Lilly, BI apply for diabetes drug approval
RIDGEFIELD, Conn. — Boehringer Ingelheim and Eli Lilly are seeking regulatory approval for an experimental drug to treat Type 2 diabetes, the companies said Monday.
BI and Lilly announced the submission of a regulatory application to the Food and Drug Administration for empagliflozin. The drug belongs to a new drug class known as SGLT2 inhibitors, which work by removing excess glucose through the urine by blocking its reabsorption in the kidneys. The companies are testing the drug in a late-stage clinical trial for which they plan to enroll 14,500 patients.
"We are excited to have submitted an application for a potential new treatment option that may help patients better manage their Type 2 diabetes mellitus," BI VP metabolic-clinical development and medical affairs Christophe Arbet-Engels said. "Type 2 diabetes mellitus is a critical health issue facing the world today, and through Boehringer Ingelheim and Lilly Diabetes Alliance, we are committed to developing new treatments to address patients with this disease."
The submission is part of a partnership between the two companies announced in January 2011.
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Walgreens Empire State Building store opens
DEERFIELD, Ill. — Walgreens is opening its latest New York flagship store in the Empire State Building, the retail pharmacy chain said Friday.
The store, scheduled to open Saturday at 10 a.m., will include an enhanced pharmacy designed to encourage greater interaction between pharmacists and patients, a health guide to help customers find health-and-wellness products and healthcare services ranging from immunizations to health tests. An "Ask Your Pharmacist" desk, private consultation rooms and Express Rx kiosks are included as well.
"We are extremely pleased to provide another revolutionary store that demonstrates how Walgreens is transforming daily living, pharmacy and healthcare experiences nationwide," Walgreens president of operations and community management Mark Wagner said. "Walgreens innovative products and services support our commitment to help our customers get, stay and live well."
The LOOK Boutique beauty department will feature an Eyebrow Bar with shaping and grooming services, as well as dozens of brands across cosmetics, skin care and hair care, including some not typically found in drug stores, as well as beauty advisers.
For consumables, an Upmarket Cafe will have fresh coffee, pastries, doughnuts and bagels, and the store will include self-serve frozen yogurt with a toppings bar, a Coca-Cola Freestye machine that dispenses 130 varieties of Coca-Cola fountain drinks, a variety of beers — including locally brewed brands — and fresh foods such as wraps, sandwiches and salads.
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FDA commissioner calls for power to regulate compounding pharmacies
SILVER SPRING, Md. — The commissioner of the Food and Drug Administration is renewing calls for legislation to give the agency more authority to regulate pharmacy compounding.
In a blog post Friday, Margaret Hamburg wrote that while the FDA has inspected more than 30 compounding pharmacies and worked to inspect state-licensed pharmacies that produce sterile drug products, the agency’s authority remained limited and was "not the right fit for FDA to provide appropriate and efficient oversight of this growing industry."
In the past week, Hamburg wrote, there were two recalls of sterile compounded and repackaged drug products due to contamination. In one case, five patients were diagnosed with serious eye infections after receiving doses of Genentech’s Avastin (ddd) from a compounding pharmacy in Augusta, Ga. In another, fungus was found in bags of magnesium sulfate intravenous solution.
"There is a legitimate role for traditional pharmacy compounding," Hamburg wrote. "Every day, thousands of pharmacists practice traditional pharmacy compounding — mixing a drug in response to a valid prescription for an individual patient’s need." These include liquids for patients who can’t swallow pills, or medications made for patients allergic to certain ingredients.
But sterile compounding, Hamburg wrote, has evolved and "outgrown the law." Sterile compounding is a much more complex process and requires careful attention to sanitation. It generally involves medications designed for intravenous delivery.
Sterile compounding has received significant attention in recent months following a nationwide outbreak of fungal meningitis among patients who received injected steroids from the New England Compounding Center in Framingham, Mass. An investigation of the NECC found widespread contamination, disregard for safety standards, and former employees of the pharmacy have said that it had essentially become a manufacturer. According to the Centers for Disease Control and Prevention, 722 have become sick with the meningitis, and 50 have died.