相关临床试验
42
40 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2002
进行中(未招募)
40
95.2%
已完成
1
2.4%
招募中
1
2.4%
暂无批准数据
- A new $500 million nonprofit fund called Intercept launched June 24 aims to eliminate respiratory infections like the common cold and flu by de-risking early-stage drug development and deploying air-cleaning technologies. - Backed by Stripe, Anthropic, OpenAI Foundation, Bill Gates, and others, Intercept plans to shepherd at least two drug candidates through Phase I and II clinical trials to attract pharmaceutical industry partners. - The initiative also seeks corporate partners including Warby Parker, Mastercard, and JP Morgan to pilot air filtration and UV light systems in workplaces, treating airborne pathogen removal like municipal water purification. - Scientific advisors include former FDA official Peter Marks and Operation Warp Speed leader Moncef Slaoui, with University of Washington structural biologist David Veesler providing the technical vision for broad-spectrum countermeasures.
- Inventiva has appointed Dr. Jason Campagna as President of R&D and Chief Medical Officer to lead the development of lanifibranor, a first-in-class pan-PPAR agonist for MASH treatment. - Dr. Campagna brings extensive experience from Intercept, where he led the first-ever NDA submission for MASH indication and designed advanced clinical programs. - Dr. Martine Zimmermann joins as Executive Vice President of Regulatory Affairs and Quality Assurance, bringing expertise in global regulatory strategy for chronic liver diseases. - The appointments come as Inventiva advances lanifibranor through the pivotal Phase 3 NATiV3 trial, with topline results expected in the second half of 2026.
- The FDA's Gastrointestinal Drugs Advisory Committee (GIDAC) has voted against full approval of Intercept's Ocaliva for primary biliary cholangitis (PBC). - The vote raises concerns about Ocaliva's clinical benefit as a second-line therapy for PBC patients, despite eight years of real-world patient experience. - Intercept remains committed to working with the FDA to address concerns and seek full approval for Ocaliva, with a PDUFA date set for October 15, 2024. - Ocaliva, a farnesoid X receptor (FXR) agonist, is currently approved under accelerated approval based on reduction in alkaline phosphatase (ALP).