Actavis files ANDA for diabetes remedy Onglyza
DUBLIN — Actavis on Tuesday confirmed that it has filed an abbreviated new drug application with the Food and Drug Administration seeking approval to market saxagliptin hydrochloride tablets, 2.5 mg and 5 mg.
Actavis’ ANDA product is a generic version of AstraZeneca and Bristol-Myers Squibb’s Onglyza, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes.
AstraZeneca AB filed suit against Actavis on May 23, 2014 in the U.S. District Court for the District of Delaware, seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of U.S. Patent No. 7,951,400. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis’ ANDA until Jan. 31, 2017, or final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
Based on available information, Actavis believes it may be a "first applicant" to file an ANDA for the generic version of Onglyza and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
For the 12 months ending Feb. 28, 2014, Onglyza had total U.S. sales of approximately $532 million, according to IMS Health data.
Target forms new Digital Advisory Council
MINNEAPOLIS — Target has formed a Digital Advisory Council as part of its efforts to accelerate its digital transformation and will bolster its internal digital talent by hiring at least 50 new software engineers this year, the company has announced.
The panel will help guide Target’s omnichannel strategies and help to discover new ways to in which the retailer can leverage technology to enhance the guest experience — both online and in stores.
The council includes experts with varied tech backgrounds, and is comprised of:
- Ajay Agarwal, managing director of Bain Capital Ventures;
- Amy Chang, CEO/co-founder of Accompani, formerly led Google Analytics;
- Roger Liew, CTO of Orbitz Worldwide; and
- Sam Yagan, CEO of the Match Group and CEO/founder of OkCupid.
“We believe this council can play an important role in Target’s digital transformation — one of our top priorities as a company,” said Casey Carl, president of omnichannel for Target. “This new group is bringing their tremendous talents and experience to help guide Target’s strategies and tactics. They’re also providing fresh, disruptive ideas that will help us re-invent the Target run for tomorrow’s guests.”
The council will meet quarterly as a group with Carl and others driving Target’s omnichannel strategies, including Target.com and mobile teams, the enterprise strategy team and other Target leaders. Council members, who will serve two-year terms with an optional third year, also will be called upon to provide guidance on various topics and to help Target connect with other tech leaders.
In addition to forming the new council, Target is bolstering its internal digital talent, with plans to hire at least 50 new software engineers this year for Target.com and the mobile product teams. The engineers will be primarily based in Minneapolis, where they will work as part of the company’s new digital product teams. Some new engineers will be based in Target’s San Francisco office.
In the past year, Target has launched a number of digital initiatives, including the mobile coupon app Cartwheel, Target Subscriptions and Store Pickup, which allows guests to buy online at Target.com and pickup in a store. Target is now enhancing and expanding these services, while also beginning to test new offerings like same-day delivery and the ability to ship online orders from stores.
“Target is pursuing an aggressive omnichannel agenda, and we want to go faster,” Carl said. “We’re confident that such efforts as creating the council and adding new engineering talent to our organization will help us achieve our goal of becoming a leading omnichannel retailer.”
CRN adds four companies to its roster
WASHINGTON — The Council for Responsible Nutrition on Wednesday announced the addition of four new companies to its membership roster — voting members Arizona Nutritional Supplements and Ingredion and associate members AccentHealth and UL Consumer Products.
“We are very pleased with the consistent growing number of companies that are recognizing the immense benefits of membership with CRN,” stated Steve Mister, CRN president and CEO. “Not only are we seeking out leading companies that are committed to promoting and sustaining a responsible industry, but more and more, those companies willing to invest in the industry’s future are finding us.”