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COPD Post-Market Requirements: Cardiovascular Safety Could Evolve to Comparative Trials

 
• By Cole Werble

Forest's aclidinium breezed through an advisory committee review with three strong votes in favor of approval. The FDA panel, however, also included an interesting call for more head-to-head trials in COPD from the outgoing panel chair. That may impact Forest's Phase IV work--but more importantly it may be a sign of the future expectations for other sponsors in the active COPD development area.

Post-market cardiovascular safety trials are emerging as a standard feature for new anticholinerigcs for chronic obstructive pulmonary disease. The trials are the legacy of FDA’s 2007-2009 post-marketing investigation into the cardiovascular safety profile of Pfizer Inc. /Boehringer Ingelheim Pharmaceuticals Inc.'s long-acting muscarinic antagonist Spiriva (tiotropium).

The safety focus is not a surprise given the agency's long-term interest in inhaled bronchodilators. What is new is that...

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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

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Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
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US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

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US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 
• By Bridget Silverman

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US

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.