STAT+: China competition, ‘destruction’ at FDA give agency chance to restructure, Rick Pazdur says

CHICAGO — Rick Pazdur, the former top oncology regulator at the Food and Drug Administration, said the damage done under recent political appointees opens a chance for new leadership to fundamentally restructure the FDA, particularly as China’s drug industry grows more competitive

Under leaders appointed by the Trump administration, “we’ve had a lot of destruction here, and it doesn’t mean that we have to just go back and say, well, let’s rebuild it as it was,” Pazdur said Friday night at a STAT event during the annual meeting of the American Society of Clinical Oncology. “This gives us a great opportunity of — how we want to build it, what staff we want to have, how we want the administrative structure to be.”

He said the FDA has lost many valuable experts and one way to bolster the workforce is to “think creatively,” such as bringing in academics and people in the drug industry for one- or two-year terms.

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STAT+: Revolution Medicines starts shipping experimental pancreatic cancer drug

CHICAGO — The biotech company Revolution Medicines has begun sending its experimental, life-extending treatment for pancreatic cancer to physicians and their patients under an early access program authorized by the Food and Drug Administration, the company’s CEO, Mark Goldsmith, told STAT.

“We are now shipping the drug,” he said, speaking Friday evening at a STAT event held in conjunction with the annual meeting of the American Society of Clinical Oncology. 

The drug, daraxonrasib, is not yet approved. But patients with pancreatic cancer have been clamoring for it since mid-April, when Revolution reported the striking results of a Phase 3 clinical trial. Patients treated with daraxonrasib lived nearly twice as long as patients offered standard chemotherapy — an outcome unprecedented in the pancreatic cancer field. 

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STAT+: As Ebola outbreak grows, Trump administration veers from previous government playbook

WASHINGTON — In January 2025, with the Covid-19 pandemic still top of mind, the Biden administration left behind extensive plans for how the federal bureaucracy should work to stop future disease outbreaks.

The plans were hundreds of pages long and addressed dozens of specific issues, including the government response to diseases like Ebola and how to move Americans from outbreak zones back to the U.S. for care.

But weeks later, the Trump administration took Washington by storm — and began disregarding the plans, according to two former Centers for Disease Control and Prevention officials who worked in the Trump administration and four people familiar with the Biden-era plans.

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STAT+: At ASCO, positive data for Bristol in multiple myeloma and Pfizer in lung cancer

You’re reading the web edition of ASCO in 30 Seconds, STAT’s guide to the American Society of Clinical Oncology annual meeting. Sign up for email editions here.  

We’re ASCOmaxxing.

Rest assured, this will not require Adam Feuerstein, Matthew Herper or Angus Chen to hammer on their jawlines. They will, however, be scouring the ASCO annual meeting to bring you the cancer news, analysis and event coverage you crave.

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<![CDATA[Phase 2 data suggest luvesilocin quickly eases postpartum depression with durable remission and minimal breast‑milk transfer, supporting larger trials.]]>

STAT+: Trump administration seeks to overhaul federal grantmaking process, alarming researchers

The Trump administration has released a sweeping proposal to overhaul the bedrock regulation for all federal grants, and in doing so is seeking to codify tighter political control of federally funded research. 

The changes, laid out in a 400-plus-page document published this week, would deemphasize the role of peer review in determining what work to fund, limit the ability for scientists to use federal funds to publish their research or travel to conferences, and offer political appointees more latitude to terminate grants at will.

The suite of proposed changes aligns in many respects with policies the administration has attempted to implement through executive orders and one-off announcements, sometimes at individual agencies; if formalized, the revised regulation would be in effect across the government and put the regulatory authority of the White House behind it. 

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<![CDATA[Phase 3 at-home data show sublingual dexmedetomidine cuts severe agitation in bipolar disorder and schizophrenia, supporting FDA label expansion.]]>

Co-Designing a Text Messaging Intervention for Youth Transitioning From Child to Adult Mental Health Services: Participatory Design Jam Study

<strong>Background:</strong> The transition from child to adult mental health services is a vulnerable period marked by service disengagement, care gaps, and worsening mental health outcomes. Although planned, developmentally appropriate transition processes can improve functioning, youths report insufficient preparation, limited continuity of care, and unmet expectations for support. Existing transition supports remain underevaluated and require further adaptation for mental health contexts. Youth consistently report needing clearer information, concrete support, and sustained connection. Digital tools, particularly SMS text messaging, which is widely used, accessible, and acceptable to youth, offer a promising way to deliver timely transition supports. Yet most digital mental health tools are developed without meaningful youth involvement, highlighting the need for participatory approaches to ensure relevance, usability, and uptake. <strong>Objective:</strong> This study aimed to co-design and refine prototypes for a transition-focused SMS text messaging intervention by engaging youth with lived experience in a participatory co-design activity (design jam) to identify priority content, key functionality, and implementation enablers to support the transition from child to adult mental health services. <strong>Methods:</strong> We conducted a 3-hour mixed methods, participatory design jam to co-design transition-focused SMS text messaging prototypes, recruiting youth aged 16-26 years in Canada who had recently transitioned to, or were approaching transitioning to, adult mental health services. Data sources included workshop artifacts, observational field notes, and audio recordings from structured activities involving evidence review, brainstorming, rapid prototyping, brief team pitches, and evaluation. Rapid qualitative analysis, integrating open coding, content analysis of visual prototypes, and the rapid identification of themes from audio recordings, was used to identify priority content, key functionality, and implementation enablers. Findings were refined through a member-checking debrief with youth participants. <strong>Results:</strong> Seven youths aged 19-24 years participated in the design jam. Across two teams, participants generated 54 content ideas and 50 feature ideas. Two distinct prototypes were developed: one emphasizing long-term affirmation, self-advocacy, self-care, and profile-based customization, and the other prioritizing shorter-term informational support, navigation resources, and flexible message frequency. Youth across both groups highlighted the importance of interactive and visually engaging elements. Analysis revealed 3 thematic tensions shaping youth design preferences: balancing autonomy with ongoing support (roaming/reconnecting), balancing personalization with the need for simplicity (customization/convention), and balancing knowledge delivery with motivation for action (learning/living). Participants rated the design jam positively. <strong>Conclusions:</strong> Youth meaningfully contributed to co-designing an SMS text messaging intervention to support transition from child to adult mental health services, generating concrete content, functionality, and implementation priorities. Their prototypes highlighted the need to balance autonomy with support, personalization with simplicity, and information with motivational guidance. These findings demonstrate the value of participatory co-design in developing youth-centered digital transition supports and underscore the importance of evaluating such prototypes in real-world settings to determine feasibility and impact.

Kenya court suspends U.S. plan for Ebola quarantine facility for Americans

NAIROBI, Kenya — A court in Kenya on Friday suspended a U.S. plan to establish a quarantine facility for Americans exposed to a rare type of Ebola virus spreading in northeastern Congo, following a backlash by medical workers and activists.

A U.S. administration official said on Wednesday that the U.S. was planning to send Americans who are exposed to Ebola while abroad to a new facility in Kenya instead of flying them home. The official spoke on condition of anonymity to share the administration’s plans. It was unclear where in Kenya the new facility will be built or whether the Kenyan government has signed off on the plan.

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