December 2, 2015 overseas medical journal

Novo Nordisk has obtained the global commercialization right of diabetes indications and the priority license of rare disease indications of xmeta project of xoma all human INSR active allosteric monoclonal antibody The deal includes $5 million in advance and $290 million in milestones and sales share [xoma announcements license agreement with Novo Nordisk for xmeta program in diabetes] http://t.cn/ruds834 EMA granted adaxs-her2 anti osteosarcoma orphan drug qualification to adaxis company, which was granted by FDA in 2014 In addition to adxs-her2, advaxis is also developing adxs-hpv for head and neck cancer, cervical cancer and adxs-psa for prostate cancer [advaxis receives orphan drug design in the European Union for adxs-her2 for the treatment of osteosarcoma] http://t.cn/rudoawa lexicon cancer like drug telotristat The second phase III test clinical study of etiprate (nct02063659) reached the main end point After 12 weeks of treatment, the level of urinary 5-hydroxyindoleacetic acid (5-HIAA) in the treatment group was significantly lower than that in the control group, and the amount of daily defecation was significantly reduced The first phase III telestar clinical study (nct01677910) reached the primary end point in August 2015 [telotristat etiprate achievements positive top-line results in second phase 3 clinical trial] http://t.cn/rudodax FDA awarded the qualification of kevetrin (thioureidobutyronitrile) of cellceutix company for the treatment of rare paediatric diseases of retinoblastoma Once approved, the drug with the qualification will have the opportunity to obtain a priority review certificate On November 23, 2015, the drug obtained the qualification of FDA orphan drug, and is currently in the phase I clinical research stage 【Cellceutix Receives Rare Pediatric Disease Designation From FDA for Kevetrin for the Treatment of Retinoblastoma】http://t.cn/RUDKqXm FDA refused to approve the secondary hypogonadism drug enclomiphene in overweight patients of repos company, and issued a full response letter, saying that the phase III clinical study of the drug is not enough to show clinical benefits, and the method validation is defective, and recommended repors for supplementary study FDA received Lina clomiphene NDA in February 2015, and PDUFA date was November 30, 2015 [retro therapeutics receives complete response letter from FDA for envelopene] http://t.cn/rudk03c cardiocell plans to carry out the clinical study of allogeneic bone marrow mesenchymal stem cell therapy in the treatment of chronic heart failure stage Ⅱ B, and plans to recruit 600 patients with chronic heart failure The completed phase Ⅱ a clinical study showed that the therapy was safe and well tolerated, and the therapeutic effect had potential [cardiocell plans phase IIB clinical trial using its stem cells for patients with chronic heart failure] http://t.cn/rud048r British adaptimmune company and Seattle universal cells company cooperate to make full use of the advantages of adaptimmune company in TCR immunotherapy and universal cells company in general donor stem cell gene editing technology to develop general-purpose TCR immunotherapy The deal includes a $5 million advance, $41 million milestone and a sales share 【Adaptimmune and Universal Cells Announce Collaboration to Develop Allogeneic T-Cell Therapies】http://t.cn/RUD05Mz