New product approvals by the EMEA
The European Medicines Agency has given positive opinions for three new medicinal products, thereby paving the way for the European Commission to issue marketing authorisations. The products are:
The European Medicines Agency has given positive opinions for three new medicinal products, thereby paving the way for the European Commission to issue marketing authorisations. The products are:
Intercell AG of Austria said that it has received €40 million from Novartis under a vaccine-development agreement signed in July 2007, bringing total payments under the deal up to €270 million.
Silence Therapeutics Plc, which is developing siRNA-based therapies and a delivery platform, reported that its half-year revenue for the period ended June 2008 fell to £124,338 from £1,268,837 a year earlier. However, it said that its turnover for the full year would be similar to the £4 million sales it generated in 2007, “thereby ensuring a healthy year-end cash balance.”
One of the European Commission’s biggest ever antitrust probes – an investigation into competition in the pharmaceutical industry – is drawing to a close.
Pharming Group NV of the Netherlands said that it plans to submit a biologic licence application (BLA) with the US Food and Drug Administration for its lead drug, Rhucin, by the end of 2008.
The UK regenerative medicine company, Intercytex Group Plc, is moving forward with a pivotal Phase 3 trial of its lead product for chronic wounds and anticipates filing a biologic licence application for the product with the US Food and Drug Administration in the second half of 2009.
Research published in the journal, Science, and financially supported by the Wellcome Trust, describes how a new class of antibiotics could be developed to treat multi-drug resistant Staphylococcus aureus (MRSA).
ReNeuron Group Plc has asked for clearance from the UK regulator to test its stem-cell therapy for stroke in man for the first time, having failed thus far to get permission for a human study from the US Food and Drug Administration.
Antisoma Plc has ended its financial year with a profit and reported progress across all of its drug development programmes which focus on major indications in the field of oncology.
BTG Plc has announced an all-share offer for Protherics Plc valued at £218.1 million, ending weeks of speculation about the fate of Protherics, a specialty pharmaceutical company.