News

AstraZeneca’s vandetanib to get FDA priority review

Country
United Kingdom

AstraZeneca Plc said its candidate drug for thyroid cancer, vandetanib, has been given priority review status by the US Food and Drug Administration which means a decision on marketing should be taken in six months instead of the usual ten.

FDA approves Gilenya for multiple sclerosis

Country
Switzerland

The US Food and Drug Administration has approved Gilenya (fingolimod), Novartis’s oral, first-line treatment for relapsing multiple sclerosis. It is the first oral therapy for relapsing forms of MS to be approved in the US, the company said.

Genome of the Tasmanian devil sequenced

Country
United Kingdom

Researchers from the Wellcome Trust Sanger Institute in the UK and Illumina Inc of the US have mapped the genome of the Tasmanian devil, a mammal that is confronted with extinction because of infection with a transmissible facial cancer.

Avastin fails in adjuvant colon cancer

Country
Switzerland

The Roche group’s monoclonal antibody, Avastin (bevacizumab), has failed to reach its primary endpoint in a second Phase 3 trial in early-stage colon cancer. The primary endpoint was disease-free survival in patients with stage 3 colon cancer.

Immatics Biotechnologies raises €53.8 million

Country
Germany

The privately-owned German biopharmaceutical company, Immatics Biotechnologies GmbH, has raised €53.8 million in a Series C financing to perform a Phase 3 trial of its lead cancer vaccine in patients with advanced renal cell carcinoma.

FDA advisory committee recommends BI stroke prevention drug

Country
United States

An advisory committee of the US Food and Drug Administration has voted to recommend approval of Boehringer Ingelheim’s drug for the prevention of stroke in patients with atrial fibrillation. The vote to recommend was nine to zero.

FDA decision on Avastin expected before Christmas

Country
Switzerland

The US Food and Drug Administration is expected to tell Roche by 17 December 2010 whether it will be able to approve the company’s two applications for Avastin (bevacizumab) to treat advanced HER2-negative breast cancer with chemotherapy.

FDA begins safety review of Actos

Country
United States

The US Food and Drug Administration has announced a safety review of the diabetes drug, Actos (pioglitazone), on the basis of preliminary data on bladder cancer from a 10-year observational study of the drug. Takeda Pharmaceuticals is the manufacturer.

Novartis withdraws drug application from the EMA

Country
United Kingdom

Novartis Europharm Ltd has withdrawn its application to market the hypertension treatment, Rasival (aliskiren and valsartan) in Europe, according to the European Medicines Agency. At the time of withdrawal, it was under review by the CHMP.