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Sandoz launches first biosimilar

BY Alaric DeArment

TOKYO The generics arm of Swiss drug maker Novartis has launched Japan’s first biosimilar.

Sandoz announced Monday the introduction in Japan of somatropin, a recombinant human growth hormone used to treat growth disturbance in children associated with chronic renal insufficiency, also known as Turner’s syndrome. Somatropin is the first biosimilar to receive approval in Japan and is a follow-on version of Pfizer’s Genotropin.

Sandoz has already launched it under the brand name Omnitrope in Australia, the European Union and the United States. Unlike the European Union and Australia, United States lacks an abbreviated approval pathway for biosimilars, but a federal judge ordered the Food and Drug Administration to act on Sandoz’s approval application for Omnitrope in 2006, leading the agency to approve it as a drug rather than as a biologic.

“Biopharmaceuticals offer real therapeutic hope to those suffering from the most complex diseases in modern society,” Sandoz CEO Jeff George said in a statement. “Biosimilars, pioneered by Sandoz, increase access to these essential drugs, lowering treatment costs and saving money for the healthcare system.”

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FDA scientists consider HIV treatment safe as first-line treatment

BY Alaric DeArment

WASHINGTON A drug made by Pfizer for treating HIV is safe for patients who have not taken other drugs, according to briefing documents posted online Tuesday by the Food and Drug Administration.

Scientists at the FDA appear to favor approval for the new use of Selzentry (maraviroc), currently approved as a second-line treatment for HIV patients.

On Thursday, the briefing information will go before the FDA’s Antiviral Drugs Advisory Committee, which will decide whether or not to recommend approval. Advisory committees’ recommendations do not guarantee approval or rejection of a regulatory application, but they are taken into consideration when the FDA makes its final decision.

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Emerson Group announces two new hires

BY Allison Cerra

WAYNE, Pa. A consumer products equity organization has added two employees to its staff.

Emerson Group announced Monday the addition of Rob Hurd and Kevin Rasmussen to the company effective Oct. 12.

Hurd’s responsibilities will include Walmart and Kmart customer management, as well as contributing to the strategic areas of category management and client business development. He comes to Emerson from Dentek Oral Care where he was sales director (West), responsible for all account   management efforts for the Dentek brand. Rob also spent 10 years at Bayer Consumer Care where he most recently led the Walmart category management team responsible for all efforts in support of Bayer brands and the cough/cold advisor position. Prior to Bayer, Hurd worked for Revlon and P&G in various field sales roles.

Meanwhile, Rasmussen’s responsibilities with the Emerson Group will include managing Shopko, Hy-Vee,  Roundy’s and several other Midwest regional food and drug retailers. Kevin comes to the Emerson Group from Target Corp. where he was most recently positioned on the financial side of Target’s operations. He has also extensive experience in pharmacy/OTC as a merchandise specialist.

“We’re very pleased about having Rob and Kevin on the Emerson team. Their contributions will only improve the quality and depth of the service we offer our business partners as well as enhance our presence within our retailers,” said Rick Wellinger, president of the Emerson Group.

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