Tags : Completion

Biotech Regulatory

Mallinckrodt Reports Completion of BLA Submission to the US FDA

Shots: In Apr 2020, Mallinckrodt’s Stratatech initiated StrataGraft’s BLA submission process which is a regenerative skin tissue therapy to develop therapies for deep partial-thickness thermal burns in adults The BLA submission is based on P-III STRATA2016 clinical trial published in Journal of Burn Care & Research and is supported by STRATA2011 clinical trial (Published in […]Read More


Allergan Announces Completion of UBR-MD-04 & 3110-105-002 Study for Treatment

Shots: The two pivotal study conducted for assessing ubrogepant (50/100) vs usual care & ubrogepant (100) vs PBO for 1year & 8 wks. respectively to treat migrane in adults, evaluating its safety, tolerability & hepatic safety UBR-MD-04 (N=1,254) & 3110-105-002(N=516) study results: 21,454 migraine attacks were treated with 31,968 doses of ubrogepant with mean number […]Read More