2014, Clinical Development, Disease and FDA Approval

The science of ageing and restoring healthspan

Drug Target Review

JANUARY 8, 2024

It is no mystery that as we age our health starts to deteriorate, and we become increasingly susceptible to diseases. Through years of scientific exploration and research, we now know there are several biological changes that make our bodies more susceptible to disease or injury, and we can target those with therapeutic interventions.

Science

Science Disease FDA Approval Pharmaceutical Companies

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction

The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. This approval builds upon Merck’s proud history of developing therapies for the treatment of patients with cardiovascular disease.”. KENILWORTH, N.J.–(BUSINESS Forward-Looking Statement of Merck & Co., Kenilworth, N.J.,

FDA Approval

FDA Approval FDA Hospitals Treatment

Update on US Regulatory Review of Roxadustat in Anemia of Chronic Kidney Disease

The Pharma Data

DECEMBER 18, 2020

18 December 2020 — The US Food and Drug Administration (FDA) has requested further clarifying analyses of clinical data, to complete its review of the New Drug Application (NDA) for roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for patients with anemia of chronic kidney disease (CKD).

Disease

Disease FDA FDA Approval Science

VERQUVO® (vericiguat) Approved in the European Union

The Pharma Data

JULY 21, 2021

Bayer also issued a news release earlier today announcing the EC approval. Food and Drug Administration (FDA) approved VERQUVO in the U.S. The approval of VERQUVO in the EU will provide doctors, health care professionals and patients with an important treatment option to complement currently available heart failure therapies.”.

Treatment

Treatment Production Hospitals FDA Approval

Metabolism of macrocyclic drugs

Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. 20 (March 20, 2014).

Metabolic Stability

Metabolic Stability Drugs FDA Approval Treatment

Metabolism of de novo designed macrocyclic drugs

Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. 20 (March 20, 2014).

Metabolic Stability

Metabolic Stability Drugs FDA Approval Treatment

Precision Medicine: Using Genomic Data to Predict Drug Side Effects and Benefits

NIH Director's Blog: Drug Development

JUNE 14, 2016

People with type 2 diabetes are at increased risk for heart attacks, stroke, and other forms of cardiovascular disease, and at an earlier age than other people. In fact, the evidence suggests that such drugs might even offer some protection against heart disease. Food and Drug Administration. December 2008. [2] Sci Transl Med.

Drugs

Drugs Disease Drug Development Clinical Trials

OKYO Pharma Limited (“OKYO” or the “Company”) – OKYO announces filing of a patent application covering the use of Chemerin and associated analogues to treat “cytokine storm” associated with COVID-19 and ARDS

The Pharma Data

JANUARY 18, 2021

OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. OKYO is focusing on the discovery and development of novel molecules to treat inflammatory dry eye diseases and chronic pain.

Science

Science Virus FDA Approval Treatment

Unlicensed and off-label drugs: What do we know?

Drug Discovery World

JULY 13, 2023

The rules and regulations Unlicensed drugs are drugs that have not yet been assessed by a regulator, while off-label use is when an approved medication is prescribed outside of the terms of its license, e.g., for a different disease or in a different patient group.

Drugs

Drugs Licensing Licensing Regulations

Can liquid biopsies transform precision medicine?

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.

DNA

DNA Clinical Trials RNA Treatment

EMA Validates Bristol Myers Squibb’s Applications for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + Chemotherapy as First-Line Treatments for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

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. To date, the Opdivo clinical development program has treated more than 35,000 patients. About Esophageal Cancer.

Treatment

Treatment Immune Response Trials FDA Approval

A research team searches for every gene that helps tumors evade immunotherapy

Broad Institute

OCTOBER 11, 2023

He also read everything he could about her disease, including emerging evidence that suggested that the immune system could recognize and kill Merkel cell carcinoma. His mother had a presentation of the disease that suggested her immune system was already on the job.

Research

Research Immune Response Clinical Trials Cell Biology

Bristol Myers Squibb Research at ESMO 2021 Demonstrates Clinical Benefits.

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). To date, the Opdivo clinical development program has treated more than 35,000 patients.

