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. …

Pfizer’s Lyrica does not hurt sperm in study

(Reuters) – Pfizer Inc said a clinical study found its Lyrica nerve pain treatment did not affect sperm production in men taking the pill. The drugmaker conducted the study of more than 200 men as a requirement of the U.S. Food and Administration for approving Lyrica, which is one of Pfizer’s biggest-selling medicines. Lyrica, also known as pregabalin, is used for diabetic nerve pain, pain after shingles and seizures for epilepsy sufferers, among other conditions. Pfizer last week won a U.S. court case protecting Lyrica’s patent that stands to keep generic rivals at bay until 2018. …

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