Theorem Clinical Research

United States

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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Massachusetts becomes 7th state to pass law allowing pharmacy substitution of interchangeable biosimilars

Friday, June 27, 2014 12:08 PM

Massachusetts this week became the seventh state to allow for the substitution at the pharmacy of biosimilars deemed “interchangeable” with branded original drugs—legislation being enacted on a state-by-state basis.

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St. Jude Children's Research Hospital names James R. Downing CEO

Friday, June 27, 2014 11:58 AM

St. Jude Children's Research Hospital has appointed James R. Downing, M.D., as its new CEO, effective July 15. Downing most recently was the deputy director, executive vice president and scientific director of the hospital. Downing's primary focus immediately upon assuming the CEO office will be to oversee a new era of clinical, research and infrastructure expansion throughout the St. Jude global network. He succeeds Dr. William E. Evans, who is retiring from the position after 10 years and returning full time to his long-standing pharmacogenomics research program at St. Jude.

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Regional Immunotherapy Discovery Program launched by Northeast cancer centers

Thursday, June 26, 2014 02:10 PM

Physician researchers from Georgetown Lombardi Comprehensive Cancer Center in Washington, D.C., and John Theurer Cancer Center (JTCC) in Hackensack, N.J., have formed the Regional Immunotherapy Discovery Program.

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Johnson & Johnson, Dana-Farber launch $10 million lung cancer collaboration

Thursday, June 26, 2014 02:03 PM

Johnson & Johnson Innovation, Boston, and Janssen Biotech have announced a three-year immuno-oncology lung cancer collaboration with the Dana-Farber Cancer Institute. Janssen scientists will work with the research team at Dana-Farber's Belfer Institute for Applied Cancer Science to determine the clinical setting for certain immuno-oncology agents in Janssen's lung cancer discovery pipeline.

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Toronto Star, with FDA data, exposes weaknesses in Health Canada's clinical trial, inspection oversight

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