A meningococcal vaccine and a new treatment for non-Hodgkin’s B-cell lymphoma were among four new medicines to receive positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use on 17 February.
The management of Amsterdam Molecular Therapeutics NV is proposing to de-list the company and transfer its gene therapy assets to a new private concern following a regulatory rejection of its lead product Glybera. Shareholders will vote on the proposal on 30 March.
The European Medicines agency has issued contraindications and warnings for aliskiren medicines which include the Novartis drug Rasilez. The drug shouldn’t be used in patients with diabetes or renal impairment who take ACE inhibitors.
The US Food and Drug Administration has approved the synthetic steroid, mifepristone (Korlym), as a treatment for adults with endogenous Cushing’s syndrome, a rare disease caused by the overproduction of cortisol. It is the first approved treatment for this condition.
GlaxoSmithKline Plc has withdrawn an application from the European Medicines Agency to expand the use of its breast cancer drug, Tyverb (lapatinib), in combination with paclitaxel. Separately, it has applied to have the drug used with trastuzumab.
EOS imaging SA, which has developed a three-dimensional imaging system for orthopaedic investigations, has raised €38 million in an initial public offering on the Paris NYSE Euronext Exchange. The French company said its offering was 3.8 times oversubscribed at €6.87 per share.
Biogen Idec Inc has announced plans to acquire privately-owned Stromedix Inc of Cambridge, Massachusetts for $75 million upfront, plus milestones, in order to gain access to an investigational antibody for fibrotic disease.
Actelion Pharmaceuticals Ltd reported a 7% decline in revenue for 2011 and a 21% rise in operating costs, which resulted in a 95% drop in operating profit and a net loss for the year. Pressure on revenues of CHF 1.8 billion arose from the strength of the Swiss franc.
Venture-capital backed Oxitec Ltd of the UK has secured £8 million in new funding from a syndicate led by Oxford Capital Partners to finance further trials of a project designed to reduce populations of the mosquitoes that transmit dengue fever.
The US Food and Drug Administration is expected to raise the fees it charges the pharmaceutical industry and other companies for its services in order to pay for a proposed increase in its budget for the fiscal year starting on 1 October.