The US Food and Drug Administration has issued its first-ever approval of a cellular immunotherapy. The product, Provenge (sipuleucel-T), is a therapeutic vaccine developed by Dendreon Corp of Seattle, Washington.
The European Medicines Agency’s main scientific committee has recommended that AstraZeneca’s Seroquel (quetiapine fumarate) be approved as an add-on to ongoing treatment for major depressive episodes in patients with major depressive disorder.
Supply shortages for the two Genzyme Corp enzyme replacement therapies, Cerezyme and Fabrazyme, are expected to continue until at least the end of September 2010 because of a new manufacturing problem, the European Medicines Agency said.
Positive EMA opinion for Nycomed’s Daxas. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion for the Nycomed GmbH medicine, Daxas (roflumilast) for the maintenance treatment of severe chronic obstructive pulmonary disease (COPD). The opinion was issued on 23 April, 2010. Roflumilast is an anti-inflammatory agent designed to target both the systemic and pulmonary inflammation associated with COPD. It does this by reducing the activity of phosphodiesterase 4 (PDE4), an enzyme found in body cells which is important to the pathogenesis of COPD. The review of the application started in 27 May 2009 and was under active assessment for 210 days. The benefits of the drug are its ability to reduce inflammation in the lungs, to reduce narrowing of airways and to ease breathing problems in adults with severe COPD, the agency said.
Novartis said that Zortress (everolimus) has been cleared by the US Food and Drug Administration to help adult patients with kidney transplants keep the transplanted organ. The drug is already approved as an immunosuppressant and a cancer drug.
Genmab A/S is set to receive DKK 87 million ($16 million) from GlaxoSmithKline Plc following the conditional approval in Europe of Arzerra (ofatumumab), its treatment for refractory chronic lymphocytic leukaemia (CLL).
The European Medicines Agency said that Novartis Europharm Ltd has withdrawn its marketing authorisation application for a drug to treat chronic hepatitis C virus infection. The product is Joulferon (albinterferon alpha-2b).
The US Food and Drug Administration has approved a new treatment option for Tarceva (erlotinib) for patients with locally advanced or metastatic non-small cell lung cancer. This follows a positive opinion for the same indication from the EMA.
BioAlliance Pharma SA said that it has won approval from the US Food and Drug Administration to market its anti-fungal therapy, Loramyc, to treat patients whose immune systems have been compromised following chemotherapy or radiotherapy.
The US Food and Drug Administration has said it can’t approve a new lipid-lowering drug from AstraZeneca Plc and Abbott Laboratories without further data. The two companies announced receiving the complete response letter on 30 March 2010.