Broad Institute

OCTOBER 11, 2023

By Allessandra DiCorato October 11, 2023 In 2011, Robert Manguso was working in a cell biology lab when his mother was diagnosed with Merkel cell carcinoma, a rare and aggressive skin cancer. The drugs work by blocking a protein, PD-1 — which helps keep immune responses in check — and stimulating the immune system to attack tumors.

Research 137

Research Immune Response Clinical Trials Therapies 137

The Pharma Data

AUGUST 17, 2021

Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Treatment 52

Treatment Immune Response Trials FDA Approval 52

Drug Target Review

JUNE 21, 2023

Strikingly, a strong genetic link between target and disease biology is emerging as a predictor for success in clinical trials. 2,3 This is exemplified by drugs that target disease-specific genes or genetically distinct patient subsets which are more likely to succeed in demonstrating efficacy in clinical development.

Disease 111

Disease Clinical Trials Therapies Science 111

The Pharma Data

SEPTEMBER 8, 2021

Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Research 52

Research Immune Response Treatment Trials 52

Agency IQ

SEPTEMBER 22, 2023

An AgencyIQ analysis from May 2020 found that a quarter of all New Molecular Entities (NMEs) approved since 2011 had relied upon a single pivotal trial, and that this reliance had remained relatively stable between 2011-2019 despite some year-to-year variability. When should this occur? at the end-of-phase 2 meeting).

FDA 40

FDA Science Trials Clinical Trials 40

The Pharma Data

OCTOBER 25, 2020

FDA approval. About Global Blood Therapeutics Global Blood Therapeutics (GBT) is a biopharmaceutical company dedicated to the discovery, development and delivery of life-changing treatments that provide hope to underserved patient communities.

Treatment 40

Treatment Disease FDA FDA Approval 40

Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. In short, all studies found no significant difference between phenylephrine and placebo.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40