DIA Biosimilars 2013

Global News

Ensemble Therapeutics, Novartis collaborate

Wednesday, August 7, 2013 11:51 AM

Ensemble Therapeutics, a biotechnology company developing Ensemblins, a novel class of small molecule therapeutics with the power of biologics, has initiated a two-part R&D collaboration with Novartis. The companies have entered into a strategic development agreement for Ensemble's most advanced proprietary program that targets the inflammatory cytokine IL-17, and for a new program to discover novel small molecule treatments against undisclosed drug targets specified by Novartis using Ensemble's proprietary drug discovery platforms.

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Cenduit: Now with Patient Reminders

Industry associations support FDA Safety Over Sequestration Act

Wednesday, August 7, 2013 11:45 AM

Senator Mark Pryor, chairman of the Senate Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies, and Sens. Roy Blunt, Daniel Coats, Al Franken and Jerry Moran last week introduced S. 1413 to exempt future FDA user fees from sequestration. A similar bill, H.R. 2725, was introduced in the U.S. House of Representatives earlier this month by Representatives Leonard Lance, Anna Eshoo, Mike Rogers and Doris Matsui.

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CRF Health – eCOA Forum

Oncobiologics, inVentiv Health partner for biosimilars

Wednesday, August 7, 2013 11:43 AM

Privately-held biopharmaceutical company Oncobiologics and inVentiv Health have partnered around clinical development for all assets in Oncobiologic's pipeline. The global partnership will initially focus on biosimilar assets, and could be expanded to include innovative molecules.

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Komtur Pharmaceuticals forms joint venture with HenHeKangJain China

Wednesday, August 7, 2013 11:38 AM

Komtur Pharmaceuticals, a German specialist in clinical trial sourcing, is investing in Chinese HengHeKangJian Pharmaceutical Trading. The joint venture company will operate under Komtur-Solin Pharmaceuticals.

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Icon forms collaboration in Taiwan

Wednesday, August 7, 2013 11:33 AM

Global CRO Icon and the National Clinical Trials and Research Center (NCTRC) at the National Taiwan University Hospital, have formed a collaboration agreement to enhance the setup and management of clinical studies in Taiwan.

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TransCelerate BioPharma’s Clinical Trial Comparator Network now active

Wednesday, August 7, 2013 11:26 AM

TransCelerate BioPharma has reached its primary milestone in its Clinical Trial Comparator Network initiative. Formed to establish reliable, rapid sourcing of quality drug products for use in clinical trials, the Comparator Network will enable accelerated clinical trial timelines and enhanced patient safety.

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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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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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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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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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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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