Xeris Biopharma Holdings, Inc.
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Latest From Xeris Biopharma Holdings, Inc.
FDA Is ‘Getting More Aggressive’ In Going After Drug Efficacy Claims Outside Label
Regulatory experts note there has been an uptick in enforcement letters objecting to efficacy presentations in Rx drug promotions that are not consistent with FDA-required labeling. Panelists at FDLI meeting also discuss the use of real-world evidence in prescription drug promotion.
Efficacy Overstatements In Evofem’s Phexxi Brochure, Otsuka’s Rexulti TV Ad Draw Untitled Letters
US FDA releases two letters on the same day citing two different kinds of advisements for two different kinds of products, but both with a classic problem: overstatement of efficacy. And while sending multiple letters at once can be seen as bid to draw attention to its enforcement action, the move also underscores just how few letters the agency has been sending lately.
AstraZeneca Gets Rare Warning Letter Over Breztri Sales Aid; Footnotes Don’t Balance Graphics
Warning letter is first issued by US FDA’s Office of Prescription Drug Promotion in more than a year and only the seventh since March 2020, continuing a trend away from using the enforcement tool. AstraZeneca asked to distribute corrective communications about pamphlet’s efficacy claims.
With First Advertising Letter In 12 Months, US FDA Goes After Xeris’s Webpage Promotion Of Recorlev
Webpages misrepresent findings in two clinical studies to overstate efficacy of the Cushing’s syndrome drug and minimize serious risks, Office of Prescription Drug Promotion says. This is second untitled letter issued to Xeris in three years.
Company Information
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Pharmaceuticals
- Specialty Pharmaceuticals
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Drug Delivery
- Site Specific
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Biotechnology
- Large Molecule
- Other Names / Subsidiaries
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- Strongbridge Biopharma plc
- Xeris Pharmaceuticals, Inc.
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