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The Inevitable Outcome: Diabetes Safety Model Expands to Weight Loss…and Beyond?

 
• By Michael McCaughan

The cardiovascular outcomes standard used for diabetes drugs since 2008 is moving to weight loss. That is important in itself, but also for what it says about the lessons FDA has taken from the diabetes experience—and what it might mean about regulatory expectations for other chronic drug classes in the future.

Cardiologist William Hiatt (University of Colorado School of Medicine) has a problem with the Food & Drug Administration’s proposal to require cardiovascular outcomes studies for all weight loss drugs, even in the absence of a clear signal of CV risk.

“If you want to impose this requirement on a drug with no signals, I think you ought to impose it...

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ACIP Members ‘Not Easy’ To Find After Clean Sweep, US CDC Director Nominee Says

 
• By Cathy Kelly

The CDC Advisory Committee on Immunization Practices had only seven members in place as it met for the first time since HHS Secretary Robert F. Kennedy Jr. dismissed the previous panelists. CDC Director nominee Susan Monarez said finding replacements has been difficult.

Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 
• By Neena Brizmohun

The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”

MAHA Commission Outlines Enhanced Research On Drug Safety In Children

 
• By Cathy Kelly

Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

US FDA Will Help States Apply To Import Cheaper Drugs From Canada

 
• By Cathy Kelly

The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.

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Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 
• By Eliza Slawther

Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

Post-BIO Podcast: Thoughts From The Frontlines

 
• By Sarah Karlin-Smith, Mandy Jackson, and Mary Jo Laffler

Pink Sheet and Scrip journalists reflect on the mood from Boston, the most important takeaways and what’s next for industry.

New CDC Vaccine Panel Chair Vows To ‘Rebuild Public Trust’ With Evidence-Based Medicine

 
• By Sue Sutter

The newly reconstituted Advisory Committee on Immunization Practices will create new work groups to examine the cumulative impact of vaccine schedules and reexamine some older vaccines.