Результаты поиска

Amyloid Imaging Update: How the Amyloid Landscape Is Changing in Light of the Recent Food and Drug Administration Approval of Antiamyloid Therapeutics.

It has been some time since the Journal of Nuclear Medicine and Technology has published an article on best practices in amyloid imaging. In light of the recent Food and Drug Administration approval of new antiamyloid therapies (AATs) to decrease amyloid plaques in the brain and slow progression of mild cognitive impairment, and the potential increase in the number of amyloid PET scans being acquired to document amyloid plaques, the Journal of Nuclear Medicine and Technology felt it was a perfect time to publish a refresher on best practices. AATs are administered to help slow progression of m

Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017.

IMPORTANCE: Accelerated approval by the US Food and Drug Administration (FDA) grants market authorization for drugs based on clinical trials using surrogate end points likely to anticipate a clinical benefit. The FDA requires postapproval trials to confirm benefit, after which the accelerated approval is converted to a standard approval or is withdrawn. However, trials frequently fail to assess clinical benefit, and expenditure for these drugs may be substantial. OBJECTIVE: To evaluate spending by the Centers for Medicare & Medicaid Services (CMS) on drugs granted FDA accelerated approval bef

Identification of potential inhibitors of SARS-COV-2 endoribonuclease (EndoU) from FDA approved drugs: a drug repurposing approach to find therapeutics for COVID-19.

SARS-CoV-2 is causative agent of COVID-19, which is responsible for severe social and economic disruption globally. Lack of vaccine or antiviral drug with clinical efficacy suggested that drug repurposing approach may provide a quick therapeutic solution to COVID-19. Nonstructural protein-15 (NSP15) encodes for an uridylate-specific endoribonuclease (EndoU) enzyme, essential for virus life cycle and an attractive target for drug development. We have performed in silico based virtual screening of FDA approved compounds targeting EndoU in search of COVID-19 drugs from commercially available appr

Surgical Artificial Intelligence Innovation Trends and Regulatory Insights: A Systematic Analysis of Food and Drug Administration-Approved Devices.

OBJECTIVE: To characterise the landscape of surgical artificial intelligence (AI) devices approved by the US Food and Drug Administration (FDA). BACKGROUND: AI has the potential to improve surgical pathways, offering capability across screening, diagnosis, decision support, and intraoperative care. Despite this, real-world adoption remains limited. Regulatory approval serves as a key step in clinical translation but is influenced by challenges in evidence generation, safety, bias, transparency, and implementation. Consequently, the characteristics, evidence base, and functional roles of FDA-c

Anti-quorum, anti biofilm activity of FDA approved drugs against P. aeruginosa: in silico and in vitro studies.

P. aeruginosa is an opportunistic pathogen that causes various nosocomial infections. The ability of P. aeruginosa to form biofilms is one of the main factors contributing to its pathogenicity. Due to biofilm formation, bacteria get embedded in it and is able to withstand extreme environmental conditions like chemicals, UV, temperature, pH, salinity, and antibiotics. Biofilm formation is an important virulence factor associated with quorum sensing (QS), which is a cell-to-cell communication system that is influenced by cell density. P. aeruginosa is a notorious pathogen that is known to cause

Translational Liposomal Drug Delivery Systems: Clinically Approved Formulations, Scalable Manufacturing Strategies, and Emerging Characterization Approaches.

INTRODUCTION: Liposomal drug delivery systems have evolved into clinically validated platforms across diverse therapeutic areas. This review aims to provide a translational perspective by linking fundamental formulation principles with clinically approved products and industrial manufacturing strategies. METHODS: A structured narrative review was undertaken to examine liposomal formulations approved by major regulatory authorities across a range of clinical applications, including oncology, infectious diseases, vaccination, pain management, gene therapy, and regenerative medicine. The analysi

Construction of CF2 moieties in FDA-approved drugs (2016-2025): industrial routes, mechanisms, and scale-up considerations.

