United States

$650 million commitment to Stanley Center at Broad Institute aims to galvanize mental illness research

Friday, July 25, 2014 12:50 PM

The Broad Institute has announced an unprecedented commitment of $650 million from philanthropist Ted Stanley aimed at galvanizing scientific research on psychiatric disorders and bringing new treatments based on molecular understanding to hundreds of millions of people around the world.

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WIRB Copernicus Group

Changes in generic pill color and shape disrupt use

Wednesday, July 23, 2014 10:38 AM

Studying a national cohort of patients who recently suffered a heart attack, researchers from Brigham and Women’s Hospital (BWH) have found variation in appearance of generic drugs is associated with a greater risk of patients stopping their essential post-heart attack drugs.

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Butrans Transdermal System CIII receives new dosage strength approval

Wednesday, July 23, 2014 08:00 AM

Purdue Pharma has announced that the FDA approved a new 7.5mcg/hour dosage strength of Butrans (buprenorphine) Transdermal System CIII. Five strengths of Butrans now will be available: 5mcg/hour, 7.5mcg/hour, 10mcg/hour, 15mcg/hour and 20mcg/hour. The Butrans Transdermal System also is approved to allow the use of two patches to facilitate dose adjustments during titration. The total dose from both patches should not exceed 20mcg/hour. Purdue expects to launch Butrans 7.5mcg/hour commercially in the U.S. in October 2014.

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Ruthigen treats first human subjects in clinical trial for RUT58-60

Tuesday, July 22, 2014 08:00 AM

Ruthigen, a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics designed to prevent and treat infection in invasive applications, has treated the first human subjects with its drug candidate RUT58-60 in a 30 patient, 21-day skin irritation trial, which is expected to be completed in August.

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INC Research drives deeper site connections through strengthened study startup effort

Monday, July 21, 2014 03:27 PM

As part of an effort to foster strong site relationships—to optimize timelines and deliver rapid study startup for global clinical trials—and establish the foundation for successful collaboration across the duration of a study, North Carolina-based CRO INC Research has promoted Carol Aliyar to senior vice president, study startup.

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FDA approves Ruconest for hereditary angioedema attacks

Thursday, July 17, 2014 10:49 AM

The FDA has approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).

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CEL-SCI receives $225,000 NIH research grant

Wednesday, July 16, 2014 01:11 PM

CEL-SCI has been awarded a phase I Small Business Innovation Research (SBIR) grant for $225,000 from the National Institute of Arthritis Muscoskeletal and Skin Diseases (NIAMS), part of the NIH. The grant will fund the further development of CEL-SCI’s LEAPS technology as a potential treatment for rheumatoid arthritis (RA), an autoimmune disease of the joints. According to Visiongain, the world RA drug market will generate revenues of $38.5 billion in 2017.

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HD Biosciences partners with Marshall University

Monday, July 14, 2014 12:45 PM

HD Biosciences (HDB), a Shanghai-based, biology-focused preclinical drug discovery CRO, the Marshall Institute for Interdisciplinary Research (MIIR) and the Marshall University Joan C. Edwards School of Medicine have announced a new partnership to co-develop potential anti-cancer drugs.

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Report: Orphan drug approvals up, but high costs pose challenges for patients

Friday, July 11, 2014 02:02 PM

Although the pace of approvals for new orphan drugs—medicines that treat relatively rare conditions—have increased in the U.S. and Europe in recent years, patients are facing growing challenges accessing those drugs, a newly completed study by the Tufts Center for the Study of Drug Development (CSDD) at Tufts University has concluded.

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Survey shows support for increased stem cell research

Thursday, July 10, 2014 12:48 PM

Americans are in broad support of more stem cell research, according to the results of an online survey released by Cord Blood Registry (CBR) to coincide with National Cord Blood Awareness Month.

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August 25

Verizon Communications enters clinical trial space with technology, network, and cloud and data services

Sponsors look to the power of genomic profiling to screen, enroll patients in trials for targeted therapies

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The CenterWatch Monthly

August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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The CenterWatch Monthly

July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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