PHARMACY

Mylan hires Adele Gulfo to head global collaboration, strategic operations

BY Alaric DeArment

PITTSBURGH — Generic drug maker Mylan has hired a former Pfizer executive to its executive leadership team.

The company announced Wednesday the appointment of Adele Gulf as EVP global collaboration and strategic operations. Before working for Mylan, Gulfo served as regional president of Latin America for Pfizer’s Emerging Markets Business Unit, overseeing more than 4,000 employees in 23 countries and achieving more than $3 billion in sales in Latin America in 2012.

"Adele’s rich and diverse experience in the pharmaceutical industry will bring significant strategic value and leadership to Mylan in numerous areas," Mylan CEO Heather Bresch said. "For instance, we believe Adele’s expertise will support many of our key growth drivers, including our expansion in Latin America, the development and expansion of our global specialty franchise and the development of global commercial strategies to maximize our key upcoming launches of increasingly complex generic products, such as in the biologics and respiratory areas."

 

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Daiichi Sankyo hopes to get FDA nod for anti-clotting drug

BY Alaric DeArment

PARSIPPANY, N.J. — Japanese drug maker Daiichi Sankyo is seeking Food and Drug Administration approval for a once-daily tablet to reduce the risk of stroke in patients with atrial fibrillation and treatment of other conditions.

Daiichi Sankyo announced the submission of a new drug application for Savaysa (edoxaban). The company also is hoping to get the FDA’s approval for the pill as a treatment for deep vein thrombosis and pulmonary embolism, as well as preventing the recurrence of symptomatic venous thromboembolism.

"The NDA submission in the United States is an important milestone in the development of edoxaban and reflects our long-standing commitment to addressing the needs of patients living with cardiovascular disease, including those living with AF or VTE," said Daiichi Sanko senior executive officer and global head of research and development Glenn Gormley. "If approved, edoxaban may provide a new treatment option for physicians and their patients with these diseases."

 

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FDA approves Bristol-Myers Squibb’s, AstraZeneca’s Farxiga

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Bristol-Myers Squibb and AstraZeneca for treating Type 2 diabetes, the agency said Wednesday.

The FDA announced the approval of Farxiga (dapagliflozin) tablets, designed for use with exercise and dietary adjustments to control blood sugar. Type 2 diabetes affects about 24 million people in the United States, accounting for more than 90% of diabetes cases.

"Controlling blood sugar levels is very important in the overall treatment and care of diabetes, and Farxiga provides an additional treatment option for millions of Americans with Type 2 diabetes," FDA Office of Drug Evaluation II director Curtis Rosebraugh said.

The drug belongs to a class known as sodium-glucose co-transporter 2, or SGLT2, inhibitor. The drug works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion and thereby lowering blood glucose levels.

 

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