DIA Biosimilars 2013

Clinical Intelligence

Novelos enrolls first patient in solid tumor imaging trial

Thursday, October 25, 2012 09:48 AM

Novelos Therapeutics, a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer, announced that the University of Wisconsin Carbone Cancer Center (UWCCC), an oncology research institution, has enrolled the first patient in a phase I/II positron emission tomography (PET) imaging trial of I-124-CLR1404 (LIGHT), a cancer-targeted PET imaging agent, in patients with nine solid tumor types, including triple negative breast, soft tissue sarcoma, colorectal, gastric, head and neck cancer, esophageal, prostate, ovarian and pancreatic.

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Cenduit: Now with Patient Reminders

Allegro Diagnostics reveals positive results of BronchoGen genomic test for lung cancer

Wednesday, October 24, 2012 11:43 AM

Allegro Diagnostics, a molecular diagnostics company based in Maynard, Mass., released positive results from the AEGIS I (Airway Epithelium Gene Expression In the Diagnosis of Lung Cancer) clinical trial, which demonstrate the diagnostic accuracy of the BronchoGe genomic test in combination with bronchoscopy.

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CRF Health – eCOA Forum

Bayer’s riociguat meets primary endpoint in phase III study in PAH

Tuesday, October 23, 2012 07:15 AM

Bayer HealthCare Pharmaceuticals, the U.S.-based pharmaceuticals business of Bayer HealthCare, issued data from the phase III PATENT-1 pulmonary arterial hypertension (PAH) trial evaluating its investigational drug riociguat in both treatment-naive patients and those pre-treated with an endothelin receptor antagonist or an oral, inhaled or subcutaneous prostanoid.

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Lilly touts positive results from phase III trials of dulaglutide in T2D

Monday, October 22, 2012 01:24 PM

Global pharmaceutical company Eli Lilly released positive top-line results of three completed phase III AWARD trials for dulaglutide, an investigational, long-acting glucagon-like peptide 1 (GLP-1) analog being studied as a once-weekly treatment for type 2 diabetes.

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Resverlogix initiates phase II trial of RVX-208 in pre-diabetes

Friday, October 19, 2012 03:20 PM

Resverlogix, a Canadian clinical stage cardiovascular company, has initiated an exploratory phase II clinical trial in patients with pre-diabetes mellitus to examine the effects of RVX-208 and ApoA-I production on glucose metabolism.

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FDA approves Jetrea for symptomatic VMA in eyes

Wednesday, October 17, 2012 02:47 PM

The FDA has approved ThromboGenics’ Jetrea (ocriplasmin), the first drug approved to treat an eye condition called symptomatic vitreomacular adhesion (VMA).

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Arena initiates phase I trial of APD811 for hypertension

Friday, October 12, 2012 02:46 PM

Arena Pharmaceuticals, a San Diego-based biopharmaceutical company focused on novel drugs for weight management, cardiovascular disease, inflammation and other disorders, has initiated dosing in a phase I multiple dose clinical trial of APD811, a novel oral drug candidate discovered by Arena that targets the prostacyclin (IP) receptor for the treatment of pulmonary arterial hypertension (PAH).

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StemCells announces first transplant of neural stem cells into patient with dry AMD

Thursday, October 11, 2012 07:00 AM

StemCells, a cell-based therapeutics company of Newark, Calif., has enrolled and transplanted stem cells into the first patient in its phase I/II clinical trial in dry age-related macular degeneration (AMD).

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Noven initiates phase II study of investigational d-ATS for ADHD

Monday, October 8, 2012 08:00 AM

Noven Pharmaceuticals, a a specialty pharmaceutical company and wholly-owned subsidiary of Hisamitsu Pharmaceutical, has commenced a phase II study of a d-Amphetamine Transdermal System (d-ATS) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents.

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Risk gene for Alzheimer's disease associated with lower brain amyloid

Thursday, October 4, 2012 12:57 PM

Researchers investigating a known gene risk factor for Alzheimer's disease discovered it is associated with lower levels of beta amyloid—a brain protein involved in Alzheimer's—in cognitively healthy older people.

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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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