Elias Zerhouni, head of research and development at Sanofi SA, used a gathering of regulatory officials in London on 18 March to appeal for more convergent standards for drug approvals. He argued that divergent standards among the drug authorities had created needless complexity for industry.
A new treatment for polycystic kidney disease, Jinarc (tolvaptan), has been recommended for approval by the European Medicines Agency. Developed by Otsuka Pharmaceutical Co, Jinarc is designed to treat a rare, inherited form of the disorder that affects about four in 10,000 people in the EU.
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 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.
The US Food and Drug Administration has approved Farydak (panobinostat) for the treatment of patients with multiple myeloma – the first histone deacetylase (HDAC) inhibitor to be authorised for this disease. The approval was announced on 23 February 2015.
A widely prescribed monoclonal antibody for patients with wet age-related macular degeneration, Lucentis (ranibizumab), has been approved in the US for a new indication – diabetic retinopathy in patients with diabetic macular oedema.
A senior official in Britain’s Conservative-led government has outlined a policy for supporting the biotech industry that rests on aligning the clinical assets of the National Health Service more closely with some the newest technologies emerging from industry.
The US Food and Drug Administration has approved a new antibody drug, Cosentyx (secukinumab) that targets interleukin-17A, for the treatment of psoriasis, an autoimmune disorder affecting people as young as 15 years of age. Novartis is the developer.
The Food and Drug Administration has approved an electrical implant for the treatment of obesity that is intended to help adults lose weight by regulating a nerve pathway between the stomach and the brain that controls appetite.