Theorem Clinical Research

United States

PCORI, NIH request applications to study blood pressure control

Wednesday, December 10, 2014 01:05 PM

The NIH, as part of a research partnership with the Patient-Centered Outcomes Research Institute (PCORI), has issued a request for applications (RFA) to study how to improve blood pressure control among populations at highest risk for suffering hypertension-related strokes, heart attacks and other cardiovascular events. PCORI is a Wash. D.C.-based independent nonprofit organization authorized by Congress.

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Quest Diagnostics

Medidata releases Patient Profiles consulting service

Wednesday, December 10, 2014 01:02 PM

Medidata, a New York-based global provider of cloud-based solutions for clinical research in life sciences, has made available its enriched solution for risk-based monitoring (RBM) of clinical trial sites. The company’s previously announced acquisition of Patient Profiles, an early stage software company focused on improving clinical trial data quality, broadens Medidata’s best-in-class technology for RBM, a methodology for reducing trial costs while providing clinical data accuracy and quality.

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Health Decisions CEO Michael Rosenberg, Nuventra Pharma VP David Hartman killed in plane crash

Tuesday, December 9, 2014 12:47 PM

CRO Health Decisions, based in Durham, N.C., confirmed yesterday its founder and CEO Michael Rosenberg, M.D., MPH, died at 11 a.m. Monday in a private plane crash near Montgomery County Airpark in Gaithersburg, Md., a Washington, D.C. suburb.

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Aldeyra Therapeutics, National Organization for Rare Disorders collaborate

Monday, December 8, 2014 01:04 PM

Aldeyra Therapeutics, a Massachusetts-based biotechnology company focused on the development of products to treat diseases related to free aldehydes, is collaborating with the National Organization for Rare Disorders (NORD), a U.S. nonprofit organization dedicated to helping people with rare diseases.

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ALS Association, Muscular Dystrophy Association partner

Friday, December 5, 2014 12:33 PM

The ALS Association, a national nonprofit based in Wash. D.C., and the Muscular Dystrophy Association (MDA), a Chicago-based nonprofit health agency, have joined forces to fund a research project aimed at finding a potential therapy for amyotrophic lateral sclerosis, also known as ALS or Lou Gehrig's disease. Both nonprofits are focused on finding treatments and cures for ALS and providing services for those affected with the debilitating, fatal disease.  

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FDA approves Blincyto (Blinatumomab) for leukemia

Thursday, December 4, 2014 02:20 PM

The FDA has granted approval of Amgen’s Blincyto (blinatumomab) for the treatment of patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval.

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Robert Blum receives 2014 Lou Gehrig Iron Horse Award

Thursday, December 4, 2014 02:14 PM

Cytokinetics has announced that the company's president and CEO, Robert Blum, received the 2014 Lou Gehrig Iron Horse Award from ALS Therapy Development Institute (ALS.net).

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First MS patients in the U.S. receive Genzyme’s Lemtrada following FDA approval

Thursday, December 4, 2014 01:43 PM

Genzyme, a Sanofi company, has announced that the first U.S. patients have initiated treatment with Lemtrada (alemtuzumab) in the commercial setting following its Nov. 14 FDA approval for the treatment of patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

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Catalent, Valerion collaborate on orphan genetic disorder treatments

Thursday, December 4, 2014 12:32 PM

Catalent Pharma Solutions, a Somerset, N.J.-based global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, is collaborating with Valerion Therapeutics, a Concord, Mass.-based emerging science-driven company focused on the development of bio-therapeutics for orphan genetic diseases, to develop Valerion's two lead product candidates.

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NIH awards $20M for drug delivery system to prevent HIV infection in women

Thursday, December 4, 2014 12:30 PM

The University of Texas Medical Branch (UTMB) is part of a collaboration led by the Oak Crest Institute of Science that received a $20 million grant from the NIH to develop a novel intravaginal ring capable of delivering powerful antiretroviral drugs to prevent the spread of sexually transmitted HIV in women. The total award to UTMB is approximately $2.5 million.

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CWWeekly

March 23

Industry welcomes FDA draft guidance outlining the use of electronic Informed Consent for trials

Apple launches ResearchKit platform to tap millions of iPhone users to enroll in observational studies using apps

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The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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The CenterWatch Monthly

February

Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

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