相关临床试验
9
1 进行中
药物批准
56
批准总数
监管机构
2
监管机构数
成立时间
N/A
已完成
8
88.9%
尚未招募
1
11.1%
- RBX2660, a microbiota restoration therapy developed by Rebiotix and acquired by Ferring, has been granted Breakthrough Therapy Designation by the FDA for recurrent Clostridioides difficile infection. - The drug aims to restore gut microbiome balance by transplanting live, human-derived microbes into the intestinal tract, offering a potential alternative to antibiotic treatments. - Phase 3 trial data (PUNCH CD 3) demonstrated preliminary positive efficacy in reducing C. diff recurrence, positioning RBX2660 as a frontrunner in live microbiota-based therapies. - RBX2660 has already been granted orphan drug and fast-track status, potentially expediting its path to market for patients with limited treatment options.
- Ferring is expanding its manufacturing capabilities with a new 25,000 square meter facility in Finland to produce the drug substance for Adstiladrin. - The expansion follows FDA approval of Ferring's scale-up process in June 2023 and a partnership with SK pharmteco to further increase manufacturing capacity. - Adstiladrin, an adenovirus vector-based gene therapy, received FDA approval in 2022 as the first gene therapy for bladder cancer, administered via catheter directly into the bladder. - Ferring is also nearing completion of a fill/finish plant in Parsippany, New Jersey, focused on final drug product manufacturing, with larger-scale production expected in the coming years.
