Merck Serono said that its new small molecule drug for relapsing-remitting multiple sclerosis, which is an oral formulation of cladribine, has been granted priority review by the FDA, which means a decision can be expected in about six months.
A cannabis medicine developed by GW Pharmaceuticals Plc for the treatment of spasticity due to multiple sclerosis has been approved by the Spanish regulator. This follows its approval in June, 2010, by the UK regulator, the MHRA.
The European Medicines Agency’s main scientific committee has recommended that Boehringer Ingelheim’s new combination pill for hypertension, Twynsta, be approved for marketing.
At a time of intense competition in the antibody field, venture capital-backed NovImmune SA of Switzerland has secured an exclusive licensing deal with Genentech Inc for a pre-clinical compound targeting two forms of the Interleukin-17 (IL-17) family of cytokines.
A potential treatment for heart disease that uses a natural process to drain fatty material from clogged arteries is being backed by a €40 million investment from the French government and venture capitalists.
Elan Corporation Plc expects to pay $203.5 million as part of a settlement with the US relating to its sales and promotions of the epilepsy drug, Zonegran (zonisamide), a charge that largely accounted for the company’s second quarter loss of $213.1 million.
The Roche chief executive, Severin Schwan, has confirmed the company expects to see mid-single-digit sales growth in 2010, even taking into account the possible loss of an indication for its lead cancer product, Avastin (bevacizumab).
The European Medicines Agency said it expects to complete its review of the safety of rosiglitazone-containing medicines, including Avandia, by September 2010. The review is looking at the risk of cardiovascular problems with the drugs.
After nearly three years into a major restructuring programme, GlaxoSmithKline has reported flat sales and a loss for the 2010 second quarter. But the company is raising its dividend by 7% to 15 pence per share and it expects to deliver a broadly stable operating profit margin for 2010.
Actelion AG of Switzerland has paid €10 million for an option to acquire privately-owned Trophos SA of France which is developing drugs for neurodegenerative diseases. Trophos’s drug for amyotrophic lateral sclerosis (ALS) is in Phase 3.