Healthcare & Life Sciences

Honey Bee Venom Immunotherapy Randomised Safety Study, Victoria

The Royal Melbourne Hospital has registered a Phase 0 randomised controlled pilot study comparing two honey bee venom immunotherapy (HBV-VIT) initiation strategies in adults sensitised to honey bee venom. The trial will enrol 24 participants at The Royal Women's Hospital (Parkville) and Monash Medical Centre (Clayton), Victoria, with anticipated first enrolment on 30 April 2026 and final data collection by 30 July 2027. Participants will be randomised to either direct 100-µg maintenance-dose initiation (weeks 0, 4, 8, 12) or ultrarush up-dosing (escalating doses over six weeks), with safety monitoring for systemic and local reactions across the 12-week induction period. The study aims to quantify immunologic changes (HBV-specific sIgE/sIgG4), blood tryptase, late-phase symptoms, and quality-of-life outcomes.

Osteopathy Versus Physiotherapy for Chronic Low Back Pain, Warsaw Poland

ANZCTR registration ACTRN12626000521325 for a completed comparative effectiveness trial conducted entirely in Warsaw, Poland, comparing osteopathic manual therapy versus conventional physiotherapy for non-specific chronic lumbosacral pain. The trial enrolled 84 participants (target 102), was approved by the Bioethics Committee of the Medical University of Warsaw on 15/04/2014, and was retrospectively registered on 28/04/2026 after data collection concluded on 25/02/2022. No individual participant data will be shared as the survey was conducted anonymously.

Deadly Fit Mums Exercise Program for Indigenous Mothers

The Deadly Fit Mums (DFM) program is an Aboriginal community-led exercise and nutrition education program registered as a clinical trial on ANZCTR (ACTRN12626000522314). The program serves pregnant and post-partum women birthing an Aboriginal and Torres Strait Islander baby through the Birthing in Our Community (BiOC) service across four sites in South East Queensland. The primary sponsor is Federica Barzi at the University of Queensland, with the Institute for Urban Indigenous Health as a collaborator and funding from the Australian Government Department of Health Medical Research Future Fund. Ethics approval was granted by The University of Queensland Human Research Ethics Committee (2025/HE000966) on 18/06/2025. The trial is registered retrospectively with enrollment of 1,300 participants completed between January 2023 and June 2025, and final data collection anticipated by June 2026.

Effect of Spinal and General Anesthesia on Frontal QRS Axis in Total Knee Arthroplasty

NIH registered study NCT07551648, a prospective observational trial comparing frontal QRS axis changes in patients undergoing total knee arthroplasty under spinal versus general anesthesia. The study will enroll adults aged 18 years and older with ASA physical status I to III, using standard 12-lead electrocardiography to measure preoperative-to-postoperative QRS axis changes. Enrollment criteria, methodology, and outcome measures are now publicly available on ClinicalTrials.gov for research transparency purposes.

Pilot Validation of STELA Digital Preventive Medicine Platform for Cardiovascular Risk Reduction in Adults

A pilot validation study for the STELA digital preventive medicine platform has been registered on ClinicalTrials.gov (NCT07551960) by researchers at AGEL Hospital Trinec-Podlesi in Czechia. The platform is designed to identify, quantify, and reduce modifiable cardiovascular health risk factors in adults without established cardiovascular disease through comprehensive health assessments, personalized prevention plans, and coordinated wellness interventions. The study uses the AGEL Gamification Index scoring system and involves participants undergoing extensive baseline assessments including laboratory panels, physical tests, and imaging studies.

Novel MRI Sequences for Prostate Cancer Diagnosis Accuracy: NCT07552285

NCT07552285 is a prospective observational study registered at a single center evaluating the diagnostic efficacy and grading accuracy of novel MRI sequences (MAGiC, OGSE, CEST, IVIM) for prostate cancer detection. The study enrolls patients with clinical suspicion of prostate cancer and performs both conventional and new sequence magnetic resonance scans, using surgical or biopsy pathological results as the gold standard for comparison. The primary research question is whether novel non-contrast multiparametric MRI imaging can improve accuracy of prostate cancer diagnosis and grading compared to conventional approaches.

