Pharmaceutical companies that seek out and comply with scientific advice offered by the European Medicines Agency are more likely to receive positive opinions on their marketing authorization applications than those that do not, according to statistics released by the EMEA.
Sygnis Pharma Ag said it expects its net loss to increase from €6.3 in the year ended March 2008 to €12 million in 2009 as it prepares for Phase 2b efficacy trials of AX200, its candidate for treating stroke.
The European Medicines Agency and the US Food and Drug Administration plan to broaden the scope of a five-year old agreement which enables them to share confidential information submitted to them by pharmaceutical companies.
The ReNeuron Group Plc disclosed that it is to made applications in three jurisdictions to start trials of its ground-breaking stem-cell therapy for stroke and that it expects to get approval in at least one of the jurisdictions for a first-in-man trial within six- to-nine months.
National European regulatory authorities are developing common criteria for assessing applications for multi-centre clinical trials, something that is expected to reduce the cost of conducting these studies in Europe.
The UK government has reached an agreement in principle with the pharmaceutical industry to create incentives for primary care physicians to prescribe new medicines in exchange for a voluntary 2% reduction in the prices charged to the National Health Service (NHS) for branded medicines.
The German drug developer, 4SC AG, has announced plans to raise up to €29 million from its existing shareholders in order to finance the acquisition of eight oncology projects from Nycomed, a privately-owned, Zurich-based pharmaceutical company.
NOXXON Pharma AG has signed a licensing and drug discovery agreement with Eli Lilly of the US, its third such deal with a multinational pharmaceutical company in a little over two years.
Pharming Group NV said that the results of its Phase 3 North American trial of the recombinant human protein, Rhucin, were positive enabling it to proceed with regulatory filings in both the US and Europe.
Novartis Vaccines and Diagnostics, a unit of Novartis, has told the European Medicines Agency (EMEA) that it is withdrawing its marketing authorisation application for Aflunov, a pre-pandemic vaccine.