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.
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.
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.
Data from a large Phase 3 trial of a new hormone therapy, abiraterone, for men with prostate cancer has been called significant by a prostate cancer expert at Cancer Research UK. The data showed the drug gave a nearly four-month survival advantage.
Novartis has become the latest pharmaceutical company to invest in antibody-drug conjugates, a technology that is said to hold considerable promise for the treatment of cancer.