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Keep Makena Under Accelerated Approval Pending More Studies, AMAG Tells US FDA

 
• By Sue Sutter

AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.

Sand in hourglass
AMAG wants more time to gather confirmatory data for Makena. • Source: Shutterstock

AMAG Pharmaceuticals Inc. has laid out its case for keeping Makena (hydroxyprogesterone caproate) on the market under accelerated approval while it conducts retrospective and observational studies, and possibly even another randomized, placebo-controlled trial, of the drug for preventing recurrent preterm birth.

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AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

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US FDA Allows Telework For Reviewers As Companies Detail Layoff-Related Problems

 
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Trump’s US FDA Takeover Similar To Flat Earth Proponents Running NASA, Woodcock Says

 
• By Sue Sutter

The former principal deputy commissioner said the “decapitation” of senior leadership will make resolving internal disputes more difficult, which will slow application reviews. Woodcock also called the FDA layoffs a slow-moving catastrophe.

Brazil Catches Up With International Standards on Viral Safety Evaluations For Biotech Products

 
• By Francesca Bruce

The Brazilian medicines regulator will also offer more clarity on the requirements for radiopharmaceuticals that are exempt from registration.

More from Pathways & Standards

Trump’s US FDA Takeover Similar To Flat Earth Proponents Running NASA, Woodcock Says

 
• By Sue Sutter

The former principal deputy commissioner said the “decapitation” of senior leadership will make resolving internal disputes more difficult, which will slow application reviews. Woodcock also called the FDA layoffs a slow-moving catastrophe.

Updated: US Likely To Lose Its First Approver Advantage After FDA Layoffs

 
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Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.

Brazil Catches Up With International Standards on Viral Safety Evaluations For Biotech Products

 
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