The European Medicines Agency is proposing a new method for calculating the fees that it charges to industry for its services. The fee structure would be simplified, with fewer fees charged for applications for a marketing authorisation.
Sanofi-Aventis SA is acquiring TargeGen Inc, a privately held US company that specialises in developing small-molecule kinase inhibitors for treatment of haematological malignancies.
SV Life Sciences said that it has raised more than $523 million for its fifth international life sciences fund which will focus on providing start-up, early stage and expansion capital to life science companies in the US and Europe.
Sygnis Pharma AG expects that initial results from its multinational Phase 2 efficacy study of the stroke treatment, AX200, will be available in mid-2011. The German company issued the forecast with the release of its fiscal 2009/2010 results.
MorphoSys AG has agreed to pay $13 million for rights to an anti-CD19 monoclonal antibody that is scheduled to start a Phase 1 study in cancer patients in the US shortly. It is the company’s first in-licensing deal for a clinical compound.
Scientists from Yale University have shown that lung tissue engineered in a laboratory and implanted into rats can restore partial lung function. The findings represent a first step towards the goal of generating fully functional lungs in vitro.
Gilead Sciences Inc has agreed to pay up to $120 million to acquire CGI Pharmaceuticals Inc, a privately-held US company with a library of small molecule kinase inhibitors. CGI’s lead preclinical compound may have application in RA.
Sanofi-Aventis SA has entered into a licensing agreement with Metabolex Inc of the US to develop a novel treatment for Type 2 diabetes that targets the G protein-coupled receptor 119. The deal could be valued at $375 million if a product is commercialised.
Crucell NV has announced the start of a project to discover a universal prophylactic vaccine against the respiratory syncytial virus (RSV), a cause of serious respiratory illnesses in infants and children. It will be working with a unit of Johnson & Johnson.
The Pharming Group NV said that its recombinant human C1 inhibitor for hereditary angioedema, Rhucin, has received a positive opinion from the European Medicines Agency. This ends a three-year effort to gain regulatory approval for the drug.