Theorem Clinical Research

United States

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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NIH adds six clinical sites in Undiagnosed Diseases Network

Wednesday, July 2, 2014 12:40 PM

The NIH has awarded grants to six medical centers around the country to select from the most difficult-to-solve medical cases and together develop effective approaches to diagnose them. The new clinical sites added to the NIH Undiagnosed Diseases Network (UDN) will conduct clinical evaluation and scientific investigation in cases that involve patients with prolonged, undiagnosed conditions.

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Amgen receives FDA Breakthrough Therapy Designation for Blinatumomab in ALL

Wednesday, July 2, 2014 11:04 AM

The FDA has granted Breakthrough Therapy Designation to Amgen’s investigational bispecific T cell engager (BiTE) antibody blinatumomab, for adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow.

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Paratek Pharmaceuticals, Transcept Pharaceuticals to merge

Tuesday, July 1, 2014 02:51 PM

Transcept Pharmaceuticals of Point Richmond, Calif., and Boston-based Paratek Pharmaceuticals, a privately held biopharmaceutical company, have agreed to merge, with Paratek stockholders becoming the majority owners of Transcept. The operations of the two companies will be combined and the new entity will be named Paratek Pharmaceuticals.

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Trovagene inks agreement with Lurie Comprehensive Cancer Center, NMDTI

Monday, June 30, 2014 03:35 PM

Trovagene has partnered with the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and the Northwestern Medicine Developmental Therapeutics Institute (NMDTI) to conduct a translational research program designed to assess the utility of Trovagene's urine-based cell-free oncogene mutation monitoring technology in clinical practice.

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September 15

WIRB-Copernicus Group acquires New England IRB

BBK Worldwide secures $3 million in private ἀnancingto accelerate its global and technological expansion

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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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