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clinical program
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XOMA Received Orphan Drug Designation for Its IL-1 Beta Modulating Antibody 'Gevokizumab'
Feb 27, 2014US-based XOMA Corporation (XOMA) has received Orphan Drug Designation from the US Food and Drug Administration (FDA) for its IL-1 beta modulating antibody 'gevokizumab' for the treatment of pyoderma gangrenosum (PG). Gevokizumab is a ...
Tags: Orphan Drug, Medicine
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DCRI Has Been Selected by Oxygen Biotherapeutics to Conduct The Phase III Clinical Trial
Dec 13, 2013Duke University’s Duke Clinical Research Institute (DCRI) has been selected by Oxygen Biotherapeutics, a pharmaceutical company, to conduct the Phase III clinical trial of the company’s newly acquired compound, levosimendan. ...
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Favorable Results of Precision Spectra Spinal Cord Stimulator System Is Reported by Boston
Dec 11, 2013Boston Scientific has reported favorable results assessing real-world experience with the Precision Spectra spinal cord stimulator system. New retrospective data highlighting the Boston Scientific Precision Spectra spinal cord stimulator ...
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BSDI Engaged in a Positive Meeting with The US Food and Drug Administration
Dec 5, 2013BioDelivery Sciences International (BSDI) announced that it engaged in a positive meeting with the US Food and Drug Administration (FDA) regarding the clinical development program for Clonidine topical gel that will allow the program to ...
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US FDA Has Cleared The Company's Investigational New Drug (Ind) Application for Aerosurf
Nov 14, 2013Discovery Laboratories, a specialty biotechnology company dedicated to advancing a new standard of respiratory critical care, has announced that the US Food and Drug Administration (FDA) has cleared the company's investigational new drug ...
Tags: Discovery Labs, Medicine
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H Lundbeck Has Expanded Its Current Alliance with Otsuka Pharmaceutical
Nov 5, 2013H Lundbeck has expanded its current alliance with Otsuka Pharmaceutical (Otsuka) to include development and commercialization of nalmefene in Japan. Earlier in 2013, nalmefene was approved by the European Medicines Agency (EMA) as the ...
Tags: Lundbeck, Otsuka Pharmaceutical
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Loxo Oncology Acquired Rights to This Program From Array Biopharma
Oct 30, 2013US-based Loxo Oncology has announced that its lead clinical program is a potent and selective inhibitor of the Trk family of receptor tyrosine kinases. Loxo Oncology acquired rights to this program from Array Biopharma, which had pursued ...
Tags: Loxo Oncology, Medicine
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Alzheon Announced The Launch of The Company,The Securing of Initial Private Financing
Oct 28, 2013Alzheon announced the launch of the company, the securing of initial private financing, and the signing of an exclusive license agreement to a novel clinical drug candidate for Alzheimer’s disease, a family of analogs, and a drug ...
Tags: Alzheon, Alzheimer's Disease
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Cardiosonic Announced It Is Currently Enrolling Patients in The TIVUS II Clinical Trial
Oct 21, 2013Israel-based Cardiosonic announced it is currently enrolling patients in the TIVUS II clinical trial, designed to assess the safety, efficacy and performance of its TIVUS system using a next generation multidirectional catheter. TIVUS ...
Tags: Cardiosonic, Clinical Trial
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Collegium Pharmaceutical Has Announced That a Patent Has Been Issued by USPTO
Oct 21, 2013Collegium Pharmaceutical, a specialty pharmaceutical company, has announced that a patent has been issued by the US Patent and Trademark Office (USPTO) covering its Oxycodone DETERx formulation. Additionally, an application has been ...
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Novo Nordisk Has Received Biologics Licence Application Approval From FDA
Oct 18, 2013Danish pharmaceutical firm Novo Nordisk has received biologics licence application (BLA) approval from the US Food and Drug Administration (FDA) for its recombinant coagulation factor VIII, Novoeight. Novoeight is intended for adults and ...
Tags: Novo Nordisk, Drug
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The FDA Has Granted Orphan Drug Designation for LUM001 Clinical Program
Sep 29, 2013The US Food & Drug Administration (cof Orphan Product Development has granted orphan drug designation for Lumena Pharmaceuticals' LUM001 clinical program. Lumena obtained orphan designation for LUM001 in four rare cholestatic liver ...
Tags: Orphan Drug, Rare Liver Diseases
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EMA Gives Positive Opinion to Novo Nordisk for Novoeight
Sep 24, 2013Danish pharmaceutical company Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing approval for its NovoEight (turoctocog alfa), ...
Tags: Novo Nordisk, Novoeight
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HMS Wholly Owned Subsidiary Has Launched HMS Integritysource Payment Integrity Suite
Aug 22, 2013HMS Holdings wholly owned subsidiary has launched HMS IntegritySource payment integrity suite for commercial and government healthcare payers. Aimed to deliver 'one data source, many solutions', HMS IntegritySource's key components ...
Tags: HMS, Healthcare Payers
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Medtronic Submitted Its PMA for The IN.PACT Admiral Drug-Eluting Balloon
Aug 19, 2013Medtronic has submitted its first pre-market approval (PMA) module to the U.S. Food and Drug Administration (FDA) for the IN.PACT Admiral drug-eluting balloon designed to treat atherosclerotic lesions in the superficial femoral artery ...
Tags: Medtronic, Admiral Drug-Eluting
