Theorem Clinical Research

Clinical Intelligence

FDA approves Tretten to treat rare genetic clotting disorder

Tuesday, January 7, 2014 08:00 AM

The FDA has approved Tretten, Coagulation Factor XIII A-Subunit (Recombinant), the first recombinant product for use in the routine prevention of bleeding in adults and children who have a rare clotting disorder, known as congenital Factor XIII A-subunit deficiency.

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Quest Diagnostics

The CenterWatch Monthly, January 2014

Thursday, January 2, 2014 08:00 AM

Will the part-time site landscape finally consolidate?

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iHealth, UCSF, UC Berkeley Lab collaborate on clinical study

Wednesday, December 18, 2013 02:37 PM

iHealth Lab, a provider of mobile personal healthcare products that are connected through the cloud, is collaborating with UC San Francisco and University of California's Berkeley Lab on a pilot study to make arterial endothelial function testing as easy to perform as a simple blood pressure measurement.

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New presurgery combination therapy for triple-negative breast cancer

Tuesday, December 17, 2013 08:13 AM

The I-SPY 2 trial, an innovative, multidrug, phase II breast cancer trial, has yielded positive results with the first drug to complete testing in the trial. Adding the chemotherapy carboplatin and the molecularly targeted drug veliparib to standard presurgery chemotherapy improved outcomes for women with triple-negative breast cancer.

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FDA approves first generic versions of antidepressant drug Cymbalta

Friday, December 13, 2013 01:41 PM

The FDA has approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used to treat depression and other conditions.

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GSK's FluLaval Quadrivalent effective in preventing pediatric seasonal flu

Friday, December 13, 2013 01:29 PM

A peer-reviewed study issued online by the New England Journal of Medicine has reported that GlaxoSmithKline's FluLaval Quadrivalent reduced flu cases among children ages three to eight by 55.4% overall and lowered the risk of developing moderate-to-serious flu illness by 73.1%. This was the first large-scale clinical trial conducted specifically to review the safety and effectiveness of vaccinating children with a four-strain flu vaccine. The randomized, controlled clinical trial included 5,220 children and was one of the pivotal studies leading to the recent approval of FluLaval Quadrivalent by the FDA.

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FDA approves first drug treatment for Peyronie’s disease

Friday, December 13, 2013 01:10 PM

The FDA has approved a new use for Xiaflex (collagenase clostridium histolyticum) as the first FDA-approved medicine to treat men with bothersome curvature of the penis, a condition known as Peyronie’s disease.

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Bruin Biometrics conducts trials to detect pressure ulcers with the SEM Scanner

Thursday, December 5, 2013 10:36 AM

Bruin Biometrics (BBI) has announced results from two IRB-approved clinical trials conducted with the SEM Scanner, a Class IIA medical device that is intended to detect localized tissue edema and pressure induced tissue damage which may lead to the formation of pressure ulcers.

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Lexicon completes phase II study of LX1033

Thursday, December 5, 2013 09:56 AM

Lexicon Pharmaceuticals has announced top-line results from an initial phase II study exploring the use of LX1033 in diarrhea-predominant irritable bowel syndrome (IBS-d). LX1033 is an investigational drug that inhibits serotonin synthesis in the gastrointestinal tract. Serotonin is a neurotransmitter that has been shown to play a role in the symptoms of irritable bowel syndrome.

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New research shows promise for possible HIV cure

Wednesday, December 4, 2013 02:33 PM

Researchers have used radioimmunotherapy (RIT) to destroy remaining human immunodeficiency virus (HIV)-infected cells in the blood samples of patients treated with antiretroviral therapy, offering the promise of a strategy for curing HIV infection. Results of the study were presented at the annual meeting of the Radiological Society of North America (RSNA).

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AiCure
CWWeekly

March 30

Icon, Carnegie Mellon partner to research ways to improve study patients' understanding of Informed Consent

Veeva launches OpenKey, partner program to unlock difficult access to, restrictions on customer reference data

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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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