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Tzield Gets FDA Nod to Become First Approved Drug to Delay Onset of Type 1 Diabetes

XTalks

Provention Bio’s Tzield (teplizumab) has won US Food and Drug Administration (FDA) approval to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients eight years of age and older who have stage 2 type 1 diabetes. In the US, it is estimated that 1.45 million people are currently living with type 1 diabetes.

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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

First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity.

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Company Spotlight: Cue Biopharma Innovates in the Immunotherapy Space with its Immuno-STAT Platform

XTalks

Monoclonal antibodies : these are antibodies that are designed to bind to specific targets on cells. Treatment vaccines : these boost the immune system responses to target cells. Immune system modulators (i.e. receptors) of the immune system to enhance, or suppress immune responses.

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Advances in the Battle Against Autoimmune Disease

The Pharma Data

On top of this, another 8 million carry auto-antibodies, blood molecules that indicate a person’s chance of developing an autoimmune disease. Monoclonal Antibodies. The human monoclonal antibody targets specific immune plasma cells. The cells secrete auto-antibodies, but do not respond to standard immunosuppression.

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

XTalks

Acromegaly Surrogate Endpoint: Serum growth hormone and serum insulin-like growth factor 1 (IGF-1) are acceptable surrogate endpoints for acromegaly clinical trials involving somatostatin analogs such as octreotide, lanreotide and pasireotide. Nizoral is prescribed off-label, while the others are FDA approved.

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

The Pharma Data

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.

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

The Pharma Data

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.

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