Nashville, Tennessee, ʻOkakopa 12, 2021–(BUSINESS WIRE)–Revance Therapeutics, Inc. (NASDAQ: RVNC) he hui biotechnology i kālele ʻia i nā aesthetics hou a me nā huahana therapeutic.Ua pane ʻo ia i kahi noi Freedom of Information Act (FOIA) e kūʻē i ka FDA no ka pane ʻana i ka hōʻike ʻana i ka lehulehu o ka Pepa 483. ʻO ka Biologics Licensing Application (BLA) no DaxibotulinumtoxinA no ka injection aia ma lalo o ka loiloi FDA, a ke hoʻomau nei ka hui i ka FDA. e ʻae iā DaxibotulinumtoxinA no ka inikia no ka mālama ʻana i nā laina frown i 2021.
Hōʻike ʻo Revance he mea maʻamau ka puka ʻana o ka Pepa 483 ma hope o ka nānā ʻana ma ka pūnaewele.Papa helu 483 i nā ʻike i hana ʻia e ka ʻelele FDA i ka wā o ka nānā ʻana i ka hale.ʻAʻole ʻo Pepa 483 kahi hoʻoholo hope loa.
Ua pane ʻo Revance i ka Pepa 483 i Iulai 2021 ma hope o ka nānā ʻana ma mua o ka ʻae ʻia a ke kali nei ʻo ia i ka hoʻoholo a ka FDA ma ka BLA o DaxibotulinumtoxinA no ka injection no ka mālama ʻana i nā laina glabellar.Ke hilinaʻi mau nei ka ʻoihana i ka maikaʻi o kāna mau palapala BLA a ke hoʻomau nei ka manaʻo e loaʻa ka FDA i ka ʻae ʻia ma 2021.
ʻO Revance kahi hui biotechnology i kālele ʻia i nā huahana aesthetic a me ka therapeutic hou, me kāna huahana neuromodulator e hiki mai ana ʻo DaxibotulinumtoxinA no ka Injection.Hoʻohui ʻo DaxibotulinumtoxinA no ka injection i kahi peptide excipient i hoʻopaʻa ʻia a hoʻomaʻemaʻe loa i ka botulinum toxin me ka ʻole o nā mea kanaka a holoholona.Ua hoʻopau maikaʻi ʻo Revance i ke kolu o ka hana ʻo DaxibotulinumtoxinA no ka hoʻokele intra-brow (frown), a ke ʻimi nei i ka ʻae ʻia mai nā ʻoihana hoʻoponopono US.Ke loiloi pū nei ʻo Revance iā DaxibotulinumtoxinA no nā injections ma ka ʻaoʻao o luna, me nā laina glabellar, nā laina lae, a me nā wāwae o ka crow, a me ʻelua mau hōʻailona therapeutic-cervical dystonia a me ka spasm o nā lālā o luna.I mea e hui pū ai me DaxibotulinumtoxinA no ka injection, loaʻa iā Revance kahi ʻano o nā huahana kiʻekiʻe kiʻekiʻe a me nā lawelawe i hoʻohana ʻia i ka hoʻomaʻamaʻa nani ʻAmelika, e komo pū ana me nā kuleana hāʻawi kūʻokoʻa o RHA® dermal filler series ma United States.ʻO kēia ka mea mua a hoʻokahi wale nō i ʻae ʻia e ka FDA no ka hoʻohana ʻana i kahi pūʻulu o nā mea hoʻopihapiha hoʻopihapiha e hoʻoponopono ai i nā wrinkles a me nā pelu, a me ka paepae pāʻoihana pili OPUL™.Ua hui pū ʻo Revance me Viatris (ʻo Mylan NV ma mua) e hoʻomohala i kahi biosimilar o BOTOX®, e hoʻokūkū i ka mākeke neuromodulator pōkole.Hoʻopaʻa ʻia ʻo Revance e hoʻololi i ke kūlana quo ma o ka hoʻololi ʻana i ka ʻike maʻi.No ka ʻike hou aku a i ʻole e hui pū me kā mākou hui, e ʻoluʻolu e kipa www.revance.com.