The incorporation of CF2 moieties into drug molecules offers unique advantages in improving metabolic stability and target affinity, making their efficient construction a major focus in pharmaceutical process chemistry. This review systematically examines the synthetic processes of 12 FDA-approved CF2-containing drugs from 2016 to 2025, categorizing them according to the chemical environment of the CF2 group (alkyl-CF2, heteroaryl-CF2, and ArO-CF2). For each drug, the industrial routes for CF2 construction and the reasons for eliminating alternative routes are analyzed. Methods for CF2 formati

Auranofin, identified by FDA-approved drug library screening, inhibits HBs antigen secretion via lysosomal damage.

BACKGROUND AND AIM: Hepatitis B surface antigen (HBsAg) is associated with hepatocellular carcinoma risk and immune exhaustion and contributes to hepatitis B virus (HBV) persistence. Current anti-HBV treatments have a limited ability to reduce HBsAg levels. This study aimed to identify FDA-approved drugs capable of reducing HBsAg levels and explore the underlying mechanisms. METHODS: A total of 1134 FDA-approved compounds were screened at 9.9 μM for 7 days using HepG2.2.15.7 cells, which contain an integrated HBV genome. HBsAg in the supernatant and cell viability were assessed. Compounds who

Remdesivir from failed Ebola drug to first FDA-approved COVID-19 antiviral: The medico-legal integration.

Remdesivir became the first antiviral for COVID-19 to receive emergency use authorization (EUA) and, subsequently, full FDA approval. This article provides a statutory analysis of its development life cycle, tracing the contributions of nine US federal statutes from foundational coronavirus science through full approval, using a qualitative regulatory-science method that combines doctrinal and document analysis. Each statute is mapped onto a staged life cycle framework. The National Institute of Allergy and Infectious Diseases, under 42 U.S.C. § 282, designed and ran the pivotal the adaptive C

In silico repurposing of clinically approved drugs as potential BRAF inhibitors: a pharmacophore-based virtual screening and experimental investigation.

The BRAFV600E mutation is a key oncogenic driver in multiple cancers. While FDA-approved BRAF inhibitors exist, their efficacy is often limited by drug resistance and adverse effects, necessitating the discovery of novel therapeutic agents. This study aimed to computationally repurpose clinically approved drugs as potential BRAF inhibitors. A ligand-based pharmacophore model was generated using five known BRAF inhibitors and validated to identify a robust three-feature hypothesis (one hydrogen bond acceptor and two aromatic rings). This model was used to screen the E-Drug3D database of FDA-app

DROP-CARs: Engineering Reversible, Drug-Controlled CAR T-cell Activity with a Clinically Approved Small Molecule.

A major limitation in applying chimeric antigen receptor (CAR) T cells to solid tumors is toxicity in healthy tissues caused by a lack of tumor-specific targets. A promising strategy to overcome this deleterious cytotoxicity is to engineer control into CAR T cells beyond that conferred by antigen recognition alone. In a recent issue of Nature Chemical Biology, Scheller and colleagues report the development of a CAR that is inactivated through introducing the small molecule, venetoclax, which is a clinically approved targeted Bcl-2 inhibitor. The authors design venetoclax-dependent release of t

Regulatory frameworks and filing discrepancies in generic drug approvals: A cross-regional study with analysis of FDA ANDA deficiencies.

OBJECTIVES: This research aims to analyse the regulatory frameworks for generic drug applications in the U.S., EU, India, Japan, and China comparing their filing requirements to identify gaps and areas for harmonization. Additionally, it focuses on examining common deficiencies in ANDA from FDA submissions in 2014-2023 to address issues, facilitating more efficient approvals and minimizing delays. MATERIAL AND METHODS: The research involved analysing regulatory documents available on official websites, including the FDA, EMA, CDSCO, PMDA, and NMPA to achieve first objective. For second object

Evaluation of the Relationship between Vesicular Monoamine Transporter 2 (VMAT2) Inhibition and Neurologic Adverse Events in Approved Drugs.

Vesicular monoamine transporter 2 (VMAT2) is an internal membrane protein found predominantly in the central nervous system that plays an integral role in the transport of biogenic monoamines (e.g., dopamine, serotonin, and norepinephrine) into synaptic vesicles for storage within the neuron. While multiple drugs that inhibit VMAT2 have been approved by the US Food and Drug Administration (FDA) for the treatment of hyperkinetic movement disorders, it has been reported that off-target interaction with VMAT2 may lead to neuropsychiatric consequences. In the present study an in vitro analysis was

Repurposing of FDA-Approved Drugs to Disrupt Iron Uptake in Mycobacterium abscessus: Targeting Salicylate Synthase as a Novel Approach.

