FDA approves Novartis drug Afinitor for breast cancer

Reuters – 6 mins ago (Reuters) - The U.S. Food and Drug Administration said on Friday it has approved Novartis AG's drug Afinitor to treat women with a certain type of breast cancer.

The drug is the first in a class known as mTOR inhibitors to be approved for post-menopausal women with advanced hormone-receptor positive, HER2-negative breast cancer.

Afinitor, also known as everolimus, is designed to be given in combination with another drug, Aromasin, to treat women whose cancer has recurred or progressed after treatment with two other therapies.

A late-stage trial showed that patients who received Afinitor plus Aromasin had a 4.6 month improvement in the median time to disease progression or death over those receiving Aromasin plus a placebo, the FDA said.

Afinitor is already approved to treat patients with certain other types of cancer.

(Reporting By Toni Clarke; editing by Carol Bishopric)

View the Original article

FDA says unsure if Novartis MS pill caused deaths

Reuters – 24 mins ago (Reuters) - The U.S. Food and Drug Administration said it could not conclude that Novartis AG's multiple sclerosis pill Gilenya was related to unexplained deaths of patients, but it remains concerned about the cardiovascular effects of the drug after the first dose.

In recent months, doctors have grown more cautious about the drug following reports of heart problems in some patients and the death of one person in the United States within 24 hours of starting treatment.

A committee of European Medicines Agency concluded last month that the benefits of the drug continue to outweigh its risks, but along with the FDA sought stronger warnings on heart risks.

(Reporting by Anand Basu in Bangalore; Editing by Saumyadeb Chakrabarty)

View the Original article

EU OKs Novartis drug Signifor for Cushing's disease

"http://l.yimg.com/bt/api/res/1.2/BbcqzUA_ziBWVkI4Z9QzUw--/YXBwaWQ9eW5ld3M7Zmk9ZmlsbDtoPTcwO3E9ODU7dz03MA--/http://media.zenfs.com/en_us/News/afp.com/000_Par6611212.jpg" width

View the Original article