The European Medicines Agency has recommended the suspension of all medicines containing buflomedil, a vasoactive agent, which are used to treat the symptoms of chronic peripheral arterial occlusive disease. They have been on the market since the 1970s.
The US Food and Drug Administration has approved Jakafi (ruxolitinib) for myelofibrosis. The drug is a JAK inhibitor which is designed to block the JAK1 and 2 enzymes which are involved in regulating blood and immunological functioning.
The US Food and Drug Administration has approved the first haematopoietic progenitor cell-cord cell therapy. Called Hemacord, the product is manufactured by the New York Blood Center Inc of New York.
The Committee for Advanced Therapies (CAT) was set up at the European Medicines Agency in 2009 in order to give expert advice on whether advanced therapy medicinal products should be approved or not. These therapies include gene and cell therapies and products engineered from human and/or animal tissue.
The US Food and Drug Administration has approved Erbitux (cetuximab) for use with chemotherapy to treat patients with metastatic head and neck cancer. The drug is already approved to treat epidermal growth factor receptor-positive colon cancer.
Sanofi SA has filed five new products with regulatory authorities in the US and/or in the European Union since late July including a new glucagon-like peptide-1 agonist for type 2 diabetes, lixisenatide, developed by Zealand Pharma A/S of Denmark.
The US Food and Drug Administration has approved the first artificial heart valve for use in patients with a damaged valve and who are not eligible for open-heart surgery. The device is manufactured by Edwards Lifesciences LLC in the US.
The US Food and Drug Administration has approved a new medical device that gives patients with small arteries the option of less invasive surgery to repair abdominal aortic aneurysms. The device is manufactured by TriVascular Inc of California.
Eli Lilly and Company has announced the withdrawal of its treatment for septic shock, Xigris, from all markets following a new clinical study that failed to show efficacy. The study did not throw up any new safety findings.
The US Food and Drug Administration has approved Onfi (clobazam) from H. Lundbeck A/S as an adjunctive therapy for seizures associated with Lennox-Gastaut syndrome. The approval is for adults and children aged two years and older.