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臺大醫院攜手中研院 揭不孕症黃體素不足竟與腸道菌有關！
生技醫藥
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Anavex Life首款阿茲海默症雙標靶口服藥 提交EMA上市申請

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From Pilot to Production: KriSan Partners with Sartorius to Reshape Antibody Drug Manufacturing

生技醫藥
愛滋病 HIV 抗體藥物 Theratechnologies

中裕愛滋藥Trogarzo肌肉注射劑型 遭FDA拒批

2024-02-29/記者 巫芝岳
近(27)日，中裕新藥(4147)授權夥伴——加拿大生技公司Theratechnologies宣布，美國食品藥物管理局(FDA)拒絕了其愛滋病藥物Trogarzo(ibalizumab-uiyk)肌肉注射(IM)劑型的生物製劑許可申請(sBLA)。Theratechnologies表示，在FDA發出的拒絕提交信函(RTF)中指出，由於sBLA申請未包含足夠的細節，無法進行實...
醫療科技
睿傳數據 精準健康 盛弘醫藥 肺癌 AI TFDA

睿傳數據LDCT肺癌早篩平台 獲TFDA醫材AI軟體許可證 靈敏度92%

2024-02-29/記者 李林璦
今(29)日，盛弘醫藥(8403)集團下的精準健康(6991)轉投資睿傳數據宣布，其智慧醫材「LibraLung天秤肺影」肺癌早篩AI輔助平台，於本月正式獲得食藥署(TFDA)AI醫材查驗登記核准，該平台可透過資訊自動化替代人工作業，提高醫療效率，加速肺癌篩檢和追蹤治療，其肺結節偵測靈敏度Recall高達92%，平均每一掃描偽陽性僅有0.6顆。睿傳指出，將以維護訂閱方式提供醫院，期能減輕醫院負擔，...
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新聞集錦

02/29《生醫焦點雷達》

2024-02-29/新聞中心
國內快訊 3月掀掛牌熱潮生技新兵富爸爸加持工商時報2024/2/292024全球最佳醫院250強台北榮總218名全台唯一入榜聯合報2024/2/29北榮重粒子治療聞名將與梅約醫學中心合作生物研究聯合報2024/2/28中裕第三代愛滋新藥肌肉注射劑型在美國上市受挫經濟日報2024/2/28博晟新竹廠查廠通過辦私募引策略性投資人工商時報2024/2/27上市櫃生技醫療股價指數納博晟生醫、刪除生展工商...
生技醫藥
高齡醫學 多體學 高齡

《Nature》子刊：哈佛/史丹佛提「老化生物標記研究架構」 倡長期、多體學方法加速研究

2024-02-29/記者 巫芝岳
近(14)日，由史丹佛大學(StanfordUniversity)、哈佛醫學院(HarvardMedicalSchool)合作的研究團隊，首次提出一項標準化的「老化生物標記」研究架構(framework)，該團隊對目前的研究方法進行了歸納，提出目前基於體學(omics)的老化生物標記研究挑戰，以及應加強大規模、長時間的生物標記研究，來加速老化相關臨床研究。該論文發表於期刊《NatureMedici...
GBI International
GBIHighlights

BRIM Biotechnology, Inc. announced its three focus areas for this year's operations

2024-02-28/GlobalBio & Investment
#OphthalmologyInnovationGreatnewsfromBRIMBiotechnology,Inc.(6885.TWO)!Thecompanyhasannounceditsthreefocusareasforthisyear'soperations,whichinclude:1.ContinuingthedevelopmentofBRM421,theirleadasset...
GBI International
GBIHighlights

Sartorius experts highlighted the key specifications of the new PIC/S GMP Annex 1 regulation

2024-02-28/GlobalBio & Investment
#BiotechInsightsExcitingupdatesfromSartoriusandAdimmuneCorp(4142)'scorporateseminar!Sartoriusexperts,Tse-WeiChenandRZLin,highlightedthelatesttrendsincellculturedevelopmentandthekeyspecificationsof...
GBI International
GBIHighlights

AnHorn partnered with European startups to explore new treatment targets for prostate cancer

2024-02-28/GlobalBio & Investment
#InnovativeCollaborationAnHornMedicines,anAI-drivendrugdiscoverycompanyfocusedonproteindegradation,haspartneredwithEuropeanstartupstoexplorenewtreatmenttargetsforprostatecancer.On20February2024,Anhorn...
GBI International
GBIHighlights

PharmaEssentia and Oneness Biotech Co Ltd have been honored in Sustainability Yearbook 2024

2024-02-28/GlobalBio & Investment
#ESGExcellenceExcitingnews!PharmaEssentia(TPE:6446)andOnenessBiotechCoLtd(TPE:4743)havebeenhonoredintheprestigiousSustainabilityYearbook2024byS&PGlobalRatings.PharmaEssentiamarksahistoricmomentast...
GBI International
GBIHighlights

How does medical technology revolutionize commercial health insurance?

2024-02-28/GlobalBio & Investment
#MedicalInsuranceDidyouknowthattheaveragepersoninTaiwanhasthreeinsurancepolicies?Withtheriseofemergingmedicaltechnology,commercialhealthinsuranceisbeingrevolutionized.In2023,theBio-TaiwanCommittee(#BT...
GBI International
GBIHighlights

Leadgene Biomedical, Inc.'s LEADGENE® IS ELISA Kit has been approved by Taiwan's FDA...

2024-02-28/GlobalBio & Investment
#TFDAApprovalExcitingnews!LeadgeneBiomedical,Inc.'sLEADGENE®IndoxylSulfate(IS)ELISAKit,aCE-markedprotein-boundtoxindiagnosiskit,hasbeenapprovedbyTaiwan'sFDAasaClassIIIinvitrodiagnosticdevi...
GBI International
GBIHighlights

Nine biopharma companies have announced record-high revenues for January

2024-02-28/GlobalBio & Investment
#BiotechGrowthExcitingnewsfromthe#biopharmasector!Ninebiopharmacompanieshaveannouncedrecord-highrevenuesforJanuary,indicatingaprosperousstarttotheyear.Amongthem,AnxoPharmaceuticalTaiwanCo.Ltd(6677.TWO...
GBI International
GBIHighlights

FDA approves Onivyde® as a first-line therapy for metastatic pancreatic adenocarcinoma

2024-02-28/GlobalBio & Investment
**#FDAApproval**ExcitingnewsforPharmaEngineInc(4162.TWO)!FDAapproves#Onivyde®asafirst-linetherapyformetastaticpancreaticadenocarcinoma,markingapotentialnewstandardofcare.PharmaEngine'scollabor...

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