Tags : Submission

Janssen Reports the NDA Submission to the US FDA for

Shots:   The NDA submission is based on P-III UPTRAVI IV study he safety and tolerability of 20 patients with PAH temporarily switching from oral UPTRAVI to UPTRAVI IV, and then transitioning back to the initial oral dose Results demonstrated that Uptravi IV is suitable to maintain continuous dosing for short periods of time when the […]Read More

Janssen Reports sBLA Submission to the US FDA for Darzalex

Shots: The sBLA submission is based on P-III ANDROMEDA study assessing Darzalex Faspro (SC) + bortezomib, cyclophosphamide, and dexamethasone (D-VCd) vs VCd as monothx. in 388 patients with newly diagnosed (AL) amyloidosis The study resulted in meeting its 1EPs overall hematologic complete response rate. The sBLA is being reviewed under the FDA’s RTOR program and […]Read More

Kite Reports sBLA Submission to the US FDA for Yescarta

Shots: The sBLA submission is based on an ongoing P-II ZUMA-5 study assessing single infusion of Yescarta in ~160 patients (≥18 yrs.) with r/r indolent NHL of either FL or marginal zone lymphoma subtypes, prior treated with 2L therapies, including an anti-CD20 mAb combined with an alkylating agent The 1EPs of the study is ORR […]Read More

Bayer Reports the NDA Submission to NMPA for Vericiguat to

Shots: The NDA submission was submitted to NMPA’s CDE and is based on P-III VICTORIA study, seeking regulatory approval of vericiguat in China In Oct’2014, Bayer and MSD signed a WW agreement for sGC modulators. The therapy is being jointly developed by both the companies as per the collaboration and has received the US FDA’s […]Read More

BioMarin Reports NDA Submission to the US FDA for Vosoritide

Shots: BioMarin has submitted an NDA to the US FDA for vosoritide to treat children with achondroplasia The company also reported that EMA has begun validation of MAA for the therapy on 13 Aug, 2020 Vosoritide is an investigational, once-daily injection analog of C-type Natriuretic Peptide (CNP) and is potentially the first treatment for achondroplasia […]Read More

Gilead Reports NDA Submission to the US FDA for Veklury

Shots: The NDA filing is based on P-III studies evaluating Veklury vs PBO, conducted by NIAID. The studies demonstrated that Veklury led to faster time to recovery and that a 5-day or 10-day treatment duration led to similar clinical improvement Across multiple studies, Veklury was generally well-tolerated in both the 5-day and 10-day treatment groups, […]Read More

BioMarin Reports the Submission of MAA to EMA for Vosoritide

Shots: The MAA is based on P-III study assessing the efficacy and safety of vosoritide, further supported by the long-term safety and efficacy from the ongoing P-II and P-III extension studies and extensive natural history data Following the completion of EMA’s validation, BioMarin expects the initiation of the MAA review to commence in Aug’2020. The […]Read More

Biogen and Eisai Complete the Submission of BLA to the

Shots: The completed submission followed ongoing collaboration with the FDA and includes clinical data from the P-III EMERGE and ENGAGE studies along with the P-Ib PRIME study. Additionally, Biogen has requested Priority Review The P-III EMERGE study met its 1EPs in patients treated with a high dose showed a reduction of clinical decline from baseline […]Read More

RedHill Biopharma Reports the Submission of CTA for P-II/III Study

Shots: RedHill has submitted CTA with the Ministry of Health of the Russian Federation for a P-II/III clinical study evaluating Yeliva (opaganib, ABC294640)1 in patients hospitalized with severe COVID-19 and pneumonia The P-II/III study will assess opaganib vs placebo, on top of SOC and plans to enroll 270 patients with severe COVID-19 pneumonia requiring hospitalization […]Read More

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