United States

OncoGenex’s Spruce trial open for enrollment

Tuesday, August 6, 2013 10:30 AM

OncoGenex Pharmaceuticals has initiated the Spruce clinical trial, an investigator-sponsored, randomized, double-blind, placebo-controlled phase II trial evaluating OGX-427, a heat shock protein 27 (Hsp27) inhibitor, in patients with previously untreated advanced non-squamous non-small cell lung cancer (NSCLC).

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PharmAthene, Theraclone Sciences merge

Monday, August 5, 2013 11:58 AM

PharmAthene and Theraclone Sciences, a privately-held monoclonal antibody (mAb) discovery and development company, have signed a definitive merger agreement.

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DIA names Barbara Lopez Kunz global chief executive

Thursday, August 1, 2013 12:00 PM

DIA, a neutral, global, professional member-driven association of nearly 18,000 professionals involved in the discovery, development and life cycle management of pharmaceuticals, biotechnology, medical devices and related healthcare products, has named Barbara Lopez Kunz global chief executive, to lead the organization beginning in September. Kunz brings worldwide leadership experience to DIA as former president of the global health and life sciences business at Battelle, an international science and technology nonprofit organization that explores emerging areas of science, develops and commercializes technology and manages laboratories.

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SAGE Therapeutics awarded NIH grant for Fragile X Syndrome

Thursday, August 1, 2013 10:30 AM

The NIH has granted SAGE Therapeutics, a neuroscience product-focused company creating novel medicines to treat central nervous system (CNS) disorders, an award potentially worth up to $10 million to support the company's development of a novel drug which could be used to treat anxiety and social deficits in patients with Fragile X Syndrome (FXS).

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Actelion to acquire Ceptaris

Thursday, August 1, 2013 10:00 AM

San Francisco, Calif.-based pharmaceutical company Actelion will acquire Ceptaris Therapeutics, contingent upon certain closing conditions, including FDA approval of Ceptaris' product, VALCHLOR.

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Array BioPharma, Celgene announce collaboration

Wednesday, July 31, 2013 11:49 AM

Array BioPharma will collaborate with New Jersey-based biopharmaceutical company Celgene for an Array-invented preclinical development program targeting a novel inflammation pathway.  Array will receive an up-front payment of $11 million and Celgene will have an exclusive option to license multiple clinical development candidates. Array is entitled to receive potential milestone payments of up to $376 million based upon achieving certain development, regulatory and sales objectives. Array is also entitled to receive royalties on net sales of all drugs and will retain all rights to the program if Celgene does not exercise its option.

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Medistem collaborates with Boston academic researcher

Wednesday, July 31, 2013 11:45 AM

Medistem, developer of Endometrial Regenerative Cell (ERC), a universal donor adult stem cell product, will collaborate with Reza Abdi, M.D., transplant nephrologist at Brigham and Women's Hospital and assistant professor of medicine, Harvard Medical School. The company will provide Abdi with its ERCs and it is expected that his research would support FDA clearance to initiate clinical trials to use ERCs as a treatment for type 1 diabetes. The company has FDA clearance to initiate a dose-escalating phase I clinical trial to use ERCs in patients with critical limb ischemia, a complication of diabetes.

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AMC Health taps former Beardsworth CEO to head newly formed clinical trials division

Tuesday, July 30, 2013 01:42 PM

New York City-based AMC Health, a provider of end-to-end telehealth solutions, has named Michael J. O’Brien president of its Clinical Trials Division, signaling the company’s commitment to expand telemonitoring into broader areas of healthcare. O’Brien will leverage his 30 years of broad-based C-suite experience in the life sciences and information technology industries to meet the surging demand for innovative telemonitoring offerings in clinical drug development.

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HealthCarePoint and ViS Research streamline sharing of researcher qualifications

Tuesday, July 30, 2013 01:26 PM

Austin, Texas-based HealthCarePoint  and ViS Research will connect platforms to improve cost-efficiency in clinical research. The partnership will allow clinical trial planners to quickly access clinical research professionals’ Personal Experience and Training (PET) records through the ViS platform and give clinical research sites access to human resource management systems hosted by HealthCarePoint at no cost.

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BioDelivery Sciences names Adrian Hepner vice president

Tuesday, July 30, 2013 12:00 PM

Pharmaceutical company BioDelivery Sciences International (BDSI), headquartered in Raleigh, N.C., has hired Adrian Hepner, M.D., Ph.D., as vice president of clinical research and regulatory affairs. Hepner joins BDSI with over 20 years of experience in U.S. and international clinical research and drug development, including development and implementation of the clinical and regulatory strategy for a number of products from early stage development through NDA and E.U. regulatory filings.

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