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.
GlaxoSmithKline is facing continued pressure to renew its pharmaceutical-product pipeline. Patents are expiring on several lead compounds opening up competition from the manufacturers of generic medicines
Actelion AG, the Swiss biopharmaceutical company, reported higher third quarter sales and earnings largely as a result of expanding sales of Tracleer (bosentan), its treatment for pulmonary arterial hypertension (PAH).
The Roche Group said that its pharmaceutical research and development pipeline consisted of 65 new molecular entities and 54 additional indications at the end of the 2008 third quarter. Since the start of the year, 10 major projects have entered Phase 3. Roche gave the R&D update on 21 October with the release of its earnings for the first nine months of the year.
MediGene AG said that the final results of a Phase 2 study of its treatment for pancreatic cancer, EndoTAG-1, showed a median overall survival of up to 9.4 months for patients who were administered the treatment, together with the chemotherapy drug gemcitabine. The median survival for patients receiving gemcitabine alone was 7.2 months.
Pharming Group NV said that it is on course to make regulatory filings for its lead drug, Rhucin, with the US Food and Drug Administration and the European Medicines Agency. An FDA filing is expected to take place before the end of 2008 with a new submission to the EMEA shortly thereafter.
Vernalis Plc said its oncology collaboration with the privately-owned French pharmaceutical company, Servier, has reached a milestone triggering the payment to it of €500,000.