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Gilead Quad’s Side Effects Profile, Novel Agents To Get Advisory Committee Review

 
• By Martin Berman-Gorvine

FDA’s Antiviral Drugs Advisory Committee takes up the four-drug HIV-1 regimen, which includes two new agents, on May 11. The firm hopes to be able to sell the combination in part on its favorable side effects profile if the product is approved.

A favorable adverse event profile in two head-to-head trials with other HIV treatment regimens could help Gilead Sciences Inc.’s four-active-ingredient HIV treatment Quad (elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate) in its review by FDA's Antiviral Drugs Advisory Committee May 11, and in marketing if the drug is approved.

Quad has two unapproved ingredients; cobicistat is a novel boosting agent and elvitegravir is an investigational integrase inhibitor. But the...

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More from United States

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US FDA Rare Disease Hub RISEs After Slow Start

 
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More from North America

Precigen’s Papzimeous Approval Allows US FDA CBER Director To Emphasize Flexibility

 
• By Bridget Silverman

Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.

Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

 
• By Sue Sutter

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.

A US FDA Move to Revoke Pfizer’s Pediatric COVID-19 Vaccine EUA Could Raise Supply Questions

 
• By Sarah Karlin-Smith

Pfizer still has not submitted a supplemental biologics license application for the youngest population even though people familiar say it has dominated that market. Moderna says it can “step up” supply.