FDA Approval, Hormones and Immune Response - Clinical Research Informer

Sandoz’s Jubbonti and Wyost Approved as First Interchangeable Biosimilars to Amgen’s Bone Drugs Prolia and Xgeva

XTalks

MARCH 8, 2024

Risk factors include aging, hormonal changes, low body weight, low calcium intake and use of certain medications. It occurs when the formation of new bone doesn’t keep up with the loss of old bone. The disease often progresses without symptoms until a fracture happens, typically in the wrist, hip or spine.

Drugs

Drugs FDA Approval Production Immune Response

Surrogate Endpoints: How to Choose the Best One for Your Rare Disease Trial

XTalks

SEPTEMBER 17, 2020

Symptoms and Etiology: Caused by an overproduction of growth hormone, acromegaly primarily affects adults. By reducing the amount of growth hormone in the blood, progressive enlargement of bones should be slowed. By reducing the amount of growth hormone in the blood, progressive enlargement of bones should be slowed.

Trials

Trials Gene Hormones Clinical Trials

What Innovative Treatments For Metastatic Breast Cancer are being developed?

Find Me Cure

OCTOBER 13, 2019

CDK4/6 inhibitors are used alongside hormone therapy. There are antibody drugs targetting those cells that are already FDA approved and there are antibody drugs still in trials. Some kinds of cancer can protect themselves from being attacked by the immune system by stimulating proteins that keep the immune response in check.

Development

Development DNA Clinical Trials Clinical Trials

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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Pancreatic Awareness Month 2024: Advancing Research to Improve Survival

XTalks

NOVEMBER 12, 2024

Pancreatic cancer occurs when cells in the pancreas, a vital organ responsible for producing enzymes and hormones, begin to grow uncontrollably. This approval allows Onivyde to be used earlier in the treatment process, offering new options for patients with advanced disease. percent, a median duration of response of 12.6

Research

Research FDA Approval Trials Clinical Trials

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

The Pharma Data

MARCH 11, 2021

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Trials

Trials Hormones Genomics Genome

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

The Pharma Data

JULY 23, 2021

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Hormones

Hormones Trials Genome Genomics

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

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Trials

Trials Hormones Clinical Trials Clinical Trials

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

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Trials

Trials Hormones Clinical Trials Clinical Trials

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

The Pharma Data

APRIL 4, 2023

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Initiate hormone replacement as indicated. Withhold KEYTRUDA depending on severity.

FDA Approval

FDA Approval Containment Hormones Dermatology

Genentech’s Novel Anti-TIGIT Tiragolumab Granted FDA Breakthrough Therapy Designation in Combination With Tecentriq for PD-L1-High Non-Small Cell Lung Cancer

The Pharma Data

JANUARY 4, 2021

Tiragolumab is the first anti-TIGIT molecule to be granted BTD from the FDA, and the designation is based on randomized data from the Phase II CITYSCAPE trial. CITYSCAPE provides the first evidence that targeting both immune inhibitory receptors, TIGIT and PD-L1, may enhance anti-tumor activity by potentially amplifying the immune response.

Medicine

Medicine Immune Response Protein Gene

Monthly News Roundup – December 2020

The Pharma Data

DECEMBER 31, 2020

The vaccine teaches the cells to make a piece of the spike protein, which triggers an immune response to help prevent illness if later exposed to the virus. In mid-December, the FDA approved Orgovyx (relugolix), the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist for men with advanced prostate cancer.

Vaccination

Vaccination Vaccine FDA Approval Hormones

Clinical Research Informer

Sandoz’s Jubbonti and Wyost Approved as First Interchangeable Biosimilars to Amgen’s Bone Drugs Prolia and Xgeva

Surrogate Endpoints: How to Choose the Best One for Your Rare Disease Trial

Webinars

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What Innovative Treatments For Metastatic Breast Cancer are being developed?

Webinars

Pancreatic Awareness Month 2024: Advancing Research to Improve Survival

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

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

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

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

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

Genentech’s Novel Anti-TIGIT Tiragolumab Granted FDA Breakthrough Therapy Designation in Combination With Tecentriq for PD-L1-High Non-Small Cell Lung Cancer

Monthly News Roundup – December 2020

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