ʻO nā ʻōlelo i loko o kēia hoʻolaha paʻi ʻaʻole ia he mau ʻōlelo o nā ʻike mōʻaukala, me nā ʻōlelo e pili ana i ko mākou hiki a me ka manawa e loaʻa ai ka FDA apono ʻia o ka BLA no ka botulinum toxin A no ka injection no ka mālama ʻana i nā laina frown;ka maikaʻi o kā mākou mau palapala BLA piha i ka hilinaʻi;ko mākou kūlana hoʻouna BLA;Nā hualoaʻa nānā FDA o nā hale hana o ka hui ma Northern California, a me nā hopena o ka hoʻomohala ʻana i nā biosimilars BOTOX® me kā mākou hoa Viatris;ʻO ia ka “Private Securities Litigation Reform Act of 1995″, “1933 Forward-looking statements in the meaning of Section 27A of the Securities Act of 1934 (like amended) and Section 21E of the Securities Exchange Act of 1934 (e like me ka hoololi).ʻAʻole pono ʻoe e hilinaʻi i nā ʻōlelo i mua e like me nā wānana o nā hanana e hiki mai ana.ʻOiai ke manaʻoʻiʻo nei mākou he kūpono nā manaʻo i hōʻike ʻia ma nā ʻōlelo i mua, ʻaʻole hiki iā mākou ke hōʻoiaʻiʻo e ʻike mau ʻia nā hopena o ka wā e hiki mai ana, nā pae hana, ka hana, nā hanana, nā kūlana, a i ʻole nā hoʻokō i hōʻike ʻia i nā ʻōlelo i mua.
Aia nā ʻōlelo i mua i nā pilikia a me ka maopopo ʻole, hiki ke hoʻololi i nā hopena maoli mai kā mākou mau manaʻo.ʻO kēia mau pilikia a me ka maopopo ʻole e pili ana, akā ʻaʻole i kaupalena ʻia i: nā hopena, ka manawa, ke kumu kūʻai, a me ka hoʻopau ʻana o kā mākou mau hana R&D a me nā ʻae hoʻoponopono, me ka hoʻomau mau ʻana i ka ʻae ʻana o ka FDA o ka BLA o DaxibotulinumtoxinA no ka inikia, no ka mālama ʻana i nā laina glabellar, e like me ka nānā ʻana o FDA i ka wā o ka nānā ʻana ma ka pūnaewele a i ʻole nā kumu ʻē aʻe;ua kau ka maʻi maʻi COVID-19 i kā mākou ʻoihana hana, kaulahao lako, koi mea hoʻohana hope no kā mākou huahana, hoʻoikaika ʻoihana kūʻai, nā hana ʻoihana, nā hoʻokolohua lapaʻau, a me nā ʻano ʻē aʻe o kā mākou ʻoihana a me ka mākeke Ua hiki iā mākou ke hana i nā lako no kā mākou huahana. nā moho a loaʻa nā lako o ka RHA® dermal filler series;ʻaʻole maopopo i ke kaʻina hoʻomohala lapaʻau;ʻAʻole paha i loaʻa i nā hoʻokolohua lapaʻau nā hoʻolālā kūpono a i ʻole nā hopena maikaʻi, a i ʻole maikaʻi ʻO nā hopena e hōʻoia i ka pilikia o ka ʻae kānāwai a i ʻole ka kūleʻa pāʻoihana;ka hoʻohana ʻana o nā hopena noiʻi lapaʻau i nā hopena maoli;ka lakio a me ke degere o ka waiwai waiwai, ka palekana, ka pono, ka ae ana i ke kalepa, a me ka OPUL™, RHA® dermal filler series a me ko makou Ka makeke, ka hoʻokūkū, ka unahi a me ka hiki ke ulu o ka huahana moho (inā aponoia);ko mākou hiki ke hoʻomau i ke kālepa kūleʻa i ka RHA® dermal filler series a me OPUL™, a me ka hiki ke kūʻai maikaʻi i ka DaxibotulinumtoxinA no ka injection (inā ʻae ʻia), a ʻO ka