The European Medicines Agency has recommended approval of a ‘pre-pandemic’ vaccine that will generate an immune response to the ‘bird flu’ virus, H5N1 in case it evolves into a pandemic human influenza.
Actelion Pharmaceuticals Ltd has decided to withdraw its application to the European Medicines Agency (EMEA) for an extended indication for its orphan product, Zavesca (miglustat).
The number of companies seeking SME status (Small and Medium-sized Enterprise) with the European Medicines Agency rose by 40% in 2007 from a year earlier, according to Melanie Carr, head of the agency’s SME office.
Small and medium-sized companies (SMEs) that have done preclinical work on developing advanced therapies, such as gene or cell products, will be eligible to receive a certificate from the European Medicines Agency (EMEA) verifying that their preclinical data package meets European regulatory standards for quality and safety.
Medicines indicated for diabetes and containing rosiglitazone will be required to display a new warning on their labels stating that they should not be taken by patients with ischemic heart disease and/or peripheral arterial disease.
The European Medicines Agency (EMEA) and Health Canada have signed an agreement to exchange confidential information about the authorisation and safety of medicines. This is the latest in a growing number of bilateral agreements between regulators around the world, enabling them to share information submitted to them by companies and to react quickly to drug safety problems which could potentially affect the general public.
The European Medicines Agency’s Committee for Orphan Medicinal Products has recommended that nine medicines be given orphan designation, thus qualifying them for financial and regulatory incentives. The final decision on designation will be taken by the European Commission.
Member states of the European Union have approved a new research initiative for the life sciences that, for the first time, will bring the European Commission and industry together into a public-private partnership to improve the way new drugs are developed.
Companies that wish to develop drugs for rare or life-threatening diseases can now apply for financial incentives from the US and the European Union (EU) using a single application form.
The European Medicines Agency’s Committee for Orphan Medicinal Products has recommended that seven medicines be given orphan designation, thus qualifying them for financial and regulatory incentives.