The Pharma Data

OCTOBER 29, 2020

30, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today new data for baricitinib (marketed as OLUMIANT ® ) will be presented at the annual Fall Clinical Dermatology meeting taking place virtually October 29-November 1, 2020. INDIANAPOLIS , Oct.

Dermatology 52

Dermatology Development Medicine Clinical Trials 52

The Pharma Data

JUNE 7, 2022

The new findings from the Phase 3 clinical trials (ADvocate 1 and 2) showed eight out of ten patients who achieved clinical response (EASI-75*) with lebrikizumab monotherapy at 16 weeks maintained skin clearance at one year of treatment with the once every two weeks or four weeks regimen. About Lebrikizumab.

Trials 40

Trials Clinical Trials Clinical Trials Medicine 40

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. This marks the first time an anti-PD-1 therapy has been approved in combination with anantibody-drug conjugate in the U.S. confirmatory trial for the accelerated approval.

FDA Approval 40

FDA Approval Containment Hormones Dermatology 40

The Pharma Data

JANUARY 13, 2021

Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics.

Clinical Trials 52

Clinical Trials Clinical Trials Trials In-Vitro 52

The Pharma Data

MARCH 4, 2021

This classification aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over already available therapies on a clinically significant endpoint(s). Increases of ALT ?5x

Trials 52

Trials Development Dermatology Clinical Trials 52

The Pharma Data

AUGUST 19, 2021

Food and Drug Administration (FDA) approval for patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, based on data showing an ORR of 40 percent (95 percent CI, 29 – 51) and median duration of response of 11.1 Dermatologic Adverse Reactions 7. of patients.

FDA Approval 52

FDA Approval Dermatology Genetics Development 52

The Pharma Data

MARCH 23, 2021

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.

HR 52

HR FDA Approval Containment Genome 52