manawa a me ke kumukūʻai o nā hana kālepa;ko mākou hiki ke hoʻonui i ke kūʻai aku a me ke kūʻai aku;ke kūlana o ka hui ʻoihana;ko mākou hiki ke loaʻa kālā no kā mākou mau hana;ko mākou kumukūʻai a me ka hiki ke pale aku iā mākou iho i ke kuleana o ka huahana, ka waiwai naʻauao a me nā hihia ʻē aʻe;Loaʻa iā mākou ka hiki ke hoʻomau i ka loaʻa ʻana a me ka mālama ʻana i ka palekana o ka waiwai naʻauao o kā mākou mau moho lāʻau lapaʻau;kā mākou hana kālā, me ka loaʻa kālā e hiki mai ana, nā lilo a me nā koi kālā;a me nā pilikia ʻē aʻe.No nā kikoʻī e pili ana i nā kumu e ʻokoʻa ai nā hopena maoli mai nā mea i hōʻike ʻia a i ʻole i loko o nā ʻōlelo i loko o kēia hoʻokuʻu paʻi, e ʻoluʻolu e nānā i kā mākou palapala maʻamau i waiho ʻia me ka United States Securities and Exchange Commission (SEC), me nā mea ma ka ʻāpana i kapa ʻia. "Risk" ʻO nā mea i wehewehe ʻia i loko o nā "factor" ma ka Form 10-K a mākou i waiho ai me ka SEC ma Pepeluali 25, 2021, akā ʻaʻole i kaupalena ʻia i ka 10th o ka hapaha i pau i Iune 30, 2021, a mākou i waiho ai me ka SEC ma ʻAukake 5, 2021. -Q papaʻaina.ʻO nā ʻōlelo i mua o kēia hoʻolaha paʻi e hoʻomaka wale ana i ka lā o ka hoʻolaha ʻana.ʻAʻole mākou e hana i kekahi kuleana e hoʻonui i kēia mau ʻōlelo i mua.
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
Ua ʻōlelo ʻo Crispr i ka Pōʻalua ma hope o ka hoʻohiki ʻana i nā hoʻokolohua, hoʻolālā ʻo ia e hoʻomaka i ka noiʻi koʻikoʻi e pili ana i kāna mau lāʻau anti-cancer.Eia naʻe, hāʻule ka waiwai o CRSP i ka hana hope.
ʻOiai ma hope o ka lohi ʻana o ka Food and Drug Administration i ka hōʻike ʻana i ka nui o ka hoʻoikaika ʻana o ka hui o Covid injections, ua piʻi ka waiwai o Moderna i ka Pōʻalua.
ʻO kēia pule e hōʻailona ai i kahi manawa wai wai hou no ka lāʻau lapaʻau Covid-19 o Moderna Inc.: e hui kahi komite ʻōlelo aʻoaʻo nui o ka US Food and Drug Administration e kūkākūkā i ka mea i kapa ʻia ʻo "boost injection".
ʻO ke kiʻi i lawe ʻia e Martin Sanchez ma Unsplash Merck & Co (NYSE: MRK) hoʻolaha i nā hopena kupaianaha o kāna COVID-19 antiviral drug monupiravir i ka Pōʻalima i hala.No ka mea e koi ʻia ka lāʻau lapaʻau i ke kolu o ka booster injection, a ʻo ka poʻe kūʻē i ka maʻi kano i ka pilikia o ka hale hoʻokipa, ka make, a me nā hōʻailona koʻikoʻi o COVID-19, ua huli ka manaʻo o ke kaiāulu ʻepekema a me Wall Street i ka COVID-19 therapy ka mea maikaʻi loa. ala e hana ai me nā maʻi maʻi.Ke piʻi nei ka wā e hiki mai ana.ʻO nā lāʻau antiviral nā mea hoʻokūkū ikaika loa
He kahua hoʻonaʻauao ola kino ka "School of Knowledge", e ʻae iā ʻoe e ʻike i kou olakino mai nā kihi he nui, a aʻo i ka ʻike olakino noʻonoʻo i kēlā me kēia manawa, ma nā wahi āpau.
