广东药学院《药学快讯》.docx
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广东药学院《药学快讯》.docx
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广东药学院《药学快讯》
目录
【医药进展】1
美国FDA批准一种治疗银屑病新药Stelara(ustekinumab)1
美国FDA批准第一种治疗周围T细胞淋巴瘤(PTCL)新药Folotyn(pralatrexate)1
美国FDA批准Sabril用于婴儿抽搐及癫痫发作2
美国FDA批准Saphris用于治疗精神分裂症与躁狂症(双相障碍)3
美国FDA批准一种新降胆固醇药物Livalo(pitavastatin)4
美国FDA批准一种治疗II型糖尿病新药Onglyza(saxagliptin)5
美国批准秋水仙碱药Colcrys用于治疗急性痛风和地中海热6
美国FDA批准2009-2010年季节性流感疫苗7
美国FDA批准阿片类镇痛药Onsolis用于癌症患者8
美国FDA批准Effient(prasugrel)片剂用于血管成形术病人9
美国FDA批准第一种用于晚期或转移性肺癌患者的维持治疗药物Alimta(pemetrexed)10
美国FDA批准Multaq(dronedarone)片剂用于治疗心率失常11
美国FDA批准一种通用名版紧急避孕处方药用于17岁及以下少女11
美国FDA批准布洛芬(Ibuprofen)注射剂Caldolor12
【政策法规】13
9部门联合发出通知要求加强食品添加剂监督管理工作13
关于印发加强基本药物质量监督管理规定的通知13
国家食品药品监督管理局要求暂停销售使用标示为多多药业有限公司双黄连注射液15
国家食品药品监督管理局要求加强甲型H1N1流感疫苗安全监管工作15
国家食品药品监督管理局印发含辅酶Q10和含大豆异黄酮保健食品产品注册申报与审评有关规定15
药品不良反应信息通报(第23期)16
国家食品药品监督管理局修订溴隐亭和二氢麦角隐亭制剂说明书18
国家食品药品监督管理局关于印发药品技术转让注册管理规定的通知18
国家食品药品监督管理局启动流感防控药械督查工作对甲型H1N1流感防控药械生产、经营、储备、使用环节进行核查19
【业界新闻】20
2008年度SFDA药监统计年报20
国家基本药物制度工作正式启动21
我国药品注册管理出现新变化22
2009年9月美国FDA药品审批情况一览表(本月数据截至9月24日)25
2009年8月美国FDA药品审批情况一览表31
国家药物安全评价监测中心率先接受美国FDA GLP检查36
中国药品行政保护36
【国外知名药企动态】38
ResultsReportedforExploratoryPhaseIITrialofNexavarinCombinationwithChemotherapeuticAgentPaclitaxelforTreatmentofAdvancedBreastCancer38
葛兰素史克完成对Stiefel的并购38
流感大流行(H1N1)2009最新消息:
来自GSK的关于H1N1佐剂疫苗第一项临床试验的初步结果39
BSI-201治疗转移性三阴乳腺癌进入III期临床40
一年给药一次的创新药物密固达有效提高绝经后骨质疏松患者对药物治疗的依从性,全面提升骨密度,降低骨质疏松骨折风险41
MerckKGaASubmitsApplicationforCladribineTabletsasMultipleSclerosisTherapyinEurope42
SecondPhaseIIIStudyShowedLucentisImprovedVisioninPatientswithRetinalVeinOcclusion43
【专题】43
美国FDA批准4种H1N1流感病毒疫苗43
新华网:
美国正式批准4种甲型流感疫苗上市44
国外有关研究显示:
甲型H1N1流感病毒传染期或长达一周45
国家食品药品监管局批准华兰公司甲型H1N1流感疫苗注册申请45
国家食品药品监督管理局批准北京科兴甲型H1N1流感疫苗注册申请45
美国FDA提醒公众警惕网上有关出售抗H1N1流感产品的虚假信息47
图书馆关于定向信息咨询师调整的通知48
【医药进展】
美国FDA批准一种治疗银屑病新药Stelara(ustekinumab)
FDAApprovesNewDrugtoTreatPsoriasis(Sept.25,2009)
TheU.S.FoodandDrugAdministrationtodayapprovedStelara(ustekinumab),abiologicproductforadultswhohaveamoderatetosevereformofpsoriasis.