Goserelin Preserves Ovarian Function in Aplastic Anemia Following Allogeneic HSCT

This ClinicalTrials.gov registration documents NCT07552506, a prospective randomized multicenter clinical trial investigating whether Goserelin prophylaxis preserves ovarian function in 132 female patients aged 14-50 with severe aplastic anemia undergoing allogeneic hematopoietic stem cell transplantation. Patients will be stratified by busulfan conditioning status and randomized 1:1 to receive a single 3.6 mg subcutaneous Goserelin injection 1-3 days prior to conditioning or standard transplantation regimen without Goserelin. The primary endpoint is menstrual recovery rate at 6 months post-transplant, defined as at least 3 naturally occurring menstrual cycles without intervention by menstrual-regulating drugs.

Astragalus Membranaceus 480mg/day 10-Week Muscle Function Study NCT07552675

This double-blind, placebo-controlled, randomized clinical trial (NCT07552675) evaluated whether daily supplementation with Astragali radix extract (480 mg/day) for 10 weeks could attenuate training-induced impairments in muscle function, joint pain, and inflammatory markers in moderately active young adults during 8 weeks of progressive resistance training followed by 2 weeks of intensified training. Participants were randomized to receive either the herbal extract or placebo, with primary outcome measured as maximal voluntary isometric torque (MVIT) of the knee extensors and secondary outcomes including 1RM strength, knee range of motion, muscle soreness, and circulating biomarkers of muscle damage and inflammation. The study record was processed and made publicly available on ClinicalTrials.gov.

Trapeziometacarpal Joint Arthroplasty Versus Trapeziectomy for Thumb Carpometacarpal Osteoarthritis RCT

Sahlgrenska University Hospital in Gothenburg, Sweden has registered a single-centre, blinded randomized controlled trial comparing trapeziometacarpal prosthetic arthroplasty versus trapeziectomy for symptomatic thumb carpometacarpal osteoarthritis in adults aged 18-69 years with Eaton grade 2-3 disease refractory to 3 months of non-operative treatment. The target enrollment is 64 participants randomized 1:1, with primary outcome of day-by-day pain measured on a numeric rating scale (NRS 0-10) and follow-up extending to 10 years.

CABG Trial Comparing Radial Artery vs No-Touch Vein Graft in Women

A randomized controlled trial comparing outcomes of coronary artery bypass grafting (CABG) in women at 1 year post-surgery has been registered on ClinicalTrials.gov under identifier NCT07552948. The main group includes 55 patients receiving CABG with radial artery grafts, while the control group includes 55 patients receiving CABG with great saphenous vein prepared using the no-touch technique, both for revascularization of the circumflex artery. The study examines the condition of coronary artery atherosclerosis.

Adapted RPM-08 for Substance Use Disorder in Pakistan

This ClinicalTrials.gov registration (NCT07552623) describes an eight-week randomized controlled trial in Pakistan testing whether a culturally adapted Relapse Prevention Module (RPM-08) combined with usual treatment reduces relapse risk in adults with substance use disorders, compared to usual treatment alone. Participants will attend eight structured group sessions and complete questionnaires at baseline, post-intervention, and follow-up to assess whether the adapted intervention's effects are sustained over time. This trial registration provides study design and participant information but does not impose compliance obligations on regulated entities.

Clinical Performance of Laryseal Clear vs Ambu Aura40 Laryngeal Mask Airway for Preschool Children

A clinical trial comparing the performance of Laryseal Clear and Ambu Aura40 laryngeal mask airways in preschool children undergoing surgical procedures has been registered on ClinicalTrials.gov. The study will evaluate both devices as supraglottic airway devices in pediatric anesthesia settings. NCT07553247 was registered on April 27, 2026, and the trial will assign participants to either the LarySeal clear Group or the Ambu Aura40 Group.

