Ark Therapeutics Group Plc has issued the first update of the results of a Phase 3 trial of its gene therapy, Cerepro. The product is currently under review at the European Medicines Agency for the treatment of operable malignant glioma.
Active Biotech AB, a Swedish biotech company with five drug projects under clinical development, has announced details of its SEK 256 million (€23.8 million) rights issue scheduled for completion on 10 June 2009.
The French regulator, Agence Française de Sécurité Sanitaire des Produits de Santé (Afssaps), has become the fourth European authority to approve the sale of a muscle relaxant developed for aesthetic use. The product is manufactured by Ipsen SA.
The Food and Drug Administration has approved Intercell AG’s vaccine for Japanese Encephalitis, paving the way for the product’s launch on the US market in the second quarter of 2009. Intercell announced the approval on 30 March 2009.
Bavarian Nordic A/S of Denmark expects to draw down its cash reserves in 2009 in order to prepare for Phase 3 studies of its candidate vaccines for prostate cancer and smallpox.
Reform of the patent system in Europe is once more on the political agenda. On 24 March 2009, the European Commission set in motion a procedure that will give it authority to negotiate the creation of a unified patent litigation system for the European Union.
Evotec AG, which develops small-molecule therapies for central nervous system diseases and inflammation, is undertaking “significant” cost reductions and looking for partners for more of the products it is developing.
Galápagos NV has announced the start of a first-in-man study of a candidate rheumatoid arthritis treatment which targets a protein kinase previously not associated with RA. The target is MAPKAPK5.
GPC Biotech AG said it will be looking for partnering opportunities for its rejuvenated oncology portfolio once it completes a proposed merger with Agennix of the US.
SkyePharma Plc, which develops technologies for delivering drugs, essentially broke even in 2008 before exceptional items and expects to be well off in the future provided its pending US application for an asthma drug is approved, the UK company’s directors said in their annual report and during a meeting with analysts on 26 March 2009.