Pharmaceutical Technology

FEBRUARY 24, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Douglas collaborates with scientific researchers and external medical experts to advance clinical research. Its investigational medicinal products comprise R-107, R-131 and R-147.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

Pharmaceutical Technology

FEBRUARY 24, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Douglas collaborates with scientific researchers and external medical experts to advance clinical research. Its investigational medicinal products comprise R-107, R-131 and R-147.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

The Pharma Data

JULY 22, 2021

The approval for this population is based on results from the pivotal Phase 3 KEYNOTE-775/Study 309 trial, in which KEYTRUDA plus LENVIMA demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 32% (HR=0.68 [95% CI, 0.56-0.84];

HR 52

HR Trials Dermatology Hormones 52

The Pharma Data

APRIL 4, 2023

Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The approval is based on data from the KEYNOTE-869 trial (also known as EV-103) dose escalation cohort, Cohort A and Cohort K, which was conducted in collaboration with Seagen and Astellas.

FDA Approval 40

FDA Approval Containment Hormones Dermatology 40