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fda pdufa 在竹科大小事 Facebook 的最佳貼文

2017-11-09 16:55:24 有 28 人按讚

極速施工進程─
中裕新藥公司新竹生醫園區自建新廠上樑

中裕新藥公司在新竹生醫園區投資設置國內第一座蛋白質藥廠，甫於本(106)年6月28日動土，經過4個多月來的積極趕工，隨即於本日(11月9日)舉行上樑儀式，由董事長陳志全主持，新竹縣副縣長楊文科、科管局副局長張金豐等貴賓應邀參與盛會。全部興建工程將於107年中旬完工，開始各項設備安裝、技轉、生產製程確效和藥品穩定性的測試作業，預期在未來的2至3年內陸續供應臨床試驗用藥，並取得美國FDA、歐盟EMA及台灣TFDA針對TMB-355商業量產的核准，並參與供應愛滋病新藥TMB-355之全球銷售。
中裕新藥公司以愛滋病新藥TMB-355 為目標，投入新建廠房工程，除提供未來TMB-355行銷全球之藥品製造外，也將會是全台第一座FDA藥證核可的蛋白質藥廠。TMB-355先前已獲得美國FDA核准通過應用於愛滋病多重抗藥性病人「孤兒藥」及「突破性治療」資格，並於106年5月正式完成向美國FDA提出生物製劑藥品上市查驗登記(BLA)申請，並於7月獲得6個月優先審查(Priority Review)資格，審查完成期限Prescription Drug User Fee Act(PDUFA)日期是107年1月，正努力進行最後衝刺，期望能於近期內達成台灣廠商獲得美國FDA核准取得第一張蛋白質新藥藥證之重大里程碑。
新廠總投資額新台幣8.7億元，預計興建地上5層地下1層之全新蛋白質GMP工廠，總樓地板面積約5,500平方公尺，預計安裝4座2,000L拋棄式生物反應槽，提供未來TMB-355商業化之全球藥品供應，及供應該公司後續研發計畫臨床試驗用藥之需求。

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竹科大小事

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民國69年12月15日新竹科學園區經國家政策推動正式成立，科技部新竹科學園區管理局（以下簡稱竹科管理局）在科技部的領導下負責新竹科學園區開發、營運與管理，涵蓋新竹園區、竹南園區、龍潭園區、銅鑼園區、宜蘭園區和新竹生物醫學園區6個園區約1,375公頃。主要任務與目標在引進高級技術產業及科學技術人才，提升區域創新整合能量，以激勵國內產業技術之研究創新，並促進高級技術之產業發展。　　竹科管理局設立企劃、投資、環安、工商、營建、建管6個組及秘書、人事、主計、政風4個室，為園區廠商建設優質基礎建設、提供單一窗口服務、創新研發機制及產學研合作機制。竹科發展迄今的成功經驗，已成為許多國家發展科學園區爭相學習的典範，群聚於竹科的半導體產業，擁有晶圓代工、設計、光罩、封裝及測試等完整垂直分工體系，不僅創造多項世界第一的產品，更被譽為「臺灣的矽谷」。其璀璨的成功經驗，先後傳承設立南部及中部科學園區，為臺灣建構完整的點、線、面西部高科技走廊，驅動國內上、中、下游產業的蓬勃發展。未來竹科管理局將秉持便民、效率、忠誠與廉能的核心價值，以專業、效率、主動為民服務的精神，為園區廠商積極建置優質的投資環境，協助高科技廠商結合學研資源發揮高效能研發能量，培育優秀科技人才，激勵創新國內研發實力，祈願促成科學園區永續發展成為全球最佳的「創新產業聚落」。

竹科大小事是科技部新竹科學園區管理局所設立的，提供管理局與民眾或園區廠商互動/分享/溝通竹科大小事之管道，亦希望粉絲朋友們，記得要常至本專區參與及互動，熱絡粉絲專頁。

fda pdufa 在台灣光鹽生物科技學苑 Facebook 的精選貼文

By 台灣光鹽生物科技學苑

2017-07-03 10:30:20 有 63 人按讚

<產業訊息>中裕愛滋新藥　獲美FDA上市優先審查

#美國食品藥物管理局 #FDA #愛滋新藥 #上市查驗登記申請 #BLA #優先審查 #PriorityReview #藥品標籤 #藥證 #快速審查 #孤兒藥 #突破性治療

中裕新藥宣布，已接獲美國食品藥物管理局（FDA）通知，正式接受愛滋新藥TMB-355上市查驗登記（BLA）申請，並予以優先審查（Priority Review）資格，審查時程縮短為6個月。此次繼獲得快速審查、突破性療法資格後，再獲得優先審查上市，意味藥品上市時程將加速。

