Nashville, Tennessee, Oktoba 12, 2021–(WIRE KASUWANCI)–Revance Therapeutics, Inc. (NASDAQ: RVNC) kamfani ne na fasahar kere-kere da ke mai da hankali kan sabbin kayan kwalliya da samfuran warkewa.Ya amsa buƙatun Dokar 'Yancin Bayanai (FOIA) akan FDA don amsawa ga bayyanar da jama'a na Form 483. Aikace-aikacen Lasisi na Biologics (BLA) don DaxibotulinumtoxinA don allura har yanzu yana ƙarƙashin nazarin FDA, kuma kamfanin ya ci gaba da tsammanin FDA. don amincewa DaxibotulinumtoxinA don allura don kula da layukan daure fuska a cikin 2021.
Revance ya nuna cewa ba sabon abu ba ne don fitar da Form 483 bayan an duba wurin.Form 483 ya lissafa abubuwan lura da wakilin FDA ya yi yayin binciken kayan aikin.Form 483 ba ya zama yanke shawara na ƙarshe na hukuma.
Revance ya amsa Form 483 a cikin Yuli 2021 bayan an riga an duba amincewa kuma a halin yanzu yana jiran shawarar FDA akan BLA na DaxibotulinumtoxinA don allura don kula da layin glabellar.Kamfanin ya kasance da kwarin gwiwa kan ingancin gabatar da BLA ɗin sa kuma yana ci gaba da tsammanin FDA za ta sami amincewa a cikin 2021.
Revance kamfani ne na fasahar kere-kere da ke mai da hankali kan sabbin kayan kwalliya da kayan warkewa, gami da samfurin neuromodulator na gaba DaxibotulinumtoxinA don allura.DaxibotulinumtoxinA don allura yana haɗo madaidaicin peptide excipient da kuma tsabtace botulinum mai tsafta ba tare da abubuwan ɗan adam ko na dabba ba.Revance ya yi nasarar kammala kashi na uku na DaxibotulinumtoxinA don allurar ciki (fuska), kuma yana neman izini daga hukumomin Amurka.Har ila yau, Revance yana kimanta DaxibotulinumtoxinA don allurai a fadin fuskar sama, gami da layin glabellar, layin goshi, da ƙafafun hankaka, da kuma alamun warkewa guda biyu- dystonia na mahaifa da kuma spasm babba na babba.Domin yin aiki tare da DaxibotulinumtoxinA don allura, Revance yana da jerin samfuran samfura da sabis masu inganci na musamman da aka yi amfani da su a aikin kyawun Amurka, gami da keɓantaccen haƙƙin rarrabawa na RHA® dermal filler series a cikin Amurka.Wannan shi ne na farko kuma kawai wanda FDA ta amince da shi don amfani da shi a cikin jerin sauye-sauye masu ƙarfi don gyara wrinkles da folds na fuska, da dandalin kasuwanci na dangantakar OPUL™.Har ila yau, Revance ya yi haɗin gwiwa tare da Viatris (tsohon Mylan NV) don haɓaka wani nau'in halitta na BOTOX®, wanda zai yi gasa a cikin kasuwar neuromodulator mai gajeren lokaci.Revance ya himmatu don canza halin da ake ciki ta hanyar canza ƙwarewar haƙuri.Don ƙarin bayani ko don shiga ƙungiyarmu, da fatan za a ziyarci www.revance.com.
Duk wani bayani a cikin wannan sakin labaran da ba bayanan bayanan tarihi ba, gami da maganganun da suka danganci iyawarmu da lokacinmu don samun amincewar FDA na BLA don toxin botulinum A don allura don kula da layukan murƙushe;ingancin gabatar da BLA ɗin mu Cike da tabbaci;Matsayin ƙaddamarwar mu na BLA;Sakamakon binciken FDA na masana'antar masana'anta a Arewacin California, da sakamakon haɓakar BOTOX® biosimilars tare da abokin aikinmu Viatris;ya ƙunshi "Dokar Gyara Shari'a ta Masu Zaman Kansu na 1995", "1933 Maganganun gaba-gaba a cikin ma'anar Sashe na 27A na Dokar Tsaro na 1934 (kamar yadda aka gyara) da Sashe na 21E na Dokar Canjin Tsaro na 1934 (kamar yadda aka gyara).Kada ku dogara ga maganganun sa ido a matsayin hasashen abubuwan da zasu faru nan gaba.Ko da yake mun yi imanin cewa tsammanin da aka nuna a cikin maganganun sa ido na gaba yana da ma'ana, ba za mu iya ba da tabbacin cewa sakamakon gaba, matakan aiki, aiki, abubuwan da suka faru, yanayi, ko nasarorin da aka nuna a cikin maganganun da ake sa ran za su kasance ko da yaushe a tabbata ko faruwa.
