The US Food and Drug Administration has issued a complete response letter to GlaxoSmithKline Plc relating to its supplemental new drug application for Avodart (dutasteride) for prostate cancer. This does not affect approved uses for the drug.
AstraZeneca Plc plans to nearly double the size of its share repurchases in 2011 even though projected revenues remain flat or slightly negative. Continued productivity gains have made it possible to finance the share buybacks as well as to declare a 2010 dividend of $2.55 per share, up 11% from 2009.
Scientists from the Anglo-German company, Cellzome, have reported that methodology known as chemoproteomics can show how drugs that are designed to inhibit epigenetic targets interact with molecular complexes not just single proteins.
In separate statements, Santhera Pharmaceuticals of Switzerland and Newron Pharmaceuticals SpA of Italy have announced that discussions are taking place between them, the outcome of which cannot be predicted.
In yet another example of the fast pace of cancer research, Sanofi-Aventis has signed an exclusive licensing deal with Oxford BioTherapeutics Ltd to gain access to a preclinical antibody programme that can be used to develop antibody-drug conjugate products.
Amgen Inc has made an agreed bid for privately-owned BioVex Group Inc of the US of which has a therapeutic cancer vaccine in late clinical development against metastatic melanoma and head and neck cancer.
Sanofi-Aventis SA is extending its offer for Genzyme Corp until 15 February 2011 at an unchanged price of $69 per share. The all-cash offer was previously scheduled to expire on 21 January. In share trading, Genzyme was quoted at $71.48 on 24 January.
The European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion to Gilenya (fingolimod), Novartis’s oral, first-line treatment for relapsing multiple sclerosis. It received FDA approval in 2010.
MorphoSys AG said its preliminary, unaudited financial results for 2010 show revenue of €87 million, up by 7.4% from a year earlier, and an operating profit of €10 million, down by 12.3%. Both figures are lower than the forecasted amounts.
The US Food and Drug Administration has approved a new drug to treat major depressive disorder in adults. The drug, Viibryd (vilazodone hydrochloride), is a dual-acting modulator of serotonin neurotransmission developed by Clinical Data Inc.