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STAT+: FDA panel will meet to discuss allowing broader access to certain peptides

WASHINGTON — The Food and Drug Administration will convene an outside panel of advisers to discuss whether to allow compounding pharmacies to manufacture certain peptides, the agency announced on Wednesday. The meetings will take place July 23 and 24. Another will be held before the end of February 2027.

In 2023, the FDA removed 19 peptides from a list of drugs the agency allows compounding pharmacies to produce.  The July panel will discuss whether to add back seven peptides. At a future meeting that has yet to be scheduled, the panel will discuss whether to add back five.

There is limited data on the effectiveness and safety of many of these products, but they have become increasingly popular, promoted by online influencers and health secretary Robert F. Kennedy Jr. The move comes after Kennedy told podcaster Joe Rogan in February that he wanted to make those peptides more accessible. 

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STAT+: A $15 AI test, Project Glasswing, and how Doctronic pilot blindsided Utah medical board

You’re reading the web edition of STAT’s AI Prognosis newsletter, our subscriber-exclusive guide to artificial intelligence in health care and medicine. Sign up to get it delivered in your inbox every Wednesday. 

This newsletter will be taking a break next week as I head to the Grand Canyon. Please send must-see northern Arizona sights, and — you know the drill — Phoenix ice cream recommendations: aiprognosis@statnews.com

There are so many important things going on that we’re bringing you a big ol’ roundup this week.

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STAT+: Pharmalittle: We’re reading about FDA seeking more data on a Lilly obesity pill, a pharma 340B win, and more

Top of the morning to you. The middle of the week is upon us and, since you made it this far, why not forge ahead? After all, there is always light at the end of the proverbial tunnel. You never know what you may accomplish. So please join us as we celebrate this notion with a cup or three of delicious stimulation. Our choice today is chocolate raspberry. Meanwhile, we have assembled the latest menu of tidbits to help you along. So please dig in. Have a smashing day, and please feel free to forward any secrets you come across. Our “in basket” is always open. …

The U.S. Food and Drug Administration asked Eli Lilly for more data on liver injury linked to its newly approved ​obesity pill, Reuters says, citing a letter posted on the agency website. The April 1 letter also said Lilly must conduct post-marketing trials to assess risks related to cardiovascular events and delayed gastric emptying. The drugmaker is required to also conduct a milk-only lactation study in ​lactating women who have received a dose of the pill to assess concentrations of the drug ​in breast milk using a validated assay. The weight loss pill, ‌branded Foundayo, a once-daily oral medication that targets the GLP-1 hormone, won approval earlier this month under the Commissioner’s National Priority voucher program, which aims to speed FDA decisions on drugs deemed critical to public health or ​national security.

AbbVie, Novartis, AstraZeneca, and the Pharmaceutical Research & Manufacturers of America, the industry trade group, notched a victory after a U.S. appeals court vacated an order rejecting their request to block a Maryland drug discount law, remanding the decision for review, Bloomberg Law reports. The U.S. Court of Appeals for the Fourth Circuit ruled that a lower court erred when it denied a motion filed by the companies and the trade group for a preliminary injunction against a Maryland law. H.B. 1056, currently in effect, requires manufacturers to distribute discounted drugs to an unlimited number of pharmacies that contract with health providers under the 340B Drug Discount Program. They argued the law improperly forces drug companies to supply so-called contract pharmacies as part of the program, and that the law is illegal because it is preempted by federal law and also violates the U.S. Constitution.

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Aberrant local and global neural activation patterns in pediatric Prader–Willi syndrome

PurposeAlthough cognitive disorders in children with Prader–Willi syndrome (PWS) are linked to abnormalities in spontaneous neural activation and functional connectivity (FC), the specific neural activation patterns remain uncertain, especially in young children with PWS.MethodsThe current study set out to explore specific local and global neural activation in pediatric PWS using the amplitude of low-frequency fluctuations (ALFF), regional homogeneity (ReHo), and seed-based whole brain FC. Information was gathered from 35 pediatric PWS patients and 33 healthy controls (HC). Both groups’ ALFF and ReHo values were computed, and FC were constructed on the basis of altered ALFF and ReHo regions. The relationships between altered ALFF, ReHo, and FC and the Griffiths Developmental Scales (GDS) of the PWS group were analyzed using partial correlation analysis.ResultsBoth ALFF and ReHo exhibited decreases in occipital lobe, temporal lobe, and cingulate gyrus, and altered ReHo was present in parietal lobe, frontal lobe, and basal ganglia areas. Moreover, ALFF and ReHo also exhibited increases in occipital and temporal lobes. Decreased FC was detected in the visual network (VN), sensorimotor network (SMN), salience network (SAN), and default mode network (DMN). The SMN-, cingulate-, and occipital lobe-related neural activation patterns were significantly positively correlated with the GDS score.ConclusionThe PWS group was characterized mainly by decreased neuronal physiological function and the ReHo was similar to ALFF but more extensive. The decreased local and global brain neural activation patterns may serve as early physiological indicators of cognitive abnormalities.
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Early tinnitus burden and subjective hearing are candidate markers of 2-year quality of life after cochlear implantation in single-sided deafness

