Nashville, Tennessee, Lub Kaum Hli 12, 2021–(BUSINESS WIRE)–Revance Therapeutics, Inc. (NASDAQ: RVNC) yog lub tuam txhab biotechnology tsom rau kev zoo nkauj tshiab thiab cov khoom kho mob.Nws tau teb rau Txoj Cai Lij Choj ntawm Cov Ntaub Ntawv (FOIA) thov tawm tsam FDA hauv kev teb rau pej xeem nthuav tawm ntawm Daim Ntawv 483. Daim Ntawv Tso Cai Biologics Licensing (BLA) rau DaxibotulinumtoxinA rau kev txhaj tshuaj tseem nyob hauv FDA tshuaj xyuas, thiab lub tuam txhab tseem cia siab tias FDA kom pom zoo DaxibotulinumtoxinA rau kev txhaj tshuaj rau kev kho cov kab frown hauv 2021.
Revance tau taw qhia tias nws tsis yog qhov tsis yooj yim rau Daim Ntawv 483 yuav tsum tau muab tawm tom qab kev tshuaj xyuas ntawm qhov chaw.Daim ntawv 483 teev cov kev soj ntsuam los ntawm FDA tus neeg sawv cev thaum lub sijhawm tshuaj xyuas ntawm lub chaw.Daim ntawv 483 tsis yog qhov kev txiav txim siab zaum kawg ntawm lub koomhaum.
Revance tau teb rau Daim Ntawv 483 thaum Lub Xya Hli 2021 tom qab kev tshuaj xyuas ua ntej kev pom zoo thiab tam sim no tseem tos FDA qhov kev txiav txim siab ntawm BLA ntawm DaxibotulinumtoxinA rau kev txhaj tshuaj rau kev kho cov kab glabellar.Lub tuam txhab tseem muaj kev ntseeg siab rau qhov zoo ntawm nws cov ntaub ntawv BLA thiab tseem cia siab tias FDA tau txais kev pom zoo hauv xyoo 2021.
Revance yog lub tuam txhab biotechnology tsom rau cov khoom siv kho kom zoo nkauj thiab kho tshiab, suav nrog nws cov khoom siv neuromodulator tom ntej DaxibotulinumtoxinA rau Txhaj.DaxibotulinumtoxinA rau kev txhaj tshuaj sib xyaw ua ke cov khoom siv ruaj khov peptide thiab cov tshuaj botulinum purified heev yam tsis muaj tib neeg lossis tsiaj txhu.Revance tau ua tiav theem peb ntawm DaxibotulinumtoxinA rau kev txhaj tshuaj intra-brow (frown), thiab tab tom nrhiav kev pom zoo los ntawm US cov koom haum tswj hwm.Revance tseem tab tom ntsuas DaxibotulinumtoxinA rau kev txhaj tshuaj thoob plaws lub ntsej muag, suav nrog cov kab glabellar, kab hauv pliaj, thiab kab laug sab ko taw, nrog rau ob qho kev qhia txog kev kho mob-cervical dystonia thiab cov neeg laus sab sauv qaum spasm.Txhawm rau koom tes nrog DaxibotulinumtoxinA rau kev txhaj tshuaj, Revance muaj cov khoom lag luam zoo tshwj xeeb thiab cov kev pabcuam siv hauv Asmeskas kev coj ua zoo nkauj, suav nrog cov cai faib tshwj xeeb ntawm RHA® dermal filler series hauv Tebchaws Meskas.Qhov no yog thawj zaug thiab tsuas yog ib qho kev pom zoo los ntawm FDA rau siv nyob rau hauv A series ntawm dynamic fillers los kho lub ntsej muag wrinkles thiab folds, thiab OPUL ™ kev sib raug zoo lag luam platform.Revance kuj tau koom tes nrog Viatris (yav tas los Mylan NV) los txhim kho biosimilar ntawm BOTOX®, uas yuav sib tw hauv kev ua lag luam luv luv neuromodulator.Revance tau cog lus los hloov cov xwm txheej quo los ntawm kev hloov cov kev paub ntawm tus neeg mob.Yog xav paub ntxiv lossis koom nrog peb pab neeg, thov mus saib www.revance.com.
