Pediatric Extrapolation Approach for U.S. Food and Drug Administration Approval of Brexpiprazole in Patients Aged 13 to 17 Years with Schizophrenia
This report illustrates the potential of leveraging previously collected efficacy, safety, and PK data in adult patients to make a regulatory decision in pediatric patients for the indication of schizophrenia.PMID:38488344 | DOI:10.1002/jcph.2429 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - March 15, 2024 Category: Drugs & Pharmacology Authors: Huixia Zhang Jie Liu Vishnu Sharma Luning Zhuang Pamela Horn Ramana Uppoor Mehul Mehta Hao Zhu Source Type: research

Quercetin attenuates cisplatin-induced mitochondrial apoptosis via PI3K/Akt mediated inhibition of oxidative stress in pericytes and improves the blood labyrinth barrier permeability
Chem Biol Interact. 2024 Mar 13:110939. doi: 10.1016/j.cbi.2024.110939. Online ahead of print.ABSTRACTCisplatin (CDDP) is broadly employed to treat different cancers, whereas there are no drugs approved by the Food and Drug Administration (FDA) for preventing its side effects, including ototoxicity. Quercetin (QU) is a widely available natural flavonoid compound with anti-tumor and antioxidant properties. The research was designed to explore the protective effects of QU on CDDP-induced ototoxicity and its underlying mechanisms in male C57BL/6 J mice and primary cultured pericytes (PCs). Hearing changes, morphological chang...
Source: Chemico-Biological Interactions - March 15, 2024 Category: Molecular Biology Authors: Tian-Lan Huang Wen-Jun Jiang Zan Zhou Tian-Feng Shi Miao Yu Meng Yu Jun-Qiang Si Yan-Ping Wang Li Li Source Type: research

Pediatric Extrapolation Approach for U.S. Food and Drug Administration Approval of Brexpiprazole in Patients Aged 13 to 17 Years with Schizophrenia
This report illustrates the potential of leveraging previously collected efficacy, safety, and PK data in adult patients to make a regulatory decision in pediatric patients for the indication of schizophrenia.PMID:38488344 | DOI:10.1002/jcph.2429 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - March 15, 2024 Category: Drugs & Pharmacology Authors: Huixia Zhang Jie Liu Vishnu Sharma Luning Zhuang Pamela Horn Ramana Uppoor Mehul Mehta Hao Zhu Source Type: research

Pediatric Extrapolation Approach for U.S. Food and Drug Administration Approval of Brexpiprazole in Patients Aged 13 to 17 Years with Schizophrenia
This report illustrates the potential of leveraging previously collected efficacy, safety, and PK data in adult patients to make a regulatory decision in pediatric patients for the indication of schizophrenia.PMID:38488344 | DOI:10.1002/jcph.2429 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - March 15, 2024 Category: Drugs & Pharmacology Authors: Huixia Zhang Jie Liu Vishnu Sharma Luning Zhuang Pamela Horn Ramana Uppoor Mehul Mehta Hao Zhu Source Type: research

Mechanism of action of nadofaragene firadenovec-vncg
Effective bladder-preserving therapeutic options are needed for patients with bacillus Calmette-Guérin unresponsive non–muscle-invasive bladder cancer. Nadofaragene firadenovec-vncg (Adstiladrin®) was approved by the US Food and Drug Administration as the first gene therapy in urology and the first intravesical gene therapy indicated for the treatment of adult patients with high-risk bacillus Calmette-Guérin–unresponsive non–muscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors. The proposed mechanism of action underlying nadofaragene firadenovec efficacy is likely due to the pleio...
Source: Frontiers in Oncology - March 15, 2024 Category: Cancer & Oncology Source Type: research

Blood glucose monitoring devices for type 1 diabetes: a journey from the food and drug administration approval to market availability
Blood glucose monitoring constitutes a pivotal element in the clinical management of Type 1 diabetes (T1D), a globally escalating metabolic disorder. Continuous glucose monitoring (CGM) devices have demonstrated efficacy in optimizing glycemic control, mitigating adverse health outcomes, and augmenting the overall quality of life for individuals afflicted with T1D. Recent progress in the field encompasses the refinement of electrochemical sensors, which enhances the effectiveness of blood glucose monitoring. This progress empowers patients to assume greater control over their health, alleviating the burdens associated with...
Source: Frontiers in Endocrinology - March 15, 2024 Category: Endocrinology Source Type: research

