DIA Biosimilars 2013

Articles Published in 2008

Suven Teams up With Chinese CRO VPSCRO

Friday, April 11, 2008 12:54 PM

Asian Clinical Trials (ACT), the CRO of Hyderabad, India-based pharmaceutical company Suven Life Sciences, has entered into a pact with the Beijing -based company VPSCRO to conduct clinical trial services in India and China. VPSCRO claims it is the largest Chinese CRO in term of numbers of ongoing trials. The companies stated that the agreement will provide cost-effective services with faster patient recruitment speeds in the two regions.

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Cenduit: Now with Patient Reminders

Parexel's Josef von Rickenbach On Phase I Activity

Tuesday, April 8, 2008 06:16 AM

Parexel recently expanded its early phase operations in three of its phase I facilities. The move brings the company’s global phase I bed capacity to one of the largest in the industry, at 550.

Parexel also has phase I services in India through a partially owned venture with Synchron Clinical Research’s Ahmedabad-based facility, which has 86 beds. Last month, Parexel increased its ownership stake in that venture from 19.5% to 31% at a cost of $5 million. At the same time, Parexel sold its France-based bioanalytical and biomarker testing laboratory facility—owned since 1999—to a subsidiary of Synchron for approximately $6.7 million. The unit will now be called Synexel Research International and will stay within Synchron’s operational network.

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CRF Health – eCOA Forum

U.S. Disease Foundation Investment in Biopharmaceutical Industry Continues to Rise

Monday, April 7, 2008 02:47 PM

U.S. disease foundations invested about $75 million last year in biopharmaceutical companies to fund discovery and development of new drugs and therapies for their corresponding diseases, according to CenterWatch estimates published in the August 2007 issue of The CenterWatch Monthly.

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EDICT Report Provides Road Map To Comprehensive Patient Enrollment

Monday, April 7, 2008 06:01 AM

A much anticipated report published by Baylor College’s Eliminating Disparities in Clinical Trials [EDICT] project has provided a nine-step action plan for improving the policies surrounding the conduct of clinical trials. The EDICT project set out to create a series of policy proposals designed to help patient recruitment and retention in clinical trials. The four-year project is supported by an unrestricted grant from Genentech.

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CWWeekly March 31st 2008 Issue

Friday, April 4, 2008 12:01 PM

Top News

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Parexel Buys Larger Stake in India Venture and Expands Phase I Business in U.S., Europe

Friday, April 4, 2008 11:09 AM

Waltham, Mass.-based contract research organization (CRO) Parexel has grown its early phase operations with an expansion of three clinical pharmacology units (CPUs), located in Baltimore, London and Berlin.

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Averion Sees Fruits of Acquisition

Thursday, April 3, 2008 01:28 PM

Southborough, Mass.-based contract research organization (CRO) Averion showed signs that its recent acquisitions and operational changes are paying off. Averion reported that 2007 net service revenue was up an impressive 163% to $34.8 million, due primarily to its acquisition of Swiss-based CRO Hesperion. Averion paid $36.2 million for the company in November. That acquisition doubled the size of Averion’s staff to 400 and expanded its operations into 14 countries.

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NPS Pharmaceutical in Talks with FDA After More Positive Results with Gattex

Wednesday, April 2, 2008 07:28 AM

NPS Pharmaceuticals issued positive results from a phase III extension study of Gattex (teduglutide), an injectable glucagon-like peptide-2 (GLP-2) analog, for the treatment of short bowel syndrome (SBS) in subjects who are dependent upon parenteral nutrition (PN).  PN is the practice of feeding a patient intravenously, the cost of which can exceed $100,000 a year.

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MHRA’s New Phase I Accreditation Scheme in Effect Today

Tuesday, April 1, 2008 01:26 PM

The Medicines and Healthcare products Regulatory Agency’s (MHRA) voluntary Phase I Accreditation Scheme went into effect today with the stated goal of formalizing routine inspections and increasing the scope and depth of inspections. Most importantly, the aim of the MHRA’s new scheme is to avoid harm to trial subjects and for handling medical emergencies during first-in-human trials should they arise.

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Quintiles to Partner with Japanese Lab Company Medca

Monday, March 31, 2008 03:31 PM

Research Triangle Park, N.C.-based CRO Quintiles inked an agreement with Medca Japan, a laboratory testing and nursing care services company based outside Tokyo in Saitama, to use its lab to support clinical trials in the country. Medca Japan’s facility and staff are College of American Pathologists (CAP)-certified and its data will be available on Quintiles’ QNET database. Quintiles stated that Japanese regulations are changing in a positive way and are now allowing pivotal clinical trials to be conducted outside of Japan into the greater Asia region.

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CWWeekly

September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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