Clinical Trials
53
23 active
Approvals
44
Total approvals
Agencies
6
Regulatory bodies
Founded
2015
Active, not recruiting
23
43.4%
Completed
11
20.8%
Recruiting
10
18.9%
Terminated
7
13.2%
Unknown
2
3.8%
- Alfasigma S.p.A. has entered a share purchase agreement with SEVER Life Sciences B.V. to acquire 100% of Nordic Group B.V. and its subsidiaries. - The deal adds Nordic Pharma's rheumatoid arthritis business, led by the Nordimet® methotrexate franchise, to Alfasigma's rheumatology portfolio alongside Jyseleca®. - The acquisition deepens Alfasigma's commercial reach across 18 European countries and adds platforms in Canada and Japan, bringing 265 employees and approximately €190 million in 2025 revenue. - The transaction supports Alfasigma's M&A-led growth strategy focused on gastroenterology and immunology, subject to customary closing conditions and regulatory clearances.
- Intercept Pharmaceuticals announced the voluntary withdrawal of OCALIVA (obeticholic acid) from the US market for primary biliary cholangitis treatment following an FDA request. - The FDA has placed a clinical hold on all US clinical trials involving obeticholic acid, citing ongoing safety concerns about liver injury in patients. - OCALIVA received accelerated approval in 2016 but was denied full approval in November 2024 due to insufficient safety and effectiveness data. - The drug's conditional authorization was also revoked by European regulators in June 2024, with confirmatory trial recruitment halted due to patient enrollment difficulties.
- COBALT trial data, published in *The American Journal of Gastroenterology*, shows obeticholic acid (OCA) significantly reduces adverse outcomes in PBC patients. - The study compared OCA-treated patients to an external control arm derived from real-world U.S. claims data. - OCA treatment was associated with a 61% lower relative risk of death, liver transplant, or hepatic decompensation (HR, 0.39; P=0.0010). - Findings support the use of external control arms in rare disease trials, where placebo groups pose ethical and practical challenges.
