Food and Drug Administration (FDA) Research This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Mavacamten: A Review of a Novel Therapeutic Approach for Hypertrophic Cardiomyopathy
Cardiovasc Hematol Agents Med Chem. 2024 Apr 5. doi: 10.2174/0118715257283752240325082733. Online ahead of print.ABSTRACTHypertrophic Cardiomyopathy (HCM) is a heart disease that can cause left ventricular hypertrophy, arrhythmias, heart failure, and sudden cardiac death. Currently, pharmacological treatment is limited and ineffective. Mavacamten (CamzyosTM) is a cardiac myosin inhibitor developed as a therapeutic option to reduce myocardial contractility and restoration of myocardial function. The Food and Drug Administration (FDA) approved the use of Mavacamten in 2022 for HCM symptoms. Clinical studies have proven that ...
Source: Cardiovascular and Hematological Agents in Medicinal Chemistry - April 8, 2024 Category: Cardiology Authors: Ayesha Abdul Qadir Memon Areeba Shamim Sanoober Mirza Muhammad Osama Iyad Naeem Muhammad Calvin R Wei Source Type: research

Neural tissue tolerance to synthetic dural mater graft implantation in a rabbit durotomy model
This study evaluated the safety of ArtiFascia, a synthetic dura mater graft composed of poly(l-lactic-co-caprolactone acid) and poly(d-lactic-co-caprolactone acid), in a rabbit durotomy model. Previously, ArtiFascia demonstrated positive local tolerance and biodegradability in a 12-month preclinical trial. Here, specialized stains were used to evaluate potential brain damage associated with ArtiFascia use. Histochemical and immunohistochemical assessments included Luxol Fast Blue, cresyl Violet, Masson's Trichrome, neuronal nuclei,, Glial Fibrillary Acidic Protein, and ionized calcium-binding adaptor molecule 1 stains. The...
Source: Journal of Toxicologic Pathology - April 8, 2024 Category: Toxicology Authors: Yuval Ramot Noam Kronfeld Michal Steiner Nora Nseir Manassa Amir Bahar Abraham Nyska Source Type: research

Leveraging Modeling and Simulation to Enhance the Efficiency of Bioequivalence Approaches for Generic Drugs: Highlights from the 2023 Generic Drug Science and Research Initiatives Public Workshop
AbstractThe 2023 Generic Drug Science and Research Initiative Public Workshop organized by the U.S. Food and Drug Administration (FDA) discussed the research needs to improve and enhance bioequivalence (BE) approaches for generic drug development. FDA takes such research needs and panel discussions into account to develop its Generic Drug User Fee Amendments III (GDUFA III) Science and Research Initiatives specific to generics. During the five workshop sessions, presentations and panel discussions focused on identifying and addressing scientific gaps and research needs related to nitrosamine impurity issues, BE assessment ...
Source: The AAPS Journal - April 8, 2024 Category: Drugs & Pharmacology Source Type: research

Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval
This study aims to determine whether cancer drugs granted accelerated approval from the US Food and Drug Administration ultimately demonstrate clinical benefit and to evaluate the basis of conversion to regular approval. (Source: JAMA - Journal of the American Medical Association)
Source: JAMA - Journal of the American Medical Association - April 7, 2024 Category: General Medicine Source Type: research

Bird flu may be spreading in cows via milking and herd transport
The bird flu virus spreading through dairy cattle in the United States may be expanding its reach via milking equipment, the people doing the milking, or both U.S. Department of Agriculture (USDA) representatives reported today at an international, virtual meeting held to update the situation. The avian virus may not be spreading directly from cows breathing on cows, as some researchers have speculated, according to USDA scientists who took part in the meeting organized jointly by the World Organisation for Animal Health and the U.N.’s Food and Agricultural Organization. “We haven't seen any true indication that ...
Source: Science of Aging Knowledge Environment - April 5, 2024 Category: Geriatrics Source Type: research

WHO Documents Rising Resistance to First-Line HIV Drug
Currently, the World Health Organization (WHO) recommends using dolutegravir, an integrase strand transfer inhibitor approved by the US Food and Drug Administration in 2013, as a first- and second-line drug for treating people with HIV. But resistance to the treatment is on the rise. About 4% to as many as about 20% of people in 4 countries reporting data —Malawi, Mozambique, Uganda, and Ukraine—who had not achieved viral suppression exhibited resistance while taking the drug as part of their antiretroviral therapy, a recent report by the WHO found. (Source: JAMA - Journal of the American Medical Association)
Source: JAMA - Journal of the American Medical Association - April 5, 2024 Category: General Medicine Source Type: research

Current issues in dose-finding designs: A response to the US Food and Drug Adminstrations's oncology center of excellence project optimus
Clin Trials. 2024 Apr 3:17407745241234652. doi: 10.1177/17407745241234652. Online ahead of print.ABSTRACTWith the advent of targeted agents and immunological therapies, the medical research community has become increasingly aware that conventional methods for determining the best dose or schedule of a new agent are inadequate. It has been well established that conventional phase I designs cannot reliably identify safe and effective doses. This problem applies, generally, for cytotoxic agents, radiation therapy, targeted agents, and immunotherapies. To address this, the US Food and Drug Administration's Oncology Center of E...
Source: Clinical Trials - April 4, 2024 Category: Research Authors: Peter F Thall Elizabeth Garrett-Mayer Nolan A Wages Susan Halabi Ying Kuen Cheung Source Type: research

Scoring PD-L1 Expression in Urothelial Carcinoma: An International Multi-Institutional Study on Comparison of Manual and Artificial Intelligence Measurement Model (AIM-PD-L1) Pathology Assessments
AbstractAssessing programmed death ligand 1 (PD-L1) expression on tumor cells (TCs) using Food and Drug Administration-approved, validated immunoassays can guide the use of immune checkpoint inhibitor (ICI) therapy in cancer treatment. However, substantial interobserver variability has been reported using these immunoassays. Artificial intelligence (AI) has the potential to accurately measure biomarker expression in tissue samples, but its reliability and comparability to standard manual scoring remain to be evaluated. This multinational study sought to compare the %TC scoring of PD-L1 expression in advanced urothelial car...
Source: Virchows Archiv - April 4, 2024 Category: Pathology Source Type: research

Programmatic considerations and evidence gaps for chikungunya vaccine introduction in countries at risk of chikungunya outbreaks: Stakeholder analysis
by Megan Auzenbergs, Clara Maure, Hyolim Kang, Andrew Clark, Oliver Brady, Sushant Sahastrabuddhe, Kaja Abbas Chikungunya can have longstanding effects on health and quality of life. Alongside the recent approval of the world ’s first chikungunya vaccine by the US Food and Drug Administration in November 2023 and with new chikungunya vaccines in the pipeline, it is important to understand the perspectives of stakeholders before vaccine rollout. Our study aim is to identify key programmatic considerations and gaps in Ev idence-to-Recommendation criteria for chikungunya vaccine introduction. We used purposive and snowball...
Source: PLoS Neglected Tropical Diseases - April 4, 2024 Category: Tropical Medicine Authors: Megan Auzenbergs Source Type: research