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Janssen seeks FDA approval for canagliflozin as Type 2 diabetes treatment

BY Allison Cerra

RARITAN, N.J. — A Johnson & Johnson subsidiary is seeking approval for a Type 2 diabetes treatment.

Janssen Research and Development has submitted a new drug application to the Food and Drug Administration for the approval of canagliflozin — an investigational oral, once-daily, selective sodium glucose co-transporter 2 inhibitor — for use in adult patients. Canagliflozin blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels, the company said.

The filing was supported by a comprehensive global phase-3 clinical development program, which included nine multicenter, randomized clinical studies that enrolled approximately 10,300 patients. The late-stage clinical trial evaluated the safety and efficacy of canagliflozin across the spectrum of Type 2 diabetes and included placebo- and active comparator-controlled studies. The program also included a dedicated cardiovascular study conducted in patients who have or are at high risk for developing cardiovascular disease.

Janssen and its affiliates have rights to canagliflozin through a license agreement with Mitsubishi Tanabe Pharma. Janssen Pharmaceuticals has marketing rights in North America, South America, Europe, Middle East, Africa, Australia, New Zealand and parts of Asia.


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C.Morton says:
Jan-10-2013 02:15 pm

According to this article, http://www.rxwiki.com/news-article/canagliflozin-type-2-diabetes-closer-approval-may-have-safety-issues Researchers found that the drug was able to lower blood sugar levels but may increase the risk of heart, kidney and bone-related problems. But how do you decide if it's worth the risk?

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Navarro Discount Pharmacy launches Spanish-language site

BY Antoinette Alexander

MIAMI — Hispanic-owned pharmacy chain Navarro Discount Pharmacy has added a Spanish-language version to its website at Navarro.com.

“The new Spanish-language content allows us to better serve loyal customers already familiar with the Navarro brand and reach out to the millions of U.S. Hispanics who are online today,” stated Gus Milla, director of e-commerce for Navarro Discount Pharmacy. “Proud of their Hispanic origins, these Hispanics are in search of products familiar to them from their countries of origin, such as food, tea, nectars and cola, soap, cleaners and [such] entertainment [as] domino tables and cards.”

Navarro.com En Español includes video and media content on family- and health-related topics plus product reviews, prescription management tools and e-commerce purchasing capabilities for all of its signature products. Customers may refill prescriptions, check order status and purchase such products as Cuban coffee, pastelitos, ethnic cookies, Cuban bread, domino tables, OTC and beauty products.

In addition, the entire line of Vida Mia private-label bilingual products in English and Spanish, including more than 300 product SKUs, also are available at Navarro.com En Español. Vida Mia’s product categories include household, beauty, food, body, baby and OTC. It is estimated that nearly 30 million U.S. Hispanics currently are online, many of them native-born Hispanics rather than immigrants.

Online orders are processed immediately through Navarro’s fulfillment center in Miami. Navarro.com accepts all major credit cards, and free shipping is available for online orders of $25 or more.

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Hy-Vee executive newest GMA hall of fame inductee

BY DSN STAFF

WASHINGTON — Ric Jurgens spent the past 43 years working for and building Hy-Vee into a strong regional chain, and later this summer his accomplishments will be acknowledged by the Grocery Manufacturers Association when he receives the organization’s Hall of Achievement Award.

Jurgens announced plans to retire last December with an effective date of June 1. He is succeeded by Randy Edeker, an executive who spent the past 30 years with the grocer and most recently served as president and COO of the employee owned company. Jurgens served as CEO since 2003 and added the chairman title in 2006. Hy-Vee operates 235 stores in eight Midwestern states with annual sales of $7.3 billion.

"It has been my privilege to serve Hy-Vee and our customers for over 43 years," Jurgens said of his retirement decision. "I’m eternally grateful for the support and guidance given to me by our employees throughout our eight-state area. Since I’ve given my entire working life to Hy-Vee, the future of our company is very important to me. I retire with great confidence knowing that we have a strong, talented leader in Randy Edeker, and knowing he is surrounded by an outstanding team of executives at every level who will make Hy-Vee even better in the years to come."

In addition to acknowledging Jurgens, GMA also plans to honor Dean Pappas, CEO of Clement Pappas and Company, a leading supplier of private label fruit juices and beverages and cranberry sauce. Pappas joined the family-owned company in 1962 and served as CEO until last June when the business was sold.

“Lifetime achievement is the hallmark of the GMA Hall of Achievement Award, and by that standard, no two people are more deserving than Ric Jurgens and Dean Pappas,” said GMA president and CEO Pam Bailey. “Their business savvy, their desire to make the world a better place and their compassion for their associates, their communities and their consumers sets them apart.”

The awards will be presented during a ceremony at the GMA Executive Conference held August 25-27 in Colorado Springs.

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