WORCESTER -- Advanced Cell Technology, Inc. (OTCBB: ACTC – News), a biotechnology company applying cellular technology in the field of regenerative medicine, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the company’s MA09-hRPE

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BRISBANE, Calif. -- InterMune, Inc. (Nasdaq: ITMN) today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF) in the European

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NEW ORLEANS -- C1-esterase inhibitor (C1-INH) concentrate is an effective, well-tolerated therapy that rapidly relieves acute swelling attacks and successive attacks at any body location in patients with hereditary angioedema (HAE), a rare and serious genetic disorder, according to data presented

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ALLSCHWIL/BASEL, SWITZERLAND -- Actelion Ltd (SIX: ATLN) today announced the initial results of BUILD-3, a clinical study evaluating the safety and efficacy of bosentan in patients suffering from idiopathic pulmonary fibrosisWhile there was a consistent trend in favor of bosentan, the primary endp

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Cambridge, MA -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for VPRIV, a human cell line derived enzyme replacement therapy (ERT) for the long-term treatment of

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CAMBRIDGE, Mass. -- ARIAD Pharmaceuticals, Inc. today announced that its investigational pan-BCR-ABL inhibitor, AP24534, has been granted orphan drug designation by both the U. S. Food and Drug Administration (FDA) and the European Medicines Agency (EMAIn the U.S., the orphan designation of AP2453

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QUEBEC CITY -- Æterna Zentaris Inc. ( AEZS, TSX:AEZ) (the "Company"), a late-stage drug development company specialized in oncology and endocrinology, today announced that it has received a positive opinion for orphan medicinal product designation for its compound perifosine from the Keryx B

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WHITE OAK, Md. -- In recognition of World Rare Disease Day, the U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced a more streamlined process to help regulators better identify and share information throughout the development process of orphan drug and Both a

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DUBLIN -- Research and Markets (http://www.researchandmarkets.com/research/eaee20/orphan_drugs_in_as) has announced the addition of the "Orphan Drugs in Asia 2010: Guidelines and Regulatory Requirements to Help Orphan Drug Products Enter the Asian Market" report to their offeringFollowing the exam

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SCOTTSDALE, Ariz. -- Cancer researchers have high hopes for a new therapy for patients with certain types of lymphoma and leukemiaPCI-32765 is a new drug being assessed in a Phase I clinical trial at the Virginia G. Piper Cancer Center in collaboration with the Clinical Division of the Translation

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