United Therapeutics Announces Hypertension Drug Approval in Europe

SILVER SPRING, Md. and CHERTSEY, England, Dec. 27, 2011 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) and its wholly-owned subsidiary, United Therapeutics Europe, Ltd., announced today that the French regulatory agency Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) has approved intravenous use of Remodulin® (treprostinil) for the treatment of pulmonary arterial hypertension (PAH). Remodulin is already approved in most of Europe for the continuous subcutaneous infusion treatment of idiopathic or heritable PAH to improve exercise tolerance and symptoms of the disease in patients classified as New York Heart Association (NYHA) functional class III. The AFSSAPS' approval follows a review period during which 22 European member nations, each of which had previously approved subcutaneous Remodulin through the mutual recognition process, reviewed and endorsed the final variation assessment report (FVAR) issued by AFSSAPS, which will allow the use of the intravenous route of delivery to the Remodulin in the labeling in those nations.

Rockville Biomed Firm Advances Neuroregenerative Drug to Phase Ib Clinical Trial for Depression

ROCKVILLE, Md., Dec. 27, 2011 /PRNewswire/ -- Neuralstem, Inc. (NYSE Amex: CUR) announced that it has been approved by the Food and Drug Administration to advance to Phase Ib in its ongoing clinical trial to test its novel neuroregenerative compound,NSI-189, for the treatment of major depressive disorder (MDD). Phase Ib will test the safety and tolerability of the drug in depressed patients. NSI-189 is a proprietary new chemical entity discovered by Neuralstem that stimulates new neuron growth in the hippocampus, an area of the brain that is believed to be involved in MDD as well as other diseases and conditions, such as Alzheimer's disease and post-traumatic stress disorder (PTSD).