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Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

The Pharma Data

First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. futility analysis).

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Trodelvy has been Approved for ER+/HER2- Patients with Advanced or Metastatic Breast Cancers

XTalks

HR+/HER2- breast cancer is the most common type of breast cancer, with the National Cancer Institute (NCI) estimating 287,850 new cases of female breast cancer in 2022 alone. What does this Approval Mean for Breast Cancer Patients? months in HR+/HER2- Patients The average five-year rate of survival is 30 percent in HR+/HER2- patients.

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Enhertu Approved in the U.S. for the Treatment of Patients With Previously Treated HER2 Positive Advanced Gastric Cancer

The Pharma Data

Enhertu is approved with Boxed WARNINGS for interstitial lung disease (ILD)/pneumonitis and embryo-fetal toxicityEnhertu. 4.3] (HR=0.47; 95% CI 0.31-0.71) Enhertu is the first antibody drug conjugate to receive approval in the U.S. is a HER2 directed antibody drug conjugate (ADC). months [95% CI 9.6-14.3]

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Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. It contains the antiviral medications nirmatrelvir and ritonavir. In addition, the FDA approved Pfizer’s pneumococcal 20-valent conjugate vaccine, Prevnar 20, for the first time in June 2021.

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First Anti-PD-1 in Combination With Chemotherapy Approved for the First-Line Treatment of Esophageal and GEJ Carcinoma, Regardless of Histology or PD-L1 Expression

The Pharma Data

The approval is based on results from the Phase 3 KEYNOTE-590 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for KEYTRUDA plus fluorouracil (FU) and cisplatin versus FU and cisplatin alone, regardless of histology or PD-L1 expression status.

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Trodelvy®, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival

The Pharma Data

The approval is supported by data from the Phase 3 ASCENT study, in which Trodelvy demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival (PFS)), extending median PFS to 4.8 months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; months vs. 6.9

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Pfizer Responds to Research Claims

Pfizer

This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern. This work is undertaken once a new variant of concern has been identified by public health authorities. No dosage adjustment is needed in patients with mild renal impairment.

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