根據美國現行法規，如果BLA申請被FDA接受，則在所有文件送入FDA後的60天視為正式申請日。由於中裕是於5月3日送件，正式申請日被訂為7月3日。TMB-355的審查完成期限（Prescription Drug User Fee Act, PDUFA）日期是2018年1月3日。

美國FDA並通知，如無重大缺失，中裕可望於10月3日接獲藥品標籤及TMB-355上市後的相關規定及要求通知。此外，美國FDA認為TMB-355在核准藥證前不需交付諮詢委員會討論。

TMB-355先前已獲得美國FDA核准「快速審查」資格，並通過應用於多重抗藥性病人「孤兒藥」及「突破性治療」資格。本次獲得「優先審查」資格，將加速未來藥物上市時程。

資料來源：http://www.appledaily.com.tw/…/article/new/20170701/1152026/

Tags: fda pdufa 美國食品藥物管理局 FDA 愛滋新藥上市查驗登記申請 BLA 優先審查 PriorityReview 藥品標籤藥證快速審查孤兒藥突破性治療

台灣光鹽生物科技學苑

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這個學苑,不僅有生技製藥產業職場從業人員實務培訓課程, 也有最能思考激盪的學習氛圍,還有認真堅持的學員!

fda pdufa 在股市達人鄭瑞宗 Facebook 的最佳貼文

By 股市達人鄭瑞宗

2015-08-13 17:47:55 有 71 人按讚

智擎獲利不賴，難怪今天先出量了

《業績-生醫》授權金大補，智擎H1每股賺3.84元創新高
2015/08/13 17:27 時報資訊

【時報記者郭鴻慧台北報導】智擎生技 (4162) 上半年營收5.03億元、稅前盈餘為4.07億元，每股稅前盈餘為4元；稅後淨利3.91億元，每股稅後盈餘為3.84元，創歷史新高。智擎表示，上半年獲利創新高主要是來自於授權夥伴美國Merrimack所支付之發展里程碑授權金和再授權金共1600萬美元(約4.94億台幣）。

智擎公司主要著力於開發癌症治療及亞洲盛行疾病的新藥，共有三個新藥專案在進行中，目前開發進度最快的研發專案PEP02(MM-398)，第一適應症是用以治療轉移性胰臟癌，已經被美國FDA、歐盟EMA、台灣TFDA接受其藥證的申請，目前皆已進入法規審查階段中。其中美國FDA給予新藥優先審查資格(Priority Review)，並確定今年10月24日為新藥藥證核定與否目標日（PDUFA datedate）。

據美國Merrimack在8月11日法人說明會所公布資訊，為能在PDUFA date之前完成法規審查，美國FDA已完成了MM-398商業化製造廠房的核准藥證前查核工作，由於前述兩項查核工作係為美國FDA法規審查程序中重要步驟，且美國FDA並未在查核中提出重大的考量或問題，足見MM-398法規審查進度已顯著前進一大步。

智擎指出，另一個研發專案PEP503(NBTXR3)，已在亞太地區數個國家申請進行軟組織肉瘤跨國樞紐性臨床試驗，目前已經獲得香港法規單位核准進行；此外，台灣TFDA亦核准PEP503進行直腸癌第一/二期臨床試驗。智擎第三個研發專案PEP06係為針對癌症療法開發的新成分新藥(NCE)。

智擎總經理暨執行長葉常菁博士表示，公司的三項新藥專案PEP02、PEP503及 PEP06的藥證申請及研發進度均符合預期。

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股市達人鄭瑞宗

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在股市達人的粉絲網頁中，瑞宗會跟大家分享節目中看好的產業趨勢與投資標的。尤其是節目時間有限，無法好好完整表達的東西，也會在這個粉絲網頁跟大家交流，希望可以幫助大家在台股中趨吉避凶，每個人都成為贏家！官方網站 | https://www.stockmaster888.com/ Line＠ | ＠stockmaster Telegram | stockmaster888

鄭瑞宗老師與大家分享投資心得的園地大來國際證券投資顧問股份有限公司 (108)金管投顧新字第012號台北市羅斯福路二段100號26樓之1 (02)2365-9333 客戶申訴專線0800-756-999

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fda pdufa 在 Prescription Drug User Fee Amendments | FDA 的相關結果

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fda pdufa 在《FDA》在什麼樣的情況下會延遲PDUFA Action Date? - Genet ... 的相關結果

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fda pdufa 在 What Is a PDUFA Date? | The Motley Fool 的相關結果

Once the FDA accepts a filing for the approval of a drug, the agency must complete its review process within 10 months in most cases. The date ... ... <看更多>

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Prescription Drug User Fee Act (PDUFA) goal date of September 28, 2022 NEW YORK, Dec. 14, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, ...

