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., Expanded access is an important mechanism for providing access to unproven, but promising, interventions for seriously and terminally ill patients who lack approved treatment options.

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Drugs Licensing Licensing Regulations 237

NIH Director's Blog: Drug Development

JUNE 14, 2016

Scott and colleagues focused on six genes that encode potential drug targets licensed or in development by GlaxoSmithKline for the treatment of obesity or diabetes. That’s critical considering that just 1 in 10 drug candidates entering human clinical trials successfully goes on to receive FDA approval [5].

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Drugs Disease Drug Development Clinical Trials 52

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.

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DNA Clinical Trials RNA Treatment 147

The Pharma Data

AUGUST 17, 2021

In the Opdivo plus Yervoy arm, patients received treatment with Opdivo 3 mg/kg every 2 weeks and Yervoy 1 mg/kg every 6 weeks up to 24 months or until disease progression or unacceptable toxicity. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

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Treatment Immune Response Trials FDA Approval 52

Broad Institute

OCTOBER 11, 2023

Manguso, who’d recently graduated from college and was conducting research at the University of Copenhagen as a Fulbright scholar, moved back to the Boston area to be with his mother as she underwent treatment. 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

JUNE 30, 2021

The EC’s decision is based on results from the Phase 2 CheckMate -142 trial in which Opdivo plus Yervoy demonstrated a clinically meaningful improvement in objective response rate (ORR) in patients with MSI-H/dMMR mCRC who received prior treatment with fluoropyridine, oxaliplatin and irinotecan. achieving a complete response.

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Treatment Trials FDA Approval Disease 52

The Pharma Data

SEPTEMBER 8, 2021

Phase 3 data from RELATIVITY-047 demonstrate prolonged benefit beyond initial treatment of the LAG-3 blocking antibody relatlimab and PD-1 inhibitor nivolumab fixed-dose combination for patients with previously untreated unresectable or metastatic melanoma. Summary of Presentations. All times noted are Central European Summer Time (CEST).

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Research Immune Response Treatment Trials 52

The Pharma Data

APRIL 11, 2021

Data selected for an oral presentation in a Clinical Trials Plenary Session at the American Association for Cancer Research Annual Meeting 2021. The ultimate goal of treatment in earlier stages of cancer is to prevent the disease from coming back as we work towards a cure for these patients. vs 8.9%; OR 5.70, 95% CI: 3.16-10.26),

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Trials Treatment Immune Response Clinical Trials 52

The Pharma Data

AUGUST 11, 2020

development lead, Gastrointestinal Cancers, Bristol Myers Squibb. “We We look forward to engaging health authorities worldwide with the goal of bringing this immunotherapy-based treatment option to patients as soon as possible.”. Waxman, M.D., While GEJ cancer has a lower prevalence than gastric cancer, it continues to rise.

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Treatment Trials Therapies Clinical Trials 52

The Pharma Data

JUNE 26, 2021

Food and Drug Administration (FDA) for the use of XARELTO ® (rivaroxaban) in pediatric patients. If approved, XARELTO ® will be the first and only oral Factor Xa inhibitor indicated in the U.S. for use in pediatric patients. Learn more: [link].

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Doctors Hospitals Clinical Trials Treatment 52

The Pharma Data

MARCH 11, 2021

“We support the FDA’s efforts to evaluate accelerated approvals across the industry as an important element of how the agency ensures the integrity of the accelerated approval program,” said Ian M. development lead, gastrointestinal cancers, Bristol Myers Squibb. “In Waxman, M.D., INDICATIONS.

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Treatment Trials Therapies FDA Approval 52

The Pharma Data

AUGUST 11, 2020

In the trial, treatment with Opdivo following neoadjuvant chemoradiation therapy (CRT) and complete surgical resection demonstrated a statistically significant improvement in the primary endpoint of DFS compared to placebo in the all-randomized population. MBA, Director of the Charles A.

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Therapies Trials Disease Treatment 52