February 4, 2012
Pharmacy news, jobs, continuing education, community and more.
Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced results from a pre-specified meta-analysis of cardiovascular (CV) safety data from 14 Phase 2b/3 trials in adult patients with type 2 diabetes, which showed that the investigational compound dapagliflozin was not associated with an unacceptable increase in CV risk relative to all comparators pooled [...]
Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) announced today that the U.S. Food and Drug Administration (FDA) has extended the action date for dapagliflozin for the treatment of type 2 diabetes by three months. The new Prescription Drug User Fee Act (PDUFA) goal date is January 28, 2012. “Bristol-Myers Squibb and AstraZeneca are [...]
PRINCETON, N.J. & WILMINGTON, Del. – Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today reported the outcome of the U.S. Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee meeting on the New Drug Application for the investigational compound dapagliflozin. “Do the efficacy and safety data provide substantial evidence to support [...]
AstraZeneca announced that it has commenced dosing patients in a global Phase IIb study to compare the efficacy and safety of AZD9773 (CytoFab) with placebo in adult patients with severe sepsis and/or septic shock receiving best supportive care. Sepsis occurs when the body’s immune system sets off a chain reaction and “overreacts” to an infection. [...]
AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMA) concluded that the benefit-risk profile of once-daily SEROQUEL XR (quetiapine fumarate) extended-release tablets was positive as an add-on medication for major depressive episodes in major depressive disorder patients who have had sub-optimal response to treatment with [...]
A jury in a New Jersey state court ruled in favor of AstraZeneca by rejecting a Louisiana plaintiff’s claims that Seroquel caused alleged injuries. AstraZeneca, a global biopharmaceutical business with global revenues of $32.8 billion in 2009, had Seroquel first approved in the US in 1997 and is currently approved for depressive episodes in bipolar [...]
PRINCETON, N.J. & WILMINGTON, Del. – Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for an investigational fixed dose combination of ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin HCl extended-release tablets as a [...]
PRINCETON, N.J. & WILMINGTON, Del.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced the commencement of the “Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus” trial (SAVOR-TIMI 53), a multicenter, randomized, double-blind, placebo-controlled Phase 4 study, to evaluate treatment with ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, in adult [...]
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