BioSpace News Archive

Policy

Canadian Government Takes U.S. and Switzerland Off Drug Pricing Comparison List, Pushes for More Transparency

This is an area where the U.S. is considering changes as well. Earlier this year, the U.S. Department of Health and Human Services proposed a new policy called the International Pricing Index.

August 9, 2019
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3 min read
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Mark Terry
Policy

FDA Issues Draft Guidance for Fabry Disease Drugmakers

Before it finalizes the guidance, the FDA is seeking comment from drugmakers about the proposed plans.

August 9, 2019
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2 min read
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Alex Keown
Immunoglobulin Shortages Pressure Hospitals and Manufacturers While Patients Suffer

The shortage isn’t new, although it appears to be hitting more of a crisis point.

August 9, 2019
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4 min read
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Mark Terry
Drug Development

Lexicon Posts Positive 52-Week Pooled Zynquista Data in Type 1 Diabetes

The pooled data results came five months after the FDA rejected Zynquista following a split advisory committee vote.

August 9, 2019
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2 min read
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Alex Keown
Drug Development

Clinical Catch-up for August 5-9

Last week was a particularly busy week for biopharma companies to release information about ongoing clinical trials. Here’s a look.

August 9, 2019
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9 min read
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Mark Terry
Policy

FDA Action Alert: Regeneron, Kala and Vanda

Now that July has come and gone, the U.S. Food and Drug Administration is back to work approving drugs. This week marks three PDUFA target action dates, although one has already been rejected and another hit a snag that doesn’t appear to affect the decision date.

August 9, 2019
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3 min read
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Mark Terry