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The Inevitable Outcome: Diabetes Safety Model Expands To Weight Loss…And Beyond?

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, MD (University of Colorado School of Medicine) has a problem with the Food and 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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Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Early Development Deals: Ipsen's Strategy For Biomarker-Driven Success

 
• By Eliza Slawther

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Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access In Vivo, or if you love it how it is, now is the time to have your voice heard.

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Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.

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Pharma’s Space Trails Entering Transformative Era

 
• By Anju Ghangurde

Merck and Lilly are among the leading pharma players using space-based research to power drug development. From reusable satellites to process drugs in low earth orbit to biomanufacturing labs experts discuss R&D opportunities in the starry canvas above.

Surgical Robotics CEOs Talk Metrics For Success, Valuations And Competition

 
• By Marion Webb

Leaders of robotic systems companies Distalmotion, Neocis and Noah Medical discussed success metrics, competition and funding. Institutional investors are focusing on utilization, procedure rates and a clear path to profitability as the IPO window reopens, BTIG analyst Ryan Zimmerman said.

Podcast: Astellas SVP On Doubling Down On Gene Therapy Despite Industry Headwinds

 
• By David Wild

Richard Wilson, SVP and primary focus lead for genetic regulation at Astellas, talks with In Vivo about the company's commitment to AAV as a gene therapy delivery vehicle, recent company investments and the regulatory environment under Trump's FDA.