Geron Corporation of Menlo Park, California, has submitted further animal data to the US Food and Drug Administration on its first-in-man study of a stem cell treatment for spinal cord injury and the agency has put a clinical hold on the study.
The European Medicines Agency gave a record number of positive opinions for new medicines in 2008. However the number of applications that were rejected by the agency, or withdrawn by the applicant, also increased significantly, according to the EMEA’s 2008 annual report.
The US Food and Drug Administration has approved H. Lundbeck A/S’s anti-epileptic drug, Sabril (vigabatrin), to treat spasms in infants and seizures in adults. Lundbeck acquired Sabril when it bought Ovation Pharmaceuticals Inc in March.
The French national research agency, ANR (L'Agence nationale de la recherche), is to award €2.2 million to TcL Pharma, a biotechnology company which is developing drugs for organ and tissue transplantation and auto-immune disease.
Intercell AG reported revenue of €14.9 million in the second quarter of 2009, helped by the launch of its first product, a vaccine to protect against Japanese Encephalitis, on markets in Europe, the US and Australia.
Pronova BioPharma ASA has completed construction of a new plant in Denmark which will enable it to meet higher demand for its omega-3 derived prescription drug for hypertriglyceridemia, Omacor/Lovaza.
Crucell NV expects that revenue and other operating income will increase by 20% in 2009, confirming that it does not expect to be materially affected by the global recession.
Evotec AG has raised its revenue guidance for 2009 following the strong performance of its drug discovery business in the second quarter. Revenue for the year is now expected to be more than 40 million euros.
MediGene AG reported an increase in revenue in the first half of 2009, mainly generated from the commercialisation in Europe of its treatment for prostate cancer, Eligard.
Galapagos NV expects to report revenue of 100 million euros in 2009, up by 30% from a year earlier on growth in income from its risk-sharing alliances with Big Pharma and from its service division.