News

Novartis’s net income rose 10% in third quarter

Novartis International AG has reported a 10% rise in net income to $2.3 billion in the 2010 third quarter on net sales of $12.6 billion. Recently launched products accounted for 20% of third-quarter sales, up from 15% a year earlier.

MDxHealth adopts a personalised-medicine strategy

Country
Belgium

OncoMethylome Sciences SA, which recently re-launched itself as MDxHealth, is shifting its business strategy away from the development of biomarker services for third parties to focus on stand-alone diagnostics for the detection and prognosis of cancers.

FDA approves Pradaxa for stroke prevention

Country
United States

The US Food and Drug Administration has approved Pradaxa capsules (dabigatran etexilate) for the prevention of stroke and blood clots in patients with atrial fibrillation. The product has been developed by Boehringer Ingelheim GmbH.

FDA rejects new drug application for Bydureon

Country
United States

Eli Lilly and Co, Amylin Pharmaceuticals Inc and Alkermes Inc have received a ‘complete response letter’ from the US Food and Drug Administration for Bydureon which is intended to improve glycemic control for adults with Type 2 diabetes.

GSK invests in ex vivo gene therapy

Country
United Kingdom

GlaxoSmithKline Plc is to pay €10 million to the Italian medical charity, Fondazione Telethon, for access to a new gene therapy that can be carried out on stem cells taken from a patient’s own bone marrow. GSK will investigate the therapy for rare diseases.

Cellectis in-licenses iPS cell technology

Country
France

Cellectis SA of France has signed two separate non-exclusive agreements with iPS Academia Japan Inc giving it access to the induced pluripotent stem cell patent portfolio arising from the work of Shinya Yamanaka at the University of Kyoto.

Genmab gives regulatory update for zalutumumab

Country
Denmark

Genmab A/S said that, based on discussions with regulators, it has sufficient data to file a marketing authorisation application in Europe for zalutumumab for the second-line treatment of patients with head and neck cancer.

Prosensa receives £7.5 million milestone from GSK

Country
Netherlands

Prosensa BV of the Netherlands has received a £7.5 million milestone payment from GlaxoSmithKline Plc in connection with early clinical data from an antisense oligonucleotide that is being investigated for Duchenne Muscular Dystrophy.

FDA approves Botox for migraine

Country
United States

The US Food and Drug Administration has approved the use of Botox (onabotulinumtoxinA) to prevent headaches in adults with chronic migraine. This is the newest indication for a product that was first approved for eye muscle disorders.