Low Intensity Laser Therapy Study, Children, Pneumonia

Clinical trial NCT07552116 registered on ClinicalTrials.gov evaluates whether low intensity laser therapy combined with standard medical treatment improves immune response in children with Down syndrome (DS) and pneumonia. The randomized controlled study enrolled 40 DS children with bronchopneumonia, assigning 20 to receive low intensity laser therapy three times weekly for one month alongside inspiratory muscle training and medical treatment. Both groups had immune system markers (WBCs, IgG, IgA, IgM), respiratory rate, and oxygen saturation measured before and after the one-month treatment period.

Ponlimsi Biosimilar to Prolia Approved March 2026

Ponlimsi Biosimilar to Prolia Approved March 2026

CAPTIVATE Trial Diet Microbiome Triple Negative Breast Cancer

The NIH has registered NCT07551765, the CAPTIVATE trial, a multi-center observational study examining the impact of diet-driven gut microbiome on treatment outcomes in women with untreated, stage I-III Triple Negative Breast Cancer undergoing neoadjuvant treatment with and without immune checkpoint inhibitors. The trial will collect stool samples, core tumor biopsies, and research blood samples at various study timepoints for analysis. As an observational registry entry, this posting does not impose compliance obligations on regulated entities.

ANKTIVA Plus BCG Versus BCG Monotherapy in High-Grade Non-Muscle Invasive Papillary Bladder Cancer, Phase 3 Study

NIH registered a Phase 3 clinical trial (NCT07551544) on April 27, 2026, evaluating intravesical ANKTIVA (400µg) plus BCG (50mg) against BCG monotherapy (50mg) in participants with histologically confirmed BCG-naïve or BCG-exposed high-grade Ta/T1 papillary non-muscle invasive bladder cancer. The open-label, randomized study will assess the contribution of ANKTIVA as an experimental neoadjuvant therapy in papillary NMIBC.

NK Cell Therapy for Malignant Solid Brain Tumors

A multi-center, open-label investigator-initiated trial (IIT) registered on ClinicalTrials.gov evaluating the safety, tolerability, and feasibility of combined intracranial and intravenous administration of ex vivo expanded and activated natural killer (NK) cells in adult patients with malignant solid brain tumors who have failed standard treatment modalities. The primary objective is to determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of the combined NK cell therapy. Secondary objectives include preliminary assessment of anti-tumor activity as measured by progression-free survival (PFS), overall survival (OS), objective response rate (ORR) per RANO criteria, and evaluation of immunological effects.

Lidocaine Infusion Reduces Opioid Requirements in Children - Phase 4 Trial NCT07552766

NIH registered a Phase 4 clinical trial (NCT07552766) on April 27, 2026 to evaluate whether intraoperative intravenous lidocaine infusion reduces total perioperative opioid requirements in 90 pediatric patients ages 3-18 undergoing surgical fixation of upper extremity long bone fractures. The prospective, randomized, double-blind trial enrolls participants 1:1 to receive either IV lidocaine or placebo (normal saline) during surgery under general anesthesia. The primary outcome measures total opioid consumption 60 minutes after arrival to the post-anesthesia care unit (PACU), with secondary outcomes including opioid use at additional time points, postoperative pain scores, PACU length of stay, rescue antiemetic use, and relationship between infusion duration and outcomes.

Observational Study on Pleasant Touch in Chronic Pain

NIH has registered a new observational study (NCT07551687) examining pleasant touch perception in individuals with chronic pain and its association with central sensitization and interoceptive awareness. Participants will be recruited from a specialist Pain Clinic in Västra Götaland, Sweden, and will complete online questionnaires assessing pain, touch experience, interoceptive awareness, and central sensitization. The study aims to compare pleasant touch perception across different pain mechanism types: nociceptive, neuropathic, and nociplastic.

Oxygen Modulator Hypoxic/Hyperoxic Tabata Training Study

NIH registered a clinical trial (NCT07551869) examining how breathing air with different oxygen concentrations during high-intensity interval training (Tabata protocol) affects aerobic capacity, ventilatory thresholds, blood lactate levels, and perceived exertion. The three-week study will enroll participants randomly assigned to breathe hyperoxic or hypoxic air during training sessions. This is a research study registry entry with no compliance obligations.