Txhua nqe lus hauv tsab ntawv tshaj tawm no uas tsis yog cov lus qhia txog keeb kwm tseeb, suav nrog cov lus hais txog peb lub peev xwm thiab lub sijhawm kom tau txais FDA pom zoo ntawm BLA rau botulinum toxin A rau kev txhaj tshuaj rau kev kho cov kab frown;qhov zoo ntawm peb cov ntaub ntawv BLA Tag nrho ntawm kev ntseeg siab;peb qhov kev xa tawm BLA;FDA soj ntsuam cov txiaj ntsig ntawm lub tuam txhab cov chaw tsim khoom hauv Northern California, thiab cov txiaj ntsig ntawm kev txhim kho BOTOX® biosimilars nrog peb tus khub Viatris;tsim "Private Securities Litigation Reform Act of 1995", "1933 Forward-looking statements in the meaning of Section 27A of the Securities Act of 1934 (raws li hloov kho) thiab Tshooj 21E ntawm Securities Exchange Act of 1934 (raws li hloov kho).Koj yuav tsum tsis txhob cia siab rau cov lus qhia yav tom ntej raws li kev kwv yees ntawm cov xwm txheej yav tom ntej.Txawm hais tias peb ntseeg hais tias qhov kev cia siab uas tau tshwm sim hauv cov lus qhia yav tom ntej yog qhov tsim nyog, peb tsis tuaj yeem lav tias cov txiaj ntsig yav tom ntej, qib kev ua haujlwm, kev ua tau zoo, cov xwm txheej, qhov xwm txheej, lossis kev ua tiav tau tshwm sim hauv cov lus qhia yav tom ntej yuav raug pom lossis tshwm sim.
Cov nqe lus saib mus tom ntej yuav raug kev pheej hmoo thiab tsis paub tseeb, uas yuav ua rau cov txiaj ntsig tiag tiag txawv ntawm peb qhov kev cia siab.Cov kev pheej hmoo thiab kev tsis txaus ntseeg no koom nrog, tab sis tsis txwv rau: cov txiaj ntsig, sijhawm, tus nqi, thiab ua tiav ntawm peb cov haujlwm R&D thiab kev tswj hwm kev pom zoo, suav nrog kev ncua ncua ntawm FDA's BLA kev pom zoo ntawm DaxibotulinumtoxinA rau kev txhaj tshuaj, rau kev kho cov kab glabellar, suav nrog vim yog FDA qhov kev soj ntsuam thaum lub sijhawm tshuaj xyuas ntawm qhov chaw lossis lwm yam laj thawj;COVID-19 kis thoob qhov txhia chaw tau ua rau peb cov lag luam tsim khoom lag luam, cov saw hlau xa khoom, cov neeg siv khoom kawg rau peb cov khoom, kev siv zog ua lag luam, kev ua lag luam, kev sim tshuaj, thiab lwm yam ntawm peb cov lag luam thiab kev lag luam Peb muaj peev xwm tsim cov khoom siv rau peb cov khoom. cov neeg sib tw thiab tau txais cov khoom siv ntawm RHA® dermal filler series;Cov txheej txheem kho mob tsis paub meej;Cov kev sim tshuaj yuav tsis muaj cov qauv tsim los yog tsim cov txiaj ntsig zoo, lossis qhov zoo Cov txiaj ntsig yuav ua kom muaj kev pheej hmoo ntawm kev pom zoo los yog kev lag luam ua tiav;kev siv ntawm kev tshawb fawb soj ntsuam rau cov txiaj ntsig tiag;qhov piv thiab qib ntawm cov txiaj ntsig kev lag luam, kev nyab xeeb, kev ua tau zoo, kev lees paub kev lag luam, thiab OPUL ™, RHA® dermal filler series thiab peb Lub khw, kev sib tw, nplai thiab kev loj hlob ntawm cov khoom sib tw (yog tias pom zoo);peb lub peev xwm los txuas ntxiv ua tiav kev lag luam RHA® dermal muab tub lim series thiab OPUL ™, thiab muaj peev xwm ua tiav kev lag luam DaxibotulinumtoxinA rau kev txhaj tshuaj (yog tias pom zoo), thiab Lub