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In the News: October Regulatory and Development Updates

Camargo

When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. of hyponatremia, or low blood sodium levels.

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Taking a new approach to tackle neurodegenerative diseases

Drug Discovery World

The company’s candidate screening approach recapitulates aspects of tau oligomer formation in neurodegenerative diseases and enables the identification of novel therapeutic approaches. Several of the large pharma companies have recently re-entered the dementia field. Overcoming sector challenges . million in 2022 to 12.7

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

XTalks

To learn more about innovations in the field, Xtalks spoke to Anish Suri, PhD, president and chief scientific officer of Cue Biopharma about the company’s initiatives in the development of immune-based biological compounds for the treatment of cancers and autoimmune diseases. Cell-Based Immunotherapy vs. Immune Biologics.

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Life Science Trends to Look Out for in 2024

XTalks

In 2023, Dr. Varshney notes that the US Food and Drug Administration (FDA) issued a request for industry comment on the integration of AI in drug and biologics development. This year, the very first CRISPR-based therapy received FDA approval for sickle cell disease.