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ViiV Healthcare begins phase III dolutegravir/rilpivirine program for HIV maintenance therapy

Thursday, May 7, 2015 01:03 PM

ViiV Healthcare has started a phase III clinical trial program to evaluate the safety and efficacy of dolutegravir (Tivicay) and rilpivirine (Edurant) as maintenance therapy for adult patients with HIV. The phase III program comprises two replicate studies evaluating 48 week viral suppression with a two drug regimen combining an integrase inhibitor (dolutegravir) and a non-nucleoside reverse transcriptase inhibitor (rilpivirine) in patients with HIV who already have achieved viral suppression with a three drug regimen.

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Quest Diagnostics

AbbVie’s Venetoclax receives FDA Breakthrough Therapy designation for CLL

Thursday, May 7, 2015 12:54 PM

AbbVie has announced its investigational medicine venetoclax, an inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in partnership with Genentech and Roche, has been granted Breakthrough Therapy designation by the FDA for the treatment of chronic lymphocytic leukemia (CLL) in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation.

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Clinipace Worldwide co-founders named E&Y Entrepreneur of the Year finalists

Thursday, May 7, 2015 12:44 PM

Clinipace Worldwide, a global digital CRO, has announced Jeff Williams, CEO and co-founder, and Chris Porter, president and co-founder, have been named one of three finalists in the Health Care & Life Sciences category of the Ernst & Young Entrepreneur Of The Year 2015 Southeast Program, which includes Alabama, Georgia, North Carolina, South Carolina and Tennessee. The awards program recognizes entrepreneurs who demonstrate excellence and extraordinary success in areas such as innovation, financial performance and personal commitment to their businesses and communities.

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Quintiles establishes bioanalytical laboratory in Europe

Thursday, May 7, 2015 12:27 PM

Global CRO Quintiles has expanded its bioanalytical laboratory services with the establishment of a GLP-compliant bioanalytical liquid chromatography-mass spectrometry (LC-MS) lab. The lab, located in the Netherlands, will have extensive bioanalytical testing capabilities and will provide a European facility for Quintiles customers to conduct pharmacokinetics studies. 

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JSS Medical Research widens its global presence across Asia/Pacific region

Thursday, May 7, 2015 12:25 PM

JSS Medical Research, a Montreal, Canada-based CRO, has acquired Max Neeman International (MNI), a full-service CRO based in New Delhi, India. Additional regional offices are located in Ahmedabad, Bangalore, Chennai and Mumbai. Through a U.S. subsidiary, a regional office also is located in North Carolina.

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Gilead Sciences acquires EpiTherapeutics

Thursday, May 7, 2015 12:24 PM

Gilead Sciences, headquartered in Foster City, Calif., has acquired EpiTherapeutics, a privately held Danish company, for $65 million, subject to certain purchase price adjustments, to be financed through available cash on hand.

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Study: Clinical trial transparency improving

Thursday, May 7, 2015 12:23 PM

Transparency amongst industry-sponsored clinical trials continues to improve with results of 90% of trials on all new medicines approved by the EMA in 2012 disclosed within a 12-month timeframe, according to an Association of the British Pharmaceutical Industry (ABPI) study.

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Eli Lilly plans innovation center in Massachusetts

Thursday, May 7, 2015 12:22 PM

Eli Lilly plans to establish a new drug delivery and device innovation center in Cambridge, Mass.—a strategic location it says will help attract top scientists and bioengineers, as well as enhance Eli Lilly's local business development presence.

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EMA tightens rules on 'revolving door' for committee members and experts

Thursday, May 7, 2015 12:21 PM

The EMA has updated its rules on declarations of interests for scientific committee members and experts. The updates further strengthen EMA’s policy by restricting involvement of experts in the scientific assessment of medicines if they plan to take up a job in the pharmaceutical industry. The updates also include a revised guide on how to complete the agency’s declaration of interest form.

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Juno Therapeutics, Fate Therapeutics collaborate on T cell immunotherapies

Thursday, May 7, 2015 12:19 PM

Juno Therapeutics, based in Seattle, and Fate Therapeutics, headquartered in San Diego, have executed a four-year strategic research collaboration and license agreement to identify and utilize small molecules to modulate Juno's genetically-engineered T cell product candidates to improve their therapeutic potential for cancer patients.

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CWWeekly

May 26

inVentiv Health aims to help sponsors prepare for new E.U. regulations on observational studies

ACRP partners with CRO Analytics to measure investigative sites' views of clinical trial quality

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The CenterWatch Monthly

May

Job satisfaction mixed as workload increases
Salaries not keeping pace with rise in work, responsibilities

Gamification moving from early science to patient use
Pharma looking to use games for early diagnosis, recruitment, adherence

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The CenterWatch Monthly.

The CenterWatch Monthly

April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

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