Overseas medical information Morning Post

The European Commission has the conditions to approve the use of aninjin CD19 / CD3 bispecific antibody blincyto (blindumoma b) for the treatment of adult Philadelphia chromosome negative relapse / refractory precursor B-cell acute lymphoblastic leukemia The approval is based on two phase II clinical studies (study 211 and study 206), of which the complete remission rate of patients in study 211 is 42.9% In 2009, the drug was approved by the FDA on December 3, 2014 【EuropeanCommissionApprovesAmgensBLINCYTOblinatumomabfortheTreatmentofAdultsw ithPhiladelphiaChromosomeNegativeRelapsedorRefractoryBprecursorAcuteLymphoblasticLeu kemia】 http://t.cn/RU1gfMO Green Cross company of South Korea submitted ivig-sn (human immunoglobulin for intravenous injection) listing application to FDA The biological product is used for the treatment of primary immunodeficiency, which is a genetic disease that will lead to immune system defect or loss The application is based on a phase III clinical study to reach the primary end point of no acute bacterial infection FDA will respond to the application within 60 days The biological product was approved in China in 2010 [greencossubmitsbiologicslicenseapplicationtousfdaforivig-sn] http://t.cn/ru1em4x although the FDA advisory committee expressed concerns about the effectiveness and safety of the biomarindmd drug drisapersen in a briefing a few days ago, today the FDA peripheral and central nervous system drug advisory committee finally recommended approval of the drug The PDUFA date of the drug is December 27, 2015, three months earlier than that of the same drug eteplirsen of competitor Sarepta, and the PDUFA date of eteplirsen is February 26, 2016 The first approved company will also receive a priority review voucher worth more than $400 million 【BioMarinPostsPresentationFromFDAAdvisoryCommitteeMeetingforKyndrisa(TM) (drisapersen)fortheTreatmentofDuchenneMuscularDystrophyAmenabletoExon51Skipping】 http://t.cn/RUBLEGa A European study of xbiotechtruehuman monoclonal antibody lost 72 patients' data, including 25 patients' early termination, 14 patients' medication disorder in the trial group and the control group, 33 patients did not complete DEXA scanning The loss of data will greatly reduce the research accuracy, xbiotech stock fell 34% in response [xbiotechprovidesupdateonphase iiioncology studyineurope] http://t.cn/rubyzgd FDA awarded lysogeneaav gene therapy lys-saf-302 for the treatment of Type IIIA mucopolysaccharide storage syndrome (also known as Sanfilippo a mucopolysaccharide syndrome) orphan drug qualification and rare pediatric disease qualification If the drug is approved, lysogene may obtain a priority review certificate [lysogenereceivesorphan drag design and rarepediariticdiseasedesign from the FDA] http://t.cn/rublfas the European Commission approved the combination of gskvolibris and tadalafil for the first-line treatment of pulmonary hypertension The approval was based on the phase Ⅲ B / Ⅳ ambition study (nct01178073) The results showed that in untreated patients, the risk of clinical failure could be reduced by 50% compared with the combination of aniracetam or tadalafil alone On October 2, 2015, FDA also approved the combination of alisentan and tadalafil in the treatment of pulmonary hypertension [gskreceives European market ingauthorizationto expand indication for volibrinintreatmentof Pu lmonaryarterialhypertension] http://t.cn/ru1kztv European Commission approved SOBI and Baijian eloctate (efraloctocogalfa, long-term recombinant factor Ⅷ Fc fusion protein) for the treatment of hemophilia A a In addition to the EU 28, Iceland, Liechtenstein and Norway approved the drug today Approval is based on the results of two phase III clinical studies, a-long study and kidsa-long study FDA approved the drug on June 6, 2014, and Japan approved the drug on December 26, 2014. [sobiandbiogen's elocta (rfviiifc) approved in Europe for the treatment of haemophilia] http://t.cn/ru1kqre FDA approved Lilly anti EGFR monoclonal antibody necitumumab, trade name: portrazza, combined with gemcitabine and cisplatin, for the first-line treatment of advanced squamous NSCLC Based on the multicenter randomized open phase III clinical squire study (nct00981058), triple therapy was approved in comparison with gemcitabine and cisplatin to significantly prolong the overall survival (11.5mvs9.9p = 0.012) This is also the first biological product approved for first-line treatment of NSCLC [fdaapprovesportrazzatoreatadvancedsquamousnon - smallcellungcancer] http://t.cn/rublpf4 one day later, FDA approved Bristol Myers Squibb anti PD-1 monoclonal antibody opdivo (nivolumab) for the sixth time, and nivolumab was newly approved for the first-line treatment of BRAF wild-type melanoma This approval is based on the checkmate-066 multicenter, randomized, double-blind, phase III clinical study (nct01721772), with a longer median progression free survival (5.1 vs.2.2 m) and a higher objective response rate (34% vs.9%) compared to dacarbazine [Bristol - myerssquibbannouncements U.S Food and Drug Administration approval for opdivo (nivolumab) asasi ngleagent for the treatment of patientswith previously untreated wild - type advanced influenza] http://t.cn/rubyznk FDA approved the Novartis seasonal influenza trivalent vaccine fluad for the prevention of seasonal influenza in people 65 years and above Fluad was first approved in Italy in 1997 and has been approved in more than 38 countries It is also the first seasonal influenza vaccine approved by FDA 【FDAapprovesfirstseasonalinfluenzavaccinecontaininganadjuvant】 http://t.cn/RUBybxw