17 Nov 08 Ferumoxytol Resubmission Designated Complete, Class 1 Response By FDA - Iron Deficiency Anemia In Chronic Kidney Disease Patients

AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) has designated the Company’s resubmission to the October 2008 Complete Response letter for its New Drug Application (NDA) for ferumoxytol as a complete, Class 1 response. The FDA has established a December 30, 2008 Prescription Drug User Fee Act (PDUFA) target action date.
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Tags: Anemia, Chronic Kidney Disease, Disease Patients, Drug Application, Fda, Ferumoxytol, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Iron Anemia, Iron Deficiency, Iron Deficiency Anemia, Nasdaq, Nda, Pharmaceuticals Inc, Prescription Drug, Response Letter, Target Action

16 Oct 08 Phase I Clinical Trial Of ImmuFact IMP321 In Pancreatic Cancer Will Be Carried Out At Washington University In Saint Louis

Immutep S.A. announced today that the FDA, after review of the Investigational New Drug Application (IND), has allowed the administration of IMP321 in cancer patients in a Phase I trial conducted by Dr. William G. Hawkins at the Washington University School of Medicine in Saint Louis (MO).
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Tags: Cancer Patients, Clinical Trial, Dr William, Drug Application, Fda, Medicine, Pancreatic Cancer, Saint Louis Mo, School Of Medicine, Washington University In Saint Louis, Washington University School, Washington University School Of Medicine

04 Oct 08 GSK Update On FDA Review Of Promacta® (eltrombopag)

GlaxoSmithKline announced that the United States Food and Drug Administration (FDA)continues to review the new drug application for Promacta® (eltrombopag) beyond the September 19, 2008 action date. GSK continues to work closely with the FDA towards the approval of Promacta in order to provide physicians and chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients with a novel, once-daily oral option.
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Tags: Drug Application, Eltrombopag, Fda, Fda Approval, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Glaxosmithkline, Gsk, Itp Patients, Novel, Physicians, Promacta, United States

01 Oct 08 Arana Files IND For Lead Anti-Inflammatory Product ART621 In Rheumatoid Arthritis (RA) Indication

Biotechnology company Arana Therapeutics Limited (ASX: AAH) announced it has submitted an Investigational New Drug application (IND) to the FDA (U.S. Food and Drug Administration) for the anti-inflammatory product ART621 in a rheumatoid arthritis (RA) indication. The IND includes a Phase II dose ranging study of ART621/221 in RA which is planned to be an international multi-centred trial of approximately 200 patients.
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Tags: Anti Inflammatory, Arthritis, Asx, Biotechnology Company, Drug Application, Fda, Food And Drug, Food And Drug Administration, Inflammatory Arthritis, Lead, Limited, Phase Ii, Ra, Rheumatoid Arthritis

24 Sep 08 PolyMedix Initiates Dosing In Phase I Clinical Study Of Novel Anticoagulant Antagonist Compound

PolyMedix, Inc., an emerging biotechnology company developing new therapeutic drug products to treat infectious diseases and acute cardiovascular disorders based on biomimetics, has initiated dosing and commenced a Phase I clinical study in the U.S. with its anticoagulant reversing agent PMX-60056 under an Investigational New Drug application (IND) filed with the U.S. Food and Drug Administration (FDA).
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Tags: Antagonist, Biomimetics, Biotechnology Company, Cardiovascular Disorders, Drug Application, Fda, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Infectious Diseases, Novel, Therapeutic Drug

24 Sep 08 PolyMedix Initiates Dosing In Phase I Clinical Study Of Novel Anticoagulant Antagonist Compound

PolyMedix, Inc., an emerging biotechnology company developing new therapeutic drug products to treat infectious diseases and acute cardiovascular disorders based on biomimetics, has initiated dosing and commenced a Phase I clinical study in the U.S. with its anticoagulant reversing agent PMX-60056 under an Investigational New Drug application (IND) filed with the U.S. Food and Drug Administration (FDA).
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Tags: Antagonist, Biomimetics, Biotechnology Company, Cardiovascular Disorders, Drug Application, Fda, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Infectious Diseases, Novel, Therapeutic Drug

23 Sep 08 PolyMedix Initiates Dosing In Phase I Clinical Study Of Novel Anticoagulant Antagonist Compound

PolyMedix, Inc. (OTC BB: PYMX), an emerging biotechnology company developing new therapeutic drug products to treat infectious diseases and acute cardiovascular disorders based on biomimetics, has initiated dosing and commenced a Phase I clinical study in the U.S. with its anticoagulant reversing agent PMX-60056 under an Investigational New Drug application (IND) filed with the U.S. Food and Drug Administration (FDA).
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Tags: Antagonist, Biomimetics, Biotechnology Company, Cardiovascular Disorders, Drug Application, Fda, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Infectious Diseases, Novel, Otc Bb, Therapeutic Drug

23 Sep 08 Baxter Initiates Phase III Trial For The Treatment Of Alzheimer’s Disease

Baxter Healthcare Corporation announced initiation of a Phase III clinical trial following U.S. Food and Drug Administration (FDA) review of its investigational new drug application to evaluate GAMMAGARD LIQUID [Immune Globulin Intravenous (IGIV)], marketed as KIOVIG in European Union, for the treatment of mild-to-moderate Alzheimer’s disease.
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Tags: Alzheimer Disease, Alzheimer S Disease, Baxter Healthcare, Baxter Healthcare Corporation, Clinical Trial, Drug Application, European Union, Fda, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Igiv, Immune Globulin, Initiation, Phase Iii

17 Sep 08 Pro-Pharmaceuticals Submits Data For Registration Of DAVANAT(R) To Treat Late-Stage Colorectal Cancer Patients

Pro-Pharmaceuticals, Inc. (AMEX: PRW), a bio-pharmaceutical company developing proprietary polysaccharide-based therapeutic compounds to treat cancer, has submitted supporting clinical and manufacturing data to the U.S. Food and Drug Administration (FDA) for a New Drug Application (NDA) registration of DAVANAT®, a new chemical entity, for the treatment of advanced colorectal cancer.
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Tags: Advanced Cancer, Amex, Cancer Patients, Chemical Entity, Colorectal, Colorectal Cancer, Davanat, Drug Application, Fda, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Pharmaceutical Company, Pharmaceuticals Inc, Therapeutic Compounds