DIA Biosimilars 2013

Clinical Intelligence

Omeros begins enrollment in second phase III OMS302 trial

Wednesday, April 11, 2012 03:52 PM

Omeros, a Seattle-based biopharmaceutical company, has commenced enrollment in a second phase III clinical trial evaluating OMS302 in intraocular lens replacement (ILR) surgery.

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Cenduit: Now with Patient Reminders

QRxPharma concludes phase I studies for MoxDuo CR

Wednesday, April 11, 2012 03:28 PM

Australia-based QRxPharma has completed two phase I studies in healthy volunteers for MoxDuo CR, a controlled-release Dual-Opioid utilizing a 3:2 ratio of morphine and oxycodone.

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CRF Health – eCOA Forum

BIND Bioscience releases promising anti-tumor results

Wednesday, April 11, 2012 02:52 PM

BIND Biosciences, a clinical-stage biopharmaceutical company, has releases promising data from an ongoing phase I study of BIND-014, the company’s lead drug candidate within a new class of targeted therapeutics, Accurins, that are programmed to concentrate at tumors.

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Syndax initiates phase I/II study in metastatic breast cancer

Monday, April 9, 2012 04:42 PM

Syndax Pharmaceuticals, a clinical-stage epigenetics oncology company based in Waltham, Mass., has initiated a phase I/II study combining its lead product entinostat with lapatinib ditosylate (Tykerb) in patients with locally recurrent or distant relapsed metastatic breast cancer previously treated with trastuzumab (Herceptin).

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CureFAKtor drug inhibits pancreatic tumor growth

Friday, April 6, 2012 04:14 PM

CureFAKtor Pharmaceuticals, a privately-held biopharmaceutical company, has reported data demonstrating analogs of novel focal adhesion kinase (FAK) inhibitor CFAK-C4 disrupted FAK-vascular endothelial growth factor receptor 3 (FAK-VEGFR3) interaction and inhibited pancreatic tumor growth.

Data showed that oral small molecule FAK inhibitor C4 analogs disrupt FAK-VEGFR3 interaction and dramatically inhibit pancreatic tumor growth at low concentrations as single agents, as well as in combination with gemcitabine, demonstrating synergistic effect. In vivo, 30-day treatment with low doses of the four analogs led to massive reduction in tumor growth when treated as single agents (60%) and in combination with gemcitabine (80%) (P<0.05). The C4 analogs displayed enhanced potency, minimum toxicity and high specificity for the target site.

A previous CureFAKtor study pinpointed the site of interaction of VEGFR-3 and FAK to create the small molecule drug capable of disrupting signaling and causing death of many types of cancer cells.

CureFAKtor is planning a phase I clinical study of CFAK-C4 in combination with gemcitabine chemotherapy in 2012, which received Orphan Drug Designation by the FDA.

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UCB, Amgen begin phase III postmenopausal osteoporosis program

Friday, April 6, 2012 03:47 PM

UCB, a global biopharmaceutical based in Brussels, Belgium, and biotech Amgen have initiated their sclerostin antibody (CDP7851/AMG785) phase III clinical trial program for the treatment of postmenopausal osteoporosis.

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Novartis phase III COPD studies meet primary endpoints

Friday, April 6, 2012 03:08 PM

The first three Novartis Pharmaceuticals QVA149 phase III studies in the treatment of chronic obstructive pulmonary disease (COPD) all met their primary endpoints.

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Abbott touts promising results in phase II Hep C trial

Thursday, April 5, 2012 08:00 AM

Abbott has released promising data from two different interferon-free phase II studies for hepatitis C (HCV), suggesting that a 12-week regimen of two Abbott medicines, and no peginterferon, can achieve high cure rates for treatment-naïve, genotype 1 patients.

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Synta releases data on ganetespib across range of malignancies

Wednesday, April 4, 2012 09:00 AM

Lexington, Mass.-based Synta Pharmaceuticals has released results on the use of ganetespib, the most advanced heat shock protein 90 (Hsp90) inhibitor in clinical development, in melanoma and colorectal cancer.

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The CenterWatch Monthly, April 2012

Sunday, April 1, 2012 06:30 AM

Global sites see growth in trials, revenue, staffing

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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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The CenterWatch Monthly

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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