After more than two years of deliberations, the European Medicines Agency has decided to recommend approval of the first ever gene therapy. The treatment, Glybera, is indicated for the treatment of patients with a rare inherited enzyme disorder.
Sanofi SA and Regeneron Pharmaceuticals Inc have started enrolling patients in a Phase 3 programme that will evaluate the effectiveness of a new antibody in lowering low-density lipoprotein cholesterol. The antibody targets the PCSK9 enzyme.
Shire Plc has renamed one of its business units in order to demonstrate its commitment to building a presence in regenerative medicine. The unit, Advanced BioHealing Inc, will henceforth be known as Shire Regenerative Medicine Inc and will be based in San Diego.
Novartis expects that group sales this year will be in line with those reported in 2011 as income from new products offsets the loss of patent protection from the high blood pressure drug Diovan and the negative impact of changes in currency values.
From time to time, venture capital firms have been able to assemble disparate pharmaceutical assets and find the right talent to develop them into a valuable property. However, it looks as if biotechs have started to do something similar by using their widespread contacts and alliances to investigate the causes of disease.
GlaxoSmithKline Plc has announced the expansion of a collaboration with Amicus Therapeutics Inc aimed at developing and commercialising a new treatment for Fabry disease. Under the deal GSK will raise its stake in Amicus to 19.9%.
Convergence Pharmaceuticals Ltd is making plans to advance a second small molecule drug for neuropathic pain into Phase 2 following a successful first-in-man trial. The compound, CNV2197944, is a calcium channel blocker.
Domain Therapeutics SA of France has raised €2 million in funding from new and existing investors in order to finance its move from contract manufacturing to therapeutic drug development in the area of G-Protein Coupled Receptors (GPCRs)
The US Food and Drug Administration has approved a new use for the Gilead Sciences, Inc antiretroviral drug, Truvada (emtricitabine and tenofovir disoproxil fumarate), for use in individuals who are at high risk of HIV infection.
GlaxoSmithKline Plc has reached agreement to acquire Human Genome Sciences Inc following an increase in its per share offer to $14.25, up from $13 per share.