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FDA Action Alert: Urovant, Athenex, scPharmaceuticals and Vertex

The Pharma Data

Athenex and Almirall have a license deal with Almirall having the license to research, develop and commercialize the drug in the U.S. The FDA approval of Klisyri is a significant milestone for Athenex,” said Johnson Lau, chairman and chief executive officer of Athenex. and Europe, including Russia. Most Read Today.

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Biopharma Money on the Move: December 2 – 8

The Pharma Data

Through its Shielded Living Therapeutics platform, the company is developing functional cures for chronic diseases. The impact of CNS diseases extends beyond patients—to their families and society as well.” Pear’s reSET, reSET-O and Somryst are the first PDTs to receive FDA approval for treating disease.

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Advances in neuroscience drug discovery

Drug Discovery World

For diseases as serious and debilitating for patients and their families as leukodystrophies, learning about such advances in knowledge carries a great deal of hope, which IRCM warmly welcomes,” adds Dr Jean-François Côté, the IRCM’s President and Scientific Director.

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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. Novartis’ Signifor (pasireotide) is also indicated in the treatment of the disease. Nizoral is prescribed off-label, while the others are FDA approved. What Is a Surrogate Endpoint?

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