AstraZeneca dodged a bullet Tuesday, when an FDA panel of experts almost unanimously backed Onglyza's cardiovascular safety. But the committee did recommend that the label of the diabetes therapy feature information about a potential risk of heart failure.
FDA experts will grill a couple of diabetes meds next Tuesday, and the outcome of that debate could put a damper on sales. The drugs: AstraZeneca's Onglyza and Takeda's Nesina, both DPP-4 blood sugar-fighters. The questions: Do they really increase the risk of heart failure? And if so, what's to be done about it?
While its top executives were prepping for a hearing on Pfizer's megamerger offer, AstraZeneca rolled out new data from a diabetes trial. The verdict? A combination of the company's two diabetes pills, Onglyza and Farxiga, bested either drug alone.
AstraZeneca's diabetes drug Onglyza is under the FDA's microscope. The agency said it would review possible heart risks associated with the medication, which is one of the cornerstone products in the U.K.-based drugmaker's diabetes business.
The stats on Phase III success rates aren't good. About half end in failure--and that's after developers have had a chance to do some careful testing in humans. It's no wonder, then, that...
Bristol-Myers Squibb and AstraZeneca have lost out on a $1 billion boost for their diabetes partnership. Onglyza failed to beat placebo in a key outcomes trial, dashing hopes that new data would turbo-charge sales.
In an interview with Reuters yesterday, CEO Pascal Soriot warned that turning around AstraZeneca is going to require a lengthy rebuilding effort.
A safety watchdog group has analyzed the FDA's adverse event data on the entire GLP-1 class of diabetes drugs, finding more reports of pancreatitis and pancreatic cancer for these drugs compared with older treatments.
In the evolving drug payer world, pharmacy benefit managers (PBM) are commanding a bigger role. Now drug companies have a new and interesting PBM with which to contend--Costco.
Once again, European regulators have shown that they don't always see eye-to-eye with the their counterparts in the U.S. The European Commission welcomed a new diabetes drug from Bristol-Myers Squibb and AstraZeneca, dubbed Forxiga, just months after FDA rejected it on safety worries.