Ma hope o ka hoʻoholo ʻana o ka US Food and Drug Administration (FDA) a me nā Centers for Disease Control and Prevention (CDC) e ʻae i nā dosis booster o kēia kano no kekahi mau heluna ma ka hopena o Kepakemapa, ua loaʻa i nā miliona o nā mea loaʻa Pfizer i nā injections hou.Eia naʻe., Ua ao ʻia ka poʻe i loaʻa iā Moderna a me Johnson & Johnson e hoʻopaneʻe i ka ʻimi ʻana i nā lāʻau lapaʻau hou no ka mea ʻaʻole i ʻae nā komite ʻōlelo aʻoaʻo FDA a me CDC i nā mea hoʻoikaika no kekahi o kēia mau kano ʻelua.
Ke hooki nei ʻo CureVac i ka hoʻomohala ʻana i kāna kano mua Covid-19 e pili ana i ka messenger RNA.Ua hoʻomaka ka nūhou i ka luʻu ʻana i nā waihona.
He kakaikahi ka nui o na ma'i e like me ka malaria.I ka makahiki 2019, aia ma kahi o 229 miliona mau hihia o ka maʻi malaria.I ka pule i hala aku nei, ua ʻōlelo ka World Health Organization (WHO) i ka hoʻohana nui ʻana i nā maʻi malaria i nā keiki.
E noi no ka American Express Explorer™ Credit Card ma aneʻi e ʻoliʻoli i ka uku makahiki mua a me 3 mau manawa i nā helu manuahi ʻole, ke kūʻai akamai a i ʻole ka hoʻopau ʻana i nā makana like ʻole no ka hoʻolimalima!
Ua kākau ʻo Geoffrey Porges o SVB Leerink ʻo nā hopena o ka lua o ka lua o ka hoʻokolokolo kano "he hōʻailona maikaʻi no ka hoʻokolokolo ʻekolu e hiki mai ana."
Ma hope o ka hoʻolaha ʻana o CDC i ka hoʻokomo ʻana iā Covid booster i ka poʻe 65 a ʻoi aku ka nui a me nā poʻe ʻAmelika ʻē aʻe, pono anei ke kūʻai aku ʻo Pfizer?
Mea kākau: Dr. David Bautz Nasdaq: CFRX Heluhelu i ka hōʻike noiʻi CFRX piha ʻO ka hoʻonui ʻana i ka pāʻoihana Phase 2 ka hoʻonā wikiwiki o nā hōʻailona ma ka hoʻokolokolo Ma ʻOkakopa 4, 2021, ContraFect (NASDAQ: CFRX) hoʻolaha i ka exebacase 2 o ka hui ʻO ka ʻikepili hou mai ka Phase 1 Aia ka hoʻokolohua lapaʻau ma IDWeek ™, a ua emi koke nā hōʻailona o nā maʻi me Staphylococcus aureus bacteremia a hōʻike ʻia ma ke ʻano o ka hōʻike waha mai kahi mea hoʻopau hope.
Hāʻawi i nā makana a me nā makana hoʻolako a me nā lawelawe hoʻokele, inā paha no nā makana hui, hoʻolaha a i ʻole nā makana kūʻai ʻē aʻe, hiki iaʻu ke kōkua iā ʻoe me nā makana hou aʻe!Hiki iā ʻoe ke hana i ka hoʻolālā huahana, ka hana ʻana, a me ka hana ʻana.I ka manawa like, ʻoi aku ma mua o hoʻokahi haneli hale hana i hui pū.Inā noʻonoʻo ʻoe a noʻonoʻo paha, e hoʻouna hou aku au iā ʻoe no ʻoe!
Ma hope o ka noi ʻana o ka hui i ka FDA e ʻae i kāna pila Covid i ka hui pū ʻana me Ridgeback Biotherapeutics, hāʻule iki ke kumukūʻai o Merck i ka Pōʻakahi.
Ma hope o ka haʻi ʻana o ka hui biopharmaceutical Kelemania e haʻalele ʻo ia i ka hoʻomohala ʻana i kāna moho kano COVID-19 a ma kahi o ka nānā ʻana i ka hui pū ʻana me GlaxoSmithKline e hoʻomohala i ka lua o ka hanauna mRNA injection e kūʻē iā COVID-19, ʻo ke kumukūʻai kūʻai o CureVac i ke kālepa mua o ka mākeke ma ka Pōʻalua. Ua hāʻule i ka 9.6%.ʻAʻole kūpono ka ʻaelike kūʻai kūʻai e kū nei me ka European Commission.ʻO kā lākou pahuhopu e lawe mai i kahi kano COVID-19 hou i ka mākeke ma 2022.
