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.
The US Food and Drug Administration has approved Xeljanz (tofacitinib) a Janus kinase (JAK) inhibitor developed by Pfizer Inc for the treatment of rheumatoid arthritis. The approval represents a new treatment option in a field currently dominated by biologics.
After a trial delay that triggered a corporate restructuring, Pharming Group NV of the Netherlands has now reported positive clinical data for Ruconest, its lead drug for hereditary angioedema (HAE). A US regulatory filing is expected in the 2013 first half.
The Lancet has published two Phase 3 studies of the Sanofi SA multiple sclerosis drug, Lemtrada (alemtuzumab), which show that the antibody significantly reduced relapse rates of the disease compared with the standard of care – Rebif (interferon beta 1a).
The US Food and Drug Administration has approved a new drug to treat chronic myelogenous leukaemia – the second therapy to be approved for CML in about two months. The drug, Synribo (omacetaxine mepesuccinate), comes from Teva.
The European Medicines Agency has started an infringement procedure against Roche for alleged deficiencies in its medicine-safety reporting system. It is the first time the agency has started a procedure of this kind against a company.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion for a new diagnostic for patients who are being evaluated for Alzheimer’s disease – the first of its kind.