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Cempra Gets Easier Path To CRL Response, But Who Will Fund The Study?

 
• By Joseph Haas

The biotech now only needs to investigate liver toxicity in 6,000 patients – down from 9,000 – to refile its NDA, but Cempra made clear that it won't initiate the study without an external funding source.

On the same day it announced its plans to merge with privately held antibiotics developer Melinta Therapeutics Inc., Cempra Inc. revealed that it has worked out a somewhat easier path for responding to a December complete response letter for its macrolide antibiotic candidate Solithera (solithromycin) – but questions remain about who would fund a safety study with an estimated cost of $75m.

Acting CEO David Zaccardelli said Cempra negotiated with US FDA "a smaller, more focused and efficient approach" to obtain the...

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More from Complete Response Letters

Ultragenyx Says CRL Discussions ‘Productive’ Despite US FDA Leadership Upheaval

 
• By Jessica Merrill

Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.

Real-Time Release Of CRLs Is US FDA’s Goal, Agency Leaders Affirm

 
• By Michael McCaughan

The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.

Complete Response Letter Trio Raises Prospect Of Tidal Shift In Regenerative Medicine Regulation

 
• By Bridget Silverman

Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.

US FDA’s Second Half 2025 User Fee Goals Swing Toward Respiratory Disease

 
• By Bridget Silverman

The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.

More from Product Reviews

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

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.

Japan Gives Global-First Recommendations To Taisho’s Vornorexant, Santen’s Sepetaprost

 
• By Lisa Takagi

Japan gives world-first approval recommendations to two domestically originated drugs, for insomnia and glaucoma/ocular hypertension.