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.
Two US centres of the Fraunhofer-Gesellschaft in Germany, together with Boston University and the biopharmaceutical company iBio, Inc, have launched a factory that uses non-genetically modified green plants to produce vaccines.
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.
After a decade of above-average sales growth, Boehringer Ingelheim GmbH expects revenue will be flat in 2010, as it loses patent protection for some important drugs. In the current year, it plans to invest heavily in R&D which will impact on income.
Elan Corporation Plc reported an operating profit of $36.2 million for the first quarter of 2010 after an operating loss a year earlier, driven by strong sales of its multiple sclerosis drug, Tysabri (natalizumab), and a reduction in expenses.
Silence Therapeutics Plc said that it has reached an agreement with AstraZeneca Plc to extend for one year their collaboration to develop new delivery technologies for RNA interference (RNAi) therapeutics. Financial terms were not disclosed.
New products represented 16% of Novartis’s net sales of $12.1 billion in the first quarter of 2010, according to the Swiss company’s first quarter report released on 20 April 2010.
Elan Corporation Plc said that it is exploring the possibility of dividing its operations into two separate, publicly-listed companies. They would comprise a drug technology business and a neurology drug development business.
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).