Nashville, Tennessee, Oktoobar 12, 2021–(WIRE GANACSI)–Revance Therapeutics, Inc. (NASDAQ: RVNC) waa shirkad bayoolajiga ah oo diiradda saarta bilicda hal-abuurka leh iyo alaabada daweynta.Waxay ka jawaabtay sharciga Xoriyadda Macluumaadka (FOIA) codsi liddi ku ah FDA iyadoo ka jawaabaysa shaacinta dadweynaha ee Foomka 483. Codsiga Shatiga Biologics (BLA) ee DaxibotulinumtoxinA ee duritaanka ayaa wali ku hoos jirta dib u eegista FDA, shirkaduna waxay sii wadaysaa inay filayso FDA. si loo ansixiyo DaxibotulinumtoxinA cirbadeynta daawaynta khadadka wejiga 2021.
Revance wuxuu tilmaamay in aysan ahayn wax aan caadi ahayn in Foomka 483 la soo saaro ka dib kormeerka goobta.Foomka 483 wuxuu taxayaa indha-indhaynta uu sameeyay wakiilka FDA intii lagu jiray kormeerka xarunta.Foomka 483 kama dhigna go'aanka wakaalada kama dambaysta ah.
Revance wuxuu ka jawaabay Foomka 483 bishii Luulyo 2021 ka dib kormeer oggolaansho ka hor wuxuuna hadda sugayaa go'aanka FDA ee BLA ee DaxibotulinumtoxinA si loogu duro daawaynta khadadka glabellar.Shirkaddu waxay weli ku kalsoon tahay tayada soo-jeedinteeda BLA waxayna sii wadaa inay filayso FDA inay hesho oggolaansho 2021.
Revance waa shirkad bayoolaji ah oo diiradda saarta bilicda iyo alaabada daweynta cusub, oo ay ku jirto jiilka soo socda ee neuromodulator-ka DaxibotulinumtoxinA ee duritaanka.DaxibotulinumtoxinA ee duritaanku wuxuu isku daraa maaddo peptide ah oo xasiloon iyo sun botulinum oo aad loo sifeeyay oo aan lahayn qaybo dad ama xayawaan ah.Revance waxa uu si guul leh u dhamaystiray wejigii saddexaad ee DaxibotulinumtoxinA ee duritaan-brown, waxana uu oggolaansho ka raadinayaa hay'adaha sharciyeynta ee Maraykanka.Revance waxa kale oo ay qiimaynaysaa DaxibotulinumtoxinA cirbadaha wejiga sare oo dhan, oo ay ku jiraan xariijimaha glabellar, khadadka foodda, iyo cagaha tukaha, iyo sidoo kale laba tilmaamo daawaynta - dystonia ilmo-galeenka iyo qof weyn oo ka baxay addimada sare.Si loola kaashado DaxibotulinumtoxinA duritaan, Revance waxa ay haysaa taxane ah alaabo iyo adeegyo tayo sare leh oo gaar ah oo lagu isticmaalo dhaqanka quruxda Maraykanka, oo ay ku jiraan xuquuqaha qaybinta gaarka ah ee RHA® taxanaha buuxinta maqaarka ee Maraykanka.Kani waa kan ugu horreeya iyo midka kaliya ee ay ansixisay FDA si loogu isticmaalo taxane ah buuxinyaal firfircoon si loo saxo laalaabkii wejiga iyo laalaabyada, iyo OPUL™ xiriirka ganacsiga goobta.Revance waxa kale oo ay iskaashi la samaysay Viatris (oo hore u ahaan jirtay Mylan NV) si ay u horumariyaan biosimilar BOTOX®, kaas oo ku tartami doona suuqa neuromodulator-ka ee hadda jira.Revance waxaa ka go'an inuu wax ka beddelo xaaladda hadda taagan isagoo beddelaya waayo-aragnimada bukaanka.Wixii macluumaad dheeraad ah ama si aad ugu biirto kooxdayada, fadlan booqo www.revance.com.