Maganganun neman gaba suna cikin haɗari da rashin tabbas, wanda zai iya haifar da sakamako na gaske ya bambanta da abin da muke tsammani.Waɗannan hatsarori da rashin tabbas sun haɗa da, amma ba'a iyakance ga: sakamakon, lokaci, farashi, da kuma kammala ayyukan R&D da kuma yarda da ka'idoji, gami da ci gaba da jinkiri a cikin amincewar BLA na FDA na DaxibotulinumtoxinA don allura, don kula da layin glabellar, ciki har da saboda abubuwan lura na FDA yayin binciken kan-site ko wasu dalilai;Cutar ta COVID-19 ta sanya kasuwancinmu na masana'antu, sarkar samar da kayayyaki, buƙatun masu amfani na ƙarshe don samfuranmu, yunƙurin kasuwanci, ayyukan kasuwanci, gwajin asibiti, da sauran fannonin kasuwancinmu da kasuwarmu Muna da ikon kera kayayyaki don samfuranmu. 'yan takara da samun kayayyaki na RHA® dermal filler jerin;rashin tabbas tsarin ci gaban asibiti;gwaje-gwaje na asibiti bazai da ƙira masu tasiri ko samar da sakamako mai kyau, ko tabbatacce Sakamakon zai tabbatar da hadarin amincewar tsari ko nasarar kasuwanci;dacewar sakamakon binciken asibiti zuwa sakamakon ainihin;rabo da digiri na fa'idodin tattalin arziƙi, aminci, inganci, karɓar kasuwanci, da OPUL ™, RHA® dermal filler jerin da kasuwarmu, gasa, sikelin da yuwuwar haɓaka samfurin ɗan takarar (idan an yarda);ikonmu na ci gaba da samun nasarar tallata jerin abubuwan filler na RHA® da OPUL ™, da ikon samun nasarar kasuwancin DaxibotulinumtoxinA don allura (idan an yarda), da lokaci da farashin ayyukan tallace-tallace;iyawarmu don faɗaɗa iyawar tallace-tallace da tallace-tallace;matsayin haɗin gwiwar kasuwanci;ikonmu na samun kuɗi don ayyukanmu;farashin mu da ikon kare kanmu a cikin abin alhaki na samfur, dukiyar ilimi da sauran ƙararraki;Muna da ikon ci gaba da samun da kiyaye kariyar kariyar ƴan takarar mu na muggan ƙwayoyi;ayyukanmu na kuɗi, gami da samun kudin shiga na gaba, kashe kuɗi da buƙatun babban birnin;da sauran kasada.Don cikakkun bayanai kan abubuwan da za su iya haifar da sakamako na gaske ya bambanta da waɗanda aka bayyana ko aka fayyace a cikin maganganun da ke cikin wannan sakin jarida, da fatan za a duba takaddun mu na yau da kullun da aka shigar da Hukumar Tsaro da Musanya ta Amurka (SEC), gami da waɗanda ke cikin sashin mai take. "Haɗari" Abubuwan da aka bayyana a cikin "al'amuran" akan Form 10-K waɗanda muka shigar da su tare da SEC a ranar 25 ga Fabrairu, 2021 sun haɗa da amma ba'a iyakance ga 10th na kwata ya ƙare Yuni 30, 2021, wanda muka shigar da SEC a kan Agusta 5, 2021. -Q tebur.Maganganun sa ido a cikin wannan sanarwar manema labarai suna aiki ne kawai daga ranar da aka buga.Ba mu dau nauyin sabunta waɗannan kalamai masu zuwa.
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 ya fada a ranar Talata cewa, bayan da aka yi alkawalin gwaje-gwaje, tana shirin fara bincike mai mahimmanci kan magungunan cutar kansa.Koyaya, hannun jari na CRSP ya faɗi a ƙarshen aiki.
