Shots: Regenxbio has reported that the ATMOSPHERE trial evaluating RGX-314 is active and patient screening is ongoing. The study will enroll 300 patients across two RGX-314 dose arms vs ranibizumab, with anticipated initiation of patients dosing in Q1’21 The second trial is expected to be similar in design to ATMOSPHERE with its expected initiation in […]Read More
Shots: The P-ll RESTORE-1 study involves assessing NBIb-1817(VY-AADC) for the treatment of Parkinson’s disease. Neurocrine & Voyager will closely work with FDA & DCMB to determine the next clinical trial for RESTORE-1 DSMB request a clinical hold, follows the IND Safety Report submit by Neurocrine Biosciences related to the observation of MRI abnormalities in some […]Read More
Shots: The company will not expand the P-II EMERGE study that assesses Vopratelimab + ipilimumab in PD-(L)1 inhibitor experienced NSCLC patient. Early evaluation of the study showed that the trial will not meet pre-specified interim criteria for continuation of enrollment The company also reported the first patient dosing in P-II SELECT study assessing Vopratelimab + […]Read More
Shots: The updated label includes P-III DECLARE-TIMI 58 study that assesses the effect of Forxiga vs PBO on CV outcomes in 17000+ patients with T2D at risk of CV events also assessed key renal 2EPs, across 882 sites in 33 countries The study demonstrated that Forxiga achieved a significant reduction in the composite EP of […]Read More
Shots: The company highlights its lead candidate, SLN360 for CV disease associated with high Lp (a) levels and has received the US FDA’s IND approval to start dose-escalation studies in healthy volunteers and secondary prevention patients with elevated Lp(a). The company plans to start dosing healthy volunteers in the P-I study later this year The […]Read More
Shots: Denali reported the results of P-Ib studies of DNL747 in AD and ALS and provides an update on its broad RIPK1 program including DNL788 and DNL758. The P-Ib studies has met its safety endpoints in patients with ALS and AD, further dose escalation to achieve higher levels of target inhibition may be limited by […]Read More
Shots: The P-Ib/II CARTITUDE-1 study involves assessing JNJ-4528 in 29 heavily pretreated patients with r/r MM. The P-Ib results will be shared at ASCO The P-Ib/II study results: 100% ORR with 97% good PR and 3% PR; patients achieving stringent CR @median of 11.5mos (86%), PFS at 9mos (86%); median time to first response was […]Read More
Formycon signs an agreement with Bioeq AG and manufacturing partner for resubmission of BLA for FYB201 project (biosimilar, ranibizumab). Bioeq AG is in talks with the US FDA for resubmission supporting manufacturing data in the H2’20 In Oct 2019, Formycon’s FYB202 (biosimilar, ustekinumab) has completed its P-I trial with its initiation of P-III trial in […]Read More
Shots: Following the IDMC recommendation, ongoing P-III study will be amended to enroll only critical patients. The P-III study also be amended discontinue lower-dose of Kevzara (200 mg) with all new patients to receive either Kevzara (400 mg) or placebo The ongoing portion of P-III study will enroll ~600 patients in the critical group with […]Read More
Shots: Xlucane is still on track towards regulatory approval ahead of Lucentis’ patent expiration in EU July 2022. Despite the COVID-19, Xplore will continue the recruitment of new patients and treatment for patients currently in the study Xbrane will ensure the safety participants in the P-III study as well as the integrity of study data […]Read More
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