The US Food and Drug Administration has granted ‘priority review’ status to the Algeta ASA investigational therapy for the treatment of castration-resistant prostate cancer patients with bone metastases. The product (radium-223) is an alpha-emitting nuclide.
The US Food and Drug Administration has turned down Novo Nordisk A/S’s application to market the long-acting insulin drugs, Tresiba and Ryzodeg, pending the supply of more data on cardiovascular risk. It has also cited the Danish company for manufacturing violations.
The US Food and Drug Administration has approved a new indication for the Novartis drug Exjade (deferasirox) to treat patients aged 10 years and older who have chronic iron overload resulting from a genetic blood disorder.
The European Medicines Agency’s main scientific committee has turned down an application from Santhera Pharmaceuticals of Switzerland to market a drug for Leber’s Hereditary Optic Neuropathy (LHON). LHON is an inherited disease involving the progressive loss of sight.
The US Food and Drug Administration has approved a new pooled human plasma product for the treatment of patients with blood clotting disorders. The product is manufactured by Octapharma AG of Vienna, Austria.
The European Medicines Agency is recommending the suspension of Tredaptive (laropiprant and nicotinic acid) from the European market following a study that showed the drug had insufficient clinical benefit and safety problems.
The US Food and Drug Administration has approved Flublok, the first trivalent influenza vaccine made from an insect virus expression system and recombinant DNA technology. The prophylactic vaccine has been approved for people from 18 to 49 years.
Swedish Orphan Biovitrum AS (Sobi) has announced US Food and Drug Administration approval of its arthritis drug, Kineret (anakinra), for the treatment of children and adults with neonatal-onset multisystem inflammatory disease (NOMID).
The US Food and Drug Administration has approved a botanical drug to relieve the symptoms of diarrhoea in HIV/AIDS patients taking antiretroviral therapy. The drug, Fulyzaq (crofelemer), is only the second botanical drug product to be approved by the agency.
The US Food and Drug Administration has authorised the first drug to treat multi-drug resistant tuberculosis involving the lungs in an accelerated approval based on a surrogate endpoint. The drug, Sirturo (bedaquiline), was discovered and developed by Johnson & Johnson Inc.