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.
The European Medicines Agency has announced the start of a safety and efficacy review of Tredaptive (laropiprant and nicotinic acid), a licensed drug that recently completed a trial in combination with statin therapy for patients at risk of cardiovascular events.
Biotest AG of Germany has received approval from the US Food and Drug Administration to market its immunoglobulin product, Bivigam, in the US. The approval had been held up pending the completion of additional tests.
The US Food and Drug Administration has approved a new drug to treat adults with chronic myeloid leukaemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukaemia (ALL) – three months ahead of schedule.