The European Medicines Agency has issued new advice on the procedures that companies should follow in developing stem cell products. The advice is contained in a paper on the agency’s website, www.ema.europa.eu. (EMA/CAT/571134/2009).
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.
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 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.
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.
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.
Abbott Laboratories Ltd has decided to withdraw its European marketing authorisation application for Ozespa (briakinumab) which was intended to be used for moderate to severe chronic plaque psoriasis in adults, according to the EMA.
As Europe gears up to recruit a new top drug regulator, the official who is vacating this position after 10 years has thrown a spotlight on the productivity failures of the pharmaceutical industry.
The following is an update of recent European and US regulatory decisions.