The European Medicines Agency is recommending approval of a new macrocyclic antibiotic for Clostridium difficile, Dificlir (fidaxomicin). Developed by Optimer Pharmaceuticals Inc, the antibiotic was approved by the FDA in May 2011.
The European Medicines Agency has recommended restrictions on the use of Multaq (dronedarone), an anti-arrhythmic medicine marketed by Sanofi SA, due to an increased risk of liver, lung and cardiovascular adverse events.
The European Medicines Agency has started a review of orlistat-containing medicines, which are used to treat obesity, to determine whether very rare cases of liver injury affect the medicines’ overall benefit-risk profile.
Sinclair IS Pharma Plc, which was created through the merger of two UK speciality pharmaceutical companies, has ended its 2011 financial year with a pre-tax loss, but a rise in like-for-like sales and plans for several product launches.
Privately-held NovImmune SA of Geneva, Switzerland has announced the start of a proof-of-concept study of a monoclonal antibody intended to neutralise the activity of the chemokine, IP-10, in order to treat patients with primary biliary cirrhosis.
Anticipating the start of Phase 3 trials of a stem-cell therapy for heart failure, Cardio3 BioSciences SA has set up a US subsidiary in Rochester, Minnesota, the home of its minority shareholder – the Mayo Clinic. The trials are set to begin in 2012.
Silence Therapeutics Plc stoutly defended the virtues of RNA interference in presenting its first half-year results and announcing the completion of its management reorganization and downsizing.
Sanofi Pasteur is to investigate an immunological approach to acne prevention and treatment by targeting Propionibacterium acnes factors in inflammation. This will be done in collaboration with the University of California, San Diego.
Vernalis Plc said it has achieved a research milestone in its drug discovery collaboration with H. Lundbeck A/S, triggering a payment of £0.3 million. The UK company is identifying candidate compounds targeting the kinase, LRRK2.
Merck & Co has out-licensed its gene therapy portfolio to a new Finland-based company, FKD Therapies Oy, that was founded in early 2011 to source and develop gene-based medicines. Merck has taken an undisclosed equity stake in the company.