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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. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.

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Pioneering access to complex generic products 

Drug Discovery World

Claire D’Abreau-Hayling, Chief Scientific Officer at Sandoz, examines how generic products can relieve industry pressure and improve access to essential medicines. Off-patent medicines today account for about 80% of global prescriptions at an estimated 20% of the total cost. What are complex generics?

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Katie Porter attacks pharma

World of DTC Marketing

I always have pointed instances in which pharma puts Wall Street first and patients second. 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. In pharma R&D returns have declined to 1.8 percent—a slight decrease of 0.1

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