Full-Wrap vs Double-Strap Suspension for Reducing Soft Palate Injury: Multi-Center RCT

The National Institutes of Health registered NCT07552545, a prospective multi-center randomized controlled trial comparing full-wrap suspension versus traditional double-strap suspension for reducing soft palate injury during transoral and transnasal pharyngeal surgery. The study enrolls patients with adenoid hypertrophy, tonsillar hypertrophy, nasopharyngeal diseases, nasopharyngeal tumors, parapharyngeal or skull base lesions, or conditions requiring soft palate suspension. The registry entry was posted April 27, 2026.

NCT07552467: LRRC15 PET Imaging for GI Tumor Diagnosis Study

NIH ClinicalTrials.gov has registered an observational study (NCT07552467) evaluating LRRC15-specific PET radiotracers as targeted imaging agents for diagnosis and staging across eight malignant tumor types: pancreatic cancer, breast cancer, lung cancer, sarcoma, head and neck tumors, glioblastoma, colorectal cancer, and melanoma. The study will enroll both patients and healthy volunteers, comparing LRRC15 PET imaging against histopathological diagnosis and against existing agents [18F]FDG PET and [68Ga]Ga-FAPI PET to evaluate diagnostic efficacy and facilitate therapeutic decision-making.

Ripretinib Recommended for Advanced GIST After Kinase Inhibitors

NICE has published final technology appraisal TA1146 recommending ripretinib (Qinlock) for NHS use in adults with advanced gastrointestinal stromal tumours (GIST) who have received three or more kinase inhibitors. This guidance updates and replaces the prior recommendation TA881, reflecting new evidence reviewed on 28 April 2026. NHS commissioners and providers are required to fund ripretinib within three months of the publication date in accordance with NHS Constitution obligations.

12-Week PFMT With Imagery for Geriatric Urinary Incontinence

A clinical trial (NCT07551674) registered on ClinicalTrials.gov investigates the effects of a 12-week Pelvic Floor Muscle Training (PFMT) program using Action Observation Therapy (AOT) with metaphorical imagery on urinary incontinence in geriatric women aged 65 and older. The study, to be conducted between June 2025 and June 2026 in nursing homes in Istanbul, will enroll participants with stress or stress-predominant mixed urinary incontinence and normal cognitive function. Both study groups will undergo twice-weekly 45-50 minute progressive exercise sessions advancing from supine positions to standing and jumping movements, with the AOT group additionally observing metaphor-themed projected visuals. Efficacy will be evaluated using standardized tools including the Pelvic Floor Distress Inventory-20, 24-hour pad test, and Incontinence Quality of Life Scale.

Clinical Trial Tests AI Symptom Analysis via Pre-Visit Lab

NIH registered a new experimental clinical trial (NCT07552311) titled 'Generative AI Plan for Care Lab Study' on April 27, 2026. The study will observe participants' interactions with generative AI models designed to respond to consumer symptom queries, providing information about possible urgency, potential causes or diagnoses, and a summary of information to bring to a healthcare visit. The trial involves Fitbit Plan for Care Lab and Baseline Model interventions targeting Primary Health Care conditions.

Comparison of 3D Printed Resin Fixed Mandibular Retainer Versus Conventional Fixed Bonded Retainer

NIH ClinicalTrials.gov registered study NCT07552155 on April 27, 2026, comparing 3D printed resin fixed mandibular retainers to conventional fixed bonded retainers. The clinical trial will evaluate bond pair conditions across both intervention types, addressing a noted gap in evidence regarding chair side time and bond failure rates for 3D printed fixed mandibular retainers. This trial registration adds to the growing body of orthodontic research on digital manufacturing applications in dental retention therapy.

RCT Evaluates ChatGPT Teaching Model for Nursing Pain Management

Shahid Beheshti University of Medical Sciences (Tehran, Iran) is conducting a two-arm parallel-group randomized controlled trial (RCT) to evaluate the effect of a ChatGPT-driven blended teaching model on nursing students' knowledge, attitudes, competence, and learning self-efficacy in pain management. Eligible nursing students will be randomly assigned 1:1 to either the intervention group (ChatGPT-assisted blended clinical nursing rounds, 8 sessions over 4 weeks, each 90 minutes) or the control group (traditional clinical nursing rounds with no AI tools). Outcomes will be measured at baseline, immediate post-test, and 3-month follow-up using validated instruments including NKASRP, NSCS, and NLSE. This is a prospective clinical trial registration; no compliance obligations or regulatory actions are associated with this document.

