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GlaxoSmithKline Plc has withdrawn an application from the European Medicines Agency to expand the use of its breast cancer drug, Tyverb (lapatinib), in combination with paclitaxel.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 has refused to approve a new indication for Novartis’s meningococcal vaccine, Menveo, which would have extended its use to infants and toddlers. The vaccine is already approved for older age groups.
Shire Plc reported revenue of $4.3 billion in 2011, up by 23%, reflecting strong demand for the attention deficit hyperactivity disorder (ADHD) treatments, Vyvanse and Intuniv. Sales were also helped by a regenerative medicines acquisition.
Zealand Pharma A/S said it is set to receive a $20 million milestone payment from its partner, Sanofi SA, following the successful completion of the global Phase 3 programme for its glucagon-like peptide-1 agonist, lixisenatide, for type 2 diabetes.