The US Food and Drug Administration has approved a new antibacterial for the treatment of diarrhoea associated with Clostridium difficile in adults 18 years and older, according to the drug’s manufacturer, Optimer Pharmaceuticals Inc.
Intercell AG is recalling batch JEV09L37 its Japanese encephalitis vaccine, Ixiaro, because it is less potent than expected. At a result, the CHMP committee of the European Medicines Agency recommended revaccination with a different batch.
The Committee for Medicinal Products for Human Use has given a positive opinion to Benlysta (belimumab), GlaxoSmithKline’s new medicine for patients with systemic lupus erythematosus. The drug was approved by the FDA on 9 March 2011.
The US Food and Drug Administration has approved the first test for establishing whether a pregnant woman or a person with swollen lymph nodes who tests positive for toxoplasmosis has developed the infection within the past four months.
The US Food and Drug Administration has announced the approval of Victrelis (boceprevir) to treat certain adults with chronic hepatitis C. It has been authorised for use in combination with peginterferon alfa and ribavirin.
The Roche group has made regulatory submissions in the US and Europe for vemurafenib, a new drug to treat metastatic melanoma, together with a diagnostic test that would identify people with tumours carrying a specific genetic mutation.
Sanofi Pasteur has announced US Food and Drug Administration approval of a new formulation of its Fluzone Intradermal vaccine that uses a microinjection system for intradermal delivery. Delivery is via a 90% shorter needle.
The US Food and Drug Administration has announced the approval of the first test for Staphylococcus aureus (S. aureus) infections that can quickly identify whether the bacteria are methicillin resistant (MRSA) or methicillin susceptible (MSSA).
Novartis has announced US Food and Drug Administration approval of Afinitor (everolimus) for the treatment of progressive neuroendocrine tumours of pancreatic origin (NET). This is in line with a recommendation from an FDA advisory panel.
The US Food and Drug Administration has approved the proton pump inhibitor, Nexium (esomeprazole sodium), for use in children one month and older for the short-term treatment of gastroesophageal reflux disease, AstraZeneca announced.