Nashville, Tennessee, Mphalane 12, 2021–(BUSINESS WIRE)–Revance Therapeutics, Inc. (NASDAQ: RVNC) ke khamphani ea biotechnology e shebaneng le boiqapelo ba botle le lihlahisoa tsa kalafo.E ile ea arabela kopo ea Freedom of Information Act (FOIA) khahlanong le FDA ho arabela phatlalatso ea sechaba ea Foromo ea 483. The Biological Licensing Application (BLA) bakeng sa DaxibotulinumtoxinA bakeng sa ente e ntse e le tlas'a tlhahlobo ea FDA, 'me khampani e ntse e tsoela pele ho lebella FDA. ho fana ka tumello ea DaxibotulinumtoxinA bakeng sa ente bakeng sa kalafo ea lifahleho tse sosobaneng ka 2021.
Revance o supile hore ho tloaelehile hore Foromo ea 483 e fanoe ka mor'a tlhahlobo ea setšeng.Foromo ea 483 e thathamisa litebello tse entsoeng ke moemeli oa FDA nakong ea tlhahlobo ea setsi.Foromo ea 483 ha e etse qeto ea ho qetela ea setsi.
Revance e arabile Foromo ea 483 ka Phupu 2021 kamora tlhahlobo ea tumello ea pele mme hajoale e emetse qeto ea FDA mabapi le BLA ea DaxibotulinumtoxinA bakeng sa ente bakeng sa kalafo ea mela ea glabellar.Khamphani e lula e ts'epa boleng ba tlhahiso ea eona ea BLA mme e ntse e lebelletse hore FDA e tla fumana tumello ka 2021.
Revance ke k'hamphani ea biotechnology e shebaneng le lihlahisoa tse ncha tsa botle le kalafo, ho kenyelletsa le sehlahisoa sa eona sa moloko o latelang oa neuromodulator DaxibotulinumtoxinA bakeng sa Ente.DaxibotulinumtoxinA bakeng sa ente e kopanya motsoako oa peptide o tsitsitseng le chefo ea botulinum e hloekisitsoeng haholo ntle le likarolo tsa motho kapa liphoofolo.Revance e phethetse ka katleho karolo ea boraro ea DaxibotulinumtoxinA bakeng sa ente ea ka hare ho sefahleho (ea sefahleho), 'me e batla tumello ho mekhatlo ea taolo ea US.Revance e boetse e hlahloba DaxibotulinumtoxinA bakeng sa liente ho pholletsa le sefahleho se ka holimo, ho kenyelletsa mela ea glabellar, mela ea phatleng, le maoto a lekhoaba, hammoho le lipontšo tse peli tsa phekolo-cervical dystonia le motho e moholo ea holimo ea maoto le matsoho.E le ho sebelisana le DaxibotulinumtoxinA bakeng sa ente, Revance e na le letoto la lihlahisoa tse ikhethang tsa boleng bo phahameng le litšebeletso tse sebelisoang mekhoeng ea botle ba Amerika, ho kenyelletsa le litokelo tse khethehileng tsa kabo ea RHA® dermal filler series United States.Ena ke ea pele ebile e le eona feela e amohetsoeng ke FDA hore e sebelisoe Letotong la li-filler tse matla ho lokisa mats'ope le mameno a sefahleho, le sethala sa khoebo sa OPUL™.Revance e boetse e sebelisane le Viatris (eo pele e neng e le Mylan NV) ho theha biosimilar ea BOTOX®, e tla qothisana lehlokoa le 'maraka o teng oa li-neuromodulator o mokhuts'oane.Revance e ikemiselitse ho fetola maemo a teng ka ho fetola phihlelo ea mokuli.Ho fumana lintlha tse ling kapa ho ikopanya le sehlopha sa rona, ka kopo etela www.revance.com.
Lipolelo leha e le life tokollong ena ea boralitaba tseo e seng liphatlalatso tsa lintlha tsa nalane, ho kenyeletsoa le lipolelo tse amanang le bokhoni ba rona le nako ea ho fumana tumello ea FDA ea BLA bakeng sa chefo ea botulinum A bakeng sa ente bakeng sa ho phekola mela e sosobaneng;boleng ba tlhahiso ea rona ea BLA E tletse kholiseho;boemo ba rona ba tlhahiso ea BLA;Liphetho tsa tlhahlobo ea FDA ea lisebelisoa tsa tlhahiso ea k'hamphani Northern California, le liphetho tsa nts'etsopele ea li-biosimilars tsa BOTOX® le molekane oa rona Viatris;e theha "Private Securities Litigation Reform Act of 1995", "1933 Litlaleho tse shebileng pele ka har'a moelelo oa Karolo ea 27A ea Securities Act ea 1934 (joalokaha e fetotsoe) le Karolo ea 21E ea Securities Exchange Act ea 1934 (joalokaha e fetotsoe).Ha oa lokela ho itšetleha ka lipolelo tse lebeletsoeng pele e le likhakanyo tsa liketsahalo tse tlang.Leha re lumela hore litebello tse bonts'itsoeng liphatlalatsong tse lebeletsoeng pele li utloahala, re ke ke ra tiisa hore liphetho tsa nako e tlang, maemo a ts'ebetso, ts'ebetso, liketsahalo, maemo, kapa likatleho tse bonts'itsoeng liphatlalatsong tsa bokamoso li tla lula li phethahala kapa li etsahala.