Reproducibility of Dental Bite Mark Overlay Analysis Using Digital 3D Models

NIH registered an observational clinical trial (NCT07552051) evaluating the reproducibility and repeatability of a standardized digital overlay protocol in forensic odontology for bite mark analysis. The study will enroll 30 adult participants requiring routine dental care involving intraoral scanning, with four operators of varying expertise performing overlay procedures at two separate time points. The trial aims to quantify intra-operator repeatability and inter-operator reproducibility using both 2D and 3D metrics to support standardization of overlay-based forensic dentistry methods.

AI Chatbot Inoculates 5,000 Parents Against Vaccine Misinformation in Europe

A multi-country clinical trial registered on ClinicalTrials.gov (NCT07551986) evaluates an AI chatbot designed to counter cognitive biases and inoculate parents against vaccine misinformation, conducted across five European countries with 5,000 participants. The trial compares behavioral and attitudinal responses between the AI-driven chatbot intervention and standard-of-care materials such as UNICEF infographics. The study is scaled from a 2026 single-country predecessor and aims to identify scalable misinformation interventions applicable across the EU.

Phase 1 UC-MSC Stem Cell Trial, Primary Ovarian Insufficiency

NIH registered a Phase 1 clinical trial (NCT07551895) evaluating umbilical cord mesenchymal stem cell (UC-MSC) injection (HS_SW01 cells) in patients with Primary Ovarian Insufficiency (POI). The trial aims to assess safety, tolerability, and efficacy of the investigational stem cell therapy. Participants will be enrolled after signing informed consent and meeting protocol inclusion/exclusion criteria.

Picankibart Trial for Palmoplantar Pustulosis, 60 Subjects, Single-Arm Open-Label Study

A prospective, single-arm, open-label clinical study of Picankibart for the treatment of palmoplantar pustulosis has been registered on ClinicalTrials.gov under NCT07552454. The trial is sponsored by the Department of Dermatology at the First Affiliated Hospital of Air Force Medical University and plans to enroll 60 eligible subjects aged 18-65 years with confirmed diagnosis. Key eligibility criteria include failure or intolerance to at least one conventional systemic agent. Exclusion criteria include active hepatitis B, hepatitis C, tuberculosis, and pregnancy.

SAM Splint vs Usual Care Wrist Fracture Randomized Trial

NIH registered a randomized clinical trial (NCT07553000) on April 27, 2026, comparing SAM aluminium splinting against usual pain relief care for patients presenting to emergency departments with suspected wrist fractures. The trial targets adult patients with acute wrist injuries and will assess pain management and functional outcomes across the two intervention arms.

Stone Bridge Boil Water Notice Lifted in Tiverton

The Rhode Island Department of Health has announced that the boil water notice previously issued for the Stone Bridge area in Tiverton has been officially lifted. Residents and businesses in the affected area may now use water for normal consumption purposes without boiling.

DNREC, DPH Urge Tick Awareness Amid Rising Disease Risks Including First Powassan Virus Detection

The Delaware Department of Natural Resources and Environmental Control (DNREC) and the Division of Public Health (DPH) are urging Delawareans to take precautions against tick bites this spring and summer following the state's first confirmed detection of Powassan virus in a tick. The agencies report that more than 350 Lyme disease cases were reported in 2025 and more than 200 cases of alpha-gal syndrome have been reported since 2024. Prevention recommendations include using EPA-registered insect repellent containing at least 20% DEET, performing thorough tick checks after outdoor activities, and keeping yards mowed and leaf-free.

Tongue Lip Cheek Pressures on Maxillary Development

This document registers ClinicalTrials.gov study NCT07552441, an observational investigation conducted at Van Yuzuncu Yil University measuring tongue, lip, and cheek muscle pressures in patients aged 12 to 25 with and without maxillary constriction. The study uses the IOPI Pro Deluxe Kit to collect orolingual manometry data in kilopascals. The findings may inform orthodontic and dental understanding of jaw narrowness causes and treatment stability, but the study does not establish clinical practice requirements or regulatory obligations for any party.

