Contrave, a new investigational treatment for obesity and weight loss maintenance, has been rejected by the US Food and Drug Administration because of concerns about its cardiovascular safety. The drug’s sponsors are Orexigen Therapeutics and Takeda.
Pfizer Inc has announced plans to exit from research into allergy and respiratory medicines and to close its site in Sandwich UK which houses these activities. The decision is expected to result in the loss of more than 2,000 jobs.
Shares of Antisoma Plc plunged on the London Stock Exchange after the company announced the failure of a Phase 3 cancer trial, the second late-stage product in the company’s pipeline to have failed in just under a year.
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.