sijhawm thiab tus nqi ntawm kev ua lag luam;peb lub peev xwm los nthuav kev muag khoom thiab kev lag luam;cov xwm txheej ntawm kev koom tes ua lag luam;peb lub peev xwm kom tau txais nyiaj txiag rau peb txoj haujlwm;peb cov nqi thiab kev muaj peev xwm los tiv thaiv peb tus kheej hauv cov khoom lag luam, cov cuab yeej kev txawj ntse thiab lwm yam teeb meem;Peb muaj peev xwm mus txuas ntxiv kom tau txais thiab tswj kev tiv thaiv kev txawj ntse ntawm peb cov neeg sib tw tshuaj;peb cov nyiaj txiag kev ua tau zoo, suav nrog cov nyiaj tau los yav tom ntej, cov nuj nqis thiab cov peev txheej;thiab lwm yam txaus ntshai.Yog xav paub meej txog yam uas yuav ua rau cov txiaj ntsig tiag tiag sib txawv ntawm cov lus hais los yog hais hauv cov lus hauv tsab xov xwm no, thov xa mus rau peb cov ntaub ntawv tsis tu ncua uas tau xa mus rau Tebchaws Meskas Securities thiab Exchange Commission (SEC), suav nrog cov hauv seem npe. "Risk" Cov xwm txheej tau piav qhia hauv "yam" ntawm Daim Ntawv 10-K uas peb tau thov rau SEC thaum Lub Ob Hlis 25, 2021 suav nrog tab sis tsis txwv rau 10th ntawm peb lub hlis twg xaus rau Lub Rau Hli 30, 2021, uas peb tau foob rau SEC Lub Yim Hli 5, 2021. -Q table.Cov lus tshaj tawm yav tom ntej hauv xov xwm tshaj tawm no tsuas yog siv tau txij li hnub tshaj tawm.Peb tsis muaj lub luag haujlwm los hloov kho cov lus hais tom ntej no.
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 tau hais rau hnub Tuesday tias tom qab muaj kev sim siab, nws npaj yuav pib tshawb fawb tseem ceeb ntawm nws cov tshuaj tiv thaiv kab mob cancer.Txawm li cas los xij, CRSP cov khoom lag luam poob rau hauv kev ua haujlwm lig.
Txawm hais tias tom qab Lub Chaw Tswj Xyuas Khoom Noj thiab Tshuaj Khomob ncua kev pom zoo rau lub tuam txhab cov tshuaj tiv thaiv kev txhaj tshuaj, Moderna cov khoom lag luam tau nce rau hnub Tuesday.
Lub lim tiam no yog lwm lub sijhawm muaj peev xwm tso dej rau Moderna Inc.'s Covid-19 cov tshuaj tiv thaiv: Pawg kws tshaj lij tawm tswv yim tseem ceeb ntawm US Food and Drug Administration yuav ntsib los tham txog qhov hu ua "kev txhaj tshuaj txhawb nqa".
Cov duab thaij los ntawm Martin Sanchez ntawm Unsplash Merck & Co (NYSE: MRK) tau tshaj tawm cov txiaj ntsig zoo ntawm nws cov tshuaj tiv thaiv kab mob COVID-19 monupiravir hnub Friday dhau los.Txij li cov tshuaj tiv thaiv yuav tsum tau txhaj tshuaj thib peb, thiab cov neeg tiv thaiv tshuaj tiv thaiv tseem muaj kev pheej hmoo ntawm kev mus pw hauv tsev kho mob, kev tuag, thiab cov tsos mob hnyav ntawm COVID-19, kev saib xyuas ntawm zej zog kev tshawb fawb thiab Wall Street tau tig mus rau COVID-19 txoj kev kho zoo tshaj plaws. txoj kev daws cov kab mob sib kis.Tej zaum yav tom ntej surges.Cov tshuaj tiv thaiv kab mob yog cov neeg sib tw muaj zog tshaj plaws
"Lub Tsev Kawm Ntawv ntawm Kev Paub" muaj lub platform kev kawm txog kev puas hlwb, tso cai rau koj paub txog koj txoj kev noj qab haus huv los ntawm ntau lub ces kaum, thiab kawm paub txog kev mob hlwb txhua lub sijhawm, nyob qhov twg.
