News

Clinical trial data likely to be made public

Country
United States

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

FDA approves prostate treatment from GSK

Country
United Kingdom

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’s chief executive retires

Country
Denmark

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.

FDA officer vows to strengthen regulatory science

Country
United States

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.

Phase-3 trial for non-small-cell lung cancer fails

Country
United States

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.

Pharnext raises €4.8 million for trial of combination drug

Country
France

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.

FDA Advisory Committee recommends MS drug

Country
Switzerland

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 raises stake in Wilex to 18.05%

Country
Belgium

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.