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STAT+: Pharmalittle: We’re reading about an FDA push for trial transparency, a Novo-OpenAI deal, and more

Rise and shine, everyone, another busy day is on the way. And it is getting off to a good start here on the Pharmalot campus, where clear blue skies and unusually balmy breezes are greeting us. Who could ask for anything more? Actually, we could — it is time to reheat the kettle for another cuppa stimulation. Our choice today is elderberry-infused green tea. And here is a helpful tip — a teaspoon of honey enhances the flavors splendidly. Of course, you are invited to join us. For the full experience, we are now hawking replicas — take a look. Meanwhile, here are a few tidbits to help you along. As always, do keep in touch. We appreciate feedback, suggestions, criticism, and tips. …

In a bid toward greater transparency, the U.S. Food and Drug Administration sent reminder letters to more than 2,200 companies and researchers that they are required to report clinical trial results to a federal government database or they may face fines, STAT says. FDA officials disclosed that an internal analysis found results were not submitted for nearly 30% of studies that were “highly likely” to fall under mandatory reporting requirements. The agency also noted that the letters were sent to companies and researchers associated with more than 3,000 registered trials, some of which were publicly funded. In explaining its move, the regulator acknowledged a long-standing complaint from researchers who have argued that without access to specific data, trial results cannot be easily duplicated, which inhibits greater understanding of how medicines might work.

Novo Nordisk and ChatGPT maker OpenAI agreed to work together on how to leverage artificial intelligence to discover new drugs, the latest AI partnership in the medical field as health care companies seek to harness the technology to get ahead of the competition, The Wall Street Journal tells us. The drugmaker said it would integrate OpenAI’s models across its operations to help its workforce analyze complex datasets and reduce the time it takes to move from research to delivering treatments to patients. The group said the partnership would boost efficiency across the organization, with pilot programs initially launching in research and development, manufacturing, and commercial operations ahead of a full AI integration by the end of the year.

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Rise and shine, everyone, another busy day is on the way. And it is getting off to a good start here on the Pharmalot campus, where clear blue skies and unusually balmy breezes are greeting us. Who could ask for anything more? Actually, we could — it is time to reheat the kettle for another cuppa stimulation. Our choice today is elderberry-infused green tea. And here is a helpful tip — a teaspoon of honey enhances the flavors splendidly. Of course, you are invited to join us. For the full experience, we are now hawking replicas — take a look. Meanwhile, here are a few tidbits to help you along. As always, do keep in touch. We appreciate feedback, suggestions, criticism, and tips. …

In a bid toward greater transparency, the U.S. Food and Drug Administration sent reminder letters to more than 2,200 companies and researchers that they are required to report clinical trial results to a federal government database or they may face fines, STAT says. FDA officials disclosed that an internal analysis found results were not submitted for nearly 30% of studies that were “highly likely” to fall under mandatory reporting requirements. The agency also noted that the letters were sent to companies and researchers associated with more than 3,000 registered trials, some of which were publicly funded. In explaining its move, the regulator acknowledged a long-standing complaint from researchers who have argued that without access to specific data, trial results cannot be easily duplicated, which inhibits greater understanding of how medicines might work.

Novo Nordisk and ChatGPT maker OpenAI agreed to work together on how to leverage artificial intelligence to discover new drugs, the latest AI partnership in the medical field as health care companies seek to harness the technology to get ahead of the competition, The Wall Street Journal tells us. The drugmaker said it would integrate OpenAI’s models across its operations to help its workforce analyze complex datasets and reduce the time it takes to move from research to delivering treatments to patients. The group said the partnership would boost efficiency across the organization, with pilot programs initially launching in research and development, manufacturing, and commercial operations ahead of a full AI integration by the end of the year.

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Replimune looks ahead as repeat CRL speeds the company’s decline

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Replimune’s second complete response letter for its cancer therapy last week is already leading to multiple rounds of layoffs and existential questions about the company’s future unless it can figure out a path forward with …

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STAT+: Congress returns to a packed health care agenda

You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays.

Trump deleted an AI image of himself on Truth Social looking a whole lot like Jesus after conservative Christians cried blasphemy. “It’s supposed to be me as a doctor,” Trump told reporters while stepping out of the Oval Office to get a McDonald’s delivery. Send news tips and surprising health care angles to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.

Recess is over

Congress returns to a packed health care agenda after two weeks off. Here’s what to follow.

Continue to STAT+ to read the full story…

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You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays.

Trump deleted an AI image of himself on Truth Social looking a whole lot like Jesus after conservative Christians cried blasphemy. “It’s supposed to be me as a doctor,” Trump told reporters while stepping out of the Oval Office to get a McDonald’s delivery. Send news tips and surprising health care angles to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.

Recess is over

Congress returns to a packed health care agenda after two weeks off. Here’s what to follow.

Continue to STAT+ to read the full story…

Read More

Continue Reading

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Travere wins long-awaited approval for kidney disease drug

The clearance of Filspari in a condition known as FSGS ends a winding regulatory journey and unlocks a revenue opportunity believed to be worth more than $1 billion annually. 

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The clearance of Filspari in a condition known as FSGS ends a winding regulatory journey and unlocks a revenue opportunity believed to be worth more than $1 billion annually. 

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