Deception by Obfuscation: Studnicki et al. ’s retracted longitudinal cohort study of emergency room utilization following abortion
In November 2022, the anti-abortion advocacy group, Alliance for Hippocratic Medicine filed a lawsuit against the U.S. Food and Drug Administration challenging the initial 2000 approval of mifepristone and its subsequent approvals, which removed unnecessary restrictions on its use, by disputing the medication ’s safety record. Such challenges relied on a study examining the incidence of emergency room (ER) visits following medication abortion with mifepristone and procedural abortion using Medicaid claims data from 1999–2015. (Source: Contraception)
Source: Contraception - March 15, 2024 Category: OBGYN Authors: Ushma D. Upadhyay, Chris E. Adkins Source Type: research

National Survey of FACT-Accredited Cell Processing Facilities: Assessing Preparedness for Local Manufacturing of Immune Effector Cells
Immune effector cells (IECs) offer a new approach to address unmet medical needs, including malignancies, autoimmune diseases, and opportunistic infections.1,2 This family of biologics, also known as cellular immunotherapies, includes chimeric antigen receptor (CAR) T cells, tumor-infiltrating lymphocytes (TILs), and genetically modified T cell receptors (TCRs).3 Currently, six CAR T products have been approved by the U.S. Food and Drug Administration (FDA) for various hematological malignancies. (Source: Biology of Blood and Marrow Transplantation)
Source: Biology of Blood and Marrow Transplantation - March 15, 2024 Category: Hematology Authors: Magdi Elsallab, Florence Bourgeois, Marcela V. Maus Source Type: research

Cancer Vaccines: A Novel Revolutionized Approach to Cancer Therapy
AbstractOver the past few decades, there has been significant advancement in the field of tumor immunotherapy. For many years vaccination against infectious diseases have been available. On the other hand very few cancer vaccines have been approved for human use. Ideal Cancer vaccines are biological response modifier work by stimulating both humoral and cellular immunity while overcoming the immunological suppression found in tumor. Two types of cancer vaccine: Prophylactic and therapeutic cancer vaccines are recommended for clinical use of individuals. HPV and HBV vaccines are the two widely used preventive vaccine used f...
Source: Indian Journal of Clinical Biochemistry - March 15, 2024 Category: Biochemistry Source Type: research

Toripalimab: A Next Generation Designed Anti-PD-1 Antibody for Treatment of Nasopharyngeal Carcinoma
Toripalimab is a PD-1 targeting humanized IgG4 monoclonal antibody (mAb) that is currently under review by US Food and Drug Administration (FDA) for first-line treatment of nasopharyngeal carcinoma (NPC) in combination with chemotherapy. Currently approved PD-1 monoclonal antibodies (mAbs) have demonstrated significant clinical benefit particularly in patients with PD-L1 expressing tumors. However, in three multicenter on-going phase 3 trials (including NPC, Jupiter-02), toripalimab in combination with chemotherapy has demonstrated good clinical efficacy irrespective of the PD-L-1 status. (Source: International Journal of ...
Source: International Journal of Radiation Oncology * Biology * Physics - March 14, 2024 Category: Radiology Authors: N. Rajasekaran, S. Ravindranathan, X. Wang, D.J. Chin, S.Y. Tseng, S. Klakamp, K. Widmann, G. Young, B. Yu, V. Kapoor, V. Vexler, P. Keegan, S. Yao, S.D. Khare, T. LaVallee Tags: 260 Source Type: research

Pomalidomide Improves Motor Behavioral Deficits and Protects Cerebral Cortex and Striatum Against Neurodegeneration Through a Reduction of Oxidative/Nitrosative Damages and Neuroinflammation After Traumatic Brain Injury
Cell Transplant. 2024 Jan-Dec;33:9636897241237049. doi: 10.1177/09636897241237049.ABSTRACTNeuronal damage resulting from traumatic brain injury (TBI) causes disruption of neuronal projections and neurotransmission that contribute to behavioral deficits. Cellular generation of reactive oxygen species (ROS) and reactive nitrogen species (RNS) is an early event following TBI. ROS often damage DNA, lipids, proteins, and carbohydrates while RNS attack proteins. The products of lipid peroxidation 4-hydroxynonenal (4-HNE) and protein nitration 3-nitrotyrosine (3-NT) are often used as indicators of oxidative and nitrosative damage...
Source: Cell Transplantation - March 14, 2024 Category: Cytology Authors: Ya-Ni Huang Nigel H Greig Pen-Sen Huang Yung-Hsiao Chiang Alan Hoffer Chih-Hao Yang David Tweedie Ying Chen Ju-Chi Ou Jia-Yi Wang Source Type: research

