DIA Biosimilars 2013

Articles Published in 2011

Oxford BioMedica, Mayo Clinic collaborate in glaucoma research

Monday, October 31, 2011 11:04 AM

Oxford BioMedica has entered into a research and development collaboration with Mayo Clinic to develop a novel gene therapy for the treatment of chronic glaucoma. Under the terms of the agreement, Mayo Clinic and Oxford BioMedica will undertake pre-clinical studies to establish the feasibility of treating glaucoma using Oxford BioMedica's proprietary LentiVector gene delivery technology expressing a COX-2 gene and a PGF-2alpha receptor gene in order to reduce intraocular pressure. The collaboration includes an option for exclusive US rights to license Mayo Clinic's glaucoma technology, which Oxford BioMedica can exercise upon completion of pre-clinical studies under confidential terms agreed by Mayo Clinic and Oxford BioMedica.

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Cenduit: Now with Patient Reminders

Cobra Biologics acquires Unitech Pharma

Monday, October 31, 2011 10:49 AM

Cobra Biologics has acquired Unitech Pharma Group and its bio-production facility in Matfors near Sundsvall, Sweden.

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CRF Health – eCOA Forum

Proposed Common Rule updates focus on consent, definitions, streamlined IRB review, data protection

Monday, October 31, 2011 08:02 AM

A 20-year-old federal policy for protecting human subjects known as the Common Rule is soon to be updated in ways that could modernize how the industry approaches the ethics, safety and oversight of human research.

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Survey: 80% of big pharma companies restructuring to strategically outsource more trials to CROs

Monday, October 31, 2011 08:00 AM

According to a recent survey from William Blair, about 80% of big pharma companies either are in the process of restructuring or have already completed restructuring plans to strategically outsource more of their trials to CROs.

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BBK, PatientsLikeMe launch online diabetes movement

Friday, October 28, 2011 02:47 PM

BBK Worldwide and PatientsLikeMe have launched CallingAllTypes.com, an online social health initiative for people with type 1 and type 2 diabetes. CallingAllTypes.com is a vehicle for people to share their experiences with diabetes. Within seconds of individuals posting their thoughts, social media outlets including Facebook, YouTube, and Twitter will pick up their words, creating instantaneous viral awareness – a dynamic way to inform the public, including policy makers and health professionals, about the real toll diabetes takes on individuals and families. CallingAllTypes.com will donate $1 to the Atlanta chapter of the American Diabetes Association for each of the first 10,000 visitors who help to create the needed awareness about this condition by posting a comment during the month of November.

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Southern Research names directors

Friday, October 28, 2011 02:19 PM

Southern Research Institute have reported that Damon Papac, Ph.D., and Joseph Murphy, Ph.D. have joined the Birmingham, Ala.-based not-for-profit research organization to lead two key departments within its drug development division, a technology group that primarily provides contract preclinical drug development services for the pharmaceutical industry and government clients.

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Repligen acquires Novozymes business for $23 million

Friday, October 28, 2011 02:06 PM

Repligen has acquired the business of Novozymes Biopharma Sweden in a cash $22.7 million and future potential milestone payments of $5.6 million. This acquisition will elevate Repligen to a world-leading supplier of products for manufacturing biologic drugs with the potential to yield sustainable growth and profitability in fiscal year 2013, beginning April 1, 2012. The combined company is expected to generate total revenues of approximately $50 million in fiscal year 2013.

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Gilead submits NDA for HIV regimen

Friday, October 28, 2011 01:43 PM

Gilead Sciences has submitted a New Drug Application (NDA) to the FDA for marketing approval of the "Quad", a complete single-tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV-1 infection in adults. If approved, the Quad would be the only once-daily, single-tablet regimen containing an integrase inhibitor.

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Lilly selects Prasco to market generics

Friday, October 28, 2011 11:28 AM

Prasco Laboratories has signed a marketing and distribution agreement with Eli Lilly to market the authorized generic version of ZYPREXA (olanzapine) tablets and ZYPREXA ZYDIS (olanzapine) orally disintegrating tablets, in the U.S.

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Protagen, Charles River form marketing alliance

Friday, October 28, 2011 10:39 AM

Protagen and Charles River Laboratories International have formed a strategic marketing & sales alliance.

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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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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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