Pharmaceutical industry news

Device recall: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) PBCGLVBLI, Catalog Number: KIT, BLO LAVH ; 2) PB15HYFCY, Catalog Number: KIT, UMMC AB HYST II 170032 ; 3) SMA4FTLSCA, Catalog Number: TLH PACK

Official structured record identifier: 99553.

Device recall: GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis

Official structured record identifier: 99543.

Device recall: STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test

Official structured record identifier: 99531.

Device recall: LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)

Official structured record identifier: 99524.

Device recall: HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF: 10301012 (EU); HEALON DUET PRO II, REF: 10301016 (EU)

Official structured record identifier: 99496.

Device recall: Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (kit) ANAP22-01; 2) POSTERIOR PACK - 205960, Model/Item Number (kit) ANPP15-01; 3) ANEURYSM PACK, Model/Item Number (kit) BPAY14-01; 4) SPINE PACK, Model/Item Number (kit) HSLM53-01; 5) ANTERIOR CERVI

Official structured record identifier: 99469.

Device recall: Velys Enabling Tech Robotic-Assist Station REF: 451611001

Official structured record identifier: 99467.

Device recall: Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2) BLOOD CULTURE KIT 2 W/CONNECT, Model Number: DYNDH1487A

Official structured record identifier: 99334.

Clinical and Microbiological Efficacy of the Antibacterial Drug Fluorothiazinone in the Treatment of Recurrent Cystitis in a Randomized Clinical Trial

Beyond 70,000: Reassessing the Global Fontan Population Through Citation-Chain Analysis and Tiered Epidemiologic Estimation

Randomised phase III trials of cancer prevention drugs: a systematic review and prediction of trial success☆

How to Optimize Healthy Volunteer Screening and Enrolment in Clinical Trials: A Qualitative and Quantitative Approach to Evaluate Processes and Healthy Volunteers' Perceptions

Phase I Evaluation of Siltartoxatug, a First‐in‐Class Anti‐Tetanus Monoclonal Antibody: Safety, Pharmacokinetics and Pharmacodynamics in Healthy Australian and Chinese Populations

Emerging and Investigational JAK Inhibitors for Rheumatoid Arthritis: Efficacy and Safety.

Long-term safety and efficacy of vornorexant in Japanese patients with insomnia: A 52-week open-label, randomized trial.

Estimating and predicting clinical trial outcomes in China.

Next-generation therapeutics for glioblastoma: Challenges and future directions.

Celecoxib plus topical flurbiprofen patch versus celecoxib alone for symptomatic knee osteoarthritis: a randomized controlled trial.

Intranasal midazolam vs mouth-dissolving clobazam in terminating seizures: A randomized controlled trial.

Associations of Baseline Neutrophil-to-Lymphocyte Ratio with Efficacy and Toxicity of the B7H3 ADC YL201, Linked to Interleukin-6: Analysis of the Phase 1/1b Trial.

Neoadjuvant Pertuzumab Biosimilar HLX11 Versus Reference Pertuzumab for Early-stage or Locally Advanced Breast Cancer: A phase 3 Equivalence Trial.

Unveiling novel transcriptomic prognostic biomarkers for specific breast cancer subtypes and treatment regimens.

Therapeutics candidates and repurposing strategies to target parkinson's disease pathology: current evidence and future directions.

(Neo)adjuvant approvals for solid tumors by the US Food and Drug Administration 2010-2023.

A Phase 3 Trial of Vosoritide in Children with Hypochondroplasia.

Next-generation antibody-based therapeutics in cancer: antibody-drug conjugates bispecific antibodies across hematologic malignancies and solid tumors.

Regulatory and scientific challenges in pediatric oncology.

Current and forthcoming pharmacotherapies for adolescent obesity: Evidence-based review.

Association of <i>Helicobacter pylori</i> infection with insulin resistance, tumor necrosis factor-alpha, and dyslipidemia in obese children with metabolic syndrome

Phenomenology in pediatric nursing: Lessons from studies of mothers caring for children with chronic illnesses

Utilizing a Smartphone Application for Perinatal Depression Screening and Care Linkages

Network biology to artificial intelligence: building the next generation of predictive drug discovery

Interactions of Nanoparticles with Structures of the Respiratory System, Nanoparticle Endocytosis by Cells and Cell Responses

Inhaled Nanoliposomes for Treating Lung Disease Including a Case Study of Amikacin Liposome Inhalation Suspension (ALIS)

Drug-delivering particles aim to breach the blood–brain barrier

Mechanical basis of cortical cataract

NCT07811128: Leveraging Digital Health Solutions to Collect Patient-Reported Outcomes in Rectal Cancer

Study type: OBSERVATIONAL. Phase: .