Non-tuberculous mycobacteria (NTM) are opportunistic pathogens that lead to severe, persistent infections, particularly in immunocompromised or vulnerable individuals. Infection rates are rising worldwide, highlighting NTM as an increasing threat to public health. There are currently no specific drugs, and the recommended regimens are usually ineffective. This scenario underlines the urgent need to develop new strategies to effectively combat these infections in a more innovative way. However, the development of new drugs can be a lengthy process, often taking more than a decade to identify ev

Beyond the Label: Real-World Side Effects Experienced With FDA-Approved Drugs for Non-Melanoma Skin Cancers.

With immunotherapy historically focused on cutaneous melanoma, there has been a new wave of systemic medications available for treating non-melanoma skin cancers including basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and Merkel cell carcinoma (MCC). The immune checkpoint inhibitors approved by the FDA target programmed cell death protein 1 (PD-1) and the Hedgehog (Hh) signaling pathway. These medications have expanded treatment options; however, side effects are an important consideration. We used the FDA Adverse Events Reporting System (FAERS) to characterize the most prevalent,

New Oncologic Drugs from 2008 to 2023-Differences in Approval and Access between the United States, Europe and Brazil.

IntroductionAdvancements in oncology have revolutionized cancer treatment, with new drugs being approved at different rates worldwide. Our objective was to evaluate the approval of new oncological drugs for solid tumors by the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Brazilian Health Regulatory Agency (ANVISA) since 2008.MethodsData were collected from public and online databases by searching for the date of submission, the date of the procedure, the date of approval, clinical indication, and drug characteristics. The distribution was tested using the Sh

Совпадение в полном тексте источника
… Notably, we were unable to identify any drug approved by ANVISA that was not approved by either the FDA or the EMA. … Novel Drug Approvals at FDA Available online: https://www.fda.gov/drugs/development-approval-process-drugs/drug-approvals-and-databases (accessed on 22 April 2024) 4. …

Repurposing FDA-approved drugs for COVID-19: targeting the main protease through multi-phase in silico approach.

BACKGROUND: The COVID-19 pandemic has created an urgent need for effective therapeutic agents. The SARS-CoV-2 Main Protease (Mpro) plays a crucial role in viral replication and immune evasion, making it a key target for drug development. While several studies have explored Mpro inhibition, identifying FDA-approved drugs with potential efficacy remains a critical research focus. PURPOSE: This study aims to identify FDA-approved drugs that could inhibit SARS-CoV-2 Mpro. Using computational screening, we seek compounds that share structural similarities with a known co-crystallized ligand (PRD_0

Expert-approved best practice recommendations on the use of sedative drugs and intentional sedation in specialist palliative care (SedPall).

BACKGROUND: The use of sedative drugs and intentional sedation in end-of-life care is associated with clinical, ethical and legal challenges. In view of these and of the issue's great importance to patients undergoing intolerable suffering, we conducted a project titled SedPall ("From anxiolysis to deep continuous sedation - Development of recommendations for sedation in palliative care") with the purpose of developing best practice recommendations on the use of sedative drugs and intentional sedation in specialist palliative care and obtaining feedback and approval from experts in this area.

Recently Approved Drugs for Lowering and Controlling Intraocular Pressure to Reduce Vision Loss in Ocular Hypertensive and Glaucoma Patients.

Serious vision loss occurs in patients affected by chronically raised intraocular pressure (IOP), a characteristic of many forms of glaucoma where damage to the optic nerve components causes progressive degeneration of retinal and brain neurons involved in visual perception. While many risk factors abound and have been validated for this glaucomatous optic neuropathy (GON), the major one is ocular hypertension (OHT), which results from the accumulation of excess aqueous humor (AQH) fluid in the anterior chamber of the eye. Millions around the world suffer from this asymptomatic and progressive