Global News

Society for Clinical Research Sites adds Covance as Global Impact Partner

Monday, July 6, 2015 10:25 AM

The Society for Clinical Research Sites (SCRS), a global trade organization dedicated to representing the interests of clinical research sites, has announced a two-year partnership with Laboratory Corporation of America Holdings (LabCorp). Covance Drug Development will participate as a Global Impact Partner (GIP), a relationship designed to facilitate critical dialogue between industry stakeholders and clinical research sites.

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BioClinica expands, opens new European offices

Monday, July 6, 2015 10:14 AM

BioClinica, a global specialty clinical trial service provider, has opened new and expanded offices in London and Munich to better serve its growing client base in Europe. The state-of-the-art facilities will offer an array of clinical trial services including medical imaging, site training and support, and eClinical product lines to meet the growing need of European drug and medical device sponsors. BioClinica's clients include pharmaceutical, biotechnology and medical device companies, as well as CRO partnerships in Europe and across the globe.

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Report: Global biosimilars market value could hit $55B by 2020

Monday, July 6, 2015 10:07 AM

The global biosimilars market value is expected to reach $20 billion by the end of 2015 and could hit $55 billion by 2020, with growth primarily driven by a promising pipeline in active development and government efforts to reduce healthcare spending, according to business intelligence provider GBI Research.

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Quintiles, Quest Diagnostics launch Q2 Solutions

Monday, July 6, 2015 09:56 AM

Quintiles and Quest Diagnostics have launched Q2 Solutions, a new combined clinical trials laboratory services organization. Q2 Solutions brings together the clinical trials laboratory operations of the two parent organizations to provide biopharmaceutical customers with the diverse capabilities and end-to-end services required in the rapidly evolving biopharmaceutical industry. The launch of Q2Solutions is the result of the close of the previously announced global clinical trials laboratory services joint-venture transaction.

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The importance of reliability and responsiveness

Monday, July 6, 2015 08:00 AM

Life lessons of etiquette and manners resonate strongly in today’s stressful business environment.

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ERT updates executive management team

Thursday, July 2, 2015 09:36 AM

ERT, a global provider of patient safety and efficacy endpoint data collection, cloud analytics and workflow solutions, has appointed Steve Nuckols executive vice president and chief commercial officer. As chief commercial officer, Nuckols will be responsible for all global business development activities within ERT, with primary focus on ensuring ERT’s products and services best meet the needs of its global pharmaceutical customers.

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NIH begins clinical trial of new medication for alcohol use disorder

Thursday, July 2, 2015 09:28 AM

A clinical trial investigating a potential treatment for alcohol use disorder (AUD) was announced by the National Institute of Alcohol Abuse and Alcoholism (NIAAA). The study will assess the safety and efficacy of gabapentin enacarbil (HORIZANT) in extended-release tablets for treating moderate to severe AUD. NIAAA is part of the NIH.

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FDA extends PDUFA date for Genentech’s cobimetinib NDA

Thursday, July 2, 2015 09:17 AM

Exelixis has been informed by partner Genentech, a member of the Roche Group, that, in order to accommodate its review of a supplemental data submission, the FDA has extended the Prescription Drug User Fee Act (PDUFA) action date for its review of Genentech's NDA for cobimetinib by the standard extension period of three months, from Aug. 11 to Nov. 11.

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Great Basin wins NIH grant to develop test for CRE superbug

Thursday, July 2, 2015 09:01 AM

The National Institute of Allergy and Infectious Diseases, part of the NIH, has awarded a research grant to Great Basin Scientific and Brigham Young University (BYU), to develop a rapid molecular diagnostic test direct from whole blood for carbapenem-resistant Enterobacteriaceae (CRE). The NIH research grant will play a key role in meeting the goals of President Obama's recent National Action Plan for Combating Antibiotic-Resistant Bacteria.

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Baxalta launches focused on orphan diseases and underserved conditions

Thursday, July 2, 2015 08:53 AM

Baxalta has launched as a global biopharmaceutical company dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions. The company continues to advance in hematology and immunology and seeks to expand its oncology portfolio for patients with limited treatment options. Baxalta plans to launch 20 new products by 2020, leveraging the company’s existing global capabilities and footprint in more than 100 countries.

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CWWeekly

July 6

FDA sued by advocacy groups seeking hepatitis C trials data

Google to test health-tracking wristband to collect clinical trial data

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The CenterWatch Monthly

July

Integrated research partnerships build momentum
Research function provides infrastructure, leverages large pool of health systems' patients and data

'Right to Try' laws challenge clinical trial process
20 states pass, 20 more pending allowing access to study drugs without FDA and IRB approval

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June

TransCelerate Biopharma turns three
High-profile consortium has made inroads fixing wasteful practices, but it still has more work ahead

Pharma industry improves its tarnished reputation
Delivering innovation, social responsibility will help rebuild trust

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