Hadal kasta oo ku jira war-saxaafadeedkan oo aan ahayn bayaannada xaqiiqooyinka taariikhiga ah, oo ay ku jiraan odhaahyada la xidhiidha awooddayada iyo wakhtigayaga si aan u helno oggolaanshaha FDA ee BLA ee sunta botulinum A si loogu duro daawaynta khadadka wejiga;tayada soo gudbintayada BLA Kalsooni buuxda;heerka soo gudbinta BLA;Natiijooyinka baaritaanka FDA ee xarumaha wax soo saarka ee shirkadda ee Waqooyiga California, iyo natiijooyinka horumarinta BOTOX® biosimilars ee lammaaneheena Viatris;oo ka kooban "Sharciga Dib-u-habaynta Dacwadaha Damaannada Gaarka ah ee 1995", "1933 odhaahyo hore u eegaya oo ku dhex jira macnaha Qaybta 27A ee Xeerka Securities ee 1934 (sida wax laga beddelay) iyo Qaybta 21E ee Xeerka Isweydaarsiga Securities ee 1934 (sida wax laga beddelay).Waa inaadan ku tiirsanayn odhaahyada mustaqbalka ee saadaalinta dhacdooyinka mustaqbalka.In kasta oo aan aaminsanahay in rajada laga filayo odhaahyada mustaqbalka-muuqaalka ah ay yihiin kuwo macquul ah, ma dammaanad qaadi karno in natiijooyinka mustaqbalka, heerarka waxqabadka, waxqabadka, dhacdooyinka, duruufaha, ama guulaha ka muuqda odhaahyada mustaqbalka ay mar walba rumoobaan ama dhacaan.
Odhaahyada hore u eegistu waxay ku xiran yihiin khataro iyo hubanti la'aan, taas oo keeni karta in natiijooyinka dhabta ah ay ka duwan yihiin filashadayada.Khatarahan iyo hubanti-la'aantan waxay ku lug leeyihiin, laakiin kuma koobna: natiijooyinka, wakhtiga, kharashka, iyo dhamaystirka hawlaheena R&D iyo ansixinta sharciyeynta, oo ay ku jirto dib u dhaca joogtada ah ee oggolaanshaha BLA ee FDA ee DaxibotulinumtoxinA ee duritaanka, ee daaweynta khadadka glabellar, oo ay ku jiraan iyadoo ay ugu wacan tahay fiirsashada FDA inta lagu jiro kormeerka goobta ama sababo kale;Faafida COVID-19 waxay ku soo rogtay ganacsigeena wax soo saarka, silsiladda sahayda, baahida isticmaale ee alaabteena, dadaallada ganacsi, hawlgallada ganacsiga, tijaabooyinka caafimaad, iyo qaybaha kale ee ganacsigeenna iyo suuqayada Waxaan awood u leenahay inaan soo saarno sahayda badeecadeena. musharaxiinta oo hel sahayda taxanaha buuxinta maqaarka ee RHA®;habka horumarinta kiliinikada ee aan la hubin;Tijaabooyin caafimaad ma yeelan karaan naqshado wax ku ool ah ama soo saaraan natiijooyin wax ku ool ah, ama togan Natiijooyinka waxay hubin doonaan khatarta ansixinta sharciyeed ama guusha ganacsiga;ku habboonaanta natiijooyinka cilmi-baarista kiliinikada ee natiijooyinka dhabta ah;saamiga iyo heerka faa'iidooyinka dhaqaale, badbaadada, waxtarka, aqbalaadda ganacsiga, iyo OPUL ™, RHA® taxane buuxinta maqaarka iyo suuqayada, tartanka, miisaanka iyo kobaca badeecada musharraxa (haddii la oggolaado);Awooda aan u leenahay inaan sii wadno inaan si guul leh u ganacsigeyno taxanaha buuxinta maqaarka ee RHA® iyo OPUL™, iyo awoodda aan si guul leh u ganacsigeyneyno DaxibotulinumtoxinA ee duritaanka (haddii la oggolaado), iyo waqtiga iyo qiimaha waxqabadyada ganacsi;Awoodeena aan ku balaadhinno iibinta iyo awoodaha suuqgeynta;heerka iskaashiga ganacsiga;Awoodeena si aan u