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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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How will $41 million be used to fight chronic and age-related diseases? 

Drug Discovery World

The new funding will power the expansion of Juvena’s drug discovery platform and advance the company’s biologics pipeline targeting chronic and age-related diseases. . These limitations have constrained biopharma’s approach to studying the role of secreted proteins only as drug targets or biomarkers, rather than drug agents themselves. .

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

XTalks

chimeric receptor antigen [CAR] T cell) immune modulators (i.e. Immune checkpoint inhibitors : these are drugs that block immune checkpoints, allowing immune cells to elicit enhanced responses to cancer cells. Immune system modulators (i.e. protein-based biologics) and vaccine treatments.

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

XTalks

Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012. In the case of the former, pharmaceutical and biologics companies would be eligible for approval of their product through traditional regulatory pathways; the latter could support accelerated approval.

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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. Consider monitoring more frequently as compared to when the drugs are administered as single agents.

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Advances in the Battle Against Autoimmune Disease

The Pharma Data

Many drug makers are investing in new science and hope to develop new therapeutics that address autoimmune disease. Scientists will be testing a drug class targeting the C-reactive protein (CRP) marker of acute inflammation in the body. They’ll use software that searches available drugs, as well as drug-like compounds.

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

The Pharma Data

Food and Drug Administration (FDA), Bristol Myers Squibb has made the difficult decision to voluntarily withdraw the indication for Opdivo (nivolumab) as a single agent for patients with hepatocellular carcinoma (HCC) who were previously treated with sorafenib from the U.S. In consultation with the U.S. About Opdivo.