The European Medicines Agency is recommending a conditional marketing authorisation for Zykadia (ceritinib), a treatment for non-small cell lung cancers which are driven by a mutation of the anaplastic lymphoma kinase (ALK) gene.
A new indication has been recommended for Avastin (bevacizumab) in Europe, setting the Roche drug on course to be registered for a total of six major cancer indications. The new indication, which awaits formal approval from the European Commission, is for advanced cervical cancer.
The 2014 annual report of Circassia Pharmaceuticals Plc shows that the company is making progress towards a goal that very few biotechs have been able to achieve – bringing a product to the market without relying on out-licensing to fund the process.
Belgium-based Cardio3 BioSciences SA has raised €32 million through a private placement of its shares with investors in the US and Europe. The funds will support its cell therapy for the treatment of heart failure as well as recently acquired chimeric antigen receptor (CAR) technology.
Two months into his new job as chief executive of UCB SA, Jean-Christophe Tellier said the plan is to keep the company’s strategy focused on central nervous system disorders and immunology, whilst taking some risks on experimental treatments for Parkinson’s disease and lupus erythematosus.
MorphoSys reported lower revenue and a loss in 2014. But during a briefing with analysts on 26 February, management said it will initiate more clinical trials this year and pursue possible in-licensing opportunities in order to strengthen its in-house antibody portfolio.
Ablynx NV reported a 37% rise in income to €49.3 million in 2014 led by a sharp increase in paid-for research and upfront payments from partnerships. The company’s operating losses narrowed by 8% to €16.2 million despite a 25% rise in research and development spending to €54.5 million.
The US Food and Drug Administration has approved Toujeo (insulin glargine), a basal insulin for the treatment of Type 1 and Type 2 diabetes. The compound has been developed by Sanofi SA and is intended to improve glycemic control in adults living with the disease.
Prexton Therapeutics SA, a 2012 spin-out of Merck Serono, has raised €8.7 million in a Series A financing round to support development of new compounds for the treatment of central nervous system disorders. The candidate compounds are allosteric modulators.
Shire Plc, whose portfolio is split between treatments for rare diseases and attention deficit hyperactivity disorder, has acquired Meritage Pharma Inc and its late-stage product for eosinophilic esophagitis, an inflammatory disorder of the esophagus.