May 24, 2019

Vol. 16 No. 100

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Editor’s Note

In observance of the Memorial Day holiday, FDAnews Drug Daily Bulletin will not be published Monday, May 27. The next issue will be published Tuesday, May 28. Read More

CMS Backs Off Negotiated Price Rules for Part D, Medicare Advantage Drugs

The administration “remains concerned that prescription drug companies are offering seniors in Medicare substantially smaller discounts… Read More

FDA Discusses Pilot Program for Single Patient INDs

A public database tied in with the program will also list information supplied by drug companies.  Read More

House Passes CREATES, Patent Reform, ‘Pay-for-Delay’ Bills

The so-called BLOCKING Act would overhaul the 180-day exclusivity granted to the first generic on the market. Read More

Gilead CEO Takes Turn on House Hot Seat

“Gilead bore the risk and the vast majority of the cost of research and clinical studies to demonstrate Truvada’s efficacy and safety as part of combination HIV therapy,” O’Day told the panel. Read More

Feds Dole Out $9 Million for Alzheimer’s Candidate Trial

The money comes from a grant through the National Institute on Aging, a division of the National Institutes of Health. Read More