FDA approves prostate treatment from GSK
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.
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.
An advisory committee of the US Food and Drug Administration has recommended that the multiple sclerosis drug, fingolimod, be approved, according to Novartis, the drug’s manufacturer. The drug is an oral therapy that has a novel mode of action.
UCB SA of Belgium has raised its stake in the German biopharmaceutical company, Wilex AG, to 18.05% from 11.4% following the purchase of a block of shares from a fund managed by Apax Partners. The transaction was reported on 10 June 2010.
Ipsen SA of France will be listed on the over-the-counter market in the US following its agreement with Deutsche Bank to implement a level 1 American Depositary Receipt (ADR) programme. The company’s shares are already listed in Paris.
Apogenix GmbH of Heidelberg, Germany has begun recruitment for a Phase 2 study of a compound for treating glioblastoma multiforme, the most aggressive type of primary brain tumour. Interim results are expected in the first half of 2011.
Sanofi Pasteur has become the second European company in a month to invest in antibody technology in order to discover new treatments for infectious diseases. It is paying €3 million upfront to Vivalis of France for access to the technology.