The European Medicines Agency has taken the unusual step of rejecting a marketing authorisation application for an antibiotic because the human studies supporting the drug did not comply with good clinical practice.
The US Food and Drug Administration has approved MabThera ( rituximab), plus chemotherapy, for people with previously untreated or previously treated CD20-positive chronic lymphocytic leukaemia, the Roche group announced.
Ablynx NV has been awarded €1.2 million by an agency of the regional government of Flanders in Belgium to accelerate development of a preclinical antibody therapeutic for autoimmune and inflammatory diseases.
Antisoma Plc expects to report Phase 3 data for ASA404, its drug for non-small cell lung cancer, by the middle of 2011. Assuming the data are positive, the company’s partner, Novartis, will file for marketing authorisations that same year.
MorphoSys AG of Germany and Galápagos NV of Belgium have expanded a discovery alliance aimed at identifying new antibody targets in bone and joint diseases, to include a fourth target. Financial details weren’t disclosed.
Following its takeover of Schering-Plough, Merck & Co has reported steep increases in 2009 sales and net income. It has also confirmed that it will further rationalise its operations with a planned 15% reduction in its workforce by the end of 2012.
AstraZeneca Plc has become the second multinational pharmaceutical company to in-license an investigational drug from Rigel Pharmaceuticals Inc of the US that inhibits spleen tyrosine kinase (Syk), a treatment target for autoimmune diseases.
Elan Corporation PLC has begun to repair its debt-laden balance sheet and produce operating profits before interest charges.
After paring costs and redirecting its research activities, Sanofi-Aventis ended 2009 with a net income of €8.5 billion, up by 12.8% at constant exchange rates on net sales of €29.3 billion, up by 5.3%. It sees further earnings growth in 2010.
Small and medium-sized companies (SMEs) in the European Union are getting more products approved by the European drug regulator than ever before. But their success rate is still far behind that of Europe’s larger and better capitalised companies.