European Medicines Agency (EMA)
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5 Health Challenges The World Will Face In 2015
What comes next for the future of the world's health?... But these are the issues reason would suggest will set the world's health agenda next year...
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Across Pharma, Few Open Arms For Trial Data Sharing
Industry inches toward consensus on limited sharing as EMA, GSK press for open access. Read More »
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Big Pharma Opens New Chapter On Big Data Collaboration
In the course of one short week, no less than 3 different models have emerged for sharing big data in the pharmaceutical industry. The highest profile of these ‒ called Project Data Sphere (PDS here) ‒ was announced earlier today with the official opening of an online resource to share clinical trial data for use in cancer research.
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Big Pharma Plays Hide-The-Ball With Data
...[E]vidence released earlier this year by Cochrane Collaboration, a London-based nonprofit, shows that a significant amount of negative data from [Tamiflu's] clinical trials were hidden from the public. The Food and Drug Administration (FDA) knew about it, but the medical community did not; the U.S. Centers for Disease Control and Prevention (CDC), which doesn’t have the same access to unpublished data as regulators, had recommended the drug without being able to see the full picture...
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Breaking the Seal on Drug Research
Together with a band of far-flung researchers and activists, [Dr. Peter Doshi] is trying to unearth data from clinical trials — complex studies that last for years and often involve thousands of patients across many countries — and make it public. Read More »
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ClinGenuity Uses Artificial Intelligence Redaction Tool To Keep Big Pharma Compliant
ClinGenuity, the Cincinnati medical writing company with the pharmaceutical industry's first and only artificially-intelligent automated redaction management tool, has processed more than a half billion redactions for big pharma companies to help them meet the growing industry demand for pharmaceutical clinical trial disclosure and transparency initiatives...
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e-Health Project In Malaysia To Monitor Medical Drug Preservation With Waspmote
Medical drugs are very expensive, in special vaccines and others that need to be stored at a specific temperature. Therefore, real-time monitoring is vital to control whether the cold chain has been broken or not. Wireless sensor networks (WSN) are capable of getting temperature, humidity or luminosity measurements and transmit the data to a remote server periodically. In this way, real-time conditions can be monitored in order to know when a problem in a freezer or a refrigerator happens, avoiding critical situations and saving a huge amount of money.
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Good News from the European Medicines Agency
The recent conference in Cork on conflict of interest was extremely interesting and will provide the basis for a few posts on this blog – the speakers’ presentation can be seen here. Read More »
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Medidata And TransCelerate BioPharma Inc. Announce Joint Initiative
Collaboration to Explore Key Components of Recommended Risk-Based Monitoring Methodology
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Open Access in Europe to Big Pharma clinical trial data
When Guido Rasi took charge of Europe’s medicines’ regulator in 2011 he inherited an explosive dossier that is now poised to transform drug development. Read More »
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Rise Of Superbugs Threatens Antibiotic Crisis
Lethal drug-resistant organisms mean threat must be listed on register of civil emergencies, says chief medical officer Read More »
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Serious Risks and Few New Benefits from FDA-Approved Drugs
Over the past year, the U.S. Senate and The New York Times have been investigating the failure of the nation’s auto safety regulators to protect citizens from cars with occasionally dangerous faulty devices. But neither august institution has paid attention to the Food and Drug Administration’s (FDA) failure to protect the 170 million Americans who take prescription drugs from adverse reactions that are killing more than 2,400 people every week. Annually, prescription drugs cause over 81 million adverse reactions and result in 2.7 million hospitalizations...
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Simulators Help Build A Better Drug Trial
Researchers have started using powerful computer simulators to design better drug trials and help bring new medicines to market with fewer failures. Read More »
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Transparency International Reports on Massive Corruption in the Pharmaceutical Sector - Media Hardly Notices
In 2006, TI published a report on health care corruption, which asserted that corruption is widespread throughout the world, serious, and causes severe harm to patients and society. "Corruption might mean the difference between life and death for those in need of urgent care. It is invariably the poor in society who are affected most by corruption because they often cannot afford bribes or private health care. But corruption in the richest parts of the world also has its costs"...
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WATCH: What Doctors Don't Know About The Drugs They Prescribe
TEDTalks can sometimes portray science in triumphalist tones, with fabulous innovations that are changing the world forever. But the real action in science is often around dirty, messy, angry problems, and my TEDTalk is about the dirtiest I've seen yet. Read More »
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