Theorem Clinical Research

Clinical Intelligence

inVentiv Health Clinical hired by IntelliCell Biosciences for Osteoarthritis IND

Wednesday, April 16, 2014 01:39 PM

CRO inVentiv Health Clinical has been selected for an osteoarthritis Investigational New Drug application (IND) by regenerative medicine biotechnology company IntelliCell BioSciences. IntelliCell will be studying the use of adult autologous vascular cells from blood vessels in adipose tissue to treat osteoarthritis of the knee.

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New therapy for advanced prostate cancer approved in Trinidad & Tobago

Monday, April 14, 2014 10:40 AM

The Chemistry, Food and Drugs Division of the Trinidad & Tobago Ministry of Health approved the introduction of Janssen's Abiraterone Acetate, the first orally administered androgen synthesis inhibitor (testosterone) medication for the treatment of patients with metastatic castration-resistant prostate cancer.

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FDA approves expanded indication for certain pacemakers and defibrillators

Friday, April 11, 2014 01:38 PM

The FDA has approved an application from Medtronic for revised labeling for two cardiac resynchronization pacemakers (CRT-P) and eight cardiac resynchronization defibrillators (CRT-D), expanding the indication for use to patients with atrioventricular (AV) block and less severe heart failure.

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Pharmacyclics files sNDa for IMBRUVICA

Friday, April 11, 2014 01:16 PM

Pharmacyclics has submitted a supplemental New Drug Application (sNDA) to the FDA, based on data from the randomized, multi-center, open-label phase III RESONATE study, PCYC-1112, a head-to-head comparison of single agent IMBRUVICA (ibrutinib) versus ofatumumab in 391 patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who had received at least one prior therapy. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech.

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Minomic to commence two trials of prostate cancer screening technology MiStat

Friday, April 11, 2014 12:28 PM

Private Australian biotechnology company Minomic International will launch two overseas trials of its MiStat prostate cancer screening test, following an agreement with CUSP Group, a uro-oncology trials management organization in the U.S.

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FDA grants IND approval for CardioCell’s phase IIa itMSC Therapy trial

Wednesday, April 2, 2014 03:41 PM

CardioCell, a global biotechnology company, has just received the FDA’s Investigational New Drug (IND) approval for a U.S.-based, phase IIa clinical study using its allogeneic stem-cell therapy to treat subjects with chronic heart failure (CHF), which generates more than one million hospitalizations annually. Preparation is underway to initiate the study at Emory University, Northwestern University and the University of Pennsylvania in May 2014.

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The CenterWatch Monthly, April 2014

Tuesday, April 1, 2014 09:06 AM

Make way for mobile health in clinical trials

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FDA approves long-acting recombinant coagulation Factor IX concentrate for hemophilia B

Monday, March 31, 2014 01:10 PM

The FDA has approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have Hemophilia B. Alprolix is the first Hemophilia B treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.

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Kite Pharma granted FDA Orphan Drug Designation for Anti-CD19

Monday, March 31, 2014 01:06 PM

Kite Pharma, a clinical-stage biotechnology company focused on developing engineered autologous T cell therapy (eACT) products for cancer, has announced that the FDA Office of Orphan Products Development (OOPD) granted Orphan Drug Designation for the company's lead investigational therapy, an autologous engineered T cell product that targets CD19 expression on B cell malignancies, for the treatment of diffuse large B cell lymphoma (DLBCL).

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Janssen expands global cardiovascular research program with three new studies

Monday, March 31, 2014 12:56 PM

Janssen R&D is adding three new clinical trials to its EXPLORER global cardiovascular research program for XARELTO (rivaroxaban), a broadly indicated oral Factor Xa inhibitor. The additional trials will evaluate rivaroxaban for the treatment or prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in pediatric and other patient populations, including those at risk for DVT or PE due to a concurrent medical illness. The new studies will include more than 11,000 patients in over 30 countries.

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October 27

NIH’s I-Corps boot camp aims to transform researchers into better businesspeople before they launch products

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CROs driving changes in patient recruitment
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