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.
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.
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 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 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 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.
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.
The European Medicines Agency has adopted new conflict-of-interest rules for the experts that advise its scientific committees. In future, declarations from the agency’s experts will be published on the EMA website.
Crucell NV has scheduled an informal meeting of shareholders for 10 December 2010 to discuss Johnson & Johnson’s offer to acquire all of the outstanding shares in the company that it does not already own, in a bid valued at about €1.75 billion.
Following a 2% rise in group sales in the first nine months of 2010, the Roche Group has confirmed that it expects core earnings per share at constant exchange rates to show double-digit growth for the full year.