23.04.2012 - Novartis' multiple sclerosis pill Gilenya will have its label updated in the EU, enabling physicians to better manage potential adverse effects on the heart.
London – The European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that all patients beginning treatment with Gilenya (fingolimod) should have an electrocardiogram before taking the first dose and for six hours after. The body also recommends regular blood pressure and heart rate monitoring. The CHMP advises that heart activity monitoring should be extended for patients whose heart rate is lowest six hours after receiving the first dose, and that patients who develop clinically significant problems like bradycardia or atrioventricular block should be monitored until the problems have been resolved. The CHMP also adds that doctors should no longer prescribe the drug to patients with cardiovascular and cerebrovascular disease, or to patients on heart-rate lowering medications. But if these patients must receive Gilenya, their heart activity must be monitored at least over night after taking the first dose
Gilenya has been authorised in the European Union (EU) since March 2011 for the treatment of relapsing-remitting MS in patients who have not responded to treatment with beta-interferon or whose disease is severe and getting worse rapidly. It is the first disease-modifying MS treatment available as an oral formulation.
The EMA began a review of the drug in January following reports of heart problems in patients taking Gilenya. The CHMP looked at all available data on heart safety, including reports of 15 cases of sudden or explained death in patients treated with Gilenya. Most deaths occurred in patients with cardiovascular problems or those taking other medicines. However, it is still not clear if Gilenya was the cause of death. According to Novartis, some 36,000 patients have received treatment with Gilenya since February
20.01.2015 Ebola research projects are set to receive €215m in funding from the European Commission’s IMI2 Ebola+ programme. Among the project partners are vaccine developers Glaxosmithkline, Johnson&Johnson and Merck.
13.01.2015 Shire beefs up its rare disease portfolio after acquiring NPS Pharma with the aim of becoming a leading biotech in a US$5.2bn deal. Part of the deal is the US biotech's lead portfolio of gastrointestinal and hormone replacement therapies.
09.01.2015 The excitement surrounding CRISPR genome editing shows no sign of abating. This month, Novartis and US biotech Intellia Therapeutics became the first ever biotech-pharma collaboration to use the groundbreaking technology.
06.01.2015 With the aim to utilise Ireland’s many natural resources and keep abreast of the latest EU developments in bioeconomy, a multi-disciplinary team has been funded to maximise national income, exports and job creation related to Ireland’s bioeconomy.