News

Cellular Dynamics raises $40.6 million for cell technology

Country
United States

Cellular Dynamics International (CDI) Inc of Madison, Wisconsin has raised $40.6 million in a Series B private equity round to increase production capacity for its human heart cells derived from induced pluripotent stem cells (IPSCs).

MorphoSys confirms 2010 revenue and profit targets

Country
Germany

MorphoSys AG has confirmed that it expects to report revenue of between €89 to €93 million in 2010, up from €81 million in 2009, and to report an operating profit of €5 to €9 million, compared with €11.4 million the previous year.

Filling pipelines is an art rather than a science

Country
United Kingdom

Companies looking to partner or licence a medical product or platform often have difficulty working out what the value is of what they are selling. If their product or platform is really new, there is no precedent for establishing value.

AstraZeneca’s Seroquel recommended for depression

Country
United Kingdom

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 seen continuing for Genzyme drugs

Country
United States

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.

 

Regulatory Briefs

Country
United Kingdom

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.

Fraunhofer launches plant-based vaccine factory in the US

Country
United States

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 receives FDA approval for organ transplant drug

Country
Switzerland

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.

Elan shows operating profit in Q1

Country
Ireland

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.