Plaquepsoriasisisanimmunesystemdisorderthatresultsintherapidoverproductionofskincells.About6millionpeopleintheUnitedStateshaveplaquepsoriasiswhichischaracterizedbythickenedpatchesofinflamed,redskin,oftencoveredwithsilveryscales.
“Thisapprovalprovidesanalternativetreatmentforpeoplewithplaquepsoriasis,whichcancausesignificantphysicaldiscomfortfrompainanditchingandresultinpoorself-imageforpeoplewhoareself-consciousabouttheirappearance,”saidJulieBeitz,M.D.,director,OfficeofDrugEvaluationIII,intheFDA’sCenterforDrugEvaluationandResearch.
Stelaraisamonoclonalantibody,alaboratory-producedmoleculethatmimicsthebody’sownantibodiesthatareproducedaspartoftheimmunesystem.Thebiologictreatspsoriasisbyblockingtheactionoftwoproteinswhichcontributetotheoverproductionofskincellsandinflammation.
Threestudiesof2,266patientsevaluatedthebiologic’ssafetyandeffectiveness.
SinceStelarareducestheimmunesystem’sabilitytofightinfections,theproductposesariskofinfection.Seriousinfectionshavebeenreportedinpatientsreceivingtheproductandsomeofthemhaveleadtohospitalization.Theseinfectionswerecausedbyviruses,fungi,orbacteriathathavespreadthroughoutthebody.Theremayalsobeanincreasedriskofdevelopingcancer.
TheFDAisrequiringariskevaluationandmitigationstrategyorREMSforStelarathatincludesacommunicationplantargetedtohealthcareprovidersandamedicationguideforpatients.
StelaraismanufacturedbyCentocorOrthoBiotechInc.ofHorsham,Pa.,awholly-ownedsubsidiaryofJohnson&JohnsonofNewBrunswick,N.J.
(http:
//www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183851.htm)
美国FDA批准第一种治疗周围T细胞淋巴瘤(PTCL)新药Folotyn(pralatrexate)
FDAApprovesFirstDrugforTreatmentofPeripheralT-cellLymphoma(Sept.25,2009)
TheU.S.FoodandDrugAdministrationhasapprovedFolotyn(pralatrexate),thefirsttreatmentforaformofcancerknownasPeripheralT-cellLymphoma(PTCL),anoftenaggressivetypeofnon-Hodgkinslymphoma.
FolotynwasapprovedundertheFDA'sacceleratedapprovalprocess,whichallowsearlierapprovalofdrugsthatmeetunmetmedicalneeds.Itisapprovedforpatientswhohaverelapsed,orhavenotrespondedwelltootherformsofchemotherapy.
Lymphomaisacancerofthelymphaticsystem,whichispartoftheimmunesystem.Therearemanytypesoflymphoma:
onetypeiscalledHodgkin'sdisease,andtherestarecallednon-Hodgkin'slymphomas.PTCLinvolvesatypeofwhitebloodcellcalledT-cells.Itisarelativelyraredisease,occurringinlessthan9,500patientseachyearintheUnitedStates.
“Folotyn'sapprovaldemonstratesFDA'scommitmenttotherapidapprovalofdrugsforrareanduncommondiseases,”saidRichardPazdur,M.D.,directoroftheOfficeofOncologyDrugProductsintheFDA'sCenterforDrugEvaluationandResearch.
Whenstudyinganewdrug,itcantaketimetolearnwhetheradrugactuallyprovidesrealimprovementforpatients–suchaslivinglongerorfeelingbetter.Thisrealimprovementisknownasa“clinicaloutcome.”In1992FDAinstitutedacceleratedapprovalswhichallowearlierapprovalofdrugsbasedonasurrogateendpoint,alaboratorymeasurementorphysicalsignthatcanserveasanindirectorsubstitutemeasurementforclinicaloutcomes.
InthecaseofFolotyn,thismeanttheFDAapprovedthedrugbasedonevidencethatitreducestumorsize,becausetumorshrinkageisconsideredreasonablylikelytopredictaclinicalbenefitsuchasextendingthesurvivalofcancerpatients.Tumorshrinkagewasseenonimagingscansinonestudy.Of109patientswithPTCLinthetrial,27%hadreductionintumorsize.
