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.
赛默飞世尔科技（纽约证券交易所代码：TMO）是美国最大的合同药品生产基地之一，一再因违反监管规定而被举报。
Thermo Fisher's Greenville facility manufactures around 40 medicines, including Novo Nordisk A/S' (NYSE:NVO) weight-loss drug Wegovy (semaglutide).
赛默飞世尔在格林维尔的工厂生产约40种药物，包括诺和诺德A/S（纽约证券交易所代码：NVO）减肥药物Wegovy（索玛鲁肽）。
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，斯蒂芬的分析师表示，赛默飞世尔的制药服务资产，尤其是其合同开发和制造组织（CDMO），处于有利地位。在 GLP-1 需求和生物制剂药物生产的推动下，该公司将利用注射剂行业的增长机会。
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.
路透社援引美国食品和药物管理局的文件指出，在过去的十年中，格林维尔工厂因与污染预防相关的问题而被举报，其中包括今年早些时候的两起事件。
Also Read: Thermo Fisher Q2 Earnings: Marginal Revenue Dip, Completes Olink Acquisition, Lifts Annual Profit Outlook.
另请阅读：赛默飞世尔第二季度收益：边际收入下降，完成对Olink的收购，提高了年度利润前景。
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.
尽管有这些担忧，但美国食品和药物管理局没有采取监管行动，称问题已得到令人满意的解决，没有证据表明患者因此受到伤害。
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5月份的最近一次检查中，美国食品药品管理局发现赛诺菲公司（纳斯达克股票代码：SNY）和阿斯利康公司（纳斯达克股票代码：AZN）Beyfortus存在制造问题。针对婴幼儿的呼吸道合胞病毒（RSV）预防药物在2023年获得了美国食品药品管理局的批准。
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.
路透社的报道强调，美国食品和药物管理局在Beyfortus审计中发现了17个缺陷，包括对注射药物中颗粒物的目视检查不足，以及工作人员处理无菌成分时存在问题。
The agency noted that Thermo Fisher's equipment sterilization procedures were inadequate, and visual inspections for injectable drug contaminants failed.
该机构指出，Thermo Fisher的设备消毒程序不足，对可注射药物污染物的目视检查失败。
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.
此后，Thermo Fisher解决了这些问题，向美国食品药品管理局提供了必要的药物安全数据，包括控制注射药物的气泡大小。但是，专家们仍然对该工厂的质量控制方法感到担忧。
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，默沙东公司（纽约证券交易所代码：MRK）保护婴儿免受呼吸道合胞病毒（RSV）疾病侵害的克来罗维单抗（Mk-1654）的2b/3期试验（Mk-1654-004）达到了其主要的安全性和有效性终点。
Price Action: TMO stock is down 0.39% at $598.59 during the premarket session at last check Friday.
价格走势：周五最后一次盘前交易中，TMO股价下跌0.39％，至598.59美元。
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