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Keeping Track: Novartis' Ribociclib, Tesaro's Niraparib Submitted; Catalyst Clears Path For Firdapse Resubmission

 
• By Bridget Silverman

In retrospect, the European Society for Medical Oncology meeting was a showcase for pivotal trial data included in a burst of targeted therapy new drug applications, and more drug development news and highlights from our FDA Performance Tracker.

The past week brought filing news for Novartis AG's ribociclib, Tesaro Inc.'s niraparib, and Ariad Pharmaceuticals Inc.'s brigatinib – all products with significant clinical data presented at the European Society for Medical Oncology (ESMO) 2016 meeting in October. Ribociclib and brigatinib both have breakthrough therapy designations.

While FDA's novel agent approval count has been anemic this year (so far), the pipeline of agents under review for...

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More from United States

EU 15% Tariff Deal Still Leaves Questions For Pharma On Possible Grace Period, Generic Exemption

 
• By Jessica Merrill

While the 15% rate is a substantial blow for pharmaceutical firms, the US-EU deal provides a framework for trade agreements with other countries that could see the industry avoiding higher tariffs elsewhere.

Medicare Part B ASP Proposal Sets ‘Guardrails’ Around Bona Fide Service Fee Reporting

 
• By Cathy Kelly

Average sales prices, and Medicare spending on some drugs, would be expected to be lower, CMS says in the Physician Fee Schedule proposed rule.

A Record Year For US FDA Approvals? Commissioner Says It’s Possible

 
• By Michael McCaughan

FDA Commissioner Martin Makary suggested 60 new molecular entities could be approved in 2025, which appears possible, but can the strained staff deliver?

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.

More from North America

No Surprise Here: Foreign Drug Facilities Should Expect Surprise Inspections, US FDA Says

 
• By Sue Sutter

The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.

Base Benefit-Risk Decisions On Data, Not Opinion And Passion, CDER’s Tidmarsh Says

 
• By Sue Sutter

New US FDA drugs center director George Tidmarsh’s data-centric comments at a Reagan-Udall Foundation meeting on unapproved fluoride products could suggest patients’ and caregivers’ experiences will carry less weight in benefit-risk decisions under his leadership.

Pink Sheet Podcast: FDA’s New Top Drug Regulator, Sarepta’s Options After Elevidys Stand-Off

 
• By Derrick Gingery, Sarah Karlin-Smith, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the potential impact George Tidmarsh could have as director of the US FDA Center for Drug Evaluation and Research and the issues threatening the future of Sarepta’s gene therapy Elevidys.