Phase 2 Oxytocin Plus Self-compassion Training in Borderline Personality Disorder, 80 Patients

NCT07551882 is a Phase 2 randomized controlled clinical trial evaluating the combined effectiveness of self-compassion training (SCT) and intranasal oxytocin administration versus SCT plus placebo in treating borderline personality disorder (BPD). The study will enroll 80 patients with BPD who will receive a 5-week self-compassion training program along with either intranasal oxytocin or placebo. Clinical and wellness measures will be evaluated as primary outcomes. The trial is registered as Phase 2 with a start date of April 27, 2026.

Phase 3 IV Immune Globulin Trial for Stiff Person Syndrome

A Phase 3 clinical trial (NCT07552987) is investigating QIVIGY (Intravenous Human Normal Immune Globulin 10%) versus placebo in adults with stiff person syndrome (SPS). The study, sponsored by Kedrion, will evaluate both efficacy and safety of the IVIg 10% intervention against a human albumin 5% comparator. Participants enrolled in this trial will be monitored for treatment response in this rare autoimmune neurological condition.

DINGO Study Explores Gynecomastia Preferences in Prostate Cancer

The Determining INdividual Preferences for Gynecomastia Avoidance (DINGO) study is a qualitative research project examining how men with prostate cancer and high-risk biochemical recurrence perceive the risk of breast-related side effects, including gynecomastia, from cancer treatment. The study uses semi-structured interviews as its intervention method and focuses on understanding patient preferences regarding treatment side effect management. This registry entry documents a planned clinical study with no immediate regulatory or compliance implications.

Phase 2 Combat Trial: Botensilimab and Balstilimab for ctDNA-Positive Colorectal Adenocarcinoma, Apr 27 2026

A Phase II clinical trial (NCT07551596, titled 'Combat Trial') will evaluate botensilimab (AGEN1181) in combination with balstilimab (AGEN2034) for treating patients with stage II/III colorectal adenocarcinoma harboring detectable circulating tumor DNA (ctDNA). The immunotherapy regimen aims to eliminate residual microscopic cancer cells following standard treatment and uses ctDNA clearance as an early indicator of treatment response. The trial is registered with conditions including colorectal adenocarcinoma and stage-specific AJCC v8 classifications, with interventions comprising both study drugs plus biopsy, biospecimen collection, and radiographic examination procedures.

RELIEVE Study, NT 201, Overactive Bladder, Phase 2

The RELIEVE Study (NCT07553065) is a Phase 2b prospective, multicenter, double-blind, randomized, placebo and sham controlled clinical trial evaluating NT 201 delivered via the Vibe System in participants with idiopathic overactive bladder. The trial tests two dose levels of NT 201 (200U and 300U) against placebo/sham across multiple study sites. Clinical trial registrations on ClinicalTrials.gov provide public visibility into ongoing research but do not themselves create compliance obligations for regulated entities.

Speech-Based Depression and Anxiety Screening for University Students (BUAP, Mexico)

The NIH has registered an observational clinical trial (NCT07553130) evaluating acceXible, a speech-based machine learning platform, for detecting depression and anxiety in university students at Benemerita Universidad Autonoma de Puebla in Mexico. The study uses spontaneous speech analysis through open-ended interview tasks against PHQ and GAD-7 reference scales, with secondary objectives examining speech-derived variables, participant engagement with digital mental health resources, and longitudinal score changes.

Guided Imagery for Surgical Fear and Perioperative Comfort in TURP Patients NCT07552090

This randomized controlled trial registered on ClinicalTrials.gov (NCT07552090) evaluates whether structured guided imagery sessions can reduce surgical fear and improve perioperative comfort in patients undergoing Transurethral Resection of the Prostate (TURP). The study, grounded in Kolcabra's Comfort Theory, will compare an intervention group receiving guided imagery exercises against a control group receiving standard care. Participants in the intervention arm will engage in mental visualization techniques designed to activate the mind-body connection, reduce sympathetic activity, and enhance emotional regulation during the perioperative period.