Ko da bayan da Hukumar Abinci da Magunguna ta jinkirta ba da shawarar yawan karuwar kamfanin na allurar Covid, hannun jarin Moderna ya tashi a ranar Talata.
Wannan makon ya nuna wani lokacin da za a iya zubar da ruwa don rigakafin Moderna Inc.'s Covid-19: wani muhimmin kwamiti mai ba da shawara na Hukumar Abinci da Magunguna ta Amurka zai hadu don tattauna abin da ake kira "alurar haɓaka".
Hoton da Martin Sanchez ya ɗauka akan Unsplash Merck & Co (NYSE: MRK) ya sanar da sakamako mai ban sha'awa na COVID-19 maganin rigakafi na kwayar cutar monupiravir a ranar Juma'ar da ta gabata.Tunda maganin yana buƙatar allura mai ƙarfafawa na uku, kuma masu jure allurar har yanzu suna cikin haɗarin asibiti, mutuwa, da alamun alamun COVID-19, hankalin masana kimiyya da Wall Street ya koma ga COVID-19 far a matsayin mafi kyau. hanyar magance cututtuka masu tasowa.Abubuwan da za su iya faruwa a nan gaba.Magungunan rigakafi sune mafi ƙarfi masu fafatawa
"Makarantar Ilimi" tana da dandamalin koyo game da lafiyar hankali, yana ba ku damar gane lafiyar ku ta kusurwoyi da yawa, kuma ku koyi ilimin lafiyar hankali kowane lokaci, ko'ina.
Bayan Hukumar Abinci da Magunguna ta Amurka (FDA) da Cibiyar Kula da Cututtuka da Cututtuka (CDC) sun yanke shawarar amincewa da ƙarin allurai na wannan rigakafin ga wasu al'umma a ƙarshen Satumba, miliyoyin masu karɓar Pfizer yanzu suna karɓar ƙarin allurai.Duk da haka., An gargadi masu karɓar Moderna da Johnson & Johnson da su jinkirta neman ƙarin alluran rigakafin saboda FDA da kwamitocin shawarwari na CDC ba su ba da izini ga masu haɓakawa ga ɗayan waɗannan alluran guda biyu ba.
CureVac yana dakatar da haɓakar rigakafin farko na Covid-19 dangane da manzo RNA.Labarin ya jawo nutsewa cikin hannun jari.
Cututtuka kadan ne ke haifar da illa kamar zazzabin cizon sauro.A cikin 2019, an yi kiyasin mutane miliyan 229 na zazzabin cizon sauro.A makon da ya gabata ne Hukumar Lafiya ta Duniya (WHO) ta ba da shawarar yawaita amfani da allurar rigakafin zazzabin cizon sauro ga yara.
Nemi Katin Kiredit na American Express Explorer™ anan don jin daɗin kuɗin shekara ta farko da maki 3 marasa kyauta, siyayya mai kaifin baki ko daidaita lada daban-daban don ciyarwa!
Geoffrey Porges na SVB Leerink ya rubuta cewa sakamakon kashi na biyu na gwajin rigakafin "wani alama ce mai kyau ga gwaji na uku mai zuwa."
Bayan CDC ta ba da shawarar allurar haɓakar Covid ga mutane 65 zuwa sama da sauran Amurkawa marasa galihu, shin hannun jari na Pfizer ya cancanci siye?
Mawallafi: Dr. David Bautz Nasdaq: CFRX Karanta cikakken rahoton bincike na CFRX Sabunta kasuwanci Mataki na 2 saurin ƙuduri na bayyanar cututtuka a cikin gwaji A ranar 4 ga Oktoba, 2021, ContraFect (NASDAQ: CFRX) ya sanar da exebacase na kamfanin 2 Sabon bayanai daga Mataki na 1 gwaji na asibiti yana kan IDWeek™, kuma alamun marasa lafiya da Staphylococcus aureus bacteremia suna raguwa da sauri kuma ana gabatar da su ta hanyar rahoton baka daga mai ɓarna.
Bayar da kyaututtuka da kyaututtuka wadata da sabis na gudanarwa, ko don kyaututtukan kamfanoni ne, haɓakawa ko wasu kyaututtukan sayayya, Zan iya taimaka muku da ƙarin kyaututtuka!Za a iya yi muku ƙirar ƙira, ƙira, da samarwa.A sa'i daya kuma, sama da masana'antu dari sun ba da hadin kai.Idan kayi tunani ko kayi tunani akai, zan kara turo maka!