BackgroundCochlear implantation is a common treatment for adults with single-sided deafness (SSD), but patient-reported benefits vary. The relationships among tinnitus burden, perceived hearing ability, psychological distress, disease-specific health-related quality of life, and whether early postoperative outcomes predict later results are not well understood.ObjectiveThis study explores how disease-specific quality of life relates to tinnitus burden, hearing, stress, depression, and anxiety after cochlear implantation in SSD. It also seeks early markers linked to 2-year outcomes.MethodsThis secondary complete-case analysis was based on a previously reported prospective longitudinal SSD cohort. Of 70 adults with postlingual SSD, 36 (51.4%) had complete Nijmegen Cochlear Implant Questionnaire (NCIQ) data at baseline and at 6 months, 1 year, and 2 years after unilateral cochlear implantation and were included. Additional measures included the Tinnitus Questionnaire (TQ), Oldenburg Inventory (OI), PerceivFed Stress Questionnaire (PSQ), General Depression Scale (ADS-L), Generalized Anxiety Disorder 7-item scale (GAD-7), and Freiburg Monosyllable Test (FMT) at 65 dB. Timepoint-specific correlations with the NCIQ were analyzed using Spearman’s rank correlations. Exploratory multivariable analyses employed linear regression on rank-transformed variables to assess whether baseline and 6-month patient-reported profiles were associated with 2-year NCIQ outcomes. Longitudinal within-patient comparisons were conducted as a secondary descriptive analysis.ResultsHigher NCIQ scores were linked to lower tinnitus burden and better hearing across all assessments. Associations with depression and anxiety persisted, while connections with perceived stress emerged after surgery. At baseline, higher tinnitus burden was associated with lower 2-year NCIQ scores. At 6 months, higher tinnitus is still associated with lower 2-year NCIQ scores, whereas better hearing is associated with higher 2-year NCIQ scores. Early postoperative improvement was followed by stabilization over 2 years.ConclusionImprovement in health-related quality of life after cochlear implantation in adults with SSD is complex and extends beyond hearing alone. Tinnitus was the most consistent negative factor, while improved subjective hearing at 6 months was associated with better outcomes at 2 years. These results support a structured, multidimensional approach to patient-reported follow-up after cochlear implantation in SSD and suggest that early postoperative patient-reported status may serve as an early candidate marker for later quality-of-life outcomes.
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Brain-gut communication and potential applications of microecological treatments in stroke

Stroke is a cerebrovascular disease with high incidence rates, serious disability and increased mortality rates, thereby posing a serious threat to human health. The mechanisms of brain-gut communication have gradually emerged in recent times. This article focuses on the gut-brain axis and discusses the bidirectional regulatory pathways between gut microecology and stroke via the neurotransmitter, colony metabolite, endocrine, and immunoregulatory pathways. Additionally, it summarizes the latest applications of gut microecological agents in stroke, which may provide new research ideas and clinical treatment strategies for the microecological diagnosis and therapy of stroke.
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Reliability of ultra-thin metal films integrated onto embossed and bonded liquid-crystal-polymer (LCP) sheets for neural-interface applications

Liquid crystal polymer (LCP) is increasingly used in flexible implantable bioelectronic devices due to its low moisture uptake, chemical stability, and ability to form robust thermoplastic bonds. However, integrating fine-pitch thin-film metallization into bonded embossed LCP structures presents challenges related to pattern fidelity, bond integrity, alignment accuracy, and long-term electrical reliability, particularly when the metal thickness is small relative to the surface roughness. In this work, we present and characterize a fabrication process for integrating a 500-nm-thick sputtered Cr/Au thin-film metallization onto a 25-μm-thick embossed high-temperature LCP (HT-LCP) substrate, patterned into long (20 cm) and narrow (8 μm) traces using lift-off. Bond integrity between the metallized HT-LCP and a low-temperature LCP (LT-LCP) layer was evaluated using peel testing, while structural and electrical integrity were assessed using NanoCT imaging and resistance measurements. Long-term reliability was evaluated using reactive accelerated aging (RAA) at 87 °C in physiological saline with 10 mM hydrogen peroxide. The results show that the thin metal layer does not degrade bond strength and that embedded traces maintain structural and electrical integrity through bonding and aging. After 12 days of RAA testing, no measurable changes in electrical performance were observed. Electrochemical impedance spectroscopy demonstrated that electrodes coated with a 100-nm sputtered Pt layer exhibited approximately 2 × lower impedance than flat Pt electrodes, attributed to increased surface roughness. Additionally, the bonded LCP structure was thinned from 50 μm to 10 μm using CF4/O2 reactive ion etching with >90% uniformity. These results demonstrate that thin-film metallization integrated into bonded embossed LCP systems can achieve high interconnect density without compromising mechanical or electrical reliability. This work provides practical guidelines for the design of thin, flexible, and durable LCP-based implantable bioelectronic devices.