helno lacag hawlaheena;kharashkeena iyo awoodayada aan iskaga difaacno masuuliyada alaabta, hantida maskaxda iyo dacwadaha kale;Waxaan awood u leenahay inaan sii wadno helitaanka iyo ilaalinta hantida maskaxeed ee musharaxiintayada daroogada;waxqabadkeena maaliyadeed, oo ay ku jiraan dakhliga mustaqbalka, kharashyada iyo shuruudaha raasumaalka;iyo khataro kale.Faahfaahinta arrimaha keeni kara in natiijooyinka dhabta ahi ay si dhab ah uga duwan yihiin kuwa lagu muujiyey ama lagu macneeyey bayaannada ku jira war-saxaafadeedkan, fadlan tixraac dukumeentiyadayada caadiga ah ee laga xareeyay Guddiga Ilaalinta iyo Sarrifka ee Maraykanka (SEC), oo ay ku jiraan kuwa qaybta cinwaankeedu yahay "Khatarta" Qodobbada lagu sifeeyay "arrimaha" ee Foomka 10-K ee aan u gudbinay SEC Febraayo 25, 2021 waxaa ka mid ah laakiin aan ku xaddidnayn 10-kii rubuci ee dhammaaday Juun 30, 2021, kaas oo aan u gudbinay SEC Ogosto 5, 2021. -Q miiska.Odhaahyada mustaqbalka ee war-saxaafadeedkan waxay shaqaynayaan oo keliya laga bilaabo taariikhda la daabacay.Annagu ma qaadno wax waajibaad ah si aan u cusboonaysiino weedhahan mustaqbalka.
Investor Revance Therapeutics, Inc.: Jessica Serra, 626-589-1007jessica.serra@revance.com or Gilmartin Group, LLC.: Laurence Watts, 619-916-7620laurence@gilmartinir.com
Media Revance Therapeutics, Inc.: Sara Fahy, 949-887-4476sfahy@revance.com or General Media: Y&R: Jenifer Slaw, 347-971-0906jenifer.slaw@YR.com or Trade Media: Nadine Tosk, 504-4453- 834@revance.com gmail.com
Crispr ayaa sheegtay Talaadadii in ka dib baaritaano rajo leh, ay qorsheyneyso in ay bilowdo cilmi baaris muhiim ah oo ku saabsan daawooyinkeeda ka hortagga kansarka.Si kastaba ha ahaatee, saamiyada CRSP ayaa hoos u dhacay ficil dambe.
Xitaa ka dib markii Maamulka Cuntada iyo Dawooyinka uu dib u dhigay ku talinaynta qiyaasta kobcinta ee shirkadda ee irbadaha Covid, kaydka Moderna ayaa kacay Talaadadii.
Toddobaadkan waxay calaamad u tahay daqiiqad kale oo suurtagal ah oo suurtagal ah tallaalka Moderna Inc. ee Covid-19: guddi la-talin oo muhiim ah oo ka tirsan Maamulka Cuntada iyo Dawooyinka ee Mareykanka ayaa kulmi doona si ay uga wada hadlaan waxa loogu yeero "kor u qaadista duritaanka".
Sawirka uu qaaday Martin Sanchez ee Unsplash Merck & Co (NYSE: MRK) ayaa ku dhawaaqay natiijooyinka cajiibka ah ee daawadeeda COVID-19 ee ka hortagga fayraska monupiravir Jimcihii hore.Maaddaama uu tallaalku u baahan yahay duritaan xoojin ah oo saddexaad, iyo dadka tallaalka u adkaysta ay weli halis ugu jiraan isbitaal, dhimasho, iyo calaamadaha daran ee COVID-19, dareenka bulshada sayniska iyo Wall Street waxay u leexdeen daaweynta COVID-19 sida ugu wanaagsan. sida loola tacaalo caabuqyada horudhac ah.Mustaqbalka suurtagalka ah ayaa kor u kacaya.Daawooyinka ka hortagga fayraska ayaa ah kuwa ugu awoodda badan tartanka
"Dugsiga Aqoonta" waxa uu leeyahay madal lagu barto caafimaadka dhimirka, taas oo kuu ogolaanaysa in aad caafimaadkaaga ka aqoonsato dhinacyo badan, oo aad barato aqoonta caafimaadka dhimirka wakhti kasta iyo meel kasta.
