• Gedeon Richter plc, of Budapest, Hungary, and Forest Laboratories Inc., of New York, reported top-line results from a Phase III trial of cariprazine (RHG-188), an antipsychotic agent, in patients with acute mania associated with bipolar I disorder. For the primary endpoint, the Young Mania Rating Scale, data showed cariprazine-treated patients experienced significant improvements in symptoms compared to those in the placebo arm, observed as early as day five of treatment and at each subsequent time point studied.

• 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.

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.

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.

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.

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.

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.

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.

LONDON – The challenging indication of severe sepsis has confounded yet another attempt to develop a registered treatment, with the curtailment of the Phase II/III trial of Agennix AG's talactoferrin.