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.
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.
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.
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.
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.
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.
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Novartis Europharm Ltd has withdrawn its application to market the hypertension treatment, Rasival (aliskiren and valsartan) in Europe, according to the European Medicines Agency.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.
Johnson and Johnson is making an offer to acquire all the shares it doesn’t already own of Crucell NV for about €1.75 billion or at €24.75 per share. J&J currently owns 17.9% of Crucell.
Oxford Nanopore Technologies Ltd has strengthened its ties with Oxford University in the UK in order to explore new applications for its sequencing technology to the field of protein sensing.