PDC*line Pharma Presents Primary Clinical Results From Phase I/II …
Dec 14, 2024 · PDC*lung01, in combination with pembrolizumab, demonstrates the potential to provide meaningful clinical benefit compared to pembrolizumab alone in stage IV Non-Small Cell Lung Cancer patients with PD-L1 ≥ 50% and is associated with mild safety profile.
ESSENCE Phase 3 trial results demonstrating statistically significant ...
Nov 20, 2024 · The trial achieved both its primary endpoints, with semaglutide 2.4 mg demonstrating statistically significant and superior improvements in liver fibrosis with no worsening of steatohepatitis, as well as resolution of steatohepatitis with no worsening of liver fibrosis in people with MASH compared to placebo. 1 Supportive secondary endpoints showed improvements in liver enzymes, including ...
UCB Presents Encouraging Data on Bepranemab in Early …
Oct 31, 2024 · Results provide first evidence of biological and clinical effect of a mid-domain tau-targeting disease-modifying therapy 1 ; In full study population primary endpoint was not met, however in key secondary endpoints bepranemab slowed cognitive decline and rate of tau accumulation 2; In pre-defined patient subgroups, consistent treatment benefit shown across multiple primary and secondary ...
Omeros’ Narsoplimab Meets its Pivotal Trial Primary Endpoint ...
Dec 20, 2024 · Primary statistical analysis of overall survival compared TA-TMA patients treated with narsoplimab in its pivotal trial to a cohort of over 100 TA-TMA patients not treated with narsoplimab in an external control stem cell transplant registry; FDA-agreed analysis was conducted by an independent external statistical group
City Therapeutics Launches with $135 Million Series A Financing to …
Oct 9, 2024 · Harnessing next-generation siRNA engineering to improve and expand the therapeutic reach of RNAi-based medicines. Building sustainable product engine for innovative RNAi therapeutics to make a significant impact for patients across multiple disease indications, with first program expected to enter clinical development at or around year-end 2025
Metsera Reports Highly Competitive Results from Ongoing Trial of …
Sep 25, 2024 · Results include 7.5% reduction in body weight from baseline at day 36. Weight loss continued to at least 4 weeks after last dose administered. MET-097, incorporating Metsera’s HALO™ platform technology, achieved 380-hour half-life
Aflibercept 8 mg met primary endpoint in phase III study and ...
Dec 17, 2024 · Approximately 90% of aflibercept 8 mg patients were extended to every 8-week dosing and maintained their interval through 36 weeks. Aflibercept 8 mg demonstrated rapid and robust reduction of fluid in the retina, as measured by changes in central subfield thickness
REGENXBIO Presents Positive Data from the Phase II Study of …
Oct 21, 2024 · Custom Report. La Merie Publishing offers the service of preparing customized reports tailored to the needs and specifications of the customer. We conduct scientific & medical literature evaluations for clients of the biopharmaceutical industry within the scope of …
US FDA Approves Dong-A ST’s IMULDOSA™ (ustekinumab-srlf), a …
Oct 12, 2024 · Dong-A ST’s biologics license application (BLA) for Imuldosa, submitted in October 2023, is approved by the U.S. Food and Drug Administration
Sumitomo Pharma America Announces U.S. FDA Approval of …
Dec 23, 2024 · – GEMTESA ® is the first and only beta-3 agonist approved for the treatment of men with OAB symptoms who are receiving pharmacological therapy for BPH – . MARLBOROUGH, MA, USA I December 23, 2024 I Sumitomo Pharma America, Inc. (SMPA) announced today that the U.S. Food and Drug Administration (FDA) has approved GEMTESA ® (vibegron), a beta-3 (β 3) adrenergic receptor agonist, dosed once ...