The European Medicines Agency has refused to grant a marketing authorisation for Merck Serono’s new small molecule drug for relapsing-remitting multiple sclerosis, Movectro (cladribine), citing concerns about the medicine’s safety.
A study of life-science start-ups in Britain over the five years to 2009 shows that investment per start-up in some regions is too small to ensure that the companies can be sustainable.
The US and Europe took divergent paths on Thursday in managing the risk of Avandia (rosiglitazone) even as drug regulators in both countries agreed that the cardiovascular risks associated with the medicine outweigh its benefits for patients with Type 2 diabetes.
Sanofi-Aventis SA has agreed to pay $33 million upfront to the Dana-Farber Cancer Institute in Boston, Massachusetts for access to its oncology research. Sanofi will be working with Dana-Farber’s Belfer Institute of Applied Cancer Science.
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.
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.