United States

Intarcia creates vice president and global head of regulatory affairs

Thursday, July 18, 2013 10:02 AM

Biopharmaceutical company Intarcia Therapeutics has hired Dr. Eddie Li to the newly created position of vice president and global head of regulatory affairs. Li brings more than 20 years of experience in regulatory affairs to Intarcia and will be a member of the executive team overseeing the advancement of ITCA 650 (continuous subcutaneous delivery of exenatide) toward successful registration in key markets around the world. ITCA 650 is the company's diabetes drug candidate currently in global phase III clinical trials for the treatment for type 2 diabetes.

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Ultragenyx gains worldwide rights for Triheptanoin

Thursday, July 18, 2013 09:30 AM

Ultragenyx, a privately held, clinical-stage biotechnology company, has expanded its exclusive license from Baylor Research Institute (BRI) in Dallas, Texas, to develop and commercialize triheptanoin outside North America. The global license includes rights to patents, patent applications and other intellectual property related to the composition and formulation of UX007, as well as its use in treating diseases including fatty acid oxidation disorders (FAOD), the lead indication being developed by the company.

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AstraZeneca, Tufts collaborate on neuroscience research

Thursday, July 18, 2013 09:00 AM

AstraZeneca, Tufts University's School of Medicine and Sackler School of Graduate Biomedical Sciences are collaborating to establish a team of postdoctoral researchers who will work to advance understanding of diseases and disorders of the brain, including Alzheimer's disease, Parkinson's disease, neurodevelopmental and autism spectrum disorders. As part of a three-year agreement, the new team will conduct laboratory research into biological targets of interest in neuroscience.

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Spectrum Pharmaceuticals acquires Talon Therapeutics

Wednesday, July 17, 2013 03:46 PM

Spectrum Pharmaceuticals, a commercial and drug development biotech company with a primary focus in hematology and oncology, will acquire Talon Therapeutics, a biopharmaceutical company based in South San Francisco, Calif.

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ThermoGenesis, TotipotentRx merge to form Cesca

Wednesday, July 17, 2013 01:12 PM

ThermoGenesis, a supplier of enabling technologies for the processing and storage of stem cells and other biological tissues, and TotipotentRx, a privately held  developer of  cell-based therapies in  regenerative medicine, have entered into a definitive merger agreement to form a new company called Cesca Therapeutics.

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UCSD enrolling in new arm of Parkinson's Progression Markers Initiative

Wednesday, July 17, 2013 12:26 PM

University of California, San Diego School of Medicine will be one of 23 official clinical sites of the Parkinson's Progression Markers Initiative's (PPMI) new arm to study at-risk populations for Parkinson's disease (PD). The $55 million landmark observational clinical study launched in 2010 to define one or more biomarkers of PD and now seeks to better understand potential risk factors of the disease. The university has been a part of PPMI for three years and currently is enrolling for the new, pre-motor arm of the study.

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Biovest completes restructuring, emerges from bankruptcy

Wednesday, July 17, 2013 12:15 PM

Biovest International, a developer of personalized cancer vaccines, has emerged from Chapter 11 reorganization, formally completing its restructuring and recapitalization strategy with its reorganization plan. It has promoted Carlos F. Santos, Ph.D., to chief executive officer. Santos will lead the company's transition from the clinical stage to the commercial stage.

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Pharmacyclics submits NDA for Ibrutinib

Tuesday, July 16, 2013 11:36 AM

Pharmacyclics, a clinical-stage biopharmaceutical company focused on developing and commercializing small-molecule drugs for the treatment of cancer and immune mediated diseases, based in Sunnyvale, Calif., has submitted a New Drug Application (NDA) to the FDA for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor, ibrutinib, for two relapsed/refractory B-cell malignancy indications: mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

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Flint D. Besecker joins Kinex as chief financial officer

Tuesday, July 16, 2013 11:00 AM

Kinex Pharmaceuticals, a specialty biotech focused on the development and commercialization of next generation oral therapies for cancer diseases, has appointed Flint D. Besecker to its executive team as chief financial officer and executive vice president. Besecker will have primary responsibility over all non-scientific aspects of Kinex, reporting to Kinex's chief executive officer, Dr. Johnson Lau. Flint has been an investor and board director of Kinex since 2011.

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Corgenix inks contract manufacturing deal with EDP Biotech

Tuesday, July 16, 2013 10:30 AM

Corgenix Medical, a worldwide developer and marketer of diagnostic test kits, has entered into a 10-year contract manufacturing agreement with EDP Biotech, a medical device company focused on the development and commercialization of immunodiagnostic tests for humans.

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