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 licensed Amgen Inc medicine Aranesp (darbepoetin alfa) failed to meet its primary endpoint in a Phase 3 trial that was investigating the drug in a new heart failure indication. There were no new safety findings identified in the study.
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.
AstraZeneca Plc’s new chief executive, Pascal Soriot, is expected to give a fuller view of his strategy for the company on 31 January when the UK multinational releases its financial results for 2012. Mr Soriot has already eliminated two positions from his senior executive team.
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.
Galápagos NV of Belgium will be adding structure-based drug discovery to its stable of technologies with the acquisition of Cangenix Ltd, a UK start-up that was created by scientists from the former Pfizer Inc subsidiary in Sandwich UK.
AstraZeneca Plc has entered a research collaboration with Vanderbilt University of the US to identify allosteric modulators that could be used to treat psychosis and other symptoms of Alzheimer’s disease and schizophrenia.
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).
Biotech Pharmacon ASA of Norway has announced the successful placement of 9.5 million new shares with private investors thereby raising NOK 40 million (€5.45 million) in gross proceeds for product launch and development.