Ka dib markii Maamulka Cuntada iyo Dawooyinka ee Maraykanka (FDA) iyo Xarumaha Xakamaynta iyo Kahortagga Cudurrada (CDC) ay go'aansadeen inay ansixiyaan qiyaasaha xoojinta tallaalkan ee dad gaar ah dhammaadka Sebtembar, malaayiin qaatayaasha Pfizer ayaa hadda helaya irbado dheeraad ah.Si kastaba ha ahaatee., Moderna iyo Johnson & Johnson qaatayaasha ayaa looga digay inay dib u dhigaan raadinta tallaallo dheeri ah sababtoo ah FDA iyo guddiyada la-talinta CDC ma aysan fasaxin kuwa xoojiya labadan tallaal.
CureVac waxay joojinaysaa horumarinta tallaalkeedii ugu horreeyay ee Covid-19 ee ku salaysan Messenger RNA.Warku waxa uu kiciyay kaydka.
Cudurro yar ayaa keena waxyeellada u badan sida duumada.Sanadka 2019, waxaa jiray qiyaastii 229 milyan oo xaaladood oo duumo ah.Toddobaadkii hore, Hay'adda Caafimaadka Adduunka (WHO) ayaa ku talisay in carruurta si baahsan loo isticmaalo tallaallada duumada.
Ka codso American Express Explorer™ kaarka deynta halkan si aad ugu raaxaysato khidmadda sanadka ugu horeeya iyo 3 jeer dhibcaha xayawaanada la'aanta, wax iibsiga smart ama ka-hortagga abaal-marinaha kala duwan ee kharashka!
Geoffrey Porges oo ka tirsan SVB Leerink ayaa qoray in natiijada wejiga labaad ee tijaabada tallaalka "ay calaamad wanaagsan u tahay wajiga saddexaad ee tijaabada ah."
Ka dib markii CDC ay ku taliso irbado xoojiyayaasha Covid dadka 65 iyo ka weyn iyo kuwa kale ee Maraykanka ah ee danyarta ah, kaydka Pfizer miyuu mudan yahay in la iibsado?
Qoraaga: Dr. David Bautz Nasdaq: CFRX Akhri warbixinta cilmi baarista ee CFRX oo dhamaystiran Cusboonaysiinta ganacsiga Wajiga 2 xallinta degdega ah ee calaamadaha tijaabada Oktoobar 4, 2021, ContraFect (NASDAQ: CFRX) ayaa ku dhawaaqday exebacase shirkadda 2 Xogta cusub ee wajiga 1 Tijaabada caafimaadku waxay ku socotaa IDWeek™, iyo calaamadaha bukaanada qaba Staphylococcus aureus bacteremia si dhakhso ah ayey u yaraadaan waxaana lagu soo bandhigaa qaab warbixin afka ah oo ka timid khalkhal daahay.
Bixi hadiyado iyo hadiyado sahayda iyo maamulka, haddii ay tahay hadiyado shirkadeed, dallacaad ama hadiyado iibsi kale, waxaan kaa caawin karaa hadiyado badan!Naqshadaynta alaabta, wax soo saarka, iyo wax soo saarka ayaa laguu samayn karaa adiga.Isla markaana waxa iska kaashaday in ka badan boqol warshadood.Haddii aad ka fikirto ama aad ka fikirto, wax badan ayaan kuu soo diri doonaa!
Ka dib markii shirkaddu ay waydiisatay FDA inay ogolaato kaniinkeeda Covid iyadoo la kaashanaysa Ridgeback Biotherapeutics, qiimaha saamiyada Merck ayaa waxyar hoos u dhacay Isniintii.