#54. FDA Staff Disagreements May Be Cause of Delays in ...

FDA Staff Disagreements May Be Cause of Delays in Implementation of PDUFA ... that it commits to as part of the Prescription Drug User Fee Act (PDUFA).”.

#55. FDA Will Not Complete Review of BLA for Lisocabtagene ...

... prior therapies will not be completed by the prescription drug user fee act (PDUFA) action date of November 16, 2020. 1. The FDA was not ...

#56. Janssen Announces Extension of U.S. FDA ... - PR Newswire

PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) has ...

#57. Speed, Safety, and Industry Funding — From PDUFA I to ...

The FDA Reauthorization Act of 2017 includes the sixth version of the Prescription Drug User Fee Act. User fees have accelerated drug ...

#58. Legend Biotech Announces Extension of PDUFA Date for ...

“We are working closely with Janssen and the FDA to facilitate an efficient and thorough review of the BLA for cilta-cel,” said Ying Huang , Ph.

#59. Merck Receives Priority Review From FDA for New Drug ...

The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of September 15, 2021. “Von Hippel-Lindau disease is a rare ...

#60. Ten Things You Need to Know about the FDA User Fee ...

Bush signed the Prescription Drug User Fee Act (PDUFA), a law that provides the FDA with resources to accelerate the drug review and approval ...

#61. 藥華藥PV藥證獲FDA受理- 工商時報

藥華藥（6446）4日宣布，旗下治療真性紅血球增多症（PV）新藥P1101的藥證補件申請，已獲美國FDA受理，來函中敘明完成審查目標日期（PDUFA）訂為今年11 ...

#62. FDA Extends BLA PDUFA Date for CAR T-Cell Therapy for ...

The FDA has granted an extension of the Prescription Drug User Fee Act (PDUFA) date to February 28, 2022, for the Biologics License ...

#63. FDA Drug Approval: Application Review Times Largely Reflect ...

Three key NDA features determine the time frames for initial review that would meet FDA's goals under the Prescription Drug User Fee Act (PDUFA) ...

#64. UCB Announces PDUFA Date for Bimekizumab

Bimekizumab for the treatment of adults with moderate to severe plaque psoriasis is currently under review by the U.S. FDA for the BLA and the ...

#65. Pfizer and OPKO Announce Extension of U.S. FDA Review of ...

The Prescription Drug User Fee Act (PDUFA) goal date has been extended by three months to January 2022, as a result of Pfizer's submission ...

#66. BioXcel Therapeutics slumps 25% after FDA extended PDUFA ...

BioXcel Therapeutics (BTAI) drops 24.6% premarket in reaction to the announcement that the FDA has extended the PDUFA date for its review of ...

#67. FDA accepts Mannkind's response, sets PDUFA date - Fierce ...

The FDA has accepted MannKind's resubmission of its NDA for the inhaled insulin drug Afrezza and set a PDUFA action date of December 29, ...

#68. 7 FDA Drug Decisions To Watch Through July 2022 - HCPLive

From a new heart failure indication to a first-of-its-kind rare disease treatment, here's the most interesting PDUFA dates for the first ...

#69. FDA Requests RSVP for Public Meetings on PDUFA ...

The federal Food and Drug Administration (FDA) has issued a notice requesting that public stakeholders --including patient and consumer ...

#70. PDUFA Date for Rilonacept (IL-1 Trap) Extended Three ...

On October 16, 2007, the FDA requested supplemental chemistry, manufacturing and controls information. Regeneron provided this information to the FDA on October ...

#71. 2022 PDUFA Fees Announced - Lachman Consultants

After a stop-and-go where the FDA pulled back an earlier Federal Register (FR) notice due to an issue with the calculations, the new PDUFA ...

#72. FDA and Industry Map New R&D Initiatives under Next User ...

PDUFA VII also aims to enhance CBER oversight of cell and gene therapies (CGT) by expanding staff and resources for its Office of Tissues & ...

#73. The FDA Missed Egalet's PDUFA Date, But Investors Should ...

2016年10月14日 — Despite Thursday's FDA announcement that they'd miss the PDUFA date for Egalet Corp (NASDAQ: EGLT ), and Friday's sell-off in the stock, ...

#74. Prescription Drug User Fee Act (PDUFA)

drug applications at the U.S. Food and Drug Administration (FDA). PDUFA authorized FDA to collect user fees from drug sponsors to support the additional ...

#75. FDA Issues Final Guidance on PDUFA Waivers, Reductions ...

Introduction The Prescription Drug User Fee Act of 2017 (PDUFA VI) authorizes the U.S. Food and Drug Administration (FDA) to assess fees ...

