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Clinical Trial Results

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Pfizer Inc. (PFE) and BioNTech SE (BNTX), on Monday, announced encouraging topline results of a Phase 2/3 trial evaluating a third 3-g dose of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months to under 5 years of age.

Seagen Inc. (SGEN) announced Monday positive topline results from the pivotal phase 2 MOUNTAINEER clinical trial investigating TUKYSA (tucatinib) in combination with trastuzumab in patients with previously treated HER2-positive metastatic colorectal cancer (mCRC). The results showed a 38.1% confirmed...

Italian pharmaceutical company Menarini Group and Radius Health, Inc. (RDUS) announced Friday positive data from the pivotal phase 3 EMERALD clinical trial (NCT03778931) evaluating elacestrant as a monotherapy vs. standard of care for the treatment of ER+/HER2- advanced or metastatic breast cancer. The...

Bristol Myers Squibb (BMY) said the phase 3 CheckMate -901 trial, comparing Opdivo plus Yervoy to standard-of-care chemotherapy as a first-line treatment for patients with untreated unresectable or metastatic urothelial carcinoma, did not meet the primary endpoint of overall survival in patients whose...

Biopharmaceutical company AbbVie Inc. (ABBV) announced on Wednesday positive topline results from U-ENDURE, its Phase 3 maintenance study evaluating upadacitinib in adult patients with moderate to severe Crohn's disease who had an inadequate response or were intolerant to a conventional or biologic therapy. The...

Genentech, a member of the Roche Group (RHHBY), reported new three-year data from the FIREFISH study, including one-year data from the open label extension. The company said study reinforced the long-term efficacy and safety of Evrysdi (risdiplam) in infants with symptomatic Type 1 spinal muscular atrophy....

Drugmaker Eli Lilly and Co. (LLY) Thursday said its Tirzepatide (5 mg, 10 mg, 15 mg) achieved superior weight loss in adults with obesity or overweight in SURMOUNT-1 clinical trial. In topline results from the trial, the company said Tirzepatide delivered up to 22.5% weight loss in adults compared...

Valneva SE (VLA), a specialty vaccine company, and Pfizer Inc. (PFE) reported Tuesday positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15. Based on these new results, the companies plan to proceed with inclusion of pediatric participants in their planned Phase 3 trial. The...

Actinium Pharmaceuticals, Inc. (ATNM) reported data from full patient enrollment in the phase 3 SIERRA trial of Iomab-B. The company said the data from the trial showed the potential of Iomab-B in enabling successful bone marrow transplant in patients who cannot typically be transplanted. 100% of patients...

Gossamer Bio, Inc. (GOSS) reported topline results from its phase 2 SHIFT-UC clinical trial studying GB004 in patients with mild-to-moderate active ulcerative colitis. The company said neither statistically significant nor clinically meaningful differences were observed for the primary endpoint at week...

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