Novo Nordisk/AstraZeneca's Manufacturing Partner Thermo Fisher Questioned Over Manufacturing Lapses
Novo Nordisk/AstraZeneca's Manufacturing Partner Thermo Fisher Questioned Over Manufacturing Lapses
Over the past decade, the Greenville plant has been cited for issues related to contamination prevention, including two incidents earlier this year, Reuters noted, citing FDA documents.Thermo Fisher Scientific's (NYSE:TMO) one of the largest contract drug manufacturing sites in the U.S., has repeatedly been flagged for regulatory violations.
賽默飛世爾（紐交所：TMO）是美國最大的合同藥品製造基地之一，在監管違規方面屢遭指責。
Thermo Fisher's Greenville facility manufactures around 40 medicines, including Novo Nordisk A/S' (NYSE:NVO) weight-loss drug Wegovy (semaglutide).
賽默飛世爾的格林維爾工廠生產大約40種藥品，包括諾和諾德A/S（紐交所：NVO）的減肥藥偉果威（semaglutide）。
Recently, Stephen's analyst said that Thermo Fisher's pharma services assets, especially its contract development and manufacturing organization (CDMO), are well positioned. The company is set to capitalize on growth opportunities in the injectables sector, driven by GLP-1 demand and biologics drug substance production.
最近，斯蒂芬的分析師表示，賽默飛世爾的製藥服務資產，特別是其合同開發和製造組織（CDMO），處於良好位置。該公司將利用注射劑板塊的增長機會，受GLP-1需求和生物製品藥物物質生產的推動。
Over the past decade, the Greenville plant has been cited for issues related to contamination prevention, including two incidents earlier this year, Reuters noted, citing FDA documents.
在過去十年裏，格林維爾工廠因與污染預防相關的問題而受到指責，包括今年早些時候發生的兩起事件，據路透社引述FDA文件報道。
Also Read: Thermo Fisher Q2 Earnings: Marginal Revenue Dip, Completes Olink Acquisition, Lifts Annual Profit Outlook.
另請參閱：賽默飛世爾第二季度收益：營業收入略有下降，完成Olink收購，提高年度利潤展望。
Despite these concerns, the FDA did not take regulatory action, stating that the issues had been resolved to its satisfaction and that there was no evidence that patients had been harmed as a result.
儘管存在這些問題，FDA並未採取監管行動，稱問題已得到令其滿意的解決，且沒有證據表明患者因此受到傷害。
During a recent inspection in May, the FDA identified manufacturing problems with Sanofi SA (NASDAQ:SNY) and AstraZeneca Plc's (NASDAQ:AZN) Beyfortus. The respiratory syncytial virus (RSV) preventive drug for infants and toddlers scored FDA approval in 2023.
在最近的五月檢查中，FDA指出了賽諾菲安萬特SA（納斯達克：SNY）和阿斯利康公兩家公司的製造問題。針對嬰兒和幼兒的呼吸道合胞病毒（RSV）預防藥貝福特斯在2023年獲得FDA批准。
The Reuters report highlighted that the FDA identified 17 deficiencies during the Beyfortus audit, including insufficient visual inspections for particulate matter in injectable drugs and issues with staff handling of sterile components.
路透社的報道強調，FDA在貝福特斯審核過程中發現了17個缺陷，包括注射藥物中顆粒物的視覺檢查不足以及員工處理無菌元件存在問題。
The agency noted that Thermo Fisher's equipment sterilization procedures were inadequate, and visual inspections for injectable drug contaminants failed.
該機構指出，賽默飛世爾的設備消毒程序不足，注射藥物污染物的目視檢查未能通過。
Thermo Fisher has since addressed these issues, providing the FDA with the necessary data on drug safety, including control over bubble size in injectable medications. However, experts remain concerned about the plant's approach to quality control.
賽默飛世爾已經解決了這些問題，向FDA提供了關於藥物安全性的必要數據，包括控制注射藥物中泡沫大小的數據。然而，專家仍然對該工廠的質量控制方法表示擔憂。
In July, Merck & Co Inc's (NYSE:MRK) Phase 2b/3 trial (MK-1654-004) of clesrovimab (MK-1654) to protect infants from respiratory syncytial virus (RSV) disease met its primary safety and efficacy endpoints.
7月，默沙東公司(NYSE:MRK)的clesrovimab（Mk-1654）第2b/3期試驗(Mk-1654-004) 用於保護嬰兒免受呼吸道合胞病毒(RSV)疾病的試驗達到了主要的安全性和有效性終點。
Price Action: TMO stock is down 0.39% at $598.59 during the premarket session at last check Friday.
價格走勢：上週五最後查看時，TMO股價在盤前交易時段下跌0.39%，報598.59美元。
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譯文內容由第三人軟體翻譯。