DIA Biosimilars 2013

World Health Organization

FDA grants accelerated approval for Sirturo for multi-drug resistant TB

Wednesday, January 2, 2013 03:13 PM

The FDA has granted accelerated approval to Janssen Therapeutics’ Sirturo (bedaquiline) tablets for the treatment of pulmonary multi-drug resistant tuberculosis (MDR-TB) as part of combination therapy in adults. The accelerated approval is based on the surrogate endpoint of time to sputum culture conversion.

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Cenduit: Now with Patient Reminders

New phone app charts cases of infectious diseases

Wednesday, November 28, 2012 02:53 PM

Scientists at the University of Liverpool have developed a free iPhone application, ClickClinica, to help health authorities monitor cases of major infectious diseases in response to research that highlighted one in 10 meningitis patients were not reported to the Health Protection Agency (HPA).

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CRF Health – eCOA Forum

AstraZeneca, Broad Institute partner on discovery of antibacterial and antiviral agents

Wednesday, September 12, 2012 09:09 AM

AstraZeneca and the Broad Institute in Cambridge, Mass., have formed a collaboration to identify new chemical compounds targeting bacterial and viral infections that could speed the development of new antibacterial and antiviral drugs.

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Analysis: Disparity between number of children with major diseases and pediatric studies

Monday, July 23, 2012 11:54 AM

New analysis shows there are major discrepancies between the amount of pediatric clinical research for several major global diseases and the number of children who suffer from those diseases. While children bear nearly 60% of the burden of 10 major global diseases, only about 12% of the clinical trials for those diseases include or focus on children, according to Boston Children's Hospital doctors Kenneth Mandl and Florence Bourgeois’s analysis of five years of clinical trial data.

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Japan Chooses Sanofi Pasteur for First Enhanced Inactivated Polio Vaccine

Friday, May 4, 2012 08:00 AM

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Sanofi Pasteur’s, standalone Inactivated Poliovirus Vaccine (IPV) against acute flaccid poliomyelitis (Imovax Polio). Imovax Polio will be added to the country's public immunization program on September 1.

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Dementia to triple by 2050, largely ignored

Wednesday, April 11, 2012 11:35 AM

Worldwide, nearly 35.6 million people live with dementia. This number is expected to double by 2030 (65.7 million) and more than triple by 2050 (115.4 million). Dementia affects people in all countries, with more than half (58%) living in low- and middle-income countries. By 2050, this is likely to rise to more than 70%.

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Soligenix demonstrates proof of concept with vaccine technology

Tuesday, February 7, 2012 10:49 AM

Soligenix, a development-stage biopharmaceutical company, has released results from pre-clinical studies of its proprietary vaccine thermostabilization technology indicating that Soligenix is able to produce stable vaccine formulations using adjuvants, protein immunogens and other components that ordinarily would not withstand long temperature variations exceeding customary refrigerated storage conditions.

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International collaboration to combat 10 neglected tropical diseases by 2020

Monday, January 30, 2012 03:49 PM

Thirteen pharmaceutical companies, the U.S., U.K. and U.A.E governments, the Bill & Melinda Gates Foundation, the World Bank and other global health organizations will join forces to eliminate or control 10 neglected tropical diseases (NTDs) by the end of the decade.

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IDRI joins ADITEC to accelerate human vaccine development

Tuesday, October 18, 2011 02:19 PM

The Infectious Disease Research Institute (IDRI) has joined the Advanced Immunization Technologies (ADITEC) program, a collaborative initiative dedicated to accelerating the development of the next generation of human vaccines. Launched on October 1st, ADITEC will operate with 30 million euros in funding over the course of 5 years contributed by the European Union, with an additional 11 million euros in funding from collaborating organizations.

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EU Clinical Trials Register to be available on WHO’s ICTRP portal

Thursday, September 22, 2011 02:13 PM

The European Union Clinical Trials Register (EU-CTR) has been recognized as one of the primary registries for the World Health Organization’s (WHO) International Clinical Trials Registry Platform (ICTRP), according to PharmaTimes.

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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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