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Astellas, Medivation cancer drug wins FDA approval

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Astellas Pharma U.S. and Medivation for treating prostate cancer, the agency said Friday.

The FDA announced the approval of Xtandi (enzalutamide) for castration-resistant prostate cancer that has spread or recurred despite medical or surgical therapy to minimize testosterone.

"The need for additional treatment options for advanced prostate cancer continues to be important for patients," FDA Office of Hematology and Oncology Products director Richard Pazdur said. "Xtandi is the latest treatment for this disease to demonstrate its ability to extend a person’s life."

About 241,740 men will be diagnosed with prostate cancer, and 28,170 will die from it this year, according to the National Cancer Institute, part of the National Institutes of Health.


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Bayer HealthCare brings OTC migraine relief to analgesic shelves

BY Michael Johnsen

MORRISTOWN, N.J. — Bayer HealthCare’s Consumer Care Division on Tuesday introduced Bayer Migraine Formula, an over-the-counter medication designed to relieve migraine pain and accompanying symptoms like nausea, phonophobia (sound sensitivity) and photophobia (light sensitivity) through a formulation of aspirin, acetaminophen and caffeine.

"Consumers have been extremely vocal about the lack of OTC options tough enough to target throbbing migraine pain," stated Reese Fitzpatrick, Bayer Aspirin director marketing. The new formula contains the same three active ingredients and dosages for migraine relief as Novartis’ Excedrin Migraine, which became unavailable earlier this year, Bayer noted.

Bayer Migraine Formula will be packaged in a 50-count or 200-count bottle of coated caplets.


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Valeant buys Medicis for $2.6 billion

BY Alaric DeArment

MONTREAL — Canadian drug maker Valeant Pharmaceuticals International is buying Medicis Pharmaceutical for $2.6 billion, Valeant said Monday.

The $44-per-share deal, which the companies said represents a 39% premium over the closing price of Medicis’ shares on Friday, is expected to close in the first half of 2013.

"The acquisition of Medicis represents a significant next step in our journey to become the leader in dermatology by strengthening Valeant’s presence in acne, actinic keratosis, aesthetic injectables and antivirals, among others," Valeant chairman and CEO J. Michael Pearson said. "Medicis’ highly complementary portfolio of leading branded products and promising pipeline is a solid strategic fit, and we look forward to leveraging Medicis’ well-known and respected name in dermatology to drive long-term growth."

Medicis manufactures drugs for such conditions as acne, bacterial infections and skin wrinkles.


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