DIA Biosimilars 2013

Articles Published in 2011

Tang joins ICON Development Solutions

Monday, November 28, 2011 11:29 AM

ICON's Development Solutions division has named Dr. Daniel Tang general manager, Asia Pacific. Tang will lead the development of ICON’s early phase activities across the region, including bioanalytical laboratory services, and the development of strong links with key opinion leaders for early phase clinical testing.

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Cenduit: Now with Patient Reminders

FDA approves Intermezzo to treat insomnia

Monday, November 28, 2011 11:08 AM

The FDA has approved Intermezzo (zolpidem tartrate sublingual tablets) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.

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CRF Health – eCOA Forum

Regeneron, Bayer initiate phase III SIGHT trial in China

Monday, November 28, 2011 10:30 AM

Regeneron Pharmaceuticals and Bayer HealthCare have initiated a phase III clinical trial evaluating the efficacy and safety of EYLEA (aflibercept) injection in the neovascular form of age-related macular degeneration (wet AMD) in China.

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Gilead Sciences acquires Pharmasset, looks to duplicate its HIV success in hepatitis C

Monday, November 28, 2011 08:02 AM

Consolidation among drug sponsors continues. 

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UCB inks strategic partnerships with Parexel, PRA

Monday, November 28, 2011 08:00 AM

The sponsor-CRO strategic partnerships just keep coming. 

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RaySearch signs South Korean distribution agreement with OTS

Wednesday, November 23, 2011 11:04 AM
RaySearch Laboratories has entered into an exclusive distribution agreement with the South Korean distributor Oncology Total Solution, based in Seoul. The agreement means that OTS will be fully responsible for marketing, sales and service for RaySearch’s proprietary treatment planning system RayStation on the South Korean market.

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MGH, Vall d'Hebron Hospital partner with BBVA Foundation in biomarker research

Wednesday, November 23, 2011 10:47 AM

The BBVA Foundation has reported an agreement to underwrite a joint effort between Massachusetts General Hospital and Barcelona's Vall d'Hebron Hospital to search for personalized cancer therapies through biomarker research.

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Boston Scientific's PROMUS Element Stent receives FDA approval

Wednesday, November 23, 2011 10:31 AM

The FDA has approved Boston Scientific's PROMUS Element plus everolimus-eluting platinum chromium coronary stent system, the company's next-generation drug-eluting stent (DES) technology. The PROMUS Element Stent, designed to provide physicians improved DES performance in treating patients with coronary artery disease, is built on an innovative platinum chromium (PtCr) platform with
the market-leading everolimus drug.  The company plans to begin marketing
the product in the U.S. immediately.

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Aeterna Zentaris, Hikma partner in commericalization of Perifosine

Wednesday, November 23, 2011 10:03 AM

Aeterna Zentaris and Hikma Pharmaceuticals have signed an exclusive commercialization and licensing agreement for the registration and marketing of perifosine, Aeterna Zentaris' lead anti-cancer compound, for the MENA (Middle East and North Africa) region. Perifosine, a novel oral Akt inhibitor, is currently in two phase III programs for the treatment of colorectal cancer and multiple myeloma in the United States and Europe.

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U-M Medical School, MedImmune ink 3 year research agreement

Wednesday, November 23, 2011 09:42 AM

Leaders from the University of Michigan Medical School and MedImmune, the global biologics arm of AstraZeneca, have signed a new agreement to work together on a broad range of projects. The three-year strategic collaboration will bring scientists from one of the nation’s top medical research institutions together with scientists from one of the world’s leading developers of biologic therapies. UMMS and MedImmune scientists will cooperate on studies that aim to translate scientific discoveries from the laboratory into new candidates for treating cancer, heart disease, digestive disease, lung disease and diseases caused by inflammation.

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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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