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Trial results for AbbVie’s Hepatitis C candidate heat up race for effective treatment

Monday, April 14, 2014 12:51 PM

The race to replace interferon with a far more effective treatment for hepatitis C has become one of the most promising and lucrative battles in drug development, as AbbVie, Gilead Sciences, Merck and Bristol-Myers Squibb vie for the finish line.

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CRF Health eCOA webinar series

New therapy for advanced prostate cancer approved in Trinidad & Tobago

Monday, April 14, 2014 10:40 AM

The Chemistry, Food and Drugs Division of the Trinidad & Tobago Ministry of Health approved the introduction of Janssen's Abiraterone Acetate, the first orally administered androgen synthesis inhibitor (testosterone) medication for the treatment of patients with metastatic castration-resistant prostate cancer.

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Icon’s Firecrest training recognized by TransCelerate BioPharma

Monday, April 14, 2014 10:13 AM

Icon,a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, has announced that its Firecrest training meets TransCelerate BioPharma’s minimum criteria for International Conference on Harmonization Good Clinical Practice (ICH/GCP) training.

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The Pulse on Site Success By Jeffrey Adelglass, M.D.

Monday, April 14, 2014 09:00 AM

Throughout the evolution of clinical trials, patient enrollment has remained the most confounding element of timely trial completion. From the site perspective, the challenges are many. It is critical to mobilize strategies that minimize cost, maximize recruitment and avert patient attrition.

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HHS Secretary Sebelius, proponent of clinical research, resigns

Friday, April 11, 2014 03:33 PM

Health and Human Services Secretary Kathleen Sebelius—whose agenda included keeping clinical research a priority—has resigned on the heels of the Affordable Care Act (ACA) web site turmoil last October, even though more recently she had achieved the goal of 7.5 million registrations for coverage.

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FDA approves expanded indication for certain pacemakers and defibrillators

Friday, April 11, 2014 01:38 PM

The FDA has approved an application from Medtronic for revised labeling for two cardiac resynchronization pacemakers (CRT-P) and eight cardiac resynchronization defibrillators (CRT-D), expanding the indication for use to patients with atrioventricular (AV) block and less severe heart failure.

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Jon L. Hart named CEO of med fusion

Friday, April 11, 2014 01:23 PM

med fusion, an integrated, advanced laboratory and clinical trials service organization, has appointed Jon L. Hart CEO, effective March 31. This appointment is the next step in the organization’s continued drive towards becoming the clear leader in providing lab and clinical trial support to healthcare providers and biotech/pharmaceutical companies through a patient-centric support model.

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Pharmacyclics files sNDa for IMBRUVICA

Friday, April 11, 2014 01:16 PM

Pharmacyclics has submitted a supplemental New Drug Application (sNDA) to the FDA, based on data from the randomized, multi-center, open-label phase III RESONATE study, PCYC-1112, a head-to-head comparison of single agent IMBRUVICA (ibrutinib) versus ofatumumab in 391 patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who had received at least one prior therapy. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech.

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MEI Pharma adds David Urso as senior VP of Corporate Development, General Counsel

Friday, April 11, 2014 01:12 PM

MEI Pharma, an oncology company focused on the clinical development of novel therapies for cancer, has appointed David Urso senior vice president of Corporate Development and General Counsel. Urso joins MEI Pharma with more than two decades of experience in the life science industry, most recently as chief operating officer and general counsel at Tioga Pharmaceuticals, a company he co-founded in 2005 as a principal at Forward Ventures.

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Minomic to commence two trials of prostate cancer screening technology MiStat

Friday, April 11, 2014 12:28 PM

Private Australian biotechnology company Minomic International will launch two overseas trials of its MiStat prostate cancer screening test, following an agreement with CUSP Group, a uro-oncology trials management organization in the U.S.

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CWWeekly

April 14

Proposal calls for back-to-back trials to measure efficacy and effectiveness prior to FDA approval

Study: Minority populations under-represented in cancer trials, but have higher rates of incidence

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The CenterWatch Monthly

April

Make way for mobile health in clinical trials
Despite patient retention, data quality benefits, regulatory hurdles persist

Global clinical trial laboratories decentralize
Regional labs reducing complexity, delivering cost and time savings

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The CenterWatch Monthly

March

Strategic alliances hit bumps in the road
Mixed relationship performance driving new approaches

Tapping community hospitals for clinical trial volunteers
New study finds high potential but infrastructure, resources are lacking

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