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Clinical Intelligence

KaloBios publishes KB001 phase I study results

Monday, September 23, 2013 01:33 PM

KaloBios Pharmaceuticals has published phase I study results for KB001, a first-generation, anti-Pseudomonas aeruginosa (Pa) type III secretion system (TTSS) antibody for use in patients with cystic fibrosis (CF). Data from this initial single-dose clinical study support the continuation of KaloBios' ongoing phase II study of KB001-A, a second-generation, anti-TTSS antibody in CF patients with chronic Pa infections.

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CRF Health eCOA webinar series

NIH awards $33m grant to Banner Alzheimer's Institute, study planned

Friday, September 20, 2013 11:14 AM

Banner Alzheimer's Institute (BAI) has announced a major prevention trial to evaluate a treatment in cognitively healthy older adults at the highest known genetic risk for developing Alzheimer's disease at older ages. An NIH grant, expected to total $33.2 million, will support this research.

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Boehringer Ingelheim collaborates with Presidio Pharmaceuticals

Monday, September 16, 2013 03:12 PM

Boehringer Ingelheim has completed patient enrollment for a phase IIa clinical trial (NCT01859962) investigating a new interferon-free, all-oral, direct-acting antiviral (DAA) combination treatment for patients with genotype-1a chronic hepatitis C virus (HCV) infection. This trial is conducted in collaboration with Presidio Pharmaceuticals and evaluates Boehringer Ingelheim’s investigational compounds, the protease inhibitor faldaprevir (BI 201335) and non-nucleoside NS5B polymerase inhibitor, deleobuvir (BI 207127), in combination with Presidio’s investigational pan-genotypic NS5A inhibitor, PPI-668, with and without ribavirin.

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Analysis highlights predictive biomarkers discovery for Vectibix

Monday, September 16, 2013 03:11 PM

Amgen has published a biomarker analysis of Vectibix (panitumumab) in combination with FOLFOX, a type of oxaliplatin-based chemotherapy, for the first-line treatment of patients with metastatic colorectal cancer (mCRC). Published in the New England Journal of Medicine, the analysis found that RAS mutations, beyond the known KRAS exon 2 mutations, predict lack of response to Vectibix in combination with FOLFOX. RAS mutations are mutations occurring in exons 2, 3 and 4 of KRAS and NRAS.

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Camurus receives milestone from Novartis

Monday, September 16, 2013 08:45 AM

Novartis has exercised its option to acquire an exclusive license for the further development and worldwide commercialization of CAM2029 for treatment of patients with acromegaly and neuroendocrine tumors (NETs). The license also covers additional future products based on the Camurus' FluidCrystal Injection depot technology. Camurus is a research-based pharmaceutical company dedicated to developing therapeutics for diseases with high unmet medical needs.

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Study concludes Stretta is desirable GERD treatment

Tuesday, September 10, 2013 01:00 PM

A newly published peer-review study that examines Stretta therapy is bringing renewed attention to this non-surgical procedure that has 10 years of patient data and recently earned The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) highest GRADE recommendation.

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Rigel refocuses resources, cuts 30 jobs

Tuesday, September 10, 2013 11:01 AM

Rigel Pharmaceuticals plans to focus resources on the completion of three lead clinical programs. These efforts include a phase III clinical study of fostamatinib, an oral SYK inhibitor, in Immune Thrombocytopenic Purpura (ITP), pending discussions with regulatory agencies. Rigel believes that a phase III clinical program would encompass approximately 150 patients and can be completed in 2015.

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HeartWare receives FDA approval to enroll supplemental patient cohort

Friday, September 6, 2013 03:12 PM

The FDA has approved an IDE Supplement for HeartWare International, an innovator of less invasive, miniaturized circulatory support technologies for the treatment of advanced heart failure, to commence enrollment in an additional patient cohort for ENDURANCE, the company's Destination Therapy clinical study.

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Arena Pharmaceuticals completes phase Ib clinical trial

Friday, September 6, 2013 03:12 PM

Arena Pharmaceuticals has completed a phase Ib clinical trial for APD811, an investigational oral prostacyclin (IP) receptor agonist intended for the treatment of pulmonary arterial hypertension (PAH). The company plans to initiate a phase II clinical trial for APD811 in the first quarter of 2014.

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The CenterWatch Monthly, September 2013

Tuesday, September 3, 2013 08:00 AM

Sponsors look to collaborate on comparator drugs

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CenterWatch Drugs in Clinical Trials
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April 14

Proposal calls for back-to-back trials to measure efficacy and effectiveness prior to FDA approval

Study: Minority populations under-represented in cancer trials, but have higher rates of incidence

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April

Make way for mobile health in clinical trials
Despite patient retention, data quality benefits, regulatory hurdles persist

Global clinical trial laboratories decentralize
Regional labs reducing complexity, delivering cost and time savings

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March

Strategic alliances hit bumps in the road
Mixed relationship performance driving new approaches

Tapping community hospitals for clinical trial volunteers
New study finds high potential but infrastructure, resources are lacking

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