Articles Published in 2011

Cytonet’s SELICA III trial expands to Canada

Wednesday, October 19, 2011 10:58 AM

Canadian health authority, Health Canada, recently granted Cytonet approval to extend the SELICA III trial, which has been open in the United States since 2010, into Canada.

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Kaiser joins Covance

Wednesday, October 19, 2011 10:48 AM

Covance has named Raymond Kaiser, Ph.D., global science leader and vice president for biotechnology services. Kaiser will replace Dr. Carl Martin, who will be retiring from this role, after 35 years with Covance.

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GENFIT names Larue executive VP, biomarkers

Wednesday, October 19, 2011 10:30 AM

GENFIT, a biopharmaceutical company, has named Dr. Catherine Larue executive vice-president, biomarkers.

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IDRI joins ADITEC to accelerate human vaccine development

Tuesday, October 18, 2011 02:19 PM

The Infectious Disease Research Institute (IDRI) has joined the Advanced Immunization Technologies (ADITEC) program, a collaborative initiative dedicated to accelerating the development of the next generation of human vaccines. Launched on October 1st, ADITEC will operate with 30 million euros in funding over the course of 5 years contributed by the European Union, with an additional 11 million euros in funding from collaborating organizations.

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Oracle launches OutcomeLogix On Demand 3.0

Tuesday, October 18, 2011 02:10 PM

Oracle Health Sciences has launched Oracle Health Sciences OutcomeLogix On Demand 3.0, a web-based, scalable data collection system that enables life science companies and contract research organizations to efficiently capture accurate therapy outcome information from health care providers, as well as patients in late-stage studies.

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Larus joins Clinipace Worldwide

Tuesday, October 18, 2011 02:04 PM

Clinipace Worldwide has named John Larus executive vice president of clinical operations. In this newly created position, John reports directly to Chris Porter, chief operating officer, and is responsible for providing leadership and direction to the project management, clinical monitoring and safety groups within the U.S. clinical operations unit.

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TOPICA secures $27 million in Series B funding

Tuesday, October 18, 2011 01:52 PM

TOPICA Pharmaceuticals has raised $27 million in a Series B financing, led by Third Rock Ventures and existing investors Prospect Venture Partners and Yasuda Enterprise Development. Proceeds of the financing will be used to advance the company's broad-spectrum topical antifungal agent, luliconazole, for the treatment of onychomycosis, fungal infections of the nail.

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Cubist Pharmaceuticals names senior VP

Tuesday, October 18, 2011 10:06 AM

Cubist Pharmaceuticals has named Jennifer Jackson, Ph.D., senior vice president of regulatory affairs. Jackson will oversee all facets of Cubist’s regulatory affairs, providing oversight for all U.S. and international regulatory matters, including filings and interactions with regulatory authorities. Jackson will report to Steve Gilman, Ph.D., Cubist’s executive vice president of research and development and chief scientific officer.

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Panmira names Kumar CEO

Tuesday, October 18, 2011 10:01 AM

Panmira Pharmaceuticals has named Hari Kumar, PhD, chief executive officer. Until recently, Kumar served as chief business officer of Amira Pharmaceuticals.

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Roche’s Herceptin phase III trial shows positive results

Tuesday, October 18, 2011 09:45 AM

Halozyme Therapeutics has reported that the phase III HannaH trial, conducted by Roche, showed that women with HER2-positive early breast cancer who received a new, investigational subcutaneous (SC) injection of Herceptin (trastuzumab), experienced comparable results to Herceptin given as an intravenous (IV) infusion. The SC administration takes around 5 minutes to administer whereas the IV formulation (the current standard) takes around 30 minutes to infuse. Since the subcutaneous administration is an injection under the skin it may allow patients to spend less time in hospital receiving their treatment versus the intravenous method. The ready to use formulation may also significantly reduce pharmacy time as no medicine preparation time is required.

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December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

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January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

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December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

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