Pluristem applies for U.S. approval of bone marrow drug

TEL AVIV (Reuters) – Pluristem Therapeutics Inc will apply to the U.S. Food and Drug Administration for approval of its placenta-based stem cell treatment for aplastic bone marrow as an orphan drug or rare disease treatment, it said on Monday. Gaining orphan drug status is part of Pluristem’s strategy for penetrating the bone marrow recovery market, starting with treatment of aplastic anaemia, a disease that affects five to 10 people in every million. …

FDA OKs Onyx’s Kyprolis for multiple myeloma

WASHINGTON (Reuters) – U.S. drug regulators approved Onyx Pharmaceuticals Inc’s Kyprolis for people with a type of blood cancer that has failed to respond to other medicines. The U.S. Food and Drug Administration said on Friday the intravenous drug was approved for treating multiple myeloma in people who have tried at least two other medicines, including Takeda Pharmaceutical Co Ltd’s Velcade and Celgene Corp’s Revlimid or Thalomid. Multiple myeloma, a type of cancer that affects the plasma cells in bone marrow, is relatively rare in the United States but often deadly. …

FDA approves Novartis drug Afinitor for breast cancer

(Reuters) – The U.S. Food and Drug Administration on Friday approved Novartis AG 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. The European Medicines Agency in June also endorsed Afinitor as a breast cancer treatment. …

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