Clinical Intelligence

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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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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