NCT07810855: Using Bedside Ultrasound to Understand Fluid Management in Patients With Chronic Liver Disease

Study type: OBSERVATIONAL. Phase: .

NCT07810231: Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Clinically Significant Capsular Contracture

Study type: OBSERVATIONAL. Phase: .

NCT07809542: Brain Network Characteristics of Pain Patients Based on Magnetoencephalography

Study type: OBSERVATIONAL. Phase: .

NCT07809438: A Comparative Performance Study Between High and Standard Resolution Positron Emission Tomography Camera Using [18F] AV-133 in Prodromal Parkinson's Disease

Study type: INTERVENTIONAL. Phase: PHASE2.

NCT07809399: Volumetric HRCT in Stable COPD Patients.

Study type: OBSERVATIONAL. Phase: .

NCT07809087: Feasibility Study of an Interactive Wall-Based Intervention Program for Nursing Home Residents and Patients in Long-Term Care Facilities: Mur'Aventure

Study type: INTERVENTIONAL. Phase: NA.

NCT07809074: Mindfulness and Self-Compassion Intervention for Ostomy Patients Due to Colorectal Cancer on Loneliness (MSC-OP)

Study type: INTERVENTIONAL. Phase: NA.

NCT07808645: Wearable Sleep EEG and Auditory Stimulation in Healthy Adults

Study type: INTERVENTIONAL. Phase: NA.

NCT07803471: Yiqi Fumai Lyophilized Injection for Chronic Heart Failure Caused by Coronary Heart Disease

Study type: INTERVENTIONAL. Phase: NA.

NCT07770919: Continuous Theta Burst Stimulation for Generalized Anxiety Disorder

Study type: INTERVENTIONAL. Phase: NA.

NCT07755748: Glaucoma Screening to Enhance At-Risk Californians' Health - Survey Response Incentives

Study type: INTERVENTIONAL. Phase: NA.

NCT07668518: A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of KIT2014 in Patients With Moderate to Severe COPD

Study type: INTERVENTIONAL. Phase: PHASE1, PHASE2.

NCT07645443: FEEL-GOOD: A Multicenter Trial of a Mindfulness-Based Group Therapy in Young Adults With Early Psychosis

Study type: INTERVENTIONAL. Phase: NA.

NCT07509034: Autologous B7-H3 Chimeric Antigen Receptor T Cells in Previously Treated Extensive-Stage Small Cell Lung Cancer With Recurrent or Refractory Disease

Study type: INTERVENTIONAL. Phase: PHASE1.

NCT07447557: Study of Intrathecal ELP-02 for Charcot-Marie-Tooth Disease Type 4J (CMT4J)

Study type: INTERVENTIONAL. Phase: PHASE1, PHASE2.

NCT07436728: A Study of TAK-505 in Adults With Solid Tumors

Study type: INTERVENTIONAL. Phase: PHASE1, PHASE2.

NCT07241377: A Study in Healthy Adults to Compare the Bioavailability of EPA + DHA From Two Microalgal Sources to One Fish Source and Placebo

Study type: INTERVENTIONAL. Phase: PHASE3.

NCT07234942: A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants With Early Symptomatic Alzheimer's Disease (eAD)

Study type: INTERVENTIONAL. Phase: PHASE1.

NCT07224763: Study to Evaluate the Safety and Efficacy of the GGTA1 KO Thymokidney in Patients With ESRD

Study type: INTERVENTIONAL. Phase: PHASE1, PHASE2.

NCT07210398: Mindfulness-based Cognitive Therapy for the Chronic Pain-early Cognitive Decline Co-morbidity Among Older Black Individuals in the Community; The Feeling of Being Open Pilot

Study type: INTERVENTIONAL. Phase: NA.

NCT07205107: Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Triple Combination Gel in Canadian Patients With Acne Vulgaris

Study type: OBSERVATIONAL. Phase: .

NCT07166094: Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer

Study type: INTERVENTIONAL. Phase: PHASE3.

NCT06851806: Study of Palivizumab in Children With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease

Study type: INTERVENTIONAL. Phase: NA.