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
26.05.2016 BigDNA relaunches as Iceni Pharmaceuticals with the aim to develop repurposed and reformulated cancer therapies. First order of business: repurpose Merck Serono’s cilengitide as a multiple myeloma treatment.
24.05.2016 One of the pioneering companies developing pharmaceuticals and diagnostics based on the gut microbiome, Enterome Bioscience, has raised €14.5m in a Series C financing round. Among the investors were Seventure and Lundbeckfond as well as Nestlé.
20.05.2016 The long awaited global review on antimicrobial resistance by economist Lord Jim O’Neill has been published. It sets out an action plan to defeat superbugs with a huge awareness campaign and rapid diagnostics to be used before antibiotics are prescribed.
18.05.2016 Bayer is deepening its involvement in CRISPR with a licensing agreement for genome editing patents. Irish partner ERS Genomics holds the rights to the CRISPR/Cas9 tech from Emmanuelle Charpentier, one of the inventors.
11.05.2016 Newly spun out company OxStem has raised £16.9m (€21.5m) to develop regenerative meds for the treatment of age-related disease. It is the largest financing for an Oxford spin-out – or any UK academic spin-out – to date.
09.05.2016 Swiss Genentech partner AC Immune has raised CHF42.7m (€38.6m) in order to advance its therapeutic and diagnostic product pipeline in Alzheimer’s disease. The news follows a recently announced R&D collaboration with Biogen.
04.05.2016 Barcelona-based epigenetics expert Oryzon Genomics has closed a debt funding round of €10.5m, bringing the total money raised since last year to €27m. The funds will serve to advance the company’s two LSD1 inhibitors in cancer and neurodegeneration.
03.05.2016 Ipsen is strengthening its ties to long-time development partner Oncodesign, a Dijon-based cancer treatment biotech. The French pharma is handing over the pre-clinical pharmacology for its oncology research programmes to Oncodesign.
29.04.2016 Swiss bank Group UBS has raised US$471m (€412m) for the UBS Oncology Impact Fund, which was set up to invest in early-stage cancer treatments. The money raised by the fund, nearly half of which comes from investors in Asia, is the largest amount ever raised for such a cancer investment fund.