Ka dib markii shirkadda Jarmalka ee biopharmaceutical ay sheegtay inay ka tagi doonto horumarinta musharaxeeda tallaalka COVID-19 taa beddelkeedana ay diiradda saarto la-shaqeynta GlaxoSmithKline si ay u horumariso duritaanka jiilka labaad ee mRNA ee ka dhanka ah COVID-19, qiimaha saamiyada CureVac wuxuu ku jiray ganacsiga suuqa ka hor Talaadadii. Waxa uu hoos u dhacay 9.6%.Heshiiska iibka ee hadda jira ee lala leeyahay Komishanka Yurub ma sii soconayo.Hadafkayagu waa in ay suuqa keenaan tallaal cusub oo COVID-19 ah sanadka 2022.
Dhibaatada caabuqa wadnaha ee dhifka ah ee tallaalka Moderna ayaa laga yaabaa inay faa'iido u leedahay Pfizer-laakin kaliya si khafiif ah.
Horumari shaqadaada adiga oo baranaya MBA dabacsan.Ku dhammee waxbarashadaada ugu yaraan 2 sano.
Maadaama dad badan oo Maraykan ah oo uu tallaalay Pfizer ay xidhxidheen gacmahoodii si ay isugu diyaariyaan cirbadaha xoojiyeyaasha ah, malaayiin kale oo ay tallaaleen Moderna ama Johnson & Johnson ayaa si walaac leh u sugaya waqtigooda.
Sida laga soo xigtay Machadka Qaranka ee Gabowga, NIH Alzheimer had iyo jeer waxay ahayd cudur si liidata loo fahmay, kaas oo caqabad weyn ku ah helitaanka daweyn macquul ah.Saynis yahanadu waxay xitaa sahaminayaan doorashooyin aan caadi ahayn, sida dawooyin hore oo loo qoray xaalado aad u kala duwan.Waxay heleen musharrax daroogo aad u la yaab leh oo ah qaab 50-sano jir ah oo diuretic ah.
Saamiyada CureVac NV (NASDAQ: CVAC) ayaa hoos u dhacay Talaadadii ka dib markii shirkaddu ay ku dhawaaqday inay la shaqayn doonto GlaxoSmithKline si ay diiradda u saarto horumarinta tallaalkeeda COVID-19 ee horumarinta murashaxiinta tallaalka mRNA jiilka labaad.EMA waxay la laabatay tallaalkeedii jiilka kowaad intii lagu jiray nidaamka oggolaanshaha.CureVac waxay ku qiyaastay in oggolaanshaha ugu horreeya ee suurtogalka ah ee tallaalkeeda jiilka kowaad uu noqon doono rubuci labaad ee 2022. Waqtigaas, shirkaddu waxay filaysaa in murashaxiinta barnaamijka tallaalka jiilka labaad ay heli doonaan
Kooxda macalinka ah ee khadka tooska ah ama jirka ah, oo ku habboon dhammaan isdiiwaangelinta xirfadleyda, waxqabadyada dhaqameed ee bilaashka ah waqti ka waqti, waayo-aragnimada caadooyinka qaranka ee kala duwan, Prince Tuen Mun Yuen Long Tin Shui Wai Sha Tin Wind Class!
Natiijooyinka tijaabada caafimaad ee ugu horreeya ee musharraxa daroogada ee daaweynta alfa-1 yaraanta antitrypsin waxay u egtahay mid dhiirigelin leh.
Johnson & Johnson ayaa sheegay Talaadadii in 59-sano jirku uu ka tagi doono Guddoomiye kuxigeenka Guddiga Fulinta iyo Sarkaalka Sare ee Sayniska 31-ka Diseembar. iyo tignoolajiyada si loo bixiyo dawooyin hal abuur leh si loo xalliyo caqabadaha caafimaad ee ugu adag adduunka, goobta daryeelka caafimaadku waa is beddeshay,” ayuu yidhi Dr. Stoffels.Tani waa bixitaankii labaad ee maamulka sare ee ay shaaciyaan Johnson & Johnson toddobaadyadii la soo dhaafay.
Dhaqtar ayaa soo xigtay falsafada kubbadda koleyga ee Yogi Bella isagoo leh, isagoo ku booriyay qof walba inuu hoos u dhigo kor u qaadista dooda batting-ka iyo arrimaha kale ee aan la xallin.
Waqtiga boostada: Oct-13-2021