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Alexza resubmits Adasuve for regulatory review

BY Allison Cerra

MOUNTAIN VIEW, Calif. — A drug maker has resubmitted its new drug application to the Food and Drug Administration for an acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

Alexza Pharmaceuticals said it received a complete response letter for Adasuve last month from the regulatory agency. The CRL outlined the FDA’s concerns about Alexza’s manufacturing facility and the drug’s draft product labeling. Alexza said it believes it has addressed these concerns in its resubmitted application.

In the coming weeks, Alexza expects to hear from the FDA regarding the completeness of the resubmitted NDA, the classification of the resubmission (Class 1 or Class 2) and what the new Prescription Drug User Fee Act goal date will be.


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Axe Hair partners with Universal Pictures’ upcoming comedy ‘Ted’

BY Antoinette Alexander

ENGLEWOOD CLIFFS, N.J. — Unilever’s Axe Hair brand for men has teamed up with Universal Pictures’ upcoming comedy “Ted” to create a partnership that speaks to the irreverent nature and humor of both the film and the Axe Hair brand.

Complete with branded digital content and television commercials starring the film’s title character, Ted, and directed by “Ted” and “Family Guy” mastermind Seth MacFarlane, the partnership takes a comedic look at the interactions between guys and girls. “Ted” hits theaters on June 29.

Much like Ted’s character in the film, the Axe Hair content shows that Ted is able to get away with anything due to his soft "Teddy Bear Hair" and unmatchable confidence. In the commercials, Ted puts the moves on his dinner date and shares the secret to his confidence, Axe Hair styling product, with a nearby couple at the restaurant.

On June 22, Axe Hair will premiere the full-length, racy version of the content, appropriate for mature audiences only, as well as a shorter, general audience-friendly version online at YouTube.com/AXE.  The shorter spot also will live online on Facebook and will hit broadcast television on July 2.

There also will be an on-screen cameo by Axe Hair when the movie hits the big screen on June 29. In the bathtub scene, Ted uses Axe Anti-Dandruff 2 in 1 Shampoo + Conditioner to achieve soft, touchable "Teddy Bear Hair" before a big night out.

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NRF appoints VP retail technologies

BY Allison Cerra

WASHINGTON — The National Retail Federation has appointed a retail technology veteran to serve as its VP retail technologies.

Effective July 2, Tom Litchford will lead and manage NRF’s Association for Retail Technology Standards and the exclusive, invite-only CIO Council. He will be responsible for developing and enhancing strategic programs, activities and relationships with retail and technology communities both domestically and internationally.

Litchford comes to NRF from Microsoft, where he directed the planning, development and execution of strategic partnerships in the retail and hospitality industries. In addition to serving in various roles at Microsoft, Litchford also was director of business impact modeling for NCR’s retail solutions group, where his team worked with retailers to help them understand the business impact of implementing various technologies.

Litchford — who will step into his new role as ARTS longstanding executive director Richard Mader will retire — will report to Vicki Cantrell, SVP of NRF’s communities and executive director of Shop.org.

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