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Anti-NGF Studies Face Major Redesign After Arthritis Advisory Cmte. Urges Resumed Testing

 
• By Martin Berman-Gorvine

Pfizer’s tanezumab, Regeneron’s REGN475 and Janssen’s fulranumab could head back to the clinic soon, but will need radical protocol changes to protect patients from the emerging risk of joint destruction.

FDA and the sponsors of anti-nerve growth factor drugs now face the challenge of redesigning clinical trials for the experimental agents after the agency’s Arthritis Advisory Committee urged that the studies be resumed at a March 12 meeting.

The committee felt that the trials – which FDA placed on clinical hold when some patients experienced accelerated joint destruction...

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More from United States

Merck, AstraZeneca Downplay Impact of European Tariffs Despite Timing Uncertainties

 
• By Cathy Kelly

Meanwhile, companies continue discussions with the Trump Administration over ways of increasing what European nations pay for drugs as an alternative to imposing a Most Favored Nation drug pricing policy in the US.

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?

More from North America

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.

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.