Pharmaceutical News and Updates
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Disclosure by drug companies of results of clinical trials not necessary when they don’t lead to product development or commercialisation, but maybe useful for all parties involved.
Drug companies sponsoring human trials of possible new medications have ethical responsibilities to study participants and to science to disclose the results of their clinical research – even when product development is no longer being…
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Critics raise concerns over research, incentives of European pediatric exclusivity regulations
By Karyn Korieth Regulations introduced four years ago in Europe to encourage research into medicines for children have lead to important therapeutic breakthroughs for pediatric patients. Yet concerns also have been raised about how well…
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ENCePP publishes the ‘guide on methodological standards in pharmacoepidemiology’
The European Medicines Agency and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) have published the ENCePP guide on methodological standards in pharmacoepidemiology, an important tool that reviews and gives direct electronic access…
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The EU executive is planning a major overhaul of the rules governing medical research amid a growing acceptance that a directive in place since 2004 has hampered clinical trials
The European Commission says it accepts that the implementation of the directive has been deeply flawed and will legislate to fix the problems by October 2011. The Commission’s health directorate – which was handed control…
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Innovation is in for EU’s Healthcare SystemEurope aim to increase jobs and growth through its “Europe 2020” strategy
By Peter O’Donnell It will come as little consolation to those already struggling to keep up with change to learn that more change is already on the way. Innovation is in, in Europe—again. And not…
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European Medicines Agency holds first stakeholder forum on the implementation of the new pharmacovigilance legislation
European Medicines Agency holds first stakeholder forum on the implementation of the new pharmacovigilance legislation On 15 April 2011, the European Medicines Agency held a stakeholder forum on the implementation of the new pharmacovigilance legislation…
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Should Doctors Shoulder Healthcare Costs?
By Jennifer Ringler As the debate over the rising costs of new drug R&D and brand name medications rages on, physicians are increasingly doing their part to minimize collateral damage inflicted upon the patient. A…
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Justices debate lawsuits over generic drug safety
By Bill Mears, CNN Supreme Court Producer Two women developed tardive dyskinesia after taking generic drugs The justices are considering cases against pharmaceutical manufacturers Generic drugs account for 70% of all prescriptions filled in the…
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Can you apply for a Centralised Marketing Authorisation in Europe ?
Medicinal products falling within the mandatory scope of the Annex of Regulation (EC) are obliged to apply for a Centralised Procedure: Recombinant DNA technology-Controlled expression of genes Hybridoma and monoclonal antibody methods Biosimilar biological medicinal…