Global biopharmaceutical company focused on oncology and neuroscience; established in California in 2003 and relocated its headquarters to Dublin, Ireland through a 2011 merger with Azur Pharma plc; specializes in treatments for sleep disorders and cancer.
Clinical Trials
2
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2003
Active, not recruiting
1
50.0%
Completed
1
50.0%
No approval data available
- A new comprehensive report analyzes the global clinical trials landscape for Lennox-Gastaut Syndrome, providing critical data on trial numbers, enrollment figures, and regional distribution across G7 and E7 nations. - The analysis covers diverse aspects of clinical trials categorized by region, trial phase, status, sponsorship type, and endpoint analysis, highlighting prominent drugs currently under investigation. - Major pharmaceutical companies including Jazz Pharmaceuticals, Takeda, UCB, GSK, and Eisai are actively conducting trials in this rare epilepsy syndrome space. - The report aims to facilitate strategic business planning and investment decisions while identifying optimal locations for conducting efficient clinical trials in this challenging therapeutic area.
- A U.S. District Court upheld the FDA's decision to approve Avadel's Lumryz, a once-nightly sodium oxybate formulation, for narcolepsy. - The court agreed with the FDA that Lumryz is clinically superior to Jazz Pharmaceuticals' Xywav, which requires twice-nightly dosing, due to its less disruptive effect on sleep. - The ruling affirms the FDA's authority to approve a subsequent orphan drug during the exclusivity period of an existing one if the new drug demonstrates clinical superiority. - The court rejected Jazz's claims that the FDA acted arbitrarily by not requiring 'comparable safety' and by deviating from internal dispute resolution policies.
