The European Medicines Agency has announced the start of a safety and efficacy review of Tredaptive (laropiprant and nicotinic acid), a licensed drug that recently completed a trial in combination with statin therapy for patients at risk of cardiovascular events.
Biotest AG of Germany has received approval from the US Food and Drug Administration to market its immunoglobulin product, Bivigam, in the US. The approval had been held up pending the completion of additional tests.
The US Food and Drug Administration has approved a new drug to treat adults with chronic myeloid leukaemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukaemia (ALL) – three months ahead of schedule.
The US Food and Drug Administration has approved a new monoclonal antibody to treat inhaled anthrax, considered a potential biological terrorism threat because the spores of the bacterium are resistant to destruction and can be spread in the air.
The European Medicines Agency’s main scientific committee has recommended that a new treatment for alcohol dependence, Selincro (nalmefene), be licensed in Europe. The H. Lundbeck A/S drug is for adults with high rates of alcohol consumption.
The Committee for Medicinal Products for Human Use has turned down an application from Genzyme (Sanofi) to market an antisense compound for familial hypercholesterolaemia citing safety concerns. Genzyme said it will appeal against the opinion.
Is it possible to envisage a situation where drugs could be approved sooner by a regulatory authority, but for a more restricted use? And if so, would this be a way for pharmaceutical companies to get real-life data on a drug that could then be used to expand the approved indication and satisfy the requirements of a European health authority for reimbursement?
The US Food and Drug Administration has approved a new seasonal influenza vaccine from Novartis – the first vaccine of its kind to be produced using cultured animal cells instead of fertilized chicken eggs.
The first vaccine to treat Meningitis B infection has been recommended for approval by the European Medicines Agency. Developed by Novartis, the vaccine would help protect all age groups, including infants, against the disease.
Zealand Pharma A/S’s glucagon-like peptide-1 agonist, Lyxumia (lixisenatide), has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) as a treatment for Type 2 diabetes. The drug is partnered with Sanofi SA.