Keeping Track: US FDA Receives Submissions Galore As Year Ends

A roundup of new applications submitted to FDA’s Center for Drug Evaluation and Research.

Keeping Track Feature image

The last weeks of 2018 saw a flurry of submissions to the US FDA’s Center for Drug Evaluation and Research, including at least four novel agents. Indeed, had the partial government shutdown not precluded further submissions, the end of the year might have turned into a downright blizzard.

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Mysimba Passes EU Safety Probe, But Currax Must Explore Long-Term Heart Risks

 

The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.

EU CHMP Opinions And MAA Updates

 

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 

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EMA Recommends EU Approval For Averoa’s Xoanacyl And Four Other Drugs

 

The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.

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CDRH Staff Cuts Focus On Administrative Workers, Spare Reviewers

 

One CDRH employee said the cuts already are having a major effect on morale.

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

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.

England’s NICE Wants Industry Involvement In HTA Sandbox Projects

 

Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.