Natural Products in the Modulation of Farnesoid X Receptor Against Nonalcoholic Fatty Liver Disease
Am J Chin Med. 2024 Mar 14:1-24. doi: 10.1142/S0192415X24500137. Online ahead of print.ABSTRACTNonalcoholic fatty liver disease (NAFLD) is a global health concern with a high prevalence and increasing economic burden, but official medicine remains unavailable. Farnesoid X receptor (FXR), a nuclear receptor member, is one of the most promising drug targets for NAFLD therapy that plays a crucial role in modulating bile acid, glucose, and lipid homeostasis, as well as inhibits hepatic inflammation and fibrosis. However, the rejection of the FXR agonist, obecholic acid, by the Food and Drug Administration for treating hepatic ...
Source: The American Journal of Chinese Medicine - March 14, 2024 Category: Complementary Medicine Authors: Jing Wang Na Yang Yu Xu Source Type: research

Endovascular Strategies for Aortic Arch When US Food and Drug Administration-Approved Devices Are Not Available
Tex Heart Inst J. 2024 Mar 14;51(1):e248391. doi: 10.14503/THIJ-24-8391.NO ABSTRACTPMID:38483472 | DOI:10.14503/THIJ-24-8391 (Source: Texas Heart Institute Journal)
Source: Texas Heart Institute Journal - March 14, 2024 Category: Cardiology Authors: Gabrielle Sutton Rana Afifi Source Type: research

O-Trifluoromethylation of Carboxylic Acids via the Formation and Activation of Acyloxy(phenyl)trifluoromethyl- λ < sup > 3 < /sup > -Iodanes
Angew Chem Int Ed Engl. 2024 Feb 27:e202400449. doi: 10.1002/anie.202400449. Online ahead of print.ABSTRACTHere we report the challenging O-trifluoromethylation of carboxylic acids via the formation and activation of acyloxy(phenyl)trifluoromethyl-λ3 -iodanes. The method provides an easy access to various potentially valuable and hitherto elusive trifluoromethyl carboxylic esters. A remarkably wide range of substrates with commonly encountered functional groups are compatible with this reaction, including aromatic and aliphatic carboxylic acids, as well as Food and Drug Administration (FDA) approved drugs and pharmaceutic...
Source: Angewandte Chemie - March 14, 2024 Category: Chemistry Authors: Hongye Zhu Chi Gao Ting Yu Cong Xu Mang Wang Source Type: research

Pomalidomide Improves Motor Behavioral Deficits and Protects Cerebral Cortex and Striatum Against Neurodegeneration Through a Reduction of Oxidative/Nitrosative Damages and Neuroinflammation After Traumatic Brain Injury
Cell Transplant. 2024 Jan-Dec;33:9636897241237049. doi: 10.1177/09636897241237049.ABSTRACTNeuronal damage resulting from traumatic brain injury (TBI) causes disruption of neuronal projections and neurotransmission that contribute to behavioral deficits. Cellular generation of reactive oxygen species (ROS) and reactive nitrogen species (RNS) is an early event following TBI. ROS often damage DNA, lipids, proteins, and carbohydrates while RNS attack proteins. The products of lipid peroxidation 4-hydroxynonenal (4-HNE) and protein nitration 3-nitrotyrosine (3-NT) are often used as indicators of oxidative and nitrosative damage...
Source: Cell Transplantation - March 14, 2024 Category: Cytology Authors: Ya-Ni Huang Nigel H Greig Pen-Sen Huang Yung-Hsiao Chiang Alan Hoffer Chih-Hao Yang David Tweedie Ying Chen Ju-Chi Ou Jia-Yi Wang Source Type: research