Business Wire
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Paratek Pharmaceuticals Strengthens Senior Leadership Team
6/4/2015
Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) today announced the addition of two experienced pharmaceutical executives to the company's senior leadership team to meet the company's growing needs as it advances the development program for its lead investigational antibiotic, omadacycline, and as it expands the company's pre-commercialization capabilities.
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BioInvent Receives Clinical Milestone In Partner Program
7/8/2013
BioInvent International (OMXS:BINV) today announces that it will receive a milestone payment in connection with a partner’s start of a phase I clinical study using a n-CoDeR® antibody.
BioInvent’s pipeline of external drug programmes consists of another seven antibodies in pre-clinical development of which additional candidates are expected to enter clinical trials in 2013.
Cristina Glad, CEO of BioInvent, commented: “The advancement by one of our partners of an n-CoDeR® antibody into the clinic is an important step forward for BioInvent. Progress in our external drug programmes is a key driver for BioInvent’s development.”
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Spanish Biotech PharmaMar Selects Medidata Clinical Cloud To Accelerate Trials For Marine-Based Oncology Drugs
3/18/2013
PharmaMar, a Spanish biopharmaceutical company, has selected Medidata Solutions (NASDAQ: MDSO) for its industry-leading electronic data capture (EDC) and clinical data management (CDM), safety data capture and reporting, and medical coding solutions. A member of the Zeltia Group and a leader in the development of antitumor drugs of marine origin, PharmaMar said the company’s investment in the Medidata Clinical Cloud™ will efficiently streamline its clinical trial processes in its mission to deliver drugs that treat cancer and rare ("orphan") diseases.
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Spectrum Pharmaceuticals Appoints Lee F. Allen, M.D., Ph.D., Industry Veteran, As Chief Medical Officer
3/18/2013
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced the appointment of Lee F. Allen, M.D., Ph.D., as Chief Medical Officer. Dr. Allen will be responsible for leading the clinical development of Spectrum’s product pipeline, including belinostat, for which the Company anticipates an NDA filing mid-year, apaziquone, and glycol-free formulation of melphalan for both of which the NDA filings are expected in 2014. Dr. Allen brings over 15 years of biotech and pharma experience, as well as over 10 years of extensive research experience with over 40 papers published. He will report to Ken Keller, Executive Vice President and Chief Operating Officer. Spectrum also announced today that Dr. Steve Fruchtman, previously Chief Medical Officer at Spectrum, will take on the new role of Senior Vice President, Hematology and Oncology R&D, as of March 18, 2013. In this newly created position, he will report directly to Dr. Allen.
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Cubist Announces Exclusive Option To Acquire Adynxx
2/25/2013
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) and Adynxx, Inc. announced today that they have entered into an option agreement under which Cubist has the exclusive right to acquire Adynxx following the data readout of Adynxx’s Phase 2 trial for its lead product candidate, AYX1.
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Concert Pharmaceuticals Announces Completion of Enrollment in Phase 2 CTP-499 Clinical Trial
2/19/2013
Concert Pharmaceuticals, Inc. announced today that it has completed enrollment of patients in a Phase 2 clinical trial evaluating CTP-499 for the treatment of diabetic kidney disease. CTP-499 is intended to slow progression of kidney damage in diabetic kidney disease and be additive to the current standard of care, which is treatment with an angiotensin converting enzyme inhibitor (ACEi) and/or an angiotensin receptor blocker (ARB). Concert expects to report top-line results from the Phase 2 study during the second-half of 2013.
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Wingspan Adds ICON As eTMF Client
11/20/2012
ICON Selects Wingspan eTMF as Its Preferred System in Its Efforts towards Paperless Clinical Trials.
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DSP Clinical President And Founder Darlene Panzitta Named To The PharmaVOICE 100 List Of The Most Influential People In Life Sciences Industries
8/13/2012
Darlene Panzitta, President and Founder of DSP Clinical, is among this year's PharmaVOICE 100 List of the most influential people in lifes sciences industries.
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Approval Of US Pilot Clinical Trial To Evaluate AclarusDx™, The Exonhit Investigational Test For Alzheimer's Disease Diagnosis
10/27/2011
Exonhit (Paris:ALEHT) announced today the Institutional Review Board (IRB) approval of Exonhit sponsored pilot clinical trial aimed at evaluating the performance of AclarusDx™, a blood based investigational diagnostic test, in US-based patients suffering from memory impairment and newly referred to a reference Memory Center for Alzheimer’s Disease (AD) diagnostic workup. This study will be conducted by the Cleveland Clinic Lou Ruvo Center for Brain Health.
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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).