EMA

European Medicines Agency releases updated guidance on insomnia treatments

The European Medicines Agency has updated the guideline on medicinal products for the treatment of insomnia. The update to the guideline, which was first adopted in 1991, reflects the advances in the scientific understanding of insomnia over the past two decades. The updated guideline informs companies how they should carry out studies on medicines for insomnia, in order to stand the best chances of gaining marketing authorisation. It focuses on:

European Medicines Agency reviews further data on narcolepsy and possible association with Pandemrix

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has reviewed further data from Finland on the suspected link between narcolepsy in children and adolescents and Pandemrix. The Committee concluded that the new evidence added to the concern arising from case reports in Finland and Sweden, but that the data were still insufficient to establish a causal relationship between Pandemrix and narcolepsy. Further analyses and study results are awaited to clarify the observations in Finland.

Agency releases new guidance on medicines based on stem cells

The European Medicines Agency has released new guidance on medicines based on stem cells. The guidance covers the different types of stem cells used in medicines, and the considerations that companies need to take into account when developing medicines including stem cells or developed from stem cells.

European Medicines Agency publishes final 'Road map to 2015'

The European Medicines Agency has published its final 'Road map to 2015', coinciding with the 16th anniversary of its inauguration on 26 January 2011. The 'Road map to 2015' sets out the Agency's vision in further developing its role as a European public-health agency in the field of medicines. Building on the achievements made by the previous road map initiative between 2005 and 2010, the new road map proposes three priority areas for future actions to strengthen the Agency's role in protecting and promoting human and animal health in the European Union:

European Medicines Agency and European Centre for Disease Prevention and Control agree to enhance co-operation

The European Medicines Agency and the European Centre for Disease Prevention and Control (ECDC) have signed a working arrangement, which aims to enhance co-operation and mutual consultation between the two Agencies on areas of common interest. The new arrangement, which came into force in December 2010, outlines a number of initiatives to ensure that the two Agencies make best use of their resources while avoiding duplication of effort and overlaps in their activities.

European Medicines Agency completes its review of Avastin used in breast cancer

The European Medicines Agency has confirmed that the benefits of Avastin in combination with paclitaxel outweigh its risks and that this combination remains a valuable treatment option for patients suffering from metastatic breast cancer. The Agency's Committee for Medicinal Products for Human Use (CHMP) also concluded that the balance of benefits and risks of Avastin in combination with docetaxel is negative and that this combination should no longer be used in the treatment of breast cancer.

European Medicines Agency widens public access to documents

The European Medicines Agency (EMA) has published its new policy on access to documents related to medicines for human and veterinary use. The new policy is part of the Agency's response to increasing public demand for more openness and transparency. It will give wider access than ever before to documents held by the Agency, while it ensures that personal data and commercial confidential information remain adequately protected.

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