United States

Vertex corrects, provides additional data on cystic fibrosis study

Wednesday, May 30, 2012 10:44 AM

Vertex Pharmaceuticals of Cambridge, Mass., has released a correction to the previously reported responder analysis, as well as additional data from, its recent interim analysis of an ongoing phase II combination study of VX-809 and Kalydeco (ivacaftor) that showed significant improvements in lung function (forced expiratory volume in one second, FEV1) among adults with cystic fibrosis who have two copies of the most common mutation in the cystic fibrosis transmembrane conductance regulator gene, F508del.

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Clinilabs opens phase I unit in New Jersey

Tuesday, May 29, 2012 03:25 PM

New York-based Clinilabs, an early phase and specialty CRO, has opened a second phase I unit in southern New Jersey. The 50-bed capacity, 15,000-square-foot Specialty Pharma Phase I Unit features semi-private rooms, a large PK sampling facility, a bioanalytic laboratory, pharmacy and exam rooms.

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Joshua Boger joins Alkeus Pharmaceuticals as executive chairman

Friday, May 25, 2012 01:21 PM

Alkeus Pharmaceuticals of Boston, Mass., has appointed Joshua Boger, Ph.D., as executive chairman of the company's board of directors. 

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Lilly reports positive data in phase II diabetes study of dulaglutide

Friday, May 25, 2012 01:16 PM

Eli Lilly’s investigational drug dulaglutide, a long-acting glucagon-like peptide 1 (GLP-1) analog being studied as a once-weekly treatment for type 2 diabetes, met its primary endpoint of non-inferiority for mean 24-hour systolic blood pressure (SBP, or pressure while the heart contracts) after 16 weeks.

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Paratek appoints Molnar and Loh to senior positions

Thursday, May 24, 2012 09:00 AM

Paratek Pharmaceuticals of Boston, Mass., has named Dennis Molnar as director, president and CEO, and Evan Loh, MD, as chief medical officer and chairman of the board of directors.  

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BRANY to collaborate with U of Miami

Wednesday, May 23, 2012 01:50 PM

BRANY (Biomedical Research Alliance of New York) has agreed to provide education content for the Collaborative Institutional Training Initiative (CITI) at the University of Miami for use on their online clinical research training program.

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FDA-led research discovers autoimmune mechanism for drug-induced AEs

Tuesday, May 22, 2012 02:15 PM

A team of researchers led by the FDA has discovered a new mechanism for identifying and understanding drug-related autoimmune reactions.

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Accelrys purchases cloud-based HEOS tech from Scynexis

Tuesday, May 22, 2012 11:07 AM

Accelrys, a scientific enterprise R&D software and services company based in San Diego, has purchased the web-based Hit Explorer Operating System (HEOS) from Scynexis, a drug discovery and development company.

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Datatrak selected as 2012 Crain's Leading EDGE honoree

Monday, May 21, 2012 12:08 PM

Datatrak International, a technology and services company focused on global eClinical solutions for the clinical trials industry, has been selected as a 2012 Crain's Leading EDGE award winner for the third consecutive year.

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UMass Dartmouth MAB to house biomanufacturing startups

Friday, May 18, 2012 02:26 PM

The University of Massachusetts Dartmouth has broken ground on the site for their new Massachusetts Accelerator for Biomanufacturing (MAB), a facility for startup companies to test biomanufacturing methods and bioproducts located in Fall River, Mass.

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CWWeekly

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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The CenterWatch Monthly

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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