ʻO ka pilikia ʻeha o ka naʻau o ka lāʻau ʻo Moderna hiki ke pōmaikaʻi iā Pfizer-akā, ʻoluʻolu wale nō.
E hoʻomaikaʻi i kāu ʻoihana ma ke aʻo ʻana i kahi MBA maʻalahi.E hoʻopau i kāu mau haʻawina ma ka liʻiliʻi o 2 mau makahiki.
Ma muli o ka nui o nā ʻAmelika i hoʻopaʻa ʻia e Pfizer ua ʻōwili i ko lākou mau lima e hoʻomākaukau ai no ka hoʻoikaika ʻana i nā injections, miliona o nā poʻe ʻē aʻe i hoʻopaʻa ʻia e Moderna a i ʻole Johnson & Johnson me ka hopohopo no ko lākou manawa.
Wahi a ka National Institute of Aging, ʻo NIH Alzheimer kahi maʻi i hoʻomaopopo ʻole ʻia, kahi paʻakikī nui i ka loaʻa ʻana o nā lāʻau lapaʻau kūpono.Ke ʻimi nei nā kānaka ʻepekema i nā koho unorthodox, e like me nā lāʻau lapaʻau kahiko i kuhikuhi ʻia no nā kūlana like ʻole.Ua loaʻa iā lākou kahi moho lāʻau kupanaha loa ma ke ʻano o kahi diuretic 50 makahiki.
Ua hāʻule nā'āpana CureVac NV (NASDAQ: CVAC) i ka Pōʻalua ma hope o ka hoʻolaha ʻana o ka hui e hui pū me GlaxoSmithKline e kālele i kāna hoʻomohala ʻana i ka maʻi maʻi COVID-19 i ka hoʻomohala ʻana i nā moho kano kano mRNA lua.Ua hoʻihoʻi ʻo EMA i kāna kano o ka hanauna mua i ka wā o ka ʻae ʻia.Manaʻo ʻo CureVac ʻo ka ʻae mua loa o kāna kano kano mua ma ka hapaha lua o 2022. I kēlā manawa, manaʻo ka ʻoihana e loaʻa i nā moho no ka papahana kano o ka hanauna lua.
Ma ka pūnaewele a i ʻole ka hui kumu kumu ʻoihana kino, kūpono no ka hoʻopaʻa inoa ʻoihana āpau, nā hana moʻomeheu manuahi i kēlā me kēia manawa, ʻike i nā kuʻuna aupuni like ʻole, Prince Tuen Mun Yuen Long Tin Shui Wai Sha Tin Wind Class!
ʻO nā hopena o ka hoʻāʻo mua ʻana o kahi moho lāʻau lapaʻau no ka mālama ʻana i ka hemahema alpha-1 antitrypsin he mea hoʻoikaika loa.
Ua ʻōlelo ʻo Johnson & Johnson i ka Pōʻalua e haʻalele ka 59 makahiki ma ke ʻano he Hope Pelekikena o ke Kōmike Hoʻokō a me Luna Nui ʻepekema ma ka lā 31 Dekemaba. a me ka ʻenehana e hāʻawi i nā lāʻau lapaʻau hou e hoʻoponopono ai i nā pilikia olakino koʻikoʻi o ka honua, ua loli ke kahua o ka mālama ola kino, "wahi a Kauka Stoffels.ʻO kēia ka lua o ka haʻalele ʻana i ka hoʻokele kiʻekiʻe i hōʻike ʻia e Johnson & Johnson i nā pule i hala iho nei.
Ua ʻōlelo kekahi kauka ʻo Yogi Bella i ka ʻōlelo aʻoaʻo baseball kaʻao, e koi ana i nā mea a pau e lohi i ka hoʻoikaika ʻana i ka hoʻopaʻapaʻa paʻa ʻana a me nā pilikia ʻē aʻe i hoʻoholo ʻole ʻia.
Ka manawa hoʻouna: ʻOkakopa-13-2021