NIH Director's Blog: Drug Development

JUNE 14, 2016

The study, which analyzed vast troves of genomic and clinical data collected over many years from more than 50,000 people with and without diabetes, indicates that anti-diabetes therapies that lower glucose by targeting the product of a specific gene, called GLP1R , are unlikely to boost the risk of cardiovascular disease.

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Drugs Disease Drug Development Clinical Trials 52

Drug Discovery World

JULY 13, 2023

There are various schemes in force that allow patients access to unlicensed medicines that are in the late stages of clinical development (i.e., Schemes to allow expanded access to unlicensed therapies can also be open to abuse.

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Drugs Licensing Licensing Regulations 237

Drug Discovery World

JANUARY 17, 2024

With oncology accounting for a third of pharma’s product pipeline, significant challenges include fierce competition, high research and development costs over, 10-15 years for clinical development, and pressures to rapidly meet the demand for new treatments 2-4. 21 In a recent publication, Silvestri et al.,

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DNA Clinical Trials RNA Treatment 147

Broad Institute

OCTOBER 11, 2023

But immunotherapy was not yet widely used and had not been applied clinically to Merkel cell carcinoma, so she received traditional chemotherapy and radiation therapy, suffering life-threatening complications along the way. His mother had a presentation of the disease that suggested her immune system was already on the job.

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Research Immune Response Clinical Trials Cell Biology 137

The Pharma Data

SEPTEMBER 8, 2021

Updated Phase 3 CheckMate -577 disease-free survival (DFS) results for adjuvant Opdivo treatment vs. placebo for patients with resected esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy (CRT). Early Development. Summary of Presentations. Abstract Title. Presentation. Session Title.

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Research Immune Response Treatment Trials 52

The Pharma Data

AUGUST 11, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.

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Therapies Trials Disease Treatment 52

The Pharma Data

APRIL 11, 2021

Opdivo- based therapies have now demonstrated positive results in Phase 3 trials in earlier stages of four different types of cancer: non-small cell lung cancer, esophageal/gastroesophageal junction cancer, bladder cancer and melanoma. 10.26), meaning 10% or less of their tumor cells remained after neoadjuvant therapy.

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Trials Treatment Immune Response Clinical Trials 52

The Pharma Data

JUNE 30, 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.

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Treatment Trials FDA Approval Disease 52

The Pharma Data

JUNE 26, 2021

Current guidelines are limited and recommend treating pediatric patients with or at risk for reoccurring blood clots with standard anticoagulant therapy, which often requires painful injections, dietary restrictions and regular laboratory monitoring. EINSTEIN-Jr is the largest pediatric study completed to date for the treatment of VTE.

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Doctors Hospitals Clinical Trials Treatment 52

The Pharma Data

MARCH 11, 2021

To date, the Opdivo clinical development program has treated more than 35,000 patients. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. This indication is approved under accelerated approval based on overall response rate.

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Treatment Trials Therapies FDA Approval 52

The Pharma Data

AUGUST 11, 2020

In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. To date, the Opdivo clinical development program has treated more than 35,000 patients.

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Treatment Trials Therapies Clinical Trials 52