United States

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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WIRB Copernicus Group

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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Chesapeake Urology raises $100,000 for Urology Care Foundation

Monday, June 30, 2014 03:34 PM

Sanford Siegel, M.D., president and CEO of Chesapeake Urology Associates, presented the Urology Care Foundation with $114,248 in support of its prostate cancer research efforts. The funds were raised through the Zero Prostate Cancer Challenge (ZPCC) 10K/5K run in September 2013. The Urology Care Foundation is the official foundation of the American Urological Association (AUA)—an organization of roughly 20,000 urologists.

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Ampio Pharmaceuticals closes enrollment in the OptimEyes study

Friday, June 27, 2014 01:54 PM

Ampio Pharmaceuticals has informed the Transplant and Ophthalmology Division of the FDA of its intent to reduce the patient sample size in the OptimEyes study for the treatment of diabetic macular edema (oral treatment with Optina). This trial was intended to enroll 450 patients and was powered at 95%. The present enrollment of over 355 patients provides an adequate power of 88%, which the company believes is more than sufficient for statistical evaluation.

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July 28

WCG acquires Alliance Biosciences to expand its biosafety oversight capabilities, ensure compliance

Facilitated review meetings for protocol design catching on, decreasing amendments, complexity

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

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Lessons learned from medical device trials
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