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Clinical Intelligence

Oxford BioMedica earns milestone payment from Pfizer

Thursday, August 29, 2013 10:01 AM

Oxford BioMedica, a gene-based biopharmaceutical company, has announced a $1 million milestone payment from Pfizer has been triggered by the entry of PF-06263507, a 5T4-targeted investigational antibody therapy, into human clinical trials.

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Northwestern Medicine enrolls first participant in brain tumor trial

Wednesday, August 28, 2013 02:47 PM

Northwestern Medicine recently joined a clinical trial to investigate if a vaccine made from a patient's own brain tumor is effective in slowing tumor progression and extending survival. The randomized, phase II trial will study how well giving the study vaccine with or without Avastin (bevacizumab) works in treating patients with recurrent glioblastoma multiforme (GBM).

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Boston Scientific completes enrollment in SuperNOVA clinical trial

Thursday, August 22, 2013 08:01 AM

Boston Scientifichas completed enrollment in the SuperNOVA trial, a global, single arm, prospective, multicenter trial evaluating the long-term (12 month) safety and effectiveness of the Innova Self-Expanding Stent System. This advanced stent system is designed for treating patients with a narrowing or blockage of the arteries above the knee, often associated with peripheral artery disease (PAD).

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First patients enrolled in REMEDEE registry

Tuesday, August 20, 2013 09:58 AM

Patient enrollment has been initiated in a post-market registry for OrbusNeich’s COMBO Dual Therapy Stent to evaluate its long-term safety and performance in routine clinical practice. The prospective, multicenter, all-comers REMEDEE Registry (Multicenter, Prospective, Clinical Outcomes After Deployment of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo Bio-Engineered Sirolimus Eluting Stent) Post Market Registry) will enroll 1,000 patients at nine European sites. More than 100 patients have already been enrolled.

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FDA approves multiple sclerosis stem cell clinical trial

Monday, August 19, 2013 03:41 PM

The Tisch MS Research Center of New York has received IND approval from the FDA to commence a phase I trial using autologous neural stem cells in the treatment of multiple sclerosis (MS). MS is a chronic human autoimmune disease of the central nervous system that leads to myelin damage and neurodegeneration and affects approximately 2.1 million people worldwide.

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Pathogenica achieves CE marking for HAI BioDetection Kit

Monday, August 19, 2013 03:32 PM

Pathogenica has achieved the CE mark under the European Directive on In Vitro Diagnostic Medical Devices for its HAI BioDetection kit that runs on the Ion PGM benchtop sequencer.  This milestone marks the HAI BioDetection CE-IVD kit as the first sequence-based infectious disease diagnostic kit on the market.

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Quest Diagnostics launches opioid therapy genetic test

Monday, August 12, 2013 04:23 PM

Quest Diagnostics, a provider of diagnostic information services, has launched a lab-developed genetic test to aid the delivery of personalized opioid pain-relieving treatment. It is the first clinical lab to offer testing for variants in all cytochrome P450 (CYP450) genes known to influence the CYP450 enzyme system, which affects metabolism of opioids and other medications.

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Catabasis announces successful phase I trial

Friday, August 9, 2013 02:09 PM

Catabasis Pharmaceuticals has announced preliminary data from a phase I trial of CAT-2003, an oral SMART Linker conjugate constructed using the company's proprietary technology, demonstrated a significant reduction in fasting and post-prandial triglyceride levels. CAT-2003 also had positive effects on other biomarkers, including reductions in apolipoprotein C-III (ApoC-III), a negative regulator of lipoprotein lipase, and apolipoprotein B (ApoB), the lipoprotein associated with VLDL and LDL cholesterol. In addition, reductions in plasma PCSK9 levels and LDL cholesterol were observed.

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Boehringer, Lilly enroll first patient in type 2 diabetes trial

Friday, August 9, 2013 02:07 PM

Boehringer Ingelheim Pharmaceuticals and Eli Lilly have announced enrollment of the first patient into a cardiovascular (CV) and renal outcomes trial for linagliptin (tradjenta) tablets.

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Aeterna Zentaris announces first patient dosed in phase III endometrial cancer trial

Friday, August 9, 2013 02:05 PM

Aeterna Zentaris has announced the first patient has been recruited and dosed for the phase III ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) trial in women with endometrial cancer resistant to platinum/taxane-based chemotherapy.

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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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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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