Articles Published in 2012

Synthetic completes acquisition of C. difficile infectious disease program

Tuesday, December 4, 2012 08:00 AM

Synthetic Biologics, an Ann Arbor, Mich.-based developer of synthetic biologics and innovative medicines for serious infections and diseases, has closed the previously announced deal with Prev AbR and acquired a series of beta-lactamase compounds (P1A, P2A and P3A) and related assets targeting the prevention of Clostridium difficile (C. diff) infection.

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WIRB Copernicus Group

Omeros appoints Mitro as vice president, sales and marketing

Tuesday, December 4, 2012 08:00 AM

Omeros, a Seattle, Wash.-based clinical-stage biopharmaceutical company focused on products targeting inflammation, coagulopathies and disorders of the central nervous system, has appointed Thomas A. Mitro as vice president of sales and marketing.

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CRF Health eCOA webinar series

AVEO, Astellas initiate phase II trial in triple negative breast cancer

Monday, December 3, 2012 02:11 PM

AVEO Oncology, a Cambridge, Mass.-based cancer therapeutics company, and Astellas Pharma, A Tokyo-based a pharmaceutical company, have initiated patient enrollment in a phase II trial evaluating the efficacy of tivozanib, an investigational drug, in combination with paclitaxel in patients with locally recurrent or metastatic triple negative breast cancer.

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OHE releases new study on pharmaceutical R&D costs

Monday, December 3, 2012 01:33 PM

The Office of Health Economics has released a comprehensive study of the cost of R&D for new medicines. It reviews research published over the last three decades, which shows an increase in costs from $199 million per new medicine in the 1970s to $1.9 billion in the 2000s. An OHE costs analysis based on new data for 1998-2002 agrees with comparable analyses for the same time period.

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NextPharma completes sale of U.S. affiliate

Monday, December 3, 2012 12:44 PM

NextPharma Technologies Holding, a contract manufacturer in Europe, has completed the sale of Bioserv, its U.S. affiliate based in San Diego, to KESA Partners.

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PAREXEL, NTUH to support clinical research in Taiwan

Monday, December 3, 2012 12:17 PM

PAREXEL International, a global biopharmaceutical services provider, and the National Taiwan University Hospital (NTUH) have established a collaboration to provide drug development services in Taiwan.

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FDA, new MDIC to develop regulatory science to speed access to medical devices

Monday, December 3, 2012 11:48 AM

The FDA has become part of the first public-private partnership to promote medical device regulatory science with a focus on speeding the development, assessment and review of new medical devices.

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Volcano to acquire Crux Biomedical

Monday, December 3, 2012 11:21 AM

Volcano, a developer and manufacturer of precision guided therapy tools for treatment of coronary and peripheral vascular disease, has signed an agreement to acquire Crux Biomedical, a privately-held company that has developed a highly differentiated inferior vena cava (IVC) filter—the Crux VCF System—to treat pulmonary embolisms (PE's).

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Hovione, Solvias collaborate to provide for improved drug solubility

Monday, December 3, 2012 10:54 AM

Hovione, a global group dedicated to the cGMP development and manufacture of APIs, and Solvia, a privately held solutions provider based in Basel, Switzerland, have established a collaboration focused on the development and GMP supply of pharmaceutical co-crystals.

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Cromsource appoints Milla as global head of medical division

Monday, December 3, 2012 10:25 AM

Cromsource, an international full service CRO, has appointed Dr. Christian Milla as global head of the medical division. Milla will also take responsibility for Cromsource operations in France as country manager.

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July 21

As job growth in drug development sector soars, more employees are seeking new opportunities

U.K. study: Prisoners should have the right to participatein clinical trials on moral grounds, for healthcare access

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IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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CRO market poised for growth and consolidation
Sponsors expanding pipelines, shrinking infrastructure fuel strategic outsourcing

Strategies for success evolving in phase I space
Sites see increasing complexity, more patients, greater focus on efficacy

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