News

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.

New conflict-of-interest rules for EMA advisers

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 calls shareholder meeting to discuss J&J offer

Country
Netherlands

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.

Roche confirms earnings forecast

Country
Switzerland

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.

FDA issues warning on the use of bisphosphonates

Country
United States

The US Food and Drug Administration has issued a warning about the possible risk of atypical thigh bone fracture in patients who take bisphosphonates which are used to prevent and treat osteoporosis. Manufactures are being asked to alter their labels.

Lundbeck to develop therapeutic antibodies for CNS

Country
Denmark

In a groundbreaking agreement, H. Lundbeck A/S has entered into a collaboration with Genmab A/S to develop human antibody therapeutics for disorders of the central nervous system. This will be Lundbeck’s first entry into antibody therapeutics.