Learn about the resignation of FDA Commissioner Marty Makary and the appointment of Kyle Diamantas as acting commissioner. Discover more updates from STAT.

U.S. Food and Drug Administration (FDA) Commissioner Marty Makary has announced his resignation, effective immediately. This comes after months of internal dissatisfaction within the agency regarding his leadership style. The resignation follows a tumultuous period marked by personnel changes and controversies over political interference in scientific processes.

Kyle Diamantas, currently serving as the top food regulator at the FDA, will take over as acting commissioner. His appointment was seen as a response to the growing discontent with Makary's tenure, which included ambitious initiatives such as efforts to shorten drug review timelines and crack down on misleading advertisements. However, these reforms were not without challenges, including departures of long-time staff members and disputes over political pressures affecting the agency’s scientific integrity.

Meanwhile, Eli Lilly has shared details about a late-stage trial involving its new weight loss pill Foundayo. The results indicate that patients who switched from Novo Nordisk's injectable GLP-1 medication Wegovy to Lilly's oral Foundayo regained an average of 2 pounds after a year. This finding contrasts with the outcomes observed in trials where patients shifted from other Lilly products, such as Zepbound and Mounjaro, which showed significant weight regain.

The study also revealed that patients who switched from Novo Nordisk’s Wegovy to Lilly's more potent injectable Zepbound regained an average of 11 pounds. These findings highlight the complexities in developing effective weight loss treatments within the pharmaceutical industry.

As STAT continues to provide updates on these developments and other significant events, readers can subscribe to STAT+ for exclusive content, including detailed analysis, newsletters, premium events, and news alerts.

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Former FDA Commissioner Marty Makary has announced his resignation from the agency, effective immediately. His departure follows a period of internal turmoil marked by personnel changes and disputes over political interference affecting scientific integrity.

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These updates underscore the dynamic nature of pharmaceutical regulation and industry dynamics, reflecting ongoing challenges in ensuring safe and effective medicines for patients worldwide. For more detailed insights into these developments, STAT+ subscribers have exclusive access to comprehensive analysis and premium content.

STAT Plus: Makary Departs FDA Amid Turmoil

Former FDA Commissioner Marty Makary has resigned from the agency, effective immediately. His departure follows months of criticism over his leadership style, including efforts to streamline drug review processes and address misleading advertising practices.

Kyle Diamantas, currently serving as the top food regulator at the FDA, will take over as acting commissioner. This appointment signals a shift in leadership to address ongoing concerns within the agency.

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Sanofi has requested that its diabetes drug be removed from the FDA voucher program, citing interference by political appointees during the review process. This move reflects broader concerns about the impact of political influence on drug development and approval decisions.

These updates provide a snapshot of recent developments in pharmaceutical regulation and industry dynamics, offering readers an inside look at ongoing challenges and potential solutions within the sector.

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Subscribe Now: To stay informed about these developments and more, STAT+ subscribers have exclusive access to detailed analysis, comprehensive newsletters, premium events, and real-time news alerts. Sign up today for uninterrupted coverage of the latest in pharmaceutical regulation and industry trends.

Already a subscriber? Log in now to access your personalized content and benefits.

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Former FDA Commissioner Marty Makary has resigned from his position amid a period of significant internal strife at the agency. His departure follows months of criticism over his leadership style, including efforts to streamline drug review processes and address misleading advertising practices.

These updates underscore the dynamic nature of pharmaceutical regulation and industry dynamics, reflecting ongoing challenges in ensuring safe and effective medicines for patients worldwide. For more detailed insights into these developments, STAT+ subscribers have exclusive access to comprehensive analysis and premium content.

STAT Plus: Makary Departs FDA Amid Turmoil

Former FDA Commissioner Marty Makary has resigned from the agency, effective immediately. His departure follows months of criticism over his leadership style, including efforts to streamline drug review processes and address misleading advertising practices.

Kyle Diamantas, currently serving as the top food regulator at the FDA, will take over as acting commissioner. This appointment signals a shift in leadership to address ongoing concerns within the agency.

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Sanofi has requested that its diabetes drug be removed from the FDA voucher program, citing interference by political appointees during the review process. This move reflects broader concerns about the impact of political influence on drug development and approval decisions.

These updates provide a snapshot of recent developments in pharmaceutical regulation and industry dynamics, offering readers an inside look at ongoing challenges and potential solutions within the sector.

STAT Plus: Pharma Leaders Criticize Industry Practices

Olivia Kosloff, along with six former FDA officials, has penned an article criticizing the actions of their peers within the pharmaceutical industry. The piece highlights issues such as excessive lobbying efforts, conflicts of interest, and a lack of transparency that threaten public health.

Why We Left the FDA: Six Former Officials Share Their Stories

Former FDA Commissioner Alex Hogan shares his experiences leaving the agency, detailing the reasons behind his decision to resign amid ongoing controversies and challenges. His account offers valuable insights into the complex issues facing pharmaceutical regulation today.

Subscribe Now: To stay informed about these developments and more, STAT+ subscribers have exclusive access to detailed analysis, comprehensive newsletters, premium events, and real-time news alerts. Sign up today for uninterrupted coverage of the latest in pharmaceutical regulation and industry trends.

Already a subscriber? Log in now to access your personalized content and benefits.

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The European Union has finalized a draft agreement aimed at boosting local production of medicines, aiming to reduce potential shortages. This initiative reflects efforts to ensure reliable access to essential medications across member states.

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In today’s edition of Pharmalittle, STAT covers various industry developments including pharma lobbying efforts and Bristol-Myers Squibb's strategic partnership with a Chinese company. The newsletter also delves into topics such as Medicare coverage for Alzheimer’s drugs and estrogen patch shortages.

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Colombia has secured a significant court ruling regarding the compulsory license issued for an HIV medicine, highlighting ongoing efforts to ensure equitable access to life-saving treatments in developing countries. This development reflects broader global discussions around intellectual property rights and public health priorities.

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Former FDA Commissioner Marty Makary has resigned from his position amid a period of significant internal strife at the agency. His departure follows months of criticism over his leadership style, including efforts to streamline drug review processes and address misleading advertising practices.

These updates underscore the dynamic nature of pharmaceutical regulation and industry dynamics, reflecting ongoing challenges in ensuring safe and effective medicines for patients worldwide. For more detailed insights into these developments, STAT+ subscribers have exclusive access to comprehensive analysis and premium content.

STAT Plus: Makary Departs FDA Amid Turmoil

Former FDA Commissioner Marty Makary has resigned from the agency, effective immediately. His departure follows months of criticism over his leadership style, including efforts to streamline drug review processes and address misleading advertising practices.

Kyle Diamantas, currently serving as the top food regulator at the FDA, will take over as acting commissioner. This appointment signals a shift in leadership to address ongoing concerns within the agency.

STAT Plus: Capricor Therapeutics Accuses Nippon Shinyaku of Slowing Down Duchenne Drug Plans

Capricor Therapeutics has filed a complaint against Japanese pharmaceutical company Nippon Shinyaku, accusing them of delaying plans for a Duchenne muscular dystrophy drug.