ERT

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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ERT names Kleiman Chief Medical Officer

Friday, July 8, 2011 12:36 PM

ERT, a global technology-driven provider of clinical services and customizable medical devices, has named Robert Kleiman Chief Medical Officer, in addition to his current role as Vice President of Global Cardiology. 

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FDA approval spurs Vertex move to Boston waterfront

Wednesday, May 25, 2011 11:51 AM

The approval of Vertex’s Pharmaceutical’s hepatitis C treatment triggered one the biggest real estate deals in Boston’s history and is expected to spur the economic turnaround of the waterfront’s industrial area, according to a report in The Boston Globe.

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ERT appoints of new president and CEO

Monday, May 2, 2011 12:39 PM

eResearchTechnology (ERT), a global technology-driven provider of medical devices to bio-pharmaceutical organizations and a provider for centralized cardiac safety and respiratory services in drug development, has appointed Jeffrey S. Litwin, M.D. as its new president and chief executive officer and as a member of the board.

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FDA finds Vertex’s HVC drug effective

Wednesday, April 27, 2011 01:48 PM

The FDA has indicated that Vertex Pharmaceuticals’ experimental drug telaprevir cures more patients of hepatitis C than any current therapies, according to a Bloomberg report. 

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ERT awarded over $10 Million in ePRO business

Thursday, April 14, 2011 11:59 AM

ERT, a provider of clinical services and customizable medical devices to biopharmaceutical and healthcare organizations, was awarded three new contracts with pharmaceutical companies, totalling over $10 million for its electronic patient reported outcomes (ePRO) business.

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Phase III study of VX-770 for cystic fibrosis shows positive results

Friday, April 1, 2011 11:01 AM

Massachusetts-based Vertex Pharmaceuticals announced positive results from a 24-week analysis of the ongoing phase III ENVISION study of VX-770, an oral medicine in development that targets the defective protein that causes cystic fibrosis (CF). ENVISION (n=52) was designed to evaluate VX-770 among children ages 6 to 11 with the G551D mutation in the CFTR gene.

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Pharmasset presents early-stage data

Thursday, March 17, 2011 01:40 PM

Pharmasset’s experimental hepatitis C therapies may pose a challenge to treatments from Vertex Pharmaceuticals, based on trial results to be released in late March, BMO Capital Markets Corp. analysts said, according to a Bloomberg report.

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Vertex completes phase II epilepsy study

Thursday, March 17, 2011 01:38 PM

Cambridge, Mass.-based Vertex Pharmaceuticals said results from a phase II study of VX-765 in patients with treatment-resistant epilepsy showed it met the primary endpoint of safety and tolerability. Results showed a similar safety profile for VX-765 as compared to placebo. Secondary endpoints and additional analyses evaluated the clinical activity of VX-765, and results support the initiation of a larger and longer-duration phase IIb study of VX-765 in people with treatment-resistant epilepsy. Vertex expects to begin this trial as early as the fourth quarter of 2011.

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Vertex phase III study showed improvements in lung function

Monday, March 7, 2011 07:54 AM

Vertex Pharmaceuticals announced positive results from the phase III STRIVE study of VX-770, an oral medicine that targets the defective protein that causes cystic fibrosis (CF). STRIVE was designed to evaluate people with a mutation in the CF gene known as G551D. This study showed profound improvements in lung function through week 24 and sustained through week 48 among those who received VX-770 (n=83) compared to those treated with placebo (n=78). Improvements in all key secondary endpoints were also observed through week 48 among those who received VX-770.

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December 17

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

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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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