DIA Biosimilars 2013

Clinical Intelligence

Altheus Therapeutics completes Zoenasa phase I trial in ulcerative colitis

Friday, June 15, 2012 11:34 AM

Altheus Therapeutics of Oklahoma City, Okla., has completed a two dose, double-blind, active-controlled phase I trial of the safety and tolerability of Zoenasa rectal suspension in adult patients with left-sided, or distal, ulcerative colitis.

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Cenduit: Now with Patient Reminders

Selexys Pharmaceuticals concludes phase I study in sickle cell disease

Thursday, June 14, 2012 11:54 AM

Selexys Pharmaceuticals, a privately held biopharmaceutical company based in Oklahoma City, Okla., has completed a phase I clinical study of its lead compound SelG1, an antibody specific for the pro-inflammatory cell adhesion molecule P-selectin.

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CRF Health – eCOA Forum

FDA approves Perjeta for HER2-positive metastatic breast cancer

Monday, June 11, 2012 03:03 PM

The FDA has approved Roche’s Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and docetaxel chemotherapy for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

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Novartis’ Gilenya earns positive results in extended phase III head-to-head study

Monday, June 11, 2012 02:52 PM

New long-term data for Gilenya (fingolimod), the only oral therapy approved to treat people with relapsing forms of multiple sclerosis (MS), show a sustained efficacy benefit and a consistent safety profile with up to 4.5 years of continuous treatment, according to Switzerland-based Novartis Pharma.

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Mount Sinai researchers develop multi-target approach to treating tumors

Friday, June 8, 2012 02:38 PM

Researchers from Mount Sinai School of Medicine developed a cancer model built in the fruit fly Drosophila, then used it to create a whole new approach to the discovery of cancer treatments: AD80.

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Generex touts positive AE37 cancer vaccine technology

Friday, June 8, 2012 11:56 AM

Generex Biotechnology reported promising technology and clinical results from its on-going phase II trial of the AE37 breast cancer vaccine being developed by its subsidiary Antigen Express.

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Two GSK melanoma drugs garner top results

Monday, June 4, 2012 10:21 AM

GlaxoSmithKline released results from two of its phase III melanoma studies: one evaluating single agent therapy with the targeted anti-cancer agents, dabrafenib and trametinib, in patients with BRAF V600 mutation positive metastatic melanoma; and one evaluating trametinib alone.

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Ocera drug rapidly reduces ammonia in liver cirrhosis trial

Friday, June 1, 2012 11:10 AM

Ocera Therapeutics of San Diego and the Hospital Universitari Vall d'Hebron Research Institute in Barcelona released preliminary data from an open label phase II study evaluating the overall effectiveness and safety of OCR-002 (ornithine phenylacetate) for the treatment of cirrhosis of the liver and upper GI bleeding.

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Novelos completes first cohort in phase Ib solid tumor trial

Friday, June 1, 2012 10:59 AM

Novelos Therapeutics, a Madison, Wis.-based pharmaceutical company focused on cancer, has successfully completed the first cohort in a multi-center phase Ib dose-escalation trial of its cancer-targeted molecular radiotherapeutic compound I-131-CLR1404 (HOT) in cancer patients with advanced solid tumors. 

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The CenterWatch Monthly, June 2012

Friday, June 1, 2012 09:00 AM

Western Europe sees drop in active investigators

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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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