A ‘miracle’ new drug from Janssen has been approved in the US

Azure Pharmaceuticals (AZURE) has been granted a patent for a new compound that is designed to reverse the effects of a disease called “malignant neuroendocrine syndrome”.

The company said in a press release that it has been working with a clinical trial and regulatory authorities in the USA to finalise the approval.

“We are delighted to have secured this critical new drug for AZURE, which is designed as a first-line treatment for a rare form of malignant neuroepithelial syndrome,” said Dr. Michael Berenbaum, President and CEO of Azure.

“We believe that the development of this drug will significantly advance the fight against this devastating disease, and bring hope to millions of patients around the world.”

The treatment has been developed by Janssens Therapeutics Inc, and is currently undergoing preclinical trials in the UK.

The US Food and Drug Administration approved the compound in January 2017 for the treatment of “malignancy of the central nervous system” and other rare forms of neurodegenerative disorders.

“Janssen is a leading global leader in developing new drugs to combat neurodegenesis and other disease processes,” said James Goss, President of the Azure and Ovid Therapeutic Group.

“The company has made significant progress toward achieving FDA approval for this innovative drug, which we believe will dramatically improve the lives of millions of people worldwide.”

“The Jansson Therapeutical Group’s expertise and expertise in development of innovative new treatments and cures for rare diseases is unmatched by any other company,” said David F. Stemmer, President & CEO of Jansens Therapies.

“Our team is excited to continue our successful relationship with the FDA and continue the advancement of this promising new therapy.”

“We have made great progress in advancing Jansen’s new drug and are confident that the new drug will meet all regulatory requirements,” said Professor Michael O’Reilly, Professor of Clinical Chemistry and Director of the Department of Chemistry at the University of Chicago.

“This new treatment for neuroendocrinopathies will help patients with the most common forms of this disease, as well as other rare conditions, who will benefit from the life-saving benefits of this new drug.”

“I have been impressed with the progress Janssu is making with their first-in-class therapy, which has been shown to treat many rare forms,” said Tom O’Brien, Professor in Molecular Pharmacology at the College of Medicine at the California Institute of Technology.

“I look forward to working with Janssan on further development of the drug and am excited to help continue to advance our understanding of this exciting new treatment.”

“Jenssen’s new compound is a promising tool for developing new therapeutic approaches for rare forms such as neuroendothelial disorders, as they are not currently fully understood,” said Jansssens Director of Clinical Trials, Professor Brian D. Anderson.

“It will provide tremendous potential for the development and testing of new treatments for these rare diseases and may have the potential to provide breakthroughs in the treatment and prevention of these conditions.”

“This innovative drug is the first in the Janssa group’s portfolio of novel therapeutic compounds, and we are thrilled that Jansus has been selected to be a lead participant in the Phase III clinical trial,” said Mr. Anderson, who was also a member of the advisory board of JANSS.

“Janssus has the world-class team of clinical researchers and clinical scientists at its disposal, and this drug represents a major milestone in Janssam’s development.”

“Our industry-leading research and development teams are dedicated to discovering novel treatments for rare and debilitating neurodegeners, and JansSS has made tremendous progress toward finding effective and efficacious treatments,” said Chief Executive Officer David A. O’Connor.

“Through the development, testing and commercialization of Jonssens and other new therapeutics, we believe JansS will be a leader in the pharmaceutical industry for years to come.”

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