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P&T News

August 13

First Oral Drug Increases Activity of the Body’s Deficient Enzyme
Venous Thromboembolism and Other Risks to Be Evaluated in Postmarketing Studies
New Algorithm Surveys Alterations in DNA and Millions of Points in the Human Genome

August 7

Researchers Recommend Increased Testing for Men
New Draft Guidance Seeks to Better Target Patient Needs
It’s All in How the Data Are Analyzed

July 31

Two Phase 3 Studies Met Endpoint of Complete Clearance of Lesions
Radiation Exposure Remains a Risk
Quality Metrics Will Provide Feedback to Manufacturers
Drugmaker Aiming for 25–30 New Drugs by 2022

July 24

HHS proposal designed to prevent ‘Shkrelis,’ not high drug prices overall
Some studies had linked the device to harmful side effects.
Claims that tramiprosate helps stabilize patients over an 18-month period.
The biomarker can track a number of bodily functions.
Part of an ongoing effort to better oversee use of compounded medications.

July 17

An impurity has been found to be carcinogenic.
But diabetes group tamp down expectations.
Some see the loss of an important, unbiased source of information.

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