Five new investigational medicines have been recommended for designation as orphan medicinal products by a committee of the European Medicines Agency. Producers of orphan-designated products may be eligible for grants and regulatory fee reductions.
NsGene A/S announced on 20 May 2008 that it has raised 40 million Danish Krone (€5.36 million) from its current shareholders to continue clinical development of its biodelivery products.
The UK House of Commons defeated opponents of a proposal to allow research using hybrid embryos. As a result, research involving hybrids will be allowed under a bill that updates the UK Human Fertilisation and Embryology Act 1990.
Antisoma Plc has announced plans to acquire the closely-held US oncology company, Xanthus Pharmaceuticals, Inc. of Cambridge, Massachusetts in a share transaction valued at £26.8 million.
Ark Therapeutics Group Plc said that results of a corroborative Phase 3 study of its gene-therapy treatment for malignant glioma, Cerepro (sitimagene ceradenovec), should be available in the third quarter of 2008, paving the way for the filing of a marketing authorisation application for the product in Europe.
Biovitrum, the Swedish pharmaceutical company, said on 15 May 2008 that it is implementing its strategic restructuring plan of November 2007. The plan involves licensing out or terminating most of its primary care products while bringing its niche products all the way to market
Crucell NV has reaffirmed its 20% growth target for revenue and other operating income in 2008 following a strong financial performance in the first quarter.
Shares of Allergy Therapeutics Plc rose by more than 24% following the company’s announcement on 14 May 2008 that a Phase 3 trial of its hayfever vaccine, Pollinex Quattro, had met its primary efficacy endpoints. Allergy Therapeutics said it would apply for marketing approval in the European Union during first quarter of 2009.
MorphoSys AG, the German biotechnology company, achieved a net profit of €3.3 million in the 2008 first quarter after €0.6 million a year earlier. The operating profit trebled to €4.1 million from €1.3 million on revenue of €16.3 million, against €14.1 million.