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.
Experts say that existing European law permits the establishment of common criteria for determining the relative effectiveness of licensed drugs. But will it happen?
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.
Despite downward pressure on drug prices, Big Pharma needs to keep enough research capacity in the system so that it can produce the medicines that patients will need in the future, according to Andrew Witty, chief executive officer of GlaxoSmithKline, and incoming president of the European Federation of Pharmaceutical Industries and Associations (Efpia).
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.
Regulatory authorities in the US and Europe are taking steps to make more clinical trial data available to the public, possibly including information on the results of these trials, speakers at the Drug Information Association said on 16 June 2010