相关临床试验
27
3 进行中
药物批准
12
批准总数
监管机构
2
监管机构数
成立时间
1983
进行中（未招募）
3
11.1%
已完成
22
81.5%
终止
1
3.7%
撤回
1
3.7%
- Heron Therapeutics has reached a settlement agreement with Mylan Pharmaceuticals to resolve ongoing patent litigations related to CINVANTI and APONVIE injectable emulsions. - Under the settlement terms, Heron grants Mylan a license to market generic versions of both aprepitant products in the United States beginning June 1, 2032, approximately three years before patent expiration. - The agreement concludes litigation initiated by Heron in response to Mylan's abbreviated new drug applications seeking FDA approval for generic versions prior to the 2035 patent expiration.
- Design Therapeutics has appointed Chris Storgard, M.D., as Chief Medical Officer, bringing over two decades of leadership in drug development with experience advancing multiple assets through global regulatory approvals. - Dr. Storgard previously served as CMO at ADARx Pharmaceuticals and Heron Therapeutics, where he secured U.S. and European approvals for several products in oncology and acute care. - The appointment comes at a strategic time as Design Therapeutics advances its portfolio of GeneTAC® small molecules targeting serious degenerative genetic diseases, including its lead program for Friedreich ataxia.
• The FDA has approved Heron Therapeutics' Prior Approval Supplement Application for the Zynrelef Vial Access Needle (VAN). • The VAN simplifies aseptic preparation and significantly reduces Zynrelef's withdrawal time to 20-45 seconds. • Expected to launch in Q4 2024, the VAN aims to enhance safe use, increase adoption, and improve the preparation process of Zynrelef. • Zynrelef is a dual-acting local anesthetic combining bupivacaine and meloxicam, designed to reduce postoperative pain for up to 72 hours.
• The FDA is expected to decide on Vanda Pharmaceuticals' tradipitant for gastroparesis by September 18, potentially offering a novel NK-1R antagonist treatment option. • Zevra Therapeutics awaits a verdict by September 21 on arimoclomol for Niemann-Pick disease type C, an ultrarare neurodegenerative disorder with no approved therapies. • A decision is anticipated by September 26 on Bristol Myers Squibb's KarXT for schizophrenia, representing a new pharmacological approach targeting muscarinic receptors.
• Vanda Pharmaceuticals awaits FDA decision on tradipitant for gastroparesis, a condition affecting millions in the U.S., with a verdict expected by September 18. • Zevra Therapeutics anticipates potential approval of arimoclomol for Niemann-Pick disease type C (NPC) by September 21, following positive advisory committee support. • The FDA is set to decide on Heron Therapeutics' extended-release needle for Zynrelef by September 23, designed to simplify drug preparation and administration. • Merck seeks approval for Keytruda in pleural mesothelioma, with a decision due September 25, based on Phase II/III KEYNOTE-483 trial data showing improved survival. • Bristol Myers Squibb awaits FDA decision on KarXT for schizophrenia by September 26, potentially offering a novel mechanism of action targeting muscarinic receptors. • Sanofi and Regeneron anticipate a decision on Dupixent for COPD by September 27, supported by Phase III BOREAS and NOTUS trials demonstrating reduced exacerbations.
