DIA Biosimilars 2013

Articles Published in 2013

Astellas appoints senior vp of global oncology development

Tuesday, August 6, 2013 11:30 AM

Tokyo-based Astellas Pharma Global Development has appointed Claire Thom senior vice president of global oncology development.

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Cenduit: Now with Patient Reminders

Arisaph awarded phase I STTR grant

Tuesday, August 6, 2013 11:06 AM

Arisaph Pharmaceuticals, a privately held drug discovery and development biopharmaceutical company focused on developing novel therapies for cardiometabolic diseases and cancer, has been awarded a phase I Small Business Technology Transfer (STTR) award from the National Cancer Institute of the NIH. The award supports the R&D of Arisaph's small molecule immune modulators to stimulate tumor immunity following treatment with BRAF inhibitors in cancer.  

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CRF Health – eCOA Forum

OncoGenex’s Spruce trial open for enrollment

Tuesday, August 6, 2013 10:30 AM

OncoGenex Pharmaceuticals has initiated the Spruce clinical trial, an investigator-sponsored, randomized, double-blind, placebo-controlled phase II trial evaluating OGX-427, a heat shock protein 27 (Hsp27) inhibitor, in patients with previously untreated advanced non-squamous non-small cell lung cancer (NSCLC).

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Medicines Patent Pool, Roche sign HIV agreement

Tuesday, August 6, 2013 10:01 AM

The Medicines Patent Pool and Roche have signed an agreement to increase access in 138 developing countries to Roche’s valganciclovir, a key oral medicine to treat cytomegalovirus (CMV), a viral infection that can cause blindness in people with HIV, by making it up to 90% cheaper than current prices. The companies also will enter into licensing and technology transfer negotiations to encourage the development of internationally approved quality generic versions of valganciclovir.

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Spanish Myeloma Group study a treatment milestone

Monday, August 5, 2013 12:09 PM

Early treatment of asymptomatic myeloma, which has a high risk of developing into active multiple myeloma, can significantly improve the course of the disease, delay progression and increase patient survival. These were the conclusions of a clinical trial carried out by the Spanish Myeloma Group (GEM-PETHEMA), which unites specialists from more than 80 Spanish hospitals, published in the August issue of The New England Journal of Medicine.

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PharmAthene, Theraclone Sciences merge

Monday, August 5, 2013 11:58 AM

PharmAthene and Theraclone Sciences, a privately-held monoclonal antibody (mAb) discovery and development company, have signed a definitive merger agreement.

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Teijin Pharma, Amgen collaborate for autoimmune diseases

Monday, August 5, 2013 11:57 AM

Teijin Pharma has entered into a collaborative agreement with Amgen to discover, develop and commercialize small molecule drugs that target RORγ. The agreement grants Amgen an option to obtain a worldwide (excluding Japan) exclusive license to compounds discovered in the joint research collaboration, while Teijin Pharma will hold exclusive rights in Japan. Teijin Pharma will also have the right to co-promote potential products in select Asian markets.

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Clinipace, Medfiles partner

Monday, August 5, 2013 11:55 AM

Global CRO Clinipace Worldwide has partnered with Finland-based CRO Medfiles, which specializes in pharmaceutical development and analytical services, clinical trial support, health economics and regulatory affairs.

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Daiichi Sankyo extends Medidata use to China

Monday, August 5, 2013 11:53 AM

Japan-based pharmaceutical company Daiichi Sankyo is expanding its use of Medidata Solutions' cloud-based platform to support clinical trials conducted by its division in China, an investment expected to streamline trial activities, improve the efficiency of data capture and increase the productivity of site users and clinical monitors. Daiichi Sankyo will bring Medidata's applications for electronic data capture, clinical data management and randomization and trial supply management to its expanding clinical work in China.

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The CenterWatch Monthly, August 2013

Friday, August 2, 2013 10:36 AM

Will end-to-end outsourcing take hold?

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CWWeekly

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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