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
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.
With the pace of biomedical research accelerating by the day, the need for the Food and Drug Administration to bring pharmaceutical regulation into closer alignment with inventions emerging from the laboratory is greater than ever before, according to Margaret Hamburg, the FDA Commissioner.
Bayer Healthcare Pharmaceuticals and Onyx Pharmaceuticals Inc announced that a Phase 3 trial of Nexavar (sorafenib) failed to reach its primary endpoint of improving overall survival in study of some 900 patients with advanced non-squamous, non-small-cell lung cancer.
A three-year-old French biopharmaceutical company, Pharnext SAS, has raised €4.8 million in a Series A round to take a new combination drug into the clinic to treat an inherited neurological disorder known as Charcot-Marie-Tooth disease.