Tom qab US Food and Drug Administration (FDA) thiab Lub Chaw Tiv Thaiv Kab Mob thiab Tiv Thaiv (CDC) tau txiav txim siab pom zoo cov tshuaj tiv thaiv kab mob no rau qee cov neeg thaum lub Cuaj Hlis, ntau lab tus neeg tau txais Pfizer tam sim no tau txais kev txhaj tshuaj ntxiv.Txawm li cas los., Moderna thiab Johnson & Johnson cov neeg tau txais txiaj ntsig tau ceeb toom kom ncua kev tshawb nrhiav tshuaj tiv thaiv ntxiv vim tias FDA thiab CDC pawg neeg tawm tswv yim tsis tau tso cai txhawb nqa rau ob qho tshuaj tiv thaiv no.
CureVac tab tom txwv txoj kev txhim kho nws thawj zaug Covid-19 tshuaj tiv thaiv raws li tus xa xov RNA.Cov xov xwm ua rau muaj kev dhia dej hauv cov khoom lag luam.
Ob peb kab mob ua rau muaj kev puas tsuaj ntau npaum li malaria.Hauv 2019, muaj kwv yees li 229 lab tus neeg mob malaria.Lub lim tiam dhau los, Lub Koom Haum Saib Xyuas Kev Noj Qab Haus Huv Ntiaj Teb (WHO) tau pom zoo kom siv cov tshuaj tiv thaiv kab mob malaria thoob plaws hauv cov menyuam yaus.
Thov rau American Express Explorer™ Credit Card ntawm no kom txaus siab rau thawj xyoo tus nqi thiab 3 npaug ntawm cov ntsiab lus tsis pub tsiaj, kev yuav khoom ntse lossis kev them nqi sib txawv rau kev siv nyiaj!
Geoffrey Porges ntawm SVB Leerink tau sau tias cov txiaj ntsig ntawm theem thib ob ntawm kev sim tshuaj tiv thaiv "yog ib qho teeb meem zoo rau theem peb kev sim tom ntej."
Tom qab CDC pom zoo rau Covid booster txhaj rau cov neeg 65 thiab laus dua thiab lwm cov neeg Asmeskas tsis zoo, Pfizer cov khoom lag luam puas tsim nyog yuav?
Sau: Dr. David Bautz Nasdaq: CFRX Nyeem tag nrho CFRX kev tshawb fawb daim ntawv qhia Kev lag luam hloov tshiab Theem 2 sai sai ntawm cov tsos mob hauv kev sim Lub Kaum Hli 4, 2021, ContraFect (NASDAQ: CFRX) tshaj tawm lub tuam txhab exebacase 2 Cov ntaub ntawv tshiab los ntawm Phase 1 Kev sim tshuaj yog nyob rau ntawm IDWeek ™, thiab cov tsos mob ntawm cov neeg mob nrog Staphylococcus aureus bacteremia sai sai thiab nthuav tawm hauv daim ntawv qhia qhov ncauj los ntawm kev cuam tshuam lig
Muab khoom plig thiab khoom plig muab kev pabcuam thiab kev tswj hwm, txawm hais tias nws yog rau cov khoom plig ntawm tuam txhab, kev nce qib lossis lwm yam khoom plig, kuv tuaj yeem pab koj nrog ntau yam khoom plig!Cov khoom tsim, kev tsim khoom, thiab kev tsim khoom tuaj yeem ua rau koj.Nyob rau tib lub sijhawm, ntau tshaj li ib puas lub Hoobkas tau koom tes.Yog koj xav li cas los yog xav li cas no kuv mam xa tuaj rau koj ntxiv!
Tom qab lub tuam txhab thov FDA tso cai rau nws cov tshuaj Covid hauv kev koom tes nrog Ridgeback Biotherapeutics, Merck tus nqi Tshuag tau poob me ntsis rau hnub Monday.
Tom qab lub tuam txhab tshuaj biopharmaceutical German tau hais tias nws yuav tso tseg txoj kev txhim kho ntawm nws tus neeg sib tw tshuaj tiv thaiv COVID-19 thiab hloov siab rau kev koom tes nrog GlaxoSmithKline los tsim kho mRNA thib ob tiam tiv thaiv COVID-19, CureVac tus nqi Tshuag yog nyob rau hauv kev ua lag luam ua ntej hnub Tuesday. Nws poob los ntawm 9.6%.Daim ntawv cog lus yuav khoom uas twb muaj lawm nrog European Commission tsis siv tau lawm.Lawv lub hom phiaj yog coj cov tshuaj tiv thaiv COVID-19 tshiab rau kev ua lag luam hauv xyoo 2022. "Qhov kev txiav txim siab kuj tseem ua raws li kev hloov pauv ntawm kev sib kis.
