H. Lundbeck A/S said it has completed two out of three Phase 3 studies for its candidate drug to treat alcohol dependence paving the way for a regulatory submission in Europe in the 2011 second half. The drug, nalmefene, is an opioid receptor antagonist.
Advanced Cell Technology Inc of the US has entered into an agreement with Roslin Cells Ltd of Scotland to establish a bank for GMP-grade human embryonic stem cell (hESC) lines that could be used in future research or in clinical trials.
As Europe gears up to recruit a new top drug regulator, the official who is vacating this position after 10 years has thrown a spotlight on the productivity failures of the pharmaceutical industry.
An autologous stem-cell treatment for patients with damaged heart muscle following an acute myocardial infarction has resulted in improved perfusion, a trend towards improved cardiac function, that was dose dependent, according to US research.
Proximagen Group Plc of the UK has expanded its central nervous system franchise with the purchase of rights to two assets from GlaxoSmithKline Plc that are in development for cognition, neuropathic pain and Parkinson’s disease.
AstraZeneca Plc said it is discontinuing development of the monoclonal antibody, motavizumab, for the prevention of respiratory syncytial virus disease. But it will continue work on the antibody as a treatment for RSV, a respiratory tract infection.
Sanofi-Aventis has announced plans to commit up to $800 million to a new chemistry platform that promises to deliver a class of small molecule drugs against cancer that silence disease-causing proteins. Most conventional drugs bind to their protein targets rather than silence, or shut them down entirely.
Eli Lilly and Co has completed the acquisition of Avid Radiopharmaceuticals Inc, a privately-held company in which its venture capital unit has had an equity stake since 2005. Avid has an imaging agent for detecting amyloid plaque that is poised for review by the FDA.
Merck Serono and the US unit of Sanofi-Aventis SA have signed an agreement to jointly explore new combination therapies against cancer. They will look at combinations of agents that could block specific pathways in cancer cells.
The following is an update of recent European and US regulatory decisions.