Tag:
dapagliflozin
Latest Headlines
Latest Headlines
After FDA rejection, Bristol-AstraZeneca team wins EC OK for diabetes drug dapagliflozin
AstraZeneca and Bristol-Myers Squibb were stiff-armed by the FDA on their application for the SGLT2 diabetes drug dapagliflozin, but European regulators believe the benefits outweighed the risks that pushed the agency to reject the innovative therapy early this year.
J&J grabs ADA spotlight for new diabetes drug
Determined to build its stake in the fast-growing diabetes market, Johnson & Johnson plans to showcase late-stage data this weekend on its promising SGLT2 drug candidate that has drawn both praise and skepticism from clinicians and analysts.
European committee backs AZ, BMS and Novartis drugs for approval
Several drug companies received nods of support for getting their prized drugs approved for the European market.
Bristol stays in hunt for Amylin
After Amylin reportedly declined BMS' recent buyout offer, Bristol isn't giving up on its plans to gobble up the diabetes drugmaker, The Wall Street Journal reported.
Bristol-Myers taps gas on ambitious 2012 R&D strategy
Don't look for Bristol-Myers Squibb ( $BMY ) to back away from its ambitious, multibillion-dollar R&D strategy anytime this year. After racking up a billion dollars in research expenses for the
FDA rejects dapagliflozin for diabetes, raising concerns for a class
The FDA has surprised no one with its decision to bat down dapagliflozin , an innovative but potentially risky new approach to treating diabetes. AstraZeneca ( $AZN ) and Bristol-Myers Squibb ( $BMY )
Medical experts argue in favor of beleaguered AZ/BMS diabetes drug
Last July, some analysts felt that the FDA's adcomm on diabetes drugs dealt a mortal blow to the experimental dapagliflozin from Bristol-Myers Squibb ( $BMY ) and AstraZeneca ( $AZN ) when a majority
UPDATED: FDA panel shoots down pioneering diabetes drug from AZ, BMS
Stumped by a red flag over possible liver injury as well as an elevated risk of cancer, a panel of FDA experts shot down the first in a new class of diabetes drugs advanced by AstraZeneca ( $AZN ) and
Regulatory "sword of Damocles" dangles over two big AZ drugs
AstraZeneca is bracing itself for big news on two key fronts over the next few days. On Wednesday the FDA will hit its deadline for deciding on Brilinta, its blockbuster anti-clotting hopeful. And
FDA staffers: AZ, BMS diabetes drug dapagliflozin has risks
AstraZeneca and Bristol-Myers Squibb's experimental diabetes drug dapagliflozin comes with some risks attached, according to FDA staffers. The drug appears to be linked with breast and bladder
