With European clinical trials in rapid decline, a revision of the Clinical Trials Directive (CTD) is fully underway. Elisabeth Fischer talks to academics and industry experts to hear their reactions to the Commission’s proposal for a new regulation, announced in July 2012, and discovers how a streamlined approval system and consistent standards for compliance and inspection could help to boost European health research once again.
Generally not an early adopter of new technology, Big Pharma is starting to embrace the mobile revolution. However, with tablets and smartphones developing to become their own mobile business hubs, the pharmaceutical industry still needs to tackle data and structural challenges before they truly benefit from wireless devices.
Danish pharmaceutical company Lundbeck and its Japanese partner Otsuka have announced successful results from a Phase 3 clinical trial evaluating the efficacy, safety and tolerability of a once-monthly drug for the treatment of schizophrenia.
A recent study suggested that plasma can kill viruses within seconds, which could change the way hospital infections are treated. Julia Zimmermann, research leader at the Max-Planck-Institut für extraterrestrische Physik, told Elisabeth Fischer if plasma really could be used in the fight against diseases such as HIV, the common cold and even cancer.
Research into anti-addiction drugs and vaccines is booming, but big pharmaceutical companies are yet to show support. But with mounting evidence that addiction causes physical changes in the brain, ethical issues and regulatory barriers surrounding the control and management of drug addiction medication could soon be left in the past.
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Disruptions in the cold supply chain of temperature-sensitive drugs are a major contributor to global vaccine wastage. Elisabeth Fischer profiles the next generation of packaging materials, including new types of phase change materials and foams which promise to keep medicines cool, even in the hottest temperatures.
A big chunk of the UK Government’s 2012 Budget will go into the country’s healthcare sector. Elisabeth Fischer looks into the details of Chancellor George Osborne’s financial plan for the upcoming year and explores future opportunities for the pharmaceutical and life science industries.
A European directive aims to harmonise the serialisation and verification of drugs but many details are still missing. Elisabeth Fischer finds out what still needs to be done to help pave the way for truly competitive European and global track-and-trace standards.
With companies outsourcing clinical trials to emerging nations, medical cargo theft has become a major concern. Prior to Arena International’s Clinical Trial Supply Europe, Elisabeth Fischer talks to Cathy Brown, process improvement manager within security operations at Napp Pharmaceuticals, about strategies and technologies that ensure a safe medical supply chain.