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GSK's HIV venture fails to get USFDA approval for once-a-month injection

ViiV Healthcare received a complete response letter from the Food and Drug Administration, which cited "chemistry manufacturing and controls," according to a statement from the HIV unit

GSK, PHARMA, GLAXO
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GSK Pharma

Bloomberg
The HIV venture led by GlaxoSmithKline Plc failed to win US approval for a once-a-month injection that aims to free patients from daily doses of medication.
 
ViiV Healthcare received a complete response letter from the Food and Drug Administration, which cited “chemistry manufacturing and controls,” according to a statement from the HIV unit Saturday. There haven’t been any safety issues reported, ViiV said.
 
It’s a setback for Glaxo, which has been counting on the monthly therapy to help take on rival Gilead Sciences Inc. in the market for HIV medicines. The British pharma giant and partner Pfizer Inc. are betting