The main scientific committee of the European Medicines Agency (EMEA) is recommending that two new medicines for use in surgical settings be granted marketing authorisations in Europe. But it has rejected an application for a new therapy to treat an inherited disorder known as Friedreich’s Ataxia. In a third decision, it reversed an earlier negative opinion for an orphan drug for adults with acute myeloid leukaemia.
The European Medicines Agency has recommended restrictions on the oral use of medicines containing norfloxacin for the treatment of urinary infections.
There is at least one forum every year where biopharmaceutical executives can pose questions directly to the management of the US Food and Drug Administration’s Center for Drug Evaluation and Research. This is the ‘CDER Town Meeting’ at the annual meeting of the Drug Information Association (DIA).
The UK unit of the Swiss multinational, Roche, has been suspended from the Association of the British Pharmaceutical Industry (ABPI) for six months for breaches of the association’s code of practice, the ABPI announced on 14 July 2008.
Two potential treatments for cystic fibrosis have been recommended for designation as orphan medicinal products in Europe, the European Medicines Agency said on 10 July 2008. The two treatments bring to 27 the number of drugs either designated as orphans or recommended for designation for this indication. Despite this high number none of the cystic fibrosis treatments has received a marketing authorisation. This has prompted the EMEA to issue a new guidance document for developers of cystic fibrosis products.
The European Medicines Agency (EMEA) has said that new or strengthened warnings should be included in the product information for three groups of marketed pharmaceutical products: epoetin-containing medicines, ergot-derived dopamine agonists and etoricoxib-containing medicines.
The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) recommended that the following drugs be given a marketing authorisation, subject to confirmation by the European Commission.
Pharmaceutical companies that seek out and comply with scientific advice offered by the European Medicines Agency are more likely to receive positive opinions on their marketing authorization applications than those that do not, according to statistics released by the EMEA.
The European Medicines Agency and the US Food and Drug Administration plan to broaden the scope of a five-year old agreement which enables them to share confidential information submitted to them by pharmaceutical companies.
National European regulatory authorities are developing common criteria for assessing applications for multi-centre clinical trials, something that is expected to reduce the cost of conducting these studies in Europe.