Lipolelo tse shebileng pele li ka ba le likotsi le lipelaelo, tse ka etsang hore liphetho tsa 'nete li fapane le litebello tsa rona.Likotsi tsena le lipelaelo li kenyelletsa, empa ha li felle feela ho: liphetho, nako, litšenyehelo, le ho phethoa ha mesebetsi ea rona ea R&D le litumello tsa taolo, ho kenyelletsa le tieho e tsoelang pele ea tumello ea FDA ea BLA ea DaxibotulinumtoxinA bakeng sa ente, bakeng sa kalafo ea mela ea glabellar, ho kenyelletsa ka lebaka la litebello tsa FDA nakong ea tlhahlobo ea sebaka sa marang-rang kapa mabaka a mang;seoa sa COVID-19 se kentse khoebo ea rona ea tlhahiso, phepelo ea thepa, tlhokahalo ea basebelisi ba lihlahisoa tsa rona, boiteko ba khoebo, ts'ebetso ea khoebo, liteko tsa bongaka, le likarolo tse ling tsa khoebo ea rona le mmaraka Re na le bokhoni ba ho etsa thepa bakeng sa sehlahisoa sa rona. bakhethoa le ho fumana lisebelisoa tsa RHA® dermal filler series;mokhoa o sa tsitsang oa tsoelo-pele ea kliniki;liteko tsa meriana li ka 'na tsa se ke tsa e-ba le liqapi tse sebetsang hantle kapa tsa hlahisa liphello tse ntle, kapa tse ntle Liphetho li tla netefatsa kotsi ea tumello ea taolo kapa katleho ea khoebo;ho sebetsa ha liphetho tsa lipatlisiso tsa bongaka ho liphetho tsa sebele;karo-karolelano le tekanyo ea melemo ea moruo, polokeho, katleho, kamohelo ea khoebo, le OPUL™, RHA® dermal filler series le rona The market, competition, scale and growth potential of the candidates product (haeba e amohetsoe);bokhoni ba rona ba ho tsoela pele ho rekisa ka katleho letoto la RHA® dermal filler le OPUL™, le bokhoni ba ho rekisa ka katleho DaxibotulinumtoxinA bakeng sa ente (haeba e amohelehile), le Nako le litšenyehelo tsa mesebetsi ea khoebo;bokhoni ba rona ba ho atolosa thekiso le bokhoni ba ho bapatsa;boemo ba tšebelisano ea khoebo;bokhoni ba rona ba ho fumana chelete bakeng sa ts'ebetso ea rona;litšenyehelo tsa rona le bokhoni ba ho itšireletsa melatong ea lihlahisoa, thepa ea bohlale le tse ling tse ling;Re na le bokhoni ba ho tsoela pele ho fumana le ho boloka ts'ireletso ea thepa ea bohlale ea batho ba rona ba sebelisang lithethefatsi;tshebetso ya rona ya ditjhelete, ho kenyeletswa lekeno la kamoso, ditshenyehelo le ditlhoko tsa capital;le likotsi tse ling.Bakeng sa lintlha tse mabapi le lintlha tse ka etsang hore liphetho tsa 'nete li fapane le tse boletsoeng kapa tse boletsoeng polelong ena ea boralitaba, ka kopo sheba litokomane tsa rona tse tloaelehileng tse kentsoeng ho United States Securities and Exchange Commission (SEC), ho kenyeletsoa le tse karolong e bitsoang. "Kotsi" Lintlha tse hlalositsoeng ho "mabaka" a Foromo ea 10-K tseo re li kentseng ho SEC ka la 25 Hlakola, 2021 li kenyelletsa empa ha li felle feela ho la 10 la kotara e felileng ka la 30 Phuptjane 2021, eo re e fileng SEC. ka Phato 5, 2021. -Q tafole.Lipolelo tse lebeletsoeng pele tokollong ena ea boralitaba li sebetsa feela ho tloha ka letsatsi la phatlalatso.Ha re na boitlamo leha e le bofe ba ho ntlafatsa lipolelo tsena tse lebeletsoeng pele.
