Wyeth Europa Ltd has withdrawn its marketing authorisation application for Pristiqs (desvenlafaxine) from the European Medicines Agency (EMEA) in order to conduct additional clinical studies that will address the agency’s questions about the benefit/risk profile of the product.
Alizyme Plc said that it has raised approximately £10 million before expenses following the placement of 20 million new ordinary shares with institutions.
Galapagos NV, the Belgian company that develops genomics-based drugs, is delisting its shares on Britain’s Alternative Investment Market (AIM) and offering a facility for trading the shares in the US over-the-counter market through the issuance of American Depository Receipts (ADRs). The company’s shares will continue to trade on the Euronext in Amsterdam and Brussels.
PanGenetics Bv has raised €23 million in a Series C financing from six institutional investors led by Edmond de Rothschild Investment Partners.
Regulatory agencies in both the UK and Belgium have started to review applications from pharmaceutical companies for exploratory clinical trials which are designed to generate information on the safety in man of new compounds before the traditional Phase 1 studies begin, according to speakers at a meeting of the Drug Information Association in Barcelona, Spain on 5 March 2008.
Advanced therapy medicinal products will be evaluated by a new scientific committee at the European Medicines Agency (EMEA) starting January 2009, according to Patrick Celis, scientific administrator of the agency.
Cosmo Pharmaceuticals SpA, the Italian developer of gastro-intestinal (GI) drugs, said its revenue rose 44.5% in 2007 to €21.9 million, helping it to generate a net profit of €0.1 million compared with a loss of €0.3 million in 2006.
The European system for regulating medicines may need to be fundamentally altered in the future in order to cope with the expected rise in marketing authorization applications for advanced therapies as well as applications for generic medicines, according to a panel of experts.
The European Commission expects to issue the first call for proposals to do research under the new Innovative Medicines Initiative (IMI) in April 2008, with decisions on funding announced by the end of the year, according to Irene Norstedt, deputy head of the Commission’s biotechnology unit.
Pharming Group NV of the Netherlands said that it has negotiated an exclusive, global licence for certain patents in the field of transgenic technology from Advanced Cell Technology, Inc of the US.