相关临床试验
92
80 进行中
药物批准
65
批准总数
监管机构
4
监管机构数
成立时间
N/A
进行中（未招募）
80
87.0%
已完成
5
5.4%
招募中
7
7.6%
- Amneal Pharmaceuticals received FDA approval for lanreotide injection 120 mg/0.5 mL in a single-dose prefilled syringe, referencing Ipsen's Somatuline Depot. - The product launched immediately and carries Competitive Generic Therapy designation, supported by Amneal's in-house manufacturing capacity for complex injectables. - Lanreotide is indicated for acromegaly, advanced gastro-enteropancreatic neuroendocrine tumors and carcinoid syndrome, controlling hormone levels and improving progression-free survival in eligible patients. - U.S. annual sales of Somatuline Depot reached $983 million in the 12 months ended July 2026, according to IQVIA data cited by Amneal.
- The U.S. District Court for the District of Massachusetts ruled in favor of Radius Pharmaceuticals and Ipsen in a patent infringement case against Orbicular Pharmaceutical Technologies for their proposed generic TYMLOS product. - The court upheld the validity of all five TYMLOS patents asserted, with the latest patent protection extending through April 30, 2038. - TYMLOS (abaloparatide) is an FDA-approved parathyroid hormone related peptide for treating postmenopausal women and men with osteoporosis at high risk for fracture. - The favorable ruling reinforces the strength of the TYMLOS patent portfolio and represents an important commercial victory for Radius in protecting their bone health franchise.
- A real-world study indicated that first-line NALIRIFOX had a numerically higher median overall survival (OS) of 11.1 months compared to FOLFIRINOX's 9.1 months in mPDAC patients. - The analysis included a trial-aligned cohort, an all-comer cohort, and a modified FOLFIRINOX cohort, assessing survival outcomes in metastatic pancreatic ductal adenocarcinoma. - The findings suggest NALIRIFOX may offer a survival advantage over FOLFIRINOX in treating mPDAC, warranting further studies adjusting for baseline characteristics. - Data were sourced from the Flatiron Electronic Health Record, covering patients treated between January 2014 and February 2024, providing a comprehensive real-world view.