NCT07552974: Phase 2 CBD Trial for BJJ Athletes

A Phase 2 randomized controlled trial (NCT07552974) will evaluate CBD Isolate at 100mg twice daily versus placebo in 24 Brazilian Jiu-Jitsu athletes. The study targets inflammatory cytokine modulation (IL-6, TNF-α, IL-8, IL-1β, IL-10), delayed-onset muscle soreness, sleep quality, and pain in a population where combat-sport injury prevalence reaches 28%. No regulatory submission or compliance action is associated with this trial registration.

INSPIRE Phase 2 SABR Prostate Cancer Trial NCT07552168

INSPIRE (NCT07552168) is a Phase II, single-arm, multi-centre prospective clinical trial evaluating next-generation Stereotactic Ablative Radiotherapy (SABR) for low, intermediate, and eligible high-risk prostate cancer. The trial incorporates toxicity reduction strategies and is registered with ClinicalTrials.gov with an indexed date of April 27, 2026. This represents a new clinical trial entry in the prostate cancer radiotherapy research landscape across Irish centres.

Erika Porcelli Appointed CEO of Pharmatech Associates

Erika Porcelli, a consulting executive with over 20 years of experience in regulated environments, has been appointed Chief Executive Officer of Pharmatech Associates, a wholly-owned subsidiary of the U.S. Pharmacopeia (USP). Porcelli succeeds Sireesha Yadlapalli, who led Pharmatech for the past three years. Pharmatech helps pharmaceutical, biotechnology, and advanced therapy manufacturers implement quality standards, scale complex processes, and meet global regulatory expectations.

USP Intends to Revise Pharmaceutical Compounding Quality Assurance Chapter <1163>

The USP Compounding Expert Committee intends to revise General Chapter <1163> Quality Assurance in Pharmaceutical Compounding, proposing to restructure the chapter into a main chapter <1163> and subchapter <1163.1>. The main chapter title would be updated to Quality Management in Pharmaceutical Compounding, and subchapter <1163.1> titled Special Considerations for Quality Management in Pharmaceutical Compounding, with the revision intended to strengthen QA/QC guidance and assign clear responsibilities to designated personnel. Compounding pharmacies, drug manufacturers, and healthcare organizations involved in pharmaceutical compounding should monitor for the proposed revision publication in Pharmacopeial Forum 53(5) [Sep.-Oct. 2027] and prepare to submit comments by November 30, 2027, with an expected official date of December 1, 2028.

USP Proposes Famotidine Monograph Revision Adding Dimaleate Salt Form for Related Compound B

USP's Small Molecules Therapeutic Areas 3 Committee proposes revising the Famotidine monograph to introduce the dimaleate salt form of USP Famotidine Related Compound B RS as an alternative to the current hygroscopic free base form. The revision also proposes adopting a two-table format for relative retention times and acceptance criteria, and referencing USP <477> User Determined Reporting Thresholds in the Organic Impurities test. Comments on the proposed Interim Revision Announcement are accepted through November 30, 2026.

USP Proposes Revisions to Stability Chapter <1191> for Compounding Practice

The USP Compounding Expert Committee has issued a Notice of Intent to Revise General Chapter <1191> Stability Considerations in Dispensing Practice, with a targeted official date of December 1, 2028. The revision aims to strengthen guidance for compounders on stability study design and application when establishing or extending beyond-use-dates, address practical formulation development considerations including flavorings and dyes, and potentially restructure the chapter with new subchapters <1191.1> and <1191.2>. A public comment period is expected to open in Pharmacopeial Forum 53(5) in September-October 2027, with comments due November 30, 2027.

Potassium Bromide Monograph Revision: Volumetric Solution Updates

USP has issued a Notice of Intent to Revise the Potassium Bromide monograph to update references to volumetric solutions used in the Limit of chlorine and Assay tests. The proposed changes replace 'ammonium thiocyanate VS' with '0.1N ammonium thiocyanate VS' and 'silver nitrate VS' with '0.1N silver nitrate VS' to align with reagent entries and include missing normality information. The Targeted Official Date remains to be determined.