相关临床试验
273
266 进行中
药物批准
48
批准总数
监管机构
5
监管机构数
成立时间
N/A
进行中（未招募）
266
97.4%
已完成
4
1.5%
招募中
3
1.1%
- The FDA issued a Warning Letter to Sanofi's Genzyme Ireland facility on June 22, 2026, following CGMP violations found during a January 2026 inspection of the Waterford site manufacturing Altuviiio. - Quality problems account for 62% of drug supply chain disruptions, and the Warning Letter directly threatens the multinational LIBERTY roll-over study providing continued Altuviiio access to hemophilia A patients. - Clinical sites are urged to immediately verify IP stock levels against 60-day projected visits and document all supply inquiries in the TMF to mitigate protocol deviation risks. - This marks the second FDA Warning Letter to a Sanofi manufacturing subsidiary within 18 months, signaling a systemic quality governance concern requiring formal vendor risk stratification across all active INDs.
- Novartis announced that a Phase 3 trial of its oral multiple sclerosis drug remibrutinib met its primary endpoint, significantly reducing relapses compared with teriflunomide. - Remibrutinib also outperformed teriflunomide on all key secondary endpoints while demonstrating a favorable and stable safety profile. - The results address an unmet need for oral therapies offering robust relapse prevention and slower disability progression, according to Novartis Chief Medical Officer Shreeram Aradhye. - Novartis shares rose on the news, and the company plans to present full trial data at an MS conference in Toronto in October.
- Ultragenyx Pharmaceutical appointed Eric Olson as Chief Business Officer and Executive Vice President effective September 22, 2025, following Thomas Kassberg's planned retirement after 14 years with the company. - Olson brings nearly two decades of biopharma business development experience, having led or supported over $15 billion in aggregate transaction value across rare disease and other therapeutic areas. - The appointment positions Ultragenyx to continue expanding what the company describes as the largest clinical pipeline in rare disease, building on four commercial therapies already approved. - Olson's previous roles include Chief Business Officer at Stoke Therapeutics and leadership positions at Alnylam Pharmaceuticals, Takeda, and Genzyme Corporation, with notable deals including partnerships worth billions of dollars.
- BioCryst Pharmaceuticals announced that CEO Jon Stonehouse will retire on December 31, 2025, with current Chief Commercial Officer Charlie Gayer set to succeed him as president in August and CEO in January 2026. - Gayer led the successful commercial launch of ORLADEYO (berotralstat), the first oral prophylactic therapy for hereditary angioedema, driving exceptional revenue growth with expected peak sales of $1 billion. - The leadership transition comes as BioCryst has matured into a profitable company generating increasing cash resources through ORLADEYO revenue while advancing a promising pipeline of rare disease therapies. - Gayer brings over 10 years of experience at BioCryst and extensive rare disease commercial expertise from previous roles at Talecris Biotherapeutics, Grifols, and GlaxoSmithKline.
- Crescent Biopharma has appointed Jan Pinkas, Ph.D., as chief scientific officer, bringing over two decades of oncology drug development experience including expertise in antibody-drug conjugates. - The company expects to begin dosing patients in a global Phase 1 trial of CR-001, a PD-1 x VEGF bispecific antibody, in early 2026. - Crescent anticipates submitting an IND application for CR-002, a novel antibody-drug conjugate, in mid-2026. - Dr. Pinkas previously served as chief scientific officer at Pyxis Oncology and contributed to the development of ELAHERE, an approved ADC for platinum-resistant ovarian cancer.
