DIA Biosimilars 2013

R&D Trends

StemCells launches Alzheimer's program supported by CIRM

Wednesday, July 31, 2013 11:47 AM

StemCells has launched its Alzheimer's disease program, supported by the California Institute for Regenerative Medicine (CIRM). The goal is to file, within four years, an IND application with the FDA to evaluate the company's proprietary HuCNS-SC product candidate (purified human neural stem cells) as a potential therapeutic in the treatment of Alzheimer's disease.

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Cenduit: Now with Patient Reminders

Medistem collaborates with Boston academic researcher

Wednesday, July 31, 2013 11:45 AM

Medistem, developer of Endometrial Regenerative Cell (ERC), a universal donor adult stem cell product, will collaborate with Reza Abdi, M.D., transplant nephrologist at Brigham and Women's Hospital and assistant professor of medicine, Harvard Medical School. The company will provide Abdi with its ERCs and it is expected that his research would support FDA clearance to initiate clinical trials to use ERCs as a treatment for type 1 diabetes. The company has FDA clearance to initiate a dose-escalating phase I clinical trial to use ERCs in patients with critical limb ischemia, a complication of diabetes.

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CRF Health – eCOA Forum

Ascendancy Healthcare, Quintiles collaborate in China

Monday, July 29, 2013 01:30 PM

Ascendancy Healthcare, dedicated to the commercialization of therapeutic products to meet unmet medical needs in China and other high-growth Asian markets, has announced a multi-year collaboration with Quintiles, a provider of biopharmaceutical development and commercial outsourcing services.

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Biogen Idec, Adimab expand collaboration

Friday, July 26, 2013 03:05 PM

Adimab, a provider of an integrated antibody discovery and optimization platform, has expanded its collaboration with Biogen Idec for the discovery of antibody-based therapeutics. 

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Alexion opening operations in Ireland

Friday, July 26, 2013 03:04 PM

Alexion Pharmaceuticalsis opening an office and laboratory facility in Dublin in conjunction with the company’s decision to establish a global supply chain facility in Ireland. Alexion has begun recruiting approximately 50 employees for a range of initial positions in its supply chain, quality assurance, quality control and logistics functions to open by yearend.

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Iran's healthcare market growing

Friday, July 26, 2013 03:02 PM

Iran is ranked 15th among Middle East and Africa (MEA) countries in terms of long-term investment potential—its large youth population cohort, coupled with its healthcare reforms, promise growth in the private sector and investments in the pharmaceutical, healthcare facilities and medical devices markets, according to new research from Frost & Sullivan.

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Aurora Research Institute launches new medical journal

Wednesday, July 24, 2013 02:56 PM

Wisconsin-based nonprofit Aurora Health Care’s Research Institute will launch a quarterly peer-reviewed research journal TheJournal of Patient-Centered Research and Reviews, with the first edition expected in early 2014. The journal will be available online with limited print copies.

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University of Edinburgh, Biogen Idec partner

Wednesday, July 24, 2013 02:35 PM

The University of Edinburgh and Massachusetts-based biotech Biogen Idec have partnered to research multiple sclerosis and motor neurone disease and identify drug compounds for potential treatments. The initiative is funded by Biogen Idec, which develops therapies for neurological disorders and has a portfolio of treatments for patients with multiple sclerosis.

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Aesica, QRxPharma collaborate to promote Stealth Beadlets

Wednesday, July 24, 2013 09:30 AM

Aesica Pharmaceuticals, a global contract development and manufacturing organization (CDMO), has partnered with pharmaceutical company QRxPharma to globally promote QRxPharma’s proprietary Stealth Beadlets abuse deterrence technology.

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Biotech Investment Group launches Formex

Friday, July 19, 2013 02:39 PM

Biotech Investment Group (BiG) has completed the purchase of PharmaForm and has launched Formex, a small molecule formulation company for the pharmaceutical and biotechnology industry.

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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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