Qhov teeb meem mob plawv tsis tshua muaj tshwm sim ntawm Moderna tshuaj tiv thaiv tej zaum yuav muaj txiaj ntsig zoo rau Pfizer-tab sis tsuas yog mob me.
Txhim kho koj txoj haujlwm los ntawm kev kawm MBA hloov pauv.Ua kom tiav koj cov kev kawm hauv tsawg kawg 2 xyoos.
Txij li ntau tus neeg Asmeskas tau txhaj tshuaj tiv thaiv los ntawm Pfizer tau dov lawv lub tes tsho los npaj rau kev txhaj tshuaj, ntau lab tus neeg tau txhaj tshuaj tiv thaiv los ntawm Moderna lossis Johnson & Johnson ntxhov siab tos lawv tig.
Raws li National Institute of Aging, NIH Alzheimer ib txwm yog tus kab mob nkag siab tsis zoo, uas ua rau muaj kev nyuaj siab loj los nrhiav kev kho mob.Cov kws tshawb fawb tseem tab tom tshawb nrhiav cov kev xaiv tsis zoo, xws li cov tshuaj qub uas tau muab rau cov xwm txheej sib txawv.Lawv pom ib tus neeg sib tw tshuaj xav tsis thoob hauv daim ntawv ntawm 50-xyoo-laus diuretic.
CureVac NV (NASDAQ: CVAC) shares poob rau hnub Tuesday tom qab lub tuam txhab tshaj tawm tias nws yuav koom tes nrog GlaxoSmithKline txhawm rau tsom nws cov tshuaj tiv thaiv COVID-19 rau kev tsim cov tshuaj tiv thaiv mRNA thib ob.EMA tau thim nws cov tshuaj tiv thaiv thawj zaug thaum lub sijhawm pom zoo.CureVac kwv yees tias qhov kev pom zoo ntxov tshaj plaws ntawm nws cov tshuaj tiv thaiv thawj tiam yuav nyob rau lub quarter thib ob ntawm 2022. Lub sijhawm ntawd, lub tuam txhab cia siab tias cov neeg sib tw rau qhov kev pab cuam txhaj tshuaj thib ob yuav tau txais.
Pab pawg kws tshaj lij hauv online lossis cov kws qhia lub cev, tsim nyog rau txhua tus kws tshaj lij kev tso npe, kev coj noj coj ua dawb ntawm qee lub sijhawm, muaj kev coj noj coj ua txawv teb chaws, Tub Vaj Ntxwv Tuen Mun Yuen Long Tin Shui Wai Sha Tin Cua Chav!
Cov txiaj ntsig ntawm thawj qhov kev sim tshuaj ntawm tus neeg sib tw tshuaj rau kev kho mob ntawm alpha-1 antitrypsin deficiency zoo li txhawb nqa.
Johnson & Johnson tau hais rau hnub Tuesday tias 59-xyoo-laus yuav tawm los ua Tus Lwm Thawj Coj ntawm Pawg Thawj Coj thiab Tus Thawj Saib Xyuas Kev Tshawb Fawb rau lub Kaum Ob Hlis 31. "Raws li kws kho mob thiab kws tshawb fawb, nws zoo heev uas pom tias thaum peb siv cov kev tshawb fawb zoo tshaj plaws. thiab thev naus laus zis los muab cov tshuaj tshiab los daws cov teeb meem kev noj qab haus huv uas nyuaj tshaj plaws hauv ntiaj teb, thaj chaw kho mob tau hloov pauv, "hais tias Dr. Stoffels.Qhov no yog qhov thib ob tus thawj coj loj tshaj tawm los ntawm Johnson & Johnson nyob rau lub asthiv tsis ntev los no.
Tus kws kho mob tau hais txog tus kws tshaj lij ntaus pob ntaus pob ntaus pob ntaus pob ncaws pob Yogi Bella hais tias, hais kom txhua tus kom qeeb hauv kev txhawb nqa kev sib cav sib ceg thiab lwm yam teeb meem tsis tau daws.
Post lub sij hawm: Oct-13-2021