The Pharming Group NV said that its recombinant human C1 inhibitor for hereditary angioedema, Rhucin, has received a positive opinion from the European Medicines Agency. This ends a three-year effort to gain regulatory approval for the drug.
SkyePharma Plc said it is reviewing all of its options following a meeting with the US Food and Drug Administration during which the agency outlined the work that would be required to meet its approval criteria for Flutiform, an asthma drug.
At the request of the US Food and Drug Administration, Pfizer Inc has suspended the clinical development programme for its investigational compound for osteoarthritis, tanezumab. The clinical hold follows reports of adverse events.
Diamyd Medical AB has partnered its lead antigen-based therapy for the treatment and prevention of Type1 diabetes with Ortho-McNeil-Janssen Pharmaceuticals Inc (OMJPI), a unit of Johnson & Johnson.
Sanofi-Aventis SA and Regulus Therapeutics Inc have formed a global alliance to develop and commercialise medicines based on microRNA, a class of small ribonucleic acid molecules that regulate gene expression.
The US Food and Drug Administration said that it has approved the first diagnostic assay to detect both antigen and antibodies to the Human Immunodeficiency Virus (HIV). Most current tests detect HIV antibodies only.
OncoMed Pharmaceuticals Inc of California and Bayer Schering Pharma AG of Berlin have entered into a global alliance to develop therapies that attack cancer stem cells.
An initial public offering for Carmat SAS, which makes artificial hearts, is under way on the Alternext section of the NYSE-Euronext exchange in Paris.
GlaxoSmithKline said that the US Food and Drug Administration has approved its combination treatment for benign prostatic hyperplasia, Jalyn. The drug combines dutasteride and tamsulosin in a single capsule.
Genmab A/S, which develops antibodies for cancer, announced on 15 June 2010 the retirement of its chief executive, Lisa Drakeman, who has served in that post since the Danish company was founded in 1999.