Clinical Trials Drugs Genotoxicity HR 
The Pharma Data
MARCH 25, 2021
These findings represent the first comprehensive comparative effectiveness analysis of survival outcomes for a CDK 4/6 inhibitor in routine clinical practice and were published online in Breast Cancer Research. months with letrozole alone (HR 0.58: 95% CI, 0.49 months among patients in the letrozole group (HR 0.66: 95% CI, 0.53
The Pharma Data
FEBRUARY 8, 2021
The PTE certificate was granted under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984. This PTE will be listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration (FDA).
The Pharma Data
APRIL 14, 2021
The FDA’s accelerated approval mechanism enables drugs that treat serious diseases with unmet medical need to be approved based on a surrogate or intermediate clinical endpoint. Continued approval is contingent upon verification and description of clinical benefit in a confirmatory trial. FOSTER CITY, Calif.–(BUSINESS
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