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  诺和诺德(NovoNordisk)取得了一场重大的法律胜利,这在很大程度上限制了配制药店营销或销售该制药商的畅销减肥药司美格鲁肽(Wegovy)和糖尿病治疗药物诺和泰(Ozempic)的更便宜且未经批准的仿制版本。

  当地时间周四晚些时候,得克萨斯州的一名联邦法官驳回了配制药店的一项请求,该请求试图在针对这些药物短缺的法律质疑仍在进行期间,继续生产诺和泰和司美格鲁肽的仿制版药物。这一裁决是对今年2月一个配制药品行业组织针对美国食品药品监督管理局(FDA)的一项认定提起的诉讼的回应,FDA认定这些药物的活性成分司美格鲁肽(semaglutide)在美国已不再短缺。

  在过去两年里,由于需求激增,诺和泰和司美格鲁肽出现供应短缺,或者一些患者没有保险来支付这些昂贵的治疗费用,他们纷纷选择购买更便宜的仿制药。

  在FDA宣布药品短缺期间,药剂师可以合法配制品牌药物的仿制版本。许多远程医疗公司,如希姆斯与赫尔斯公司(Hims&Hers),也提供这些仿制药。但制药商和一些健康专家一直反对这种做法,因为FDA并不批准配制药物,这些药物本质上是医生为满足特定患者需求而开的定制仿制药。

  诺和诺德公司负责法律事务的企业副总裁兼美国总法律顾问史蒂夫·本茨(SteveBenz)在一份声明中表示:“我们很高兴法院驳回了配制商试图破坏FDA基于数据做出的司美格鲁肽短缺已解决这一决定的企图。”

  他还称:“患者安全仍然是诺和诺德的首要任务,我们在全国范围内采取的广泛法律行动,旨在保护美国人免受非法‘司美格鲁肽’药物带来的健康风险,这些行动正在发挥作用。”他提到了该公司针对32个州的配制药店和其他实体提起的100多起诉讼。

  周四,美国地方法院法官马克·皮特曼(MarkPittman)明确驳回了外包设施协会(OutsourcingFacilitiesAssociation)关于初步禁令的请求,该禁令原本旨在阻止FDA对其成员生产司美格鲁肽仿制药的行为采取行动。

  这一决定维持了FDA先前关于美国司美格鲁肽短缺已结束的认定,意味着FDA现在可以立即追究那些根据特定患者的个人处方配制司美格鲁肽仿制版本的所谓503A药店的责任。

  这些药店在很大程度上是由各州监管,而非FDA。

  这些药店根据特定患者的个人处方配制药物,并且在很大程度上是由各州监管,而非FDA。

  这一决定还意味着,FDA可以在5月22日之后开始针对受联邦监管的503B药店采取行动,这些药店无论是否有处方都会批量生产配制药物。该机构的行动可以包括扣押产品和向药店发出警告信。

  在周四的这一裁决之前,诺和诺德还取得了另一场胜利。本周早些时候,得克萨斯州的另一位联邦法官做出了有利于该制药商的裁决,原告是一家503A药店——美迪奥克药店(MediOakPharmacy),法官永久性禁止该企业营销或销售配制的司美格鲁肽。

  在过去两年里,诺和诺德和礼来公司(EliLilly)都大力打击配制药店,因为它们从自家减肥药和糖尿病药物的大受欢迎中获益。

  礼来公司也对其减肥药泽普邦(Zepbound)和糖尿病治疗药物莫恩加罗(Mounjaro)的活性成分替尔泊肽(tirzepatide)经历了类似的法律程序。FDA去年宣布美国替尔泊肽短缺问题已经结束,这促使同一个配制药品行业组织就该药物起诉FDA。

  今年3月,一名联邦法官驳回了该配制药品行业组织关于对FDA针对其成员生产莫恩加罗和泽普邦仿制药采取执法行动的初步禁令请求。该配制药品行业组织已提出上诉。

  因关税政策引发经济担忧,美国消费者信心在4月大幅下滑,同时长期通胀预期升至1991年以来最高水平。

  密歇根大学周五公布的数据显示,4月消费者信心指数终值降至52.2,低于3月的57。虽然略高于初值50.8,但仍为1970年代末以来的第四低水平。

  调查显示,消费者预计未来5到10年年均通胀率将升至4.4%,为1991年以来最高。对未来一年的通胀预期为6.5%,略低于初值6.7%,但仍为1981年以来的最高水平。

  本次调查覆盖期为3月25日至4月21日。

  除了加剧通胀担忧,特朗普政府的贸易政策也加重了对经济和就业市场的焦虑。数据显示,密歇根大学消费者预期指数下滑至47.3,为2022年以来最低,且60%的受访者主动提到关税带来的冲击。

  “劳动力市场前景依然暗淡,”密歇根大学消费者调查主管JoanneHsu在声明中表示,“更令人担忧的是,消费者预计未来一年自身收入增长将放缓。若缺乏稳定强劲的收入支撑,在消费者普遍感知到各种风险信号的情况下,支出势必难以维持强劲。”

  约三分之二的受访者预计未来一年实际收入将下降,预计失业率将上升的受访者占比也有三分之二左右。

  不同党派受访者的预期也全面恶化。民主党人和独立选民的预期指数跌至新低,共和党人的预期降至五个月以来的最低水平。

  密歇根大学当前状况指数较上月下降4点至59.8,不过较初值56.5有所回升,反映暂停加税措施对信心带来些许提振。

虚有其表i车季夏江词:展现独特的魅力与智慧,让人领略生活的的相关文章 英媒:美方提出乌领土切割分管方案的相关文章
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