Remove p applicant Gilead Sciences
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European Medicines Agency Validates Gilead’s Marketing Authorization Application for Lenacapavir,

The Pharma Data

today announced that the company’s Marketing Authorization Application (MAA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, has been fully validated and is now under evaluation with the European Medicines Agency (EMA). In June 2021, Gilead submitted a New Drug Application (NDA) for lenacapavir seeking U.S.

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New phase III data shows investigational antibody cocktail casirivimab and imdevimab reduced hospitalisation

The Pharma Data

p<0.0001). p<0.0001). p<0.0001). All tested doses met the primary endpoint, rapidly and significantly reducing patients’ viral load (log10 copies/mL) compared to placebo (p<0.001), with all doses demonstrating similar efficacy. 1 COVID-19-related hospitalization or death through day 29. Risk reduction.

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Breast Cancer

The Pharma Data

Trodelvy® Continues to Show Durable Overall Survival Advantage in Pre-Treated HR+/HER2- Metastatic Breast Cancer Gilead Sciences, Inc. 0.95]; nominal p=0.0133). The European Medicines Agency has also validated a Type II Variation Marketing Authorization Application for Trodelvy in HR+/HER2- metastatic breast cancer.

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Lenacapavir, an Investigational, Long-Acting Capsid Inhibitor for the Treatment of HIV-1 in People With Limited Therapy Options

The Pharma Data

–(BUSINESS WIRE)– Gilead Sciences, Inc. Nasdaq: GILD) announced today that the company completed submission of a New Drug Application (NDA) to the U.S. Key data on lenacapavir will be presented during the 11th International AIDS Society (IAS) Conference on HIV Science in July 2021. FOSTER CITY, Calif.–(BUSINESS

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Kite Announces Yescarta® CAR T-cell Therapy Improved Event-Free Survival by 60% Over Chemotherapy Plus Stem Cell Transplant in Second-Line Relapsed or Refractory Large B-cell Lymphoma

The Pharma Data

With a median follow-up of two years, the study met the primary endpoint of event-free survival (EFS; hazard ratio 0.398, p <0.0001). Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with commercial manufacturing operations in North America and Europe. About Gilead Sciences.

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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

–(BUSINESS WIRE)– Gilead Sciences, Inc. 0.54; p<0.0001). 0.62; p<0.0001), representing a 49% reduction in the risk of death. The European Medicines Agency has also validated a Marketing Authorization Application for Trodelvy in the European Union. FOSTER CITY, Calif.–(BUSINESS

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COVID-19 Pandemic Coverage

XTalks

For example, the S&P 500 is just 100 points below its pre-pandemic peak while NASDAQ had fully recovered its losses by early June and is now reporting record highs. Meanwhile, Gilead Sciences, who is behind remdesivir, has declared that it will charge $3,120 to treat a single patient, at least those with private insurance in the US.