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FDA approves first new Hodgkin’s lymphoma treatment in 34 years

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has approved a new biotech drug for treating two types of lymphoma, the agency said Friday.

The FDA announced the approval of Seattle Genetics’ Adcetris (brentuximab vedotin) to treat Hodgkin’s lymphoma and a rare lymphoma called systemic anaplastic large-cell lymphoma. Adcetris combines an antibody with a drug, allowing the antibody to direct the drug to CD30, a target on lymphoma cells. The FDA said Adcetris was the first new treatment approved by the agency for HL since 1977 and the first approved specifically for ALCL.

The drug is designed for use by patients whose HL has progressed after stem-cell transplant or two chemotherapy treatments, as well as ALCL patients whose disease has progressed after one chemotherapy treatment.

"Early clinical data suggest that patients who received Adcetris for Hodgkin’s lymphoma and systemic anaplastic lymphoma experienced a significant response to the therapy," FDA Office of Oncology Products director Richard Pazdur said.

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HappyMe brings skin care line to mass retailers

BY Allison Cerra

LOS ANGELES — HappyMe announced that its skin care line now is available at mass retailers.

HappyMe, which touts a line of acne and anti-aging treatments, was first distributed at select Duane Reade stores. The products are free of parabens, sulfates and synthetic dyes.

HappyMe’s selection of skin care products includes:

  • Overnight pimple eliminator;

  • The natural acne wash;

  • Natural acne healing moisturizer SPF 15;

  • Skin support dietary supplement;

  • The natural acne correction system, which includes the natural acne wash, natural acne healing moisturizer and akin support dietary supplement;

  • Pore and fine line perfector and primer;

  • Hand repair SPF 30; and

  • Neck and chest repair SPF 30.

“HappyMe delivers the same results as high-end spa products for a fraction of the price,” HappyMe Skincare spokesman Jeff Schroeder said. “By taking the most effective aspects of skincare and combining them into a single product line, HappyMe is producing results beyond any other mainstream skin care system.”

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Report: Ranbaxy may sell generic Lipitor rights if unable to get FDA approval

BY Alaric DeArment

NEW YORK — While Indian generic drug maker Ranbaxy Labs is expected by many to launch a generic version of a cholesterol drug made by Pfizer later this year, it may have to sell its rights to it if it can’t win Food and Drug Administration approval in time, according to published reports.

Citing Credit Suisse analysts, Bloomberg reported that the FDA may delay approval of Ranbaxy’s version of Lipitor (atorvastatin), which would prevent it from marketing the drug starting Nov. 30, as it has planned to do.

Still, according to Bloomberg, the company — mostly owned by Japan’s Daiichi Sankyo — is in discussions with the FDA.

Lipitor is the world’s top-selling drug, with more than $7 billion in sales in the United States, according to IMS Health data.

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