Clinical Trials
14
4 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
4
28.6%
Completed
5
35.7%
Recruiting
1
7.1%
Terminated
3
21.4%
Unknown
1
7.1%
No approval data available
- Regulatory approval represents the starting line, not the finish line, for pharmaceutical companies transitioning from development to commercialization, with market success demanding entirely new capabilities beyond scientific rigor. - ARS Pharma's experience launching Neffy (epinephrine nasal spray) reveals that cultural tension between development teams' analytical caution and commercial teams' market responsiveness is the most underestimated risk in the transition. - Industry executive Amy Vie emphasizes that execution—not strategy—determines whether breakthrough therapies reach their full potential, noting that even a cure for cancer fails without proper commercial execution. - Launch preparedness creates strategic optionality and value, with commercialization needing to be the default plan regardless of whether a company ultimately partners, transacts, or launches independently.
- ANI Pharmaceuticals' NEW DAY trial of ILUVIEN for diabetic macular edema failed to meet its primary endpoint of reducing supplemental aflibercept injections compared to aflibercept alone (2.4 vs. 2.5 injections, p=0.756). - A post-hoc analysis of patients without protocol deviations showed ILUVIEN significantly reduced supplemental injections (1.8 vs. 2.5, p=0.029), resulting in fewer total injections over 18 months. - ILUVIEN demonstrated a statistically significant longer time to first supplemental injection (185.4 vs. 132.8 days, p<0.001) and showed non-inferiority in visual acuity outcomes. - The safety profile was consistent with previous studies, with 41% of ILUVIEN patients experiencing treatment-related adverse events, primarily cataracts and increased intraocular pressure.
