avandia cases. The deal comes after a Philadelphia judge brought in a mediator to handle settlement talks and set a deadline for wrapping up 85% of the