Neuropharm Group Plc said that it is on track to complete its new drug application (NDA) for the treatment for autism in the second quarter of 2009. If approved by the Food and Drug Administration, the treatment could be launched in the US in the first quarter of 2010.
MorphoSys AG has revised upward its expected operating profit for 2008 to take into account continued strong demand for its antibody technology.
Biovitrum AB has decided to discontinue early research into small molecule drugs in order to refocus its resources on the development of biologicals. This follows the company’s acquisition in September 2008 of global sales rights for two biologics from Amgen Inc and the signing of an exclusive licensing agreement for a third.
The third quarter results from Shire Plc form a basis for expecting that sales of new products could offset much of the anticipated loss of revenue for its best-selling drug, Adderall XR, which goes off-patent in 2009.
A long-standing collaboration among Cellartis AB, the Hagedorn Research Institute of Novo Nordisk, and Professor Henrik Semb of Lund University into diabetes has been upgraded with a view to developing a new cell therapy for the treatment of type 1 diabetes.
Apitope International NV, a biopharmaceutical company based in Belgium, has raised €10 million in a series A financing to develop a peptide therapeutic for multiple sclerosis.
The European Medicines Agency is recommending new marketing authorisations for three proprietary medicinal products, one of which was cleared following an appeal. The EMEA’s recommendations are usually endorsed by the European Commission, which has the power to issue authorisations.
GlaxoSmithKline Biologicals SA has agreed to pay €22.5 million upfront for access to a new vaccine technology developed by AFFiRiS GmbH of Austria. The candidate vaccines are designed to treat Alzheimer’s disease by targeting beta-amyloid, a protein which is understood to be the main constituent of amyloid plaques in the brains of Alzheimer’s disease patients.
Sanofi-Aventis has been told by the European Medicines Agency that patients taking its obesity treatment, Acomplia (rimonabant), are at risk of depression. The agency is therefore recommending the drug be pulled from the European market.
The University of Cambridge is highlighting the results of a Phase 2 study of the monoclonal antibody alemtuzumab which, it says, shows the drug has promise for treating people with multiple sclerosis.