• Clinuvel Pharmaceuticals Ltd., of Melbourne, Australia, said it submitted a marketing authorization application for Scenesse (afamelanotide 16-mg implant) to the European Medicines Agency (EMA) covering use of the product as a prophylactic treatment in adults with erythropoietic protoporphyria. Scenesse received orphan drug designation in 2008 and will be reviewed under the EMA's centralized procedure.
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LONDON – AstraZeneca plc said it will spend more of its annual $5 billion R&D budget with external partners as it announced it is once again taking the ax to the in-house R&D operations, in a third phase of restructuring that will see a further 2,200 job cuts added to the 5,300 R&D posts the company has cut since 2007. Read More
Even though ThromboGenics NV decided not to seek a priority review of its BLA for its symptomatic vitreomacular adhesion (VMA) drug ocriplasmin, the FDA decided to bestow one on the company anyway. The Leuven, Belgium-based firm now plans to withdraw its original BLA and to re-submit the file in April. The fast-track procedure should lead to a decision within six months. Read More
LONDON – Twenty-five European Union (EU) countries are to direct national funding for research in neurodegenerative disorders into a single, 10-year joint research plan which will see work in Alzheimer's and Parkinson's diseases, among others, coordinated across Europe.
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Shares in AB Science SA surged 71.5 percent last week on news that its tyrosine kinase inhibitor masitinib strongly outperformed Sutent (sunitinib malate) in a Phase II head-to-head trial in 44 patients with Gleevec-resistant gastrointestinal stromal tumors.
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LONDON – The discovery of a genetic variant that is associated with a higher risk of developing a particular type of stroke could one day lead to new treatments for that condition.
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LONDON – Splitting its internal research effort into dozens of small teams, with each focusing on a particular disease or pathway, is on track to solve GlaxoSmithKline plc's productivity woes and push its return on investment in R&D to 14 percent.
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