The European Medicines Agency has agreed to a recall of Vimpat (lacosamide), a medicine used to treat epilepsy because of a quality defect in some batches. No adverse reactions have been reported. The developer, UCB SA, proposed the recall.
The European Medicines Agency is recommending approval of a new medicine for chronic hepatitis C in adults, Incivo (telaprevir). The developer is Janssen Pharmaceutical and the drug was approved by the FDA in May.
The European Medicines Agency is recommending that pioglitazone-containing medicines for diabetes, including Actos, carry a warning of a small increased risk of bladder cancer. However it said the benefit-risk of the drugs remains positive.
Bristol-Myers Squibb Company has announced plans to acquire privately-held Amira Pharmaceuticals Inc of San Diego, California, paying $325 million upfront, in order to expand its portfolio into potential treatments for fibrotic diseases.
The Roche group is raising its outlook for core earnings per share in 2011 despite results for the first half of the year showing that sales, expressed in local currencies, were flat. The company expects that improvements in productivity, however, will enable it to deliver a per-share earnings increase of 10% for the year. In April, it forecast an increase in the high single-digit range.
Actelion Ltd reported a decline in revenue and a loss for the first six months of 2011 as the result of a damages award and a 12% decline in the Swiss franc value of dollar sales over the period.
The US Food and Drug Administration has approved Brilinta (ticagrelor), an oral antiplatelet medicine, to reduce the rate of cardiovascular death and heart attack in adult patients with acute coronary syndrome. The developer is AstraZeneca Plc.
A panel of the US Food and Drug and Administration voted narrowly not to recommend the approval of a first-in-class therapy developed by Bristol-Myers Squibb Company and Astra-Zeneca Plc for diabetes.
Consort Medical Plc, a London Stock-Exchange listed medical device company, is leading a consortium of institutional investors who are committing up to £16.9 million over three years to a UK company with a point-of-care diagnostics platform.
The specialist UK healthcare company, BTG Plc, has reported progress in the development and commercialisation of its own and partnered programmes, including recent UK approval of its antidote for digoxin overdose.