The European Medicines Agency (EMA) is inviting comments from industry, healthcare professionals and the public on its proposed strategy for the next five years, a period during which infectious disease and demographic change will put new demands on the drug regulatory system.
Galápagos NV expects to achieve an operating profit in 2010 on the back of an anticipated 20% increase in revenue to more than €120 million. The Belgium-based company issued the forecast on 29 January 2010 with the release of its unaudited results for 2009.
Ark Therapeutics Group Plc plans to reduce its staff while it appeals against a negative opinion from the European Medicines Agency for its lead gene therapy. It is also putting a hold on a Phase 3 trial for Vitor, a treatment for cancer-related muscle wasting.
The European Commission has approved the Roche group’s breast cancer treatment, Herceptin (trastuzumab), for metastatic stomach cancer. The drug is to be used in combination with chemotherapy for patients with HER2-positive stomach cancer.
AstraZeneca is reducing the size of its research and development operations in an effort to make it more flexible and productive. It is also reducing costs in other areas to adjust for loss of revenue resulting from patent expirations.
Novartis International AG has raised its dividend by 5% after reporting an 8% increase in net income to $10.3 billion in 2009 on sales of $44.3 billion. The company also announced that Joe Jimenez will take over as CEO from 1 February 2010.
A private equity group with offices in London and Guernsey is providing £5 million over three years to a UK company pursuing a new concept in biologic development.
A monoclonal antibody developed by Genmab A/S of Denmark and GlaxoSmithKline has won a positive opinion from the European Medicines Agency for the treatment of leukaemia, conditional upon the companies’ providing updates on the drug’s use.
A patient in the US has become the first person with the neurodegenerative disease, amyotrophic lateral sclerosis (ALS), to be treated with stem cells. The cells were directly injected into the spinal cord of the patient on 20 January 2010.
Oral formulations of two investigational drugs for multiple sclerosis have been shown to be effective in reducing the rate of disease relapse, according to three papers in the New England Journal of Medicine. The drugs are oral fingolimod and oral cladribine.