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FDA approves Teva biosimilar

BY Alaric DeArment

JERUSALEM — The Food and Drug Administration has approved a biosimilar drug made by Teva Pharmaceutical Industries for a condition that results from certain chemotherapy treatments, the drug maker said Thursday.

Teva announced the FDA approval of Tbo-filgrastim (XM02 filgrastim) for treating neutropenia, a condition in which the number of white blood cells is decreased, making patients more susceptible to life-threatening bacterial infections. The company sought approval using a biologics license application, or BLA, the same approval pathway used for novel biotech drugs because while the Patient Protection and Affordable Care Act created a regulatory approval pathway for biosimilars, the regulations have not yet been established.

Teva markets filgrastim in Europe under the trade name Tevagrastim, which is a biosimilar version of Amgen’s Neupogen. Teva plans to market tbo-filgrastim starting in November 2013, under an agreement with Amgen.

"As a company dedicated to bringing needed medicines to patients, we are delighted with the approval of tbo-filgrastim, which offers physicians and their patients undergoing chemotherapy a new supportive care treatment option," Teva president of global research and development and chief scientific officer Michael Hayden. "The approval of tbo-filgrastim demonstrates Teva’s strong commitment to providing patients with new treatment options. It expands upon Teva’s existing oncology portfolio with the addition of the first biologic and supportive care agent for oncology patients."


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Study: Aspirin regimen could benefit prostate cancer patients

BY Michael Johnsen

DALLAS — Men who have been treated for prostate cancer, either with surgery or radiation, could benefit from taking aspirin regularly, according to a multicenter study published in Tuesday’s issue of the Journal of Clinical Oncology.

The findings demonstrated that 10-year mortality from prostate cancer was significantly lower in a study group taking anticoagulants, compared with a group not taking anticoagulants — 3% as compared with 8%, respectively. The risks of cancer recurrence and bone metastasis also were significantly lower. Further analysis suggested that this benefit was primarily derived from taking aspirin, as opposed to other types of anticoagulants, noted study author Kevin Choe, assistant professor of radiation oncology at UT Southwestern.

The study looked at almost 6,000 men in the Cancer of the Prostate Strategic Urologic Research Endeavor database who had prostate cancer treated with surgery or radiotherapy. About 2,200 of the men involved — 37% — were receiving anticoagulants (warfarin, clopidogrel, enoxaparin and/or aspirin). The risk of death from prostate cancer was compared between those taking anticoagulants and those who were not.

“The results from this study suggest that aspirin prevents the growth of tumor cells in prostate cancer, especially in high-risk prostate cancer, for which we do not have a very good treatment currently,” Choe stated. “But we need to better understand the optimal use of aspirin before routinely recommending it to all prostate cancer patients.”


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Campbell’s celebrates Andy Warhol with limited-edition soup cans

BY Allison Cerra

CAMDEN, N.J. — To commemorate the 50th anniversary of Andy Warhol’s 1962 famed work, "32 Campbell’s Soup Cans," Campbell’s is rolling out limited-edition tomato soup cans that tout labels derived from original Warhol artwork.

The four specially-designed labels reflect Warhol’s pop-art style and use vibrant, eye-catching color combinations, such orange and blue, and pink and teal, Campbell’s said. The limited-edition cans were produced under license from The Andy Warhol Foundation, a not-for-profit corporation that promotes the visual arts.

"Campbell’s Condensed soup is an iconic brand. And thanks to Andy Warhol’s inspired paintings, Campbell’s soup will always be linked to the Pop Art movement," Campbell North America VP and general manager Ed Carolan said. "This fall, to honor the golden anniversary of his first gallery exhibit, we’ll celebrate Warhol and soup by releasing limited-edition Campbell’s Tomato soup cans and making Andy’s art available in the soup aisle of grocery stores."

The cans will be exclusively available at most Target locations nationwide beginning in September for 75 cents per 10.75-ounce can, while supplies last.

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