近日,FDA官网更新了礼来和诺和诺德原研注射制剂的短缺目录状态,由"Limited Availability"变为"Available"。这一变化引发了市场对美国药房自配制剂(Compounding)需求减弱的担忧,进而影响了国内GLP-1原料药相关公司的业绩预期。然而,中信证券的最新分析报告指出,这一变化并未对GLP-1原料药需求的中长期逻辑造成实质性影...
^https://www.fda.gov/drugs/drug-safety-and-availability/update-fdas-ongoing-evaluation-reports-suicidal-thoughts-or-actions-patients-taking-certain-type ^https://security.feishu.cn/link/safety?target=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fnews%2Fmeeting-highlights-pharmacovigilance-risk-assessment-...
[4] FDA. Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity. [https://www.fda.gov/drugs/drug-safety-and-availability/update-fdas-ongoing-evaluation-reports-suicidal-thoughts-or-a...
事项:2024年8月以来,礼来和诺和诺德因为生产供应逐步改善,替尔泊肽和司美格鲁肽原研注射制剂在FDA官网的短缺目录中的状态陆续由“Limited Availability”更新为“Available”(司美格鲁肽的小剂量0.25 mg/0.5 mL剂型除外);根据FDA规定,当原研制剂进入FDA短缺供应(Drug Shortages)目录,美国药房可以通过自配制剂...
Mounting evidence indicates that the potential of GLP-1R agonists, mimicking a 30 amino acid ligand, GLP-1, extends to the treatment of neurodegenerative conditions, with a particular focus on Alzheimer's disease (AD). However, the mechanism that underlies regulation of GLP-1R availability in ...
Dr Gabbay:This has been one of the evolving stories in the world of diabetes. Probably one of the biggest game changers over the last decade is having the availability of continuous glucose monitors. It’s very clear...
礼来和诺和诺德因为生产供应逐步改善,替尔泊肽和司美格鲁肽原研注射制剂在FDA(美国食品药品监督管理局)官网短缺目录中的状态陆续由“Limited Availability”(有限)更新为“Available”(可获得)(司美格鲁肽的小剂量0.25 mg/0.5 mL剂型除外),引发市场担忧药房市场复方制剂需求减弱,从而可能影响国内GLP-1原料药...
▍原研注射制剂短缺逐步改善,不改GLP-1原料药历史级别需求逻辑。 事项:2024年8月以来,礼来和诺和诺德因为生产供应逐步改善,替尔泊肽和司美格鲁肽原研注射制剂在FDA官网的短缺目录中的状态陆续由“Limited Availability”更新为“Available”(司美格鲁肽的小剂量0.25 mg/0.5 mL剂型除外);根据FDA规定,当原研制剂进入FDA...
which no matter what side of the aisle you fall on, I'm sure we can agree that's a really significant portion of pregnancies that are unplanned. Over the past year, we've seen a lot of progress with birth control, including the availability of Opill, which is an over-the-counter ...
▍原研注射制剂短缺逐步改善,不改GLP-1原料药历史级别需求逻辑。 事项:2024年8月以来,礼来和诺和诺德因为生产供应逐步改善,替尔泊肽和司美格鲁肽原研注射制剂在FDA官网的短缺目录中的状态陆续由“Limited Availability”更新为“Available”(司美格鲁肽的小剂量0.25 mg/0.5 mL剂型除外);根据FDA规定,当原研制剂进入FDA...