Tospeedthedrug'savailability,Folotynwasgrantedpriorityreview,ensuringareviewwithinsixmonthsratherthan10monthsforastandardreview.Thedrugwasalsodesignatedasanorphandrug,whichprovidesavarietyoffinancialincentivestomanufacturersthatdevelopdrugsforasmallnumberofpatientswithararedisorder.
ThemostcommonadversereactionsseenwithFolotynwereirritationorsoresofthemucousmembranessuchasthelips,themouth,andthedigestivetract,lowplateletcellcounts,lowwhitebloodcellcounts,fever,nausea,andfatigue.
Folotyncanharmafetus.Womenshouldavoidbecomingpregnantwhilebeingtreatedwiththisdrugandpregnantwomenshouldbeinformedofthepotentialrisk.
PatientstreatedwithFolotynshouldtakefolateandvitaminB12supplementstoreducemucousmembraneirritation.
FolotynismanufacturedbyAllosTherapeuticsInc.ofWestminster,Colo.
Asaconditionofacceleratedapproval,Alloswillconductstudiestoconfirmthattumorshrinkageactuallydoespredictthatpatientswilllivelonger.
(http:
//www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183799.htm)
美国FDA批准Sabril用于婴儿抽搐及癫痫发作
SabrilApprovedbyFDAtoTreatSpasmsinInfantsandEpilepticSeizures(Aug.21,2009)
Sabril(vigabatrin)OralSolutionhasbeenapprovedbytheU.S.FoodandDrugAdministrationtotreatinfantilespasmsinchildrenages1monthto2years.SabrilisthefirstdrugintheUnitedStatesapprovedtotreatthedisorder,characterizedbyaseveretypeofseizurethatusuallyappearsinthefirstyearoflife,typicallybetweenages4monthsand8months.Thedisordercanbedebilitatingbecauseofthefrequencyofdifficult-to-controldailyseizures.
Sabril(vigabatrin)Tabletshavebeenapprovedforadultuseincombinationwithothermedicationstotreatcomplexpartialseizuresthathavenotrespondedadequatelytopreviousdrugtherapies.
“Seizurescancauseimpairednervoussystemfunctionandreducedqualityoflife,”saidRussellKatz,M.D.,directoroftheDivisionofNeurologyProductsattheFDA’sCenterforDrugEvaluationandResearch.“Infantilespasmsinchildrenthisyoungareveryseriousandthisapprovalprovidesthesepatientsandtheirparentsatreatmentoption.”
Infantilespasmsconsistprimarilyofasuddenbendingforwardofthebodywithstiffeningofthearmsandlegs;somechildrenarchtheirbacksastheyextendtheirarmsandlegs.Spasmstendtooccuruponawakeningorafterfeeding,andoftenoccurinclustersofupto100spasms.Infantsmayhavedozensofclustersandseveralhundredspasmsperday.Manyunderlyingdisorders,suchasbirthinjury,metabolicdisorders,andgeneticdisorderscangiverisetospasms,makingitimportanttoidentifytheunderlyingcause.Insomechildren,nocausecanbefound.
Epilepsyisaneurologicalconditionthatproducesdisturbancesinthenormalelectricalfunctionsofthebrain,causingpeopletohaverecurringseizures.Seizureshappenwhennervecells,orneurons,inthebrainsendoutthewrongsignals.Peoplemayhavestrangesensationsandemotionsorbehavestrangely.Theymayhaveviolentmusclejerking,whichmayberepetitive,orloseconsciousness.
DamagetovisionisanimportantsafetyconcernwiththeuseofSabril.Thedrugwillhaveaboxedwarningtoalerthealthcareprofessionalstothisriskofaprogressivelossofperipheralvisionwithpotentialdecreaseinvisualacuity.Theriskofvisiondamagemayincreasebasedonthedosageanddurationofuse,buteventhelowestdosesofSabrilcancausevisiondamage.PeriodicvisiontestingisrequiredforthosetakingSabril.
Becauseoftheriskofpermanentvisiondamage,thedrugwillbeavailableonlythrougharestricteddistributionprogram.
SabrilwasdesignatedasanorphandrugbytheFDAforuseintreatinginfantilespasms.Adrugiseligiblefororphandrugdesignationifitisintendedtotreatadiseaseorconditionthataffectslessthan200,000peopleintheUnitedStates.Orphand
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