#76. News & Events - Vertex Pharmaceuticals

Vertex Announces U.S. FDA Acceptance of Supplemental New Drug ... -FDA grants Priority Review of the application and sets a PDUFA target ...

#77. Biogen Idec Receives Notification from FDA of PDUFA Date ...

Biogen Idec Receives Notification from FDA of PDUFA Date Extension for ALPROLIX™. December 2, 2013 • Rare and Genetic Diseases. CAMBRIDGE, Mass.

#78. Role of the FDA and PDUFA in Drug Development

Prescription Drug User Fee Act (PDUFA I). PDUFA Objective: Hire additional FDA drug reviewers to improve drug and biologics review.

#79. FDA PDUFA And Patient Engagement - Pharmaceutical Online

FDA, PDUFA, And Patient Engagement — What Pharma Companies Need To Know (And Do). By Karla S. Anderson, Tim Pantello, and Alexander Gaffney, ...

#80. Bluebird Bio : FDA PDUFA Goal Dates For Lentiviral Vector ...

The revised PDUFA goal dates for beti-cel and eli-cel are August 19, 2022 and September 16, 2022, respectively. The FDA accepted the BLA for ...

#81. Iterum Therapeutics Announces US FDA Filing Acceptance of ...

The FDA has designated this application as a priority review and consequently assigned a PDUFA (Prescription Drug User Fee Act) goal date ...

#82. Press Release - Investors - Daré Bioscience

Daré Bioscience Announces FDA Acceptance and Priority Review of New ... Six-month priority review granted for DARE-BV1 with PDUFA target ...

#83. FDA PDUFA date decision takes the heat out of NeurogesX ...

Having already secured European approval for its novel Qutenza pain patch, NeurogesX was hoping to go for the double late next week with the ...

#84. FDA grants priority review for avalglucosidase alfa, a potential ...

The target action date for the FDA decision is May 18, 2021. Avalglucosidase alfa is an investigational enzyme replacement therapy designed to ...

#85. FDA Pipeline Priority Reviews in Multiple Myeloma, Cervical ...

The Prescription Drug User Fee Act (PDUFA) target action date has been set for November 29, 2021. The regulatory submission for ciltacabtagene ...

#86. Akebia and Otsuka Announce FDA Acceptance for Filing of ...

Vadadustat assigned PDUFA target action date of March 29, 2022 ... today announced that the U.S. Food and Drug Administration (FDA) accepted for filing the ...

#87. History, Reauthorization in 2007, and Effect on FDA - Page 2 ...

The Prescription Drug User Fee Act (PDUFA): History, Reauthorization in 2007, and Effect on FDA Page: 2 of 18. This report is part of the ...

#88. FDA Revisions on Formal Meetings between FDA and ...

FDA Revisions on Formal Meetings between FDA and Sponsors of PDUFA Products ... information for sponsors of Prescription Drug User Fee Act (PDUFA) products.

#89. PDUFA/GDUFA - PAHO

New procedural goals improve communication between FDA and sponsors. •. PDUFA III: Refining the Process - From Drug Development to Application Review to ...

#90. BRIEF-Jazz Pharmaceuticals - PDUFA Goal Date For An FDA ...

JAZZ PHARMACEUTICALS ANNOUNCES FDA ACCEPTANCE OF NEW DRUG APPLICATION FOR JZP-258 FOR CATAPLEXY AND EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED ...

#91. NCCS Comments on the FDA's PDUFA Proposed ...

In 1992, Congress passed the first Prescription Drug User Fee Act (PDUFA), a law that allows the FDA to collect fees from drug companies that apply to the ...

#92. Prescription Drug User Fee Act (PDUFA) - CRS Reports

Therefore, as each reauthorization deadline approaches, FDA, industry groups, and most Members of Congress see PDUFA as must-pass legislation.

#93. Cilta-Cel PDUFA Date Delayed by FDA - Phacilitate

FDA Delays PDUFA Date for BCMA CAR-T Therapy, Cilta-Cel, Until February 2022 · SHARE NOW · Janssen has announced a delay to the planned ...

#94. Apellis Announces FDA Acceptance and Priority Review of the ...

PDUFA target action date is May 14, 2021. FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss ...

#95. Cara Therapeutics and Vifor Pharma announce U.S. FDA ...

FDA has set Prescription Drug User Fee Act (PDUFA) target action date of August 23, 2021; If approved, KORSUVA™ injection would be first ...

#96. Trevena Announces FDA Has Set PDUFA Date of August 7 ...

Trevena Announces FDA Has Set PDUFA Date of August 7, 2020 for Oliceridine · FDA considers NDA resubmission a complete Class 2 response · Updated ...

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