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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. In October, the U.S.

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Pioneering access to complex generic products 

Drug Discovery World

This will continue to be the case going forward, but the nature of the off-patent landscape will evolve in line with ongoing changes in the segment’s ‘pipeline’: the originator products of today, which will become the generic and biosimilar medicines of tomorrow. What are complex generics?

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Drug discovery hotspots: India’s Genome Valley

Drug Discovery World

Thanks to a new focus on R&D, increasing digitalisation and government investment, India is establishing itself as a significant player in drug discovery, and the Hyderabad life sciences hub has played a significant role in this. India’s domestic pharmaceutical market is expected to reach US$120-130 billion by 2030 2.

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Katie Porter attacks pharma

World of DTC Marketing

Porter points out that R&D seems to have been replaced with mergers and acquisitions, but she misses the big picture by focusing solely on drug costs. So where to start… Congresswoman Porter may want to look at the percentage of generic drugs available virus branded (89%). In pharma R&D returns have declined to 1.8

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