Research

Research Immune Response Treatment Trials

CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival

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.

Therapies

Therapies Trials Disease Treatment

Neoadjuvant Opdivo (nivolumab) Plus Chemotherapy Significantly Improves Pathologic Complete Response in Patients with Resectable Non-Small Cell Lung Cancer in Phase 3 CheckMate -816 Trial

The Pharma Data

APRIL 11, 2021

Additionally, Opdivo plus chemotherapy was well tolerated and showed consistent improvements in pCR regardless of PD-L1 expression levels, histologies or stages of disease. 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.

Trials

Trials Treatment Immune Response Clinical Trials

Opdivo (nivolumab) Plus Yervoy (ipilimumab) for the Treatment of Mismatch Repair Deficient or Microsatellite Instability–High Metastatic Colorectal Cancer After Prior Chemotherapy

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. Waxman, M.D.,

Treatment

Treatment Trials FDA Approval Disease

XARELTO® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients

The Pharma Data

JUNE 26, 2021

If approved, XARELTO ® will be the first and only oral Factor Xa inhibitor indicated in the U.S. There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure, a surgical procedure that redirects blood flow from the lower body to the lungs.

Doctors

Doctors Hospitals Clinical Trials Treatment

Bristol Myers Squibb Statement on Opdivo® (nivolumab) Hepatocellular Carcinoma U.S. Indication

The Pharma Data

MARCH 11, 2021

Opdivo and Opdivo -based combinations are important treatment options in multiple forms of cancer, with established long-term survival benefits in complex diseases, including metastatic melanoma, renal cell carcinoma and non-small cell lung cancer. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Treatment

Treatment Trials Therapies FDA Approval

CheckMate -649, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Chemotherapy vs. Chemotherapy, Meets Primary Endpoints Demonstrating Superior Overall Survival and Progression-Free Survival in First-Line Treatment of Gastric and Esophageal Cancers

The Pharma Data

AUGUST 11, 2020

Responses to the current standard chemotherapy in patients are short lived, and less than 6% of patients with metastatic disease survive beyond five years,” said Yelena Y. All patients continued treatment for two years or until disease progression, unacceptable toxicity or withdrawal of consent. Janjigian, M.D.,

Treatment

Treatment Trials Therapies Clinical Trials

Drug Discovery Digest

The science of ageing and restoring healthspan

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction

Trending Sources

Update on US Regulatory Review of Roxadustat in Anemia of Chronic Kidney Disease

VERQUVO® (vericiguat) Approved in the European Union

Metabolism of macrocyclic drugs

Metabolism of de novo designed macrocyclic drugs

Precision Medicine: Using Genomic Data to Predict Drug Side Effects and Benefits

OKYO Pharma Limited (“OKYO” or the “Company”) – OKYO announces filing of a patent application covering the use of Chemerin and associated analogues to treat “cytokine storm” associated with COVID-19 and ARDS

Unlicensed and off-label drugs: What do we know?

Can liquid biopsies transform precision medicine?

EMA Validates Bristol Myers Squibb’s Applications for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + Chemotherapy as First-Line Treatments for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

A research team searches for every gene that helps tumors evade immunotherapy

Bristol Myers Squibb Research at ESMO 2021 Demonstrates Clinical Benefits.

CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival

Neoadjuvant Opdivo (nivolumab) Plus Chemotherapy Significantly Improves Pathologic Complete Response in Patients with Resectable Non-Small Cell Lung Cancer in Phase 3 CheckMate -816 Trial

Opdivo (nivolumab) Plus Yervoy (ipilimumab) for the Treatment of Mismatch Repair Deficient or Microsatellite Instability–High Metastatic Colorectal Cancer After Prior Chemotherapy

XARELTO® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients

Bristol Myers Squibb Statement on Opdivo® (nivolumab) Hepatocellular Carcinoma U.S. Indication

CheckMate -649, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Chemotherapy vs. Chemotherapy, Meets Primary Endpoints Demonstrating Superior Overall Survival and Progression-Free Survival in First-Line Treatment of Gastric and Esophageal Cancers

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