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Transcenta Announces Orphan Drug Designation Granted to TST001 for Treatment of Gastric and Gastroesophageal Junction


Transcenta Announces Orphan Drug Designation Granted to TST001 for Treatment of Gastric and Gastroesophageal Junction
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SUZHOU, China, July 28, 2021 /PRNewswire/ Transcenta Holding Limited ( Transcenta ), a clinical stage global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to TST001, its anti-Claudin18.2 monoclonal antibody currently in Phase I clinical trial, for the treatment of patients with gastric cancer or gastroesophageal junction (GC/GEJ). According to preclinical and clinical data, TST001 displayed potent anti-tumor activities in tumor model of gastric cancer or patient of gastric cancer expressing Claudin18.2. ....

United States , Los Angeles , Michael Shi , Clinical Development Centers , Transcenta Holding , Drug Administration , Product Development Center , Translational Research Center , Prnewswire Transcenta Holding Limited , National Cancer Institute Surveillance , End Results Program , Business Development , Transcenta Immune Tolerance Breaking Technology , Holding Limited , Orphan Drug Designation , National Cancer Institute , Drug Designation , Immune Tolerance Breaking Technology , Manufacturing Facility , External Partnering Center , ஒன்றுபட்டது மாநிலங்களில் , லாஸ் ஏஞ்சல்ஸ் , மைக்கேல் ஷி , மருத்துவ வளர்ச்சி மையங்கள் , ப்ராடக்ட் வளர்ச்சி மையம் , மொழிபெயர்ப்பு ஆராய்ச்சி மையம் ,

Novartis reports clinically relevant improvement in median overall survival data in final analysis of pivotal NETTER-1 study with targeted radioligand therapy Lutathera


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EAST HANOVER, N.J., June 3, 2021 /PRNewswire/ Novartis today reported the final analysis from the NETTER-1 phase III study comparing treatment using Lutathera
® (INN: lutetium (177Lu) oxodotreotide / USAN: lutetium Lu 177 dotatate) plus 30 mg octreotide LAR to 60 mg of octreotide LAR in patients with midgut neuroendocrine tumors. The previously reported primary analysis of the trial demonstrated a statistically significant improvement in progression free survival (PFS) (HR: 0.18 , p 0.0001)
3. In the final analysis of overall survival, a secondary objective of the trial, treatment with Lutathera resulted in a clinically relevant prolongation in median overall survival of 11.7 months [48.0 months (95%CI: 37.4-55.2) compared to the control arm (36.3 months (95%CI: 25.9-51.7)] ....

United States , Isabella Zinck , Samir Shah , Julie Masow , Thomas Hungerbuehler , Sloan Simpson , Rachel Levine , Prnewswire Novartis , Nuclear Medicine Through Innovation , Virtual Scientific Program , Novartis Company , Elsevier Inc , Novartis External Communications , Exchange Commission , National Cancer Institute Surveillance , National Research Council , Institute Of Medicine , Novartis Pharmaceuticals Corporation , National Academies , Scientific Program , National Cancer Institute , End Results , Advanced Accelerator Applications , Accelerator Applications , Positron Emission Tomography , Single Photon Emission Computed Tomography ,