The US Food and Drug Administration has approved Novartis’s quadrivalent meningococcal vaccine, Menveo, for children from two to 10 years. But it has turned back an application from the Swiss company for use of the vaccine in infants.
The US Food and Drug Administration has approved Rituxan/MabThera (rituximab) as a maintenance treatment for patients with advanced follicular lymphoma who responded to initial treatment with the antibody, plus chemotherapy, Roche said.
The US subsidiary of H. Lundbeck A/S has entered into a research collaboration with the University of Massachusetts Medical School to study an RNAi-based therapy as a possible treatment for Huntington’s disease.
Novartis AG said that recently launched products represented 21% of sales in 2010, a year during which 13 medicines received regulatory approvals. Net sales rose by 14% in constant currencies to $50.6 billion.
Actelion Ltd of Switzerland and GlaxoSmithKline Plc have stopped clinical development of the Phase 3 investigational drug for insomnia, Almorexant. The decision follows a review of data from studies on the drug’s profile, including its tolerability.
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.