Kinex Pharmaceuticals announced that they have received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for KX02 for the treatment of gliomas. In what percentage of animals treated did KX02 consistently clears brain tumors after 4 weeks of therapy? Find out...
In most cases, human gene transfer research is no longer novel or controversial enough to require additional review from the National Institutes of Health's Recombinant DNA Advisory Committee, known as RAC, says a new report by the Institute of Medicine. Could RAC reviews be impeding scientific advancement? Find out...
A study just published by the London Office of Health Economics (OHE) and its collaborators demonstrates how medicines for rare disease may be effectively valued using an innovative approach- multi-criteria decision analysis (MCDA)- that can include all relevant stakeholders, including patients' groups.
Hoffmann-La Roche Ltd. (Roche), in consultation with Health Canada, announced important new safety information regarding the use of Xeloda. Severe skin reactions have been reported in patients taking Xeloda.
Mylan Inc. announced that it has completed the acquisition of India's Agila injectables businesses from Strides Arcolab Ltd. for up to $1.75 billion, which includes $250 million in contingent consideration.
Sanofi announced the results of a 24-week Phase 3b clinical study showing that Lyxumia met the primary endpoint of non-inferiority in blood sugar lowering when administered either before breakfast or the main meal of the day, indicate that lixisenatide works effectively at either time of administration.
Eli Lilly and Co. announced that results from three studies of edivoxetine did not meet the primary study objective of superior efficacy in depression after eight weeks of treatment. Lilly will not proceed with development of edivoxetine as an add-on treatment for depression.
Scientists have determined, at near-atomic resolution, the structure of a protein that plays a central role in the perception of pain and heat, a discovery which will offer fresh insights to drug designers searching for new and better pain treatment.
Researchers have discovered how prostate cancer stem cells evolve as the disease progresses, a finding that could help point the way to more highly targeted therapies.
Three major cancer research centers have joined forces to launch Juno Therapeutics Inc., a new biotechnology company focused on novel immunotherapies for cancer. Juno is being launched with an initial investment of $120 million, making it one of the largest Series A biotech startups in history.
Federal regulators gave the go-ahead to Arca Biopharma to begin human clinical testing of its treatment for atrial fibrillation, the company said Wednesday.
Immunomedics said Wednesday its cancer drug IMMU-132 will receive orphan drug incentives as a treatment for small cell lung cancer. The FDA awards orphan drug status to medications that are designed to treat diseases that affect fewer than 200,000 people in the U.S.
Cell Therapeutics Inc. announced that it concluded an agreement with the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) in Germany for Pixuvri (pixantrone).
Medivation and Astellas Pharma US announced the initiation of a Phase 2 clinical trial evaluating the safety and efficacy of enzalutamide in combination with exemestane in women with advanced breast cancer that is ER+ or PgR+, and HER2 normal.
Roche and Molecular Partners AG have entered into a research collaboration and licensing agreement to discover, develop and commercialize several proprietary therapeutics incorporating Molecular Partners’ DARPin biologics conjugated to toxic agents developed at Roche for the treatment of cancer.