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Omnitrope approved for Turner syndrome

BY Alaric DeArment

PRINCETON, N.J. — The Food and Drug Administration has approved a new use for a follow-on biologic made by Sandoz.

Sandoz, the generic drugs arm of Swiss drug maker Novartis, announced the approval of Omnitrope (somatropin [rDNA origin]) for children with growth failure due to Turner syndrome. Sandoz said Omnitrope was now approved for all the same indications as the reference product, Pfizer’s Genotropin.

"Sandoz is pleased to continue to expand patient access to this high-quality biopharmaceutical product, having received approvals for four new indications over the past two years," Sandoz president Don DeGolyer said. "The approval of Omnitrope for Turner syndrome will further allow us to meet the diverse needs of patients with growth-related conditions."

Omnitrope originally received approval from the FDA for pediatric growth-related disorders in 2006 under a new drug application, or NDA. Though Omnitrope is technically a follow-on biologic, no abbreviated approval pathway for follow-on biologics existed at the time, thus requiring its approval under the same pathway as the one used for branded pharmaceutical drugs.

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Sears, Kmart help support Irene recovery efforts

BY Antoinette Alexander

NEW YORK — Sears and Kmart stores announced that they are supporting emergency relief efforts in a dozen states to help residents recover from Hurricane Irene’s damaging winds and floodwaters.

Sears and Kmart stores will offer discounts on recovery items in stores throughout Connecticut, Delaware, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, North Carolina, Pennsylvania, Rhode Island and Vermont.

Key discounts include:

Kmart:

  • 20% off apparel and soft home from Aug. 31 to Sept. 30, 2011

  • 10% off hardlines from Sept. 7 to Sept. 30, 2011

  • Offers exclude event and clearance sales

Sears:

  • 20% off softlines from Aug. 31 to Sept. 30, 2011

  • 10% off hardlines from Sept. 7 to Sept. 30, 2011

In addition, Sears and Kmart will work with Rebuilding Together, a nonprofit working to preserve affordable homeownership, in the coming months to provide assistance to communities in their rebuilding efforts.

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Back-to-school, Irene aid Target’s August sales

BY Mike Troy

MINNEAPOLIS — The first month of Target’s third quarter is off to a solid start as the company reported a 4.1% same-store sales increase squarely in the middle of guidance that called for a low to mid single-digit gain.

The increase was driven primarily by growth in average transaction size with a lesser contribution coming from an increase in comparable-store transactions. The 4.1% increase comes on top of a prior year increase of 1.8%. The company said every region of the country experienced a healthy increase in comparable-store sales, but there was a noticeable sales acceleration in the eastern United States late in the month in advance of Hurricane Irene. Target estimated the acceleration added about a half percentage point to August comps and forecast that September comps likely would be negatively affected by a similar amount. Even so, the company maintained the monthly forecast that has been in place for most of the year, which calls for a comp increase in the range of low to mid-single digits.

“August comparable-store sales were in line with our expectations, reflecting solid results in our back-to-school and back-to-college categories,” Target chairman, president and CEO Gregg Steinhafel said. “While the pace of the economic recovery is uneven and uncertain, we are confident in our ability to execute on our strategy, to offer the right balance of extraordinary value, convenience, newness and differentiation and to remain our guests’ preferred shopping destination.”

As has been the case with prior monthly and quarterly sales reports, Target said August comparable-store sales in grocery increased in the mid to upper teens, while health care, beauty and household essentials increased in the mid single-digit range. Another area of increase was apparel, which was up slightly led by double-digit increases in the intimate, hosiery and performance segments. The company said same-store sales in hardline categories declined in the low single-digit range, and home categories declined slightly.

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