Acting on evidence that trans-unsaturated fatty acids are a risk for heart disease, the Food and Drug Administration has ordered manufacturers of processed foods to reformulate their products to remove these ingredients, also known as trans fats.
The US Food and Drug Administration has approved sirolimus for the treatment of a rare, progressive lung disease after a clinical trial in 89 patients showed the drug was effective compared with a placebo. Sirolimus trades as Rapamune and is an approved immunosuppressive agent.
Small and medium-sized enterprises (SMEs) play a special role in drug development particularly in the field of advanced therapy medicinal products (ATMPs). With small numbers of staff, many of whom are scientists, they are in a unique position to drive medical innovation.
The Brussels-based Innovative Medicines Initiative is launching three new projects around Alzheimer’s disease that will review current nomenclature, create a new network of patient data and test novel treatments in patients with early-stage disease.
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.