FDA approves new plasma product
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.
News
Phase 3 Aranesp trial fails to meet endpoint
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.
EMA recommends suspension of Merck cardiovascular drug
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.
AZ’s Soriot to give strategy on 31 January
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.
FDA approves flu vaccine made with DNA technology
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 acquires UK structure-based discovery company
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.
AZ and Vanderbilt collaborate on allosteric modulators
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.
FDA approves new indication for Kineret
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).
Biotec Pharmacon raises NOK 40 mln in placement
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.
Shire to acquire Lotus Tissue Repair
Shire Plc has taken further steps to strengthen its franchise in rare diseases with an agreement to acquire privately-owned Lotus Tissue Repair Inc which has a preclinical product for the treatment of dystrophic epidermolysis bullosa (DEB). Financial terms were not disclosed.