Latest Headlines

Latest Headlines

Indian court upholds BMS Sprycel patent, but list of challengers grows

Bristol-Myers Squibb has won a court verdict to uphold its patent on Sprycel (dasatinib), fending off a challenge, for now, from India's BDR Pharmaceuticals, which sought a compulsory license to make the drug and sell it at a lower cost domestically. But other challenges abound, including one by little-known Lee Pharma for AstraZeneca's Onglyza.

AZ's Onglyza should highlight heart failure risks, FDA panel advises

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.

AZ's Onglyza has most to lose at FDA safety confab, analysts say

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?

AstraZeneca trumpets diabetes duo's victory in Phase III

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.

FDA puts AstraZeneca's diabetes med Onglyza on review for heart safety

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 top Phase III R&D setbacks of 2013

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...

Onglyza fails outcomes trial in a $1B hit for Bristol-Myers, AstraZeneca

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.

Another drug study flops at AstraZeneca as CEO braces for bumpy turnaround

In an interview with Reuters yesterday, CEO Pascal Soriot warned that turning around AstraZeneca is going to require a lengthy rebuilding effort.

Safety watchdog flags GLP-1 drugs for pancreatitis reports to FDA

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.

Drugmakers beware, Costco now in pharmacy benefits

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.