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Regeneron Raises Possibility Of Quick CRL Resolution For High-Dose Eylea

 
• By Joseph Haas

On its earnings call, Regeneron said its 8mg formulation of aflibercept could obtain US FDA approval this quarter, despite receiving a complete response letter in June. Refiling’s fate tied to review of pozelimab, which is manufactured in the same plant with fill/finish concerns.

Regeneron
Regeneron now expects high-dose Eylea to gain approval this quarter • Source: Shutterstock: lev radin

Regeneron Pharmaceuticals, Inc. gave investors some unexpected potential good news during its second quarter sales and earnings call on 3 August, saying that its US filing of high-dose Eylea may obtain approval during the current quarter, perhaps even before the end of August, following a US Food and Drug Administration complete response letter on 27 June.

Eylea (aflibercept), an anti-VEGF agent, is approved for dosing every eight weeks at 2mg and has become the standard of...

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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.

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• 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.

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US FDA Requires Opioid Class Labeling Changes Despite Adcomm Advice

 
• By Kate Rawson

Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.

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.

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