Mirati Therapeutics Inc.发布了其备受期待的KRAS癌战斗机Adagrasib(MRTX-849)的新数据,与已在营销的竞争,Amgen Inc的Lumakras(Sotorasib)相比,结果不同。with KRAS-G12C non-small-cell lung cancer enrolled in Mirati’s registration-enabling phase II Krystal-1 study. Each had received at least one prior systemic therapy, most with a PD-1/L1 inhibitor following or in combination with chemotherapy.
Phase II melanoma data characterized by Iovance Biotherapeutics Inc. as positive failed to excite Wall Street, which took away 53.6% of the company’s share value (NASDAQ:IOVA), or $8.10, and pushed the closing price to $7.02 on May 27. The San Carlos, Calif.-based firm offered results from registrational cohort 4 (n=87) of the C-144-01 study testing lifileucel (LN-144, autologous tumor infiltrating lymphocytes) in advanced melanoma.
固体阶段III一线最高领先的结果是在印度一项针对PMZ-1620(Sovateltide)治疗中风的研究结果,它促使Pharmazz Inc.重新考虑其前往美国诊所的道路,而私有公司计划从该公司申请营销授权。印度中央药物标准控制组织,它还计划与FDA讨论启动II期研究。但是,由于新数据是如此坚实,因此可能要求在美国进行III期研究,并期望参与者的数量从印度研究中的158个增加到多达400至500名参与者U.S. and Europe, Anil Gulati, Pharmazz’s CEO and founder, toldBioworld。
The recent online publication of findings from the University of Southern California ataxia working group called Enigma served to fuel more interest in the simmering drug development space of Friederichs’s ataxia (FRDA), where a handful of gene therapies and other approaches, plus one promising small-molecule treatment, are in the works.
Just in case the U.S. FDA didn’t get the message from its advisory committee about drug applications based solely on clinical trial data from China, a trio of U.S. lawmakers wrote to FDA Commissioner Robert Califf to voice their concerns about the “current ‘East to West’ movement of clinical data” to support the approval of me-too drugs.