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
Shots: Amgen anticipates no disruption in its supply of medicines for patients across the globe due to COVID-19 and is expected to have no shortage of its therapies The company has temporarily paused the enrollment/screening in clinical studies to ensure the safety of subjects or integrity of data during a pandemic Amgen reported that P-II […]Read More
Shots: The P-III CheckMate -915 study involves assessing of Opdivo (240mg, IV, q2w) in combination with Yervoy (1 mg/kg, q6w) vs Opdivo (480mg, q4w) as monothx. as the adjuvant therapy in 1,943 patients who have had complete surgical removal of stage IIIb/c/d or stage IV melanoma The P-III CheckMate -915 study did not meet its […]Read More
Shots: The EC has approved label update which is based on Phase III DECLARE-TIMI 58 study results assessing Forxiga vs PBO on CV outcomes in 17,000 patients with T2D at risk of CV events across 33 countries The P-III DECLARE-TIMI 58 study results: reduction in hospitalization for heart failure/CV deaths, safe and effective with no […]Read More
Shots: Jounce to receive $50M up front, $180M as development & regulatory milestones, $300M as commercial milestones, royalties on global sales and will retain WW rights to its pipeline including vopratelimab, JTX-4014 and all discovery programs Celgene to get WW rights to develop & commercialize Jounce’s JTX-8064, an anti-leukocyte immunoglobulin like receptor B2 (LILRB2) Ab, […]Read More
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