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 o boletse ka Labobeli hore kamora ho ts'episa liteko, e rera ho qala lipatlisiso tsa bohlokoa ka lithethefatsi tsa eona tse thibelang mofetše.Leha ho le joalo, setoko sa CRSP se theohile ketsong ea morao.
Le kamora hore Tsamaiso ea Lijo le Lithethefatsi e liehe ho khothaletsa tekanyo ea matla ea k'hamphani ea liente tsa Covid, setoko sa Moderna se ile sa phahama ka Labobeli.
Bekeng ena e tšoaea nako e 'ngoe e ka bang teng bakeng sa ente ea Moderna Inc.'s Covid-19: komiti ea bohlokoa ea likeletso ea US Food and Drug Administration e tla kopana ho buisana ka seo ho thoeng ke "boost injection".
Setšoantšo se nkiloeng ke Martin Sanchez ho Unsplash Merck & Co (NYSE: MRK) e phatlalalitse liphetho tse khahlang tsa moriana oa eona oa antiviral oa COVID-19 monupiravir Labohlano le fetileng.Kaha ente e hloka ente ea boraro e matlafatsang, mme batho ba hananang le ente ba ntse ba le kotsing ea ho kena sepetlele, lefu le matšoao a matla a COVID-19, tlhokomelo ea sechaba sa mahlale le Wall Street e fetohile kalafo ea COVID-19 e le eona e molemo ka ho fetisisa. mokhoa oa ho sebetsana le mafu a tšoaetsanoang.Bokamoso bo ntse bo eketseha.Lithethefatsi tse thibelang kokoana-hloko ke bahlolisani ba matla ka ho fetisisa
"Sekolo sa Tsebo" se na le sethala sa thuto ea bophelo bo botle ba kelello, se u lumellang hore u lemohe bophelo bo botle ba hau ho tsoa mahlakoreng a mangata, 'me u ithute tsebo ea bophelo bo botle ba kelello neng kapa neng, kae kapa kae.
Kamora hore US Food and Drug Administration (FDA) le Centers for Disease Control and Prevention (CDC) li nke qeto ea ho amohela litekanyetso tse matlafatsang tsa ente ena bakeng sa batho ba itseng mafelong a Loetse, limilione tsa baamoheli ba Pfizer joale ba fumana liente tse ling.Leha ho le joalo., Baamoheli ba Moderna le Johnson & Johnson ba lemositsoe ho lieha ho batla liente tse ling hobane likomiti tsa boeletsi tsa FDA le CDC ha li so ka li fana ka tumello bakeng sa e 'ngoe ea liente tsena tse peli.
CureVac e emisa nts'etsopele ea ente ea eona ea pele ea Covid-19 e thehiloeng ho lenģosa la RNA.Litaba tsena li ile tsa etsa hore ho be le ho tetebela ka har'a setoko.
Ke mafu a fokolang a bakang tšenyo e khōlō joaloka malaria.Ka 2019, ho bile le linyeoe tse hakanyetsoang ho limilione tse 229 tsa malaria.Bekeng e fetileng, Mokhatlo oa Lefatše oa Bophelo (WHO) o khothalelitse tšebeliso e pharalletseng ea liente tsa malaria baneng.
Etsa kopo ea Karete ea Mokoloto ea American Express Explorer™ mona hore u natefeloe ke tefiso ea selemo sa pele le makhetlo a 3 ho feta a se nang liphoofolo tsa lapeng, ho reka ka bohlale kapa ho fokotsa meputso e fapaneng ea ho sebelisa chelete!
Geoffrey Porges oa SVB Leerink o ngotse hore liphetho tsa mohato oa bobeli oa teko ea ente "ke sesupo se nepahetseng bakeng sa teko e tlang ea mohato oa boraro."
Kamora hore CDC e khothaletse liente tsa Covid booster ho batho ba lilemo tse 65 ho ea holimo le Maamerika a mang a sotlehileng, na setoko sa Pfizer se loketse ho rekoa?
Mongoli: Dr. David Bautz Nasdaq: CFRX Bala tlaleho e feletseng ea lipatlisiso tsa CFRX Ntlafatso ea khoebo Mohato oa 2 oa tharollo e potlakileng ea matšoao nyeoeng Ka la 4 Mphalane 2021, ContraFect (NASDAQ: CFRX) e phatlalalitse exebacase ea 2 ea k'hamphani Lintlha tse ncha tse tsoang Karolong ea 1 teko ea tleliniki e ho IDWeek™, 'me matšoao a bakuli ba Staphylococcus aureus bacteremia a kokobela kapele' me a hlahisoa ka mokhoa oa tlaleho ea molomo ho tsoa ho moferefere oa morao-rao.
