News
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Lubiprostone Meets Primary Endpoint In Phase 3 Clinical Trial For Opioid-Induced Bowel Dysfunction (OBD)
2/3/2012
Sucampo Pharmaceuticals, Inc. (SPI) and Takeda Pharmaceuticals U.S.A., Inc. announced recently that lubiprostone met the primary endpoint in a phase 3 clinical trial for the treatment of opioid-induced bowel dysfunction (OBD) in patients with chronic, non-cancer pain, excluding those taking methadone.
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Neuralstem's NSI-189 Trial In Major Depressive Disorder Receives FDA Approval To Advance To Phase Ib
12/27/2011
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).
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Isis Adds Three New Drugs To Its Development Pipeline
12/16/2011
Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today that it has added three new drugs to its development pipeline, ISIS-APOARx, ISIS-DGAT2Rx and ISIS-FVIIRx.
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Frontage Hosts Pharmaceutical Globalization Workshop In Beijing
11/22/2011
Frontage Laboratories, Inc., a fully integrated global provider of drug development services recently hosted the 3rd Annual Chinese Pharmaceutical Products Globalization Seminar in Beijing, China.
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Merck Announces Presentation Of Phase III Investigational Studies Evaluating DULERA® (Mometasone Furoate And Formoterol Fumarate Dihydrate) Inhalation Aerosol in Chronic Obstructive Pulmonary Disease (COPD)
10/27/2011
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from two 26-week investigational Phase III clinical studies evaluating the efficacy and safety of two dose strengths of DULERA® (mometasone furoate and formoterol fumarate dihydrate) in adults 40 years and older with moderate to very severe chronic obstructive pulmonary disease (COPD).
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Biogen Idec And Elan Receive Notification Of PDUFA Date Extension
10/20/2011
Today Biogen Idec and Elan Corporation, plc announced that the U.S. Food and Drug Administration (FDA) has extended the initial PDUFA date for its review of the supplemental Biologics License Application (sBLA) for TYSABRI® (natalizumab).
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vRad Announces Clinical Trials Partnership With ICON Medical Imaging
10/18/2011
Virtual Radiologic (vRad), a technology-enabled national radiology practice, has announced a premier radiology partnership with ICON Medical Imaging (ICON), the medical imaging division of ICON plc.
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BARDA Funds Development Of Five Drugs To Protect Against Radiation
9/30/2011
The development of five new drugs to treat injuries associated with acute radiation syndrome will move forward under contracts awarded by the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA).
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Aastrom Announces Agreement From FDA On Special Protocol Assessment For Phase 3 Clinical Trial In No-Option Critical Limb Ischemia Patients
8/1/2011
Aastrom Biosciences, Inc. , the leading developer of patient-specific, expanded multicellular therapies for the treatment of severe, chronic cardiovascular diseases, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on the Special Protocol Assessment (SPA) for the design of the Phase 3 REVIVE-CLI clinical trial of ixmyelocel-T, the company's expanded multicellular therapy, in patients with critical limb ischemia (CLI) who have no other treatment options.
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The Lancet Publishes Clinical Trial Data That Demonstrate Statistically Significant And Dose-Dependent Expression Of Dystrophin In Duchenne Muscular Dystrophy Patients Treated With AVI BioPharma's Eteplirsen
8/1/2011
AVI BioPharma, Inc., (NASDAQ: AVII), a developer of RNA-based therapeutics, today announced that data published in The Lancet from a Phase 1b/2 study of eteplirsen, the Company's exon-skipping therapy for the treatment of Duchenne muscular dystrophy (DMD), demonstrate that the treatment was well tolerated and was shown to induce statistically significant and dose-dependent improvements in dystrophin expression in patients.
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