Momelotinib Dihydrochloride

GSK said its decoupling with Haleon is a key reason why it views itself as “well-positioned” in the face of potential pharma-specific tariffs. When the drugmaker went through its “ demerger ” with the consumer health business in 2022, there were “very intentional, deliberate choices to reset” its supply chain for “regional resilience” as well as “double sourcing” to allow for flexibility, CEO Emma Walmsley said. It has “mitigation options” that it could execute across its manufacturing networks once pharma levies are in place, the UK company said in a statement. “We’re watching it very carefully … we are well-prepared,” Walmsley said during GSK’s first-quarter earnings call with the media. Some drug developers and CDMOs have similarly expressed how their earlier moves — which were made even before the talk of tariffs emerged — would help them navigate sector-specific levies regardless of what these might look like. President Donald Trump’s tariffs have been a central theme during this earnings season as drugmakers disclose their exposures and strategies to varying degrees. Last week, Roche CEO Thomas Schinecker said the pharma tariffs could have a negative impact on dealmaking. But Walmsley somewhat disagreed, saying “there are some opportunities” for deals and that half of GSK’s pipeline comes from this business development approach. “We’re constantly looking at things … and we also continue to look at the opportunities out of China on BD. We’ve done several good deals ,” she said. GSK’s disappointing vaccine sales stood out in Q1. Sales for this franchise dropped 6% in the quarter due to “known headwinds,” GSK said. Shingrix struggled in the US due to “harder-to-reach unvaccinated customers” and increased channel inventory consumption. As for Arexvy, sales disappointed because of the FDA’s Advisory Committee on Immunization Practices’ constricted recommendation only for people aged 60 to 74. But Jefferies analysts said GSK’s vaccine sales of £2.1 billion were actually better than consensus expectations of £2.05 billion. Shingrix beat forecasts with £867 million in worldwide sales, although Arexvy sales are still notably low at £78 million. Walmsley added that both vaccines still have room for growth internationally. Despite these market challenges, Walmsley told the media GSK does not intend to change its R&D plans for vaccines. Overall, GSK had a positive total sales profile, pulling in £7.5 billion in Q1, up 4% at constant exchange rates. Its shares were up by as much as 4% on the London Stock Exchange on Wednesday morning. The company’s specialty medicines portfolio had a particularly solid performance at £2.9 billion — a 17% jump — beating Jefferies’ consensus estimates of £2.84 billion. “We’ve been able to strengthen the portfolio with a shift to more specialty medicines, and that creates oxygen through the gross margin,” Walmsley said. Notably, Jemperli pulled in £174 million in Q1 compared with a lower benchmark of £145 million. GSK said Jemperli’s US sales momentum is supported by the drug’s approval in all patients with primary advanced or recurrent endometrial cancer. GSK also touted its market progress with Ojjaara at £112 million, as the myelofibrosis therapy makes headway in the US and other territories. But analysts noted the drug’s sales just missed forecasts at £117 million. Nonetheless, GSK’s overall showing on Wednesday follows the optimistic tune played in February, when it set a higher bar for its 2031 sales outlook to at least $40 billion. This is a £2 billion jump from a prior target. Looking at its clinical pipeline, GSK discontinued a Phase 2 trial of an anti-IL18 antibody, codenamed GSK1070806, for atopic dermatitis due to pipeline prioritization. Endpoints News previously reported that GSK’s ViiV Healthcare stopped work on its HIV antiviral named VH3739937.

在医药行业，药品的处方信息准确与否直接关系到患者的用药安全。近日，葛兰素史克（GSK）因旗下 JAK 抑制剂 Omjjara 的处方信息出现 “惊人错误”，受到了相关监管机构的严厉斥责，这一事件在业内引发了广泛关注。错误处方信息曝光，引发质疑一位自称是医疗专业人员的人士向负责监督英国营销规范的机构 PMCPA 反映了 Omjjara 处方信息存在的问题。Omjjara 这款药物明确禁止在孕期使用，然而其处方信息中却写道：“使用口服激素避孕药的女性在治疗期间及最后一剂 Omjjara 服用后至少 1 周，应添加屏障避孕法。” 投诉者指出，从常理推断，任何非口服激素避孕方式同样可能存在风险，这一表述让人对 GSK 制作准确处方信息的能力产生质疑，也怀疑该公司在发布前是否对这些内容进行了充分审核。判定违规，影响公司声誉PMCPA 在接到投诉后展开调查，最终判定 GSK 违反规定。该机构认为，GSK 的这一处方信息具有误导性，尽管公司声称在创建和认证相关材料时遵循了流程，但依然未能保证信息的准确性，这表明其未能维持高标准。此外，由于该药物受到额外监管且孕期禁用，GSK 提供的误导性信息可能会对胎儿造成潜在危害，PMCPA 据此判定 GSK 的行为给医药行业带来了不良影响，这一判定通常用于特别严重的违规行为。此次违规违反了英国营销规范第 2 条条款，对 GSK 的声誉造成了不小的冲击。事件背后的行业警示GSK 此次因处方信息错误遭斥责，不仅仅是一家公司的问题，更给整个医药行业敲响了警钟。准确的处方信息是医生和患者安全用药的重要依据，任何细微的错误都可能引发严重后果。这一事件提醒各大药企，在药品研发、生产和推广的每一个环节，都要严谨对待处方信息的准确性和完整性，加强内部审核机制，确保类似错误不再发生。同时，监管机构也应加强对药企的监督力度，保障公众的用药安全。目前，GSK 尚未就此次事件做出进一步回应，后续该公司将如何整改、挽回声誉，以及行业内其他企业会从中吸取哪些教训，值得持续关注。识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。