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Bayer, Onyx seek approval for gastrointestinal tumor drug

BY Alaric DeArment

WAYNE, N.J. — Bayer HealthCare and Onyx Pharmaceuticals are seeking approval for a new drug to treat tumors of the gut, the companies said.

Bayer and Onyx announced the submission to the Food and Drug Administration of an application seeking approval for regorafenib in patients with gastrointestinal stromal tumors, or GIST. Bayer developed the drug and formed a partnership with Onyx in 2011, whereby Onyx will receive a royalty on future global net sales of the drug in cancer-related indications. Both companies will promote the drug in the United States.

"The submission of regorafenib for the treatment of GIST marks an important milestone for Bayer, bringing us one step closer to potentially addressing a significant medical need for patients with this rare but aggressive disease," Bayer HealthCare Pharmaceuticals VP and head of U.S. medical affairs Pamela Cyrus said. "With the development of regorafenib and other oncology compounds, we remain committed to discovering and advancing cancer therapies for patients who are in need of new treatment options."


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Amid customer complaints, Walmart cuts layaway fee

BY Mike Troy

BENTONVILLE, Ark. — After announcing it would move up its layaway program for the holiday season to mid-September, Walmart said it also would reduce the program fee from $15 to $5.

"This is a direct response to feedback we received since announcing this year’s holiday layaway program," said Duncan Mac Naughton, Walmart’s chief merchandising and marketing officer. "Customers who make their final payment will receive a refund of the $5 fee on a Walmart gift card. We believe this rollback strengthens our layaway offering. It’s even more attractive to our customers and makes Walmart more competitive in the marketplace."

Other terms of Walmart’s program are comparable with last year, such as a requirement for a down payment of $10 or 10% of the purchase price, whichever is greater, but the company no longer collects a cancellation fee of $10, as was the case last year.

At Walmart, the list of merchandise categories was expanded this year after the program was reinstituted last holiday season. Walmart has added small appliances and select sporting goods such as basketball goals, trampolines and large exercise equipment to electronics, toys and jewelry as categories eligible for layaway.

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FDA delays action on Salix drug

BY Alaric DeArment

RALEIGH, N.C. — The Food and Drug Administration will not decide whether to approve a drug for diarrhea in HIV patients as it continues to review the regulatory approval application for it, the drug’s manufacturer said.

Salix Pharmaceuticals said the FDA was still reviewing its application for crofelemer in the 125-mg strength. The agency was originally expected to take action on the drug Wednesday. Crofelemer is meant for treating noninfectious diarrhea in HIV and AIDS patients taking antiretroviral therapy.

"By taking no action at this time, the FDA has allowed for the currently ongoing dialogue between Salix and the FDA to continue," Salix EVP medical and research and development and chief development officer Bill Forbes said. "The continuing dialogue should allow further collaboration between us and the agency, a collaboration that has resulted in substantial progress in handling topics important to crofelemer as well as to botanical products in general."


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