Fana ka limpho le litšebeletso tsa phepelo le tsamaiso ea limpho, ekaba limpho tsa khoebo, phahamiso kapa limpho tse ling tsa theko, nka u thusa ka limpho tse ling!Moralo oa sehlahisoa, tlhahiso, le tlhahiso li ka etsoa molemong oa hau.Ka nako e tšoanang, lifeme tse fetang lekholo li sebelisane.Haeba u nahana ka eona kapa u nahana ka eona, ke tla u romella tse ling hape!
Kamora hore k'hamphani e kope FDA hore e lumelle pilisi ea eona ea Covid ka ts'ebelisano le Ridgeback Biotherapeutics, theko ea setoko sa Merck e ile ea theoha hanyane ka Mantaha.
Kamora hore k'hamphani ea Jeremane ea biopharmaceutical e bolele hore e tla tlohela nts'etsopele ea ente ea eona ea ente ea COVID-19 mme e shebane le tšebelisano 'moho le GlaxoSmithKline ho theha ente ea moloko oa bobeli oa mRNA khahlano le COVID-19, theko ea setoko ea CureVac e ne e le khoebong ea pele ho mmaraka ka Labobeli. E theohile ka 9.6%.Tumellano e teng ea ho reka le Komisi ea Europe ha e sa sebetsa.Sepheo sa bona ke ho tlisa ente e ncha ea COVID-19 'marakeng ka 2022. "Qeto e boetse e lumellana le maemo a fetohang a seoa sena
Bothata bo sa tloaelehang ba ho ruruha ha pelo ea ente ea Moderna bo ka ba molemo ho Pfizer-empa ka bonolo feela.
Ntlafatsa mosebetsi oa hau ka ho ithuta MBA e tenyetsehang.Qetella lithuto tsa hau bonyane ka lilemo tse 2.
Kaha Maamerika a mangata a entoa ke Pfizer a phuthile matsoho ho itokisetsa liente tsa booster, ba bang ba limilione ba entoa ke Moderna kapa Johnson & Johnson ba emetse nako ea bona ka tjantjello.
Ho ea ka Setsi sa Sechaba sa Botsofali, NIH Alzheimer esale e le lefu le sa utloisisoeng hantle, le bakang phephetso e kholo ea ho fumana liphekolo tse ka khonehang.Bo-rasaense ba ntse ba hlahloba mekhoa e sa tloaelehang, joalo ka meriana ea khale e behiloeng bakeng sa maemo a fapaneng haholo.Ba ile ba fumana mokhethoa ea makatsang oa lithethefatsi ka sebopeho sa diuretic ea lilemo tse 50.
Likabelo tsa CureVac NV (NASDAQ: CVAC) li theohile ka Labobeli kamora hore k'hamphani e phatlalatse hore e tla sebelisana le GlaxoSmithKline ho tsepamisa mohopolo oa eona oa ente ea COVID-19 ho nts'etsopele ea bakuli ba ente ea mRNA ea moloko oa bobeli.EMA e ile ea hula ente ea eona ea moloko oa pele nakong ea ts'ebetso ea tumello.CureVac e hakanya hore tumello ea pele e ka bang teng ea ente ea eona ea moloko oa pele e tla ba karolong ea bobeli ea 2022. Ka nako eo, k'hamphani e lebelletse hore bakhethoa ba lenaneo la ente ea moloko oa bobeli ba tla fumana.
Sehlopha sa matichere a marang-rang kapa sa 'mele, se loketseng ho ngolisoa ha litsebi, mesebetsi ea setso ea mahala nako le nako, se na le litloaelo tse fapaneng tsa naha, Prince Tuen Mun Yuen Long Tin Shui Wai Sha Tin Wind Class!
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Johnson & Johnson ba boletse ka Labobeli hore motho ea lilemo li 59 o tla theoha e le Motlatsi oa Motlatsi oa Komiti ea Phethahatso le Ofisiri e Moholo ea Saense ka la 31 Tšitoe. le thekenoloji ho fana ka meriana e ncha ho rarolla liphephetso tse thata ka ho fetisisa tsa bophelo bo botle lefatšeng, lefapha la tlhokomelo ea bophelo le fetohile,” ho boletse Dr. Stoffels.Lena ke leeto la bobeli la batsamaisi ba phahameng le senotsoeng ke Johnson & Johnson libekeng tse sa tsoa feta.
Ngaka e ’ngoe e ile ea qotsa rafilosofi oa tšōmong oa baseball Yogi Bella a re, a khothalletsa bohle hore ba khoehlise khang e matlafatsang ea ho betha le litaba tse ling tse e-s’o rarolloe.
Nako ea poso: Oct-13-2021