DIA Biosimilars 2013

United States

FDA approves multiple sclerosis stem cell clinical trial

Monday, August 19, 2013 03:41 PM

The Tisch MS Research Center of New York has received IND approval from the FDA to commence a phase I trial using autologous neural stem cells in the treatment of multiple sclerosis (MS). MS is a chronic human autoimmune disease of the central nervous system that leads to myelin damage and neurodegeneration and affects approximately 2.1 million people worldwide.

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Cenduit: Now with Patient Reminders

Ashfield names Michael Burman VP Medical Call Center

Monday, August 19, 2013 08:48 AM

Ashfield, part of United Drug, has named Dr. Michael Burman vice president of its Ivyland, Pa-based Medical Call Center. Ashfield Medical Information, formerly Alliance Healthcare, is a provider of medical information and pharmacovigilance call center services to healthcare, biotech and device companies.

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CRF Health – eCOA Forum

Boehringer Ingelheim Chemicals to close Virginia facility

Friday, August 16, 2013 01:49 PM

Boehringer Ingelheim Chemicals will close its Petersburg, Va. plant at the end of 2014. The facility will continue normal operations through the remainder of 2013 and phase out operations the following year. The closure will impact 240 employees through a multi-stage process beginning December.

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NIH awards Seattle BioMed $16.6 million tuberculosis grant

Friday, August 16, 2013 12:04 PM

Seattle BioMed, a U.S. independent nonprofit focused solely on infectious disease research, has been awarded a grant from the National Institute of Allergy and Infectious Diseases, part of the NIH, which will take a comprehensive systems approach to tuberculosis (TB) infection, harnessing the power of technology and systems biology to examine the progression from latent infection to disease. The grant will total up to $16.6 million over a five-year period.

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Theorem, RadMD collaborate

Friday, August 16, 2013 11:44 AM

Theorem Clinical Research is collaborating with RadMD, a medical imaging company.

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John Hopkins study suggests neurologists unaware of drug risks

Friday, August 16, 2013 10:41 AM

A study by Johns Hopkins researchers shows a fifth of U.S. neurologists appear unaware of serious drug safety risks associated with various anti-epilepsy drugs, potentially jeopardizing the health of patients who could be just as effectively treated with safer alternative medications.

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Certara acquires Great Lakes Drug Development

Thursday, August 15, 2013 10:11 AM

Certara, a provider of software and scientific consulting services to improve productivity and decision-making from drug discovery through drug development, has acquired drug development consultancy Great Lakes Drug Development (GLDD), based in Brighton, Mich. Both companies focus on pharmacokinetic (PK) and pharmacodynamic (PD) analysis, project management and pharmacometric modeling and simulation. GLDD focuses on early development work, while Certara’s products and services span the entire drug development continuum.

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University of Maryland Ventures partners with life sciences companies

Thursday, August 15, 2013 09:02 AM

University of Maryland (UM) Ventures has announced agreements between University of Maryland, Baltimore (UMB) and five different life sciences companies across the Baltimore/Washington metropolitan region: Rexahn Pharmaceuticals, Plasmonix, IGI Technologies, A&G Pharmaceuticals and BioAssay Works.

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Wolters Kluwer Health launches apps

Wednesday, August 14, 2013 01:08 PM

Wolters Kluwer Health, a global provider of information and point-of-care solutions for the healthcare industry, has launched two specialized mobile applications of Lippincott’s Nursing Drug Handbook, a drug reference for nurses. Designed for use with iPad and iPhone, these apps are the industry’s first electronic references for nurses to focus on drugs used in oncology and psychiatry. Both are subsets of the Nursing Drug Handbook app, which provides access to current drug information for nurses.

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Velesco expands operations with Massachusetts office

Wednesday, August 14, 2013 01:05 PM

Velesco Pharma has boosted its drug formulation, analytical development and cGMP clinical trial manufacturing services with the opening of a new business development office in the greater Boston area. Velesco is a CMC CRO formed by former pharmaceutical R&D colleagues that supports early-stage drug development. 

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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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