Bayan kamfanin ya nemi FDA da ta ba da izinin kwayar cutar ta Covid tare da haɗin gwiwar Ridgeback Biotherapeutics, farashin hannun jari na Merck ya faɗi kaɗan a ranar Litinin.
Bayan da kamfanin sarrafa magunguna na Jamus ya bayyana cewa zai yi watsi da ci gaban ɗan takararsa na rigakafin COVID-19 kuma a maimakon haka zai mai da hankali kan yin haɗin gwiwa tare da GlaxoSmithKline don haɓaka allurar mRNA ta ƙarni na biyu akan COVID-19, farashin hannun jari na CureVac yana cikin ciniki kafin kasuwa ranar Talata. Ya fadi da kashi 9.6%.Yarjejeniyar siyan da ke akwai tare da Hukumar Turai ba ta da inganci.Manufar su ita ce su kawo sabon rigakafin COVID-19 a kasuwa a cikin 2022. "Shawarar kuma ta yi daidai da yanayin ci gaban cutar.
Matsalar kumburin zuciya da ba kasafai ake yin maganin rigakafin Moderna na iya zama da amfani ga Pfizer-amma kawai a hankali.
Inganta aikin ku ta hanyar nazarin MBA mai sassauƙa.Kammala karatun ku a cikin akalla shekaru 2.
Tun da yawancin Amurkawa da Pfizer suka yi wa alurar riga kafi sun naɗe hannayensu don yin shirye-shiryen yin alluran ƙara kuzari, miliyoyin wasu da Moderna ko Johnson & Johnson suka yi wa allurar cikin damuwa suna jiran lokacinsu.
A cewar Cibiyar Nazarin tsufa ta ƙasa, NIH Alzheimer koyaushe ya kasance cutar da ba a fahimta sosai ba, wanda ke haifar da babban ƙalubale ga gano hanyoyin da za a iya amfani da su.Masana kimiyya har ma suna bincika zaɓuɓɓukan da ba su dace ba, kamar tsoffin magungunan da aka rubuta don yanayi daban-daban.Sun sami ɗan takarar magani mai ban mamaki a cikin nau'in diuretic mai shekaru 50.
Hannun jarin CureVac NV (NASDAQ: CVAC) sun fadi ranar Talata bayan kamfanin ya sanar da cewa zai hada kai da GlaxoSmithKline don mai da hankali kan ci gaban rigakafin COVID-19 kan ci gaban masu neman rigakafin mRNA na ƙarni na biyu.EMA ta janye maganin rigakafinta na ƙarni na farko yayin aiwatar da amincewa.CureVac ya yi kiyasin cewa farkon yiwuwar amincewar rigakafin ta na ƙarni na farko zai kasance a cikin kwata na biyu na 2022. A lokacin, kamfanin yana tsammanin cewa masu neman shirin rigakafin na ƙarni na biyu za su karɓi.
Ƙwararrun malamai na kan layi ko ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun ƙwararrun masu sana'a, ayyukan al'adu kyauta lokaci zuwa lokaci, ƙwarewar al'adun ƙasa daban-daban, Prince Tuen Mun Yuen Long Tin Shui Wai Sha Tin Wind Class!
Sakamakon gwaji na farko na asibiti na ɗan takarar magani don maganin rashi na alpha-1 antitrypsin yana da ban ƙarfafa sosai.
Johnson & Johnson ya fada a ranar Talata cewa dan shekaru 59 zai sauka daga mukamin mataimakin shugaban kwamitin zartarwa kuma babban jami'in kimiyya a ranar 31 ga Disamba. "A matsayin likita kuma masanin kimiyya, yana da kyau mu ga cewa yayin da muke amfani da mafi kyawun kimiyya. da fasaha don samar da sabbin magunguna don magance matsalolin kiwon lafiya mafi tsanani a duniya, fannin kiwon lafiya ya canza," in ji Dokta Stoffels.Wannan ita ce tashin manyan jami'an gudanarwa na biyu da Johnson & Johnson ya bayyana a cikin 'yan makonnin nan.
Wani likita ya ambato fitaccen masanin falsafar wasan baseball Yogi Bella yana cewa, yana mai kira ga kowa da kowa da ya rage gudu a cikin muhawarar batting da sauran batutuwan da ba a warware su ba.
Lokacin aikawa: Oktoba-13-2021