Результаты поиска

2025 New Drug Update (Part 2): Recent Approvals and Clinical Implications.

With the increasing prevalence of polypharmacy, age-related physiological changes, and the need for individualized pharmacotherapy in older patients, understanding new drug approvals is crucial to optimizing medication management. This review synthesizes the latest evidence on recently approved medications including Atzumi™ and Brekiya® (dihydroergotamine mesylate) for migraine headaches, Attruby™ (acoramidis) for transthyretin amyloid cardiomyopathy, and Blujepa® (gepotidacin) for uncomplicated urinary tract infections. Insights are offered into prescribing considerations for these agents in …

Recent and anticipated novel drug approvals (3Q 2026 through 2Q 2027).

PURPOSE: Health-system pharmacists play a crucial role in monitoring the pharmaceutical pipeline to manage formularies, allocate resources, and optimize clinical programs for new therapies. This article aims to support pharmacists by sharing new and anticipated novel drug approvals. SUMMARY: Selected drug approvals anticipated in the 12-month period covering the third quarter of 2026 through the second quarter of 2027 are reviewed. The analysis emphasizes drugs expected to have significant clinical and financial impact in hospitals and clinics selected from 66 novel drugs awaiting US Food and…

Repurposing FDA-Approved Drugs to Inhibit Fungal PPTases for Broad-Spectrum Synergy.

Fungal secondary metabolites serve as crucial virulence effectors; however, the potential of their biosynthetic pathways as antifungal targets remains inadequately comprehended. In this study, we put forward a novel antifungal strategy that targets the conserved global secondary metabolic pathway in pathogenic fungi. Through genome mining, phylogenetic analysis, and structural modeling, we identified invariant residues in phosphopantetheinyl transferases (PPTases), which are essential for secondary metabolism, and revealed them as pan-fungal targets. High-throughput screening indicated that th

Evaluation of clinically approved neuroprotective drugs as adjunct therapies in experimental cerebral malaria.

Cerebral malaria (CM) remains one of the most severe complications of Plasmodium falciparum infection, often leading to death within days and leaving survivors with lasting cognitive damage. Since current treatments target the parasite but offer little to no neuroprotection, we explored whether existing neuroprotective drugs could help fill this gap. Six clinically-approved drugs, viz. topiramate, rasagiline, vinpocetine, cilostazol, piracetam, and rivastigmine were tested for both antimalarial and anti-cerebral malaria activity. Screening against P. falciparum in vitro showed that vinpocetine

Deployment and transcriptional evaluation of nitisinone, an FDA-approved drug, to control bed bugs.

BACKGROUND: Bed bugs are blood-feeders that rapidly proliferate into large indoor infestations. Their bites can cause allergies, secondary infections and psychological stress, among other problems. Although several tactics for their management have been used, bed bugs continue to spread worldwide wherever humans reside. This is mainly due to human-mediated transport and their high resistance to several classes of insecticides. New treatment options with novel modes of action are required for their control. In this study, we evaluated the use of nitisinone (NTBC), an FDA-approved drug, for bed

An empirical analysis of overall survival in drug approvals by the US FDA (2006-2023).

BackgroundThe US Food and Drug Administration (FDA) has expanded the use of surrogate markers in drugs approved for oncology/hematology indications. This has likely resulted in a greater number of approvals and possibly drugs coming to market faster, but it is unknown whether these drugs also improve overall survival (OS) for patients taking them.MethodsWe sought to estimate the percentage of oncology drugs that have shown to improve OS in a cross-sectional analysis of US FDA oncology drug approvals (2006-2023). We searched for OS data in registration trials and the peer-reviewed literature.Re…

Approved drugs successfully repurposed against Leishmania based on machine learning predictions.

Drug repurposing is a promising approach towards the discovery of novel treatments against Neglected Tropical Diseases, such as Leishmaniases, presenting the advantage of reducing both costs and duration of the drug discovery process. In previous work, our group developed a Machine Learning pipeline for the repurposing of FDA-approved drugs against Leishmania parasites. The present study is focused on an in vitro validation of this approach by assessing the antileishmanial effects of 10 predicted drug candidates. First, we evaluated the drugs' activity against promastigotes from two strains of

Synthesis and application of clinically approved small-molecule drugs targeting androgen receptor.

Androgen receptor (AR) plays a crucial role in various physiological processes. Dysregulation of AR signaling has been implicated in several diseases, such as prostate cancer and androgenetic alopecia. Therefore, the development of drugs that specifically target AR has gained significant attention in the field of drug discovery. This review provides an overview of the synthetic routes of clinically approved small molecule drugs targeting AR and discusses the clinical applications of these drugs in the treatment of AR-related diseases. The review also highlights the challenges and future perspe

Polypharmacological repurposing approach identifies approved drugs as potential inhibitors of Mycobacterium tuberculosis.

Mycobacterium tuberculosis (M. tb), the causative pathogen of tuberculosis (TB) remains the leading cause of death from single infectious agent. Furthermore, its evolution to multi-drug resistant (MDR) and extremely drug-resistant (XDR) strains necessitate de novo identification of drug-targets/candidates or to repurpose existing drugs against known targets through drug repurposing. Repurposing of drugs has gained traction recently where orphan drugs are exploited for new indications. In the current study, we have combined drug repurposing with polypharmacological targeting approach to modulat

Marketing authorisation and pricing of FDA-approved cancer drugs in Brazil: a retrospective analysis.

BackgroundMost cancer drugs enter the US market first. US Food and Drug Administration (FDA) approvals of new cancer drugs may influence regulatory decisions in other settings. The study examined whether characteristics of available evidence at FDA approval influenced time-to-marketing authorisation (MA) in Brazil, and price differences between the two countries.MethodsAll new FDA-approved cancer drugs from 2010 to 2019 were matched to drugs with MA and prices approved in Brazil by December 2020. Characteristics of main studies, availability of randomised controlled trials (RCTs), overall surv

Совпадение в полном тексте источника
… Introduction Cancer drugs comprise the single largest category of new drug approvals. … Fig. 3 Median price difference between cancer drugs approved in the US (2010–2019) and Brazil . …

Commentaries: Lecanemab: pioneering the way as the first approved drug for Alzheimer's disease treatment.

Alzheimer's disease (AD) is a progressive neurodegenerative disorder marked by cognitive decline and neuronal abnormalities. Current therapies address symptoms without altering disease progression. Lecanemab, an anti-amyloid antibody, binds to amyloid-beta (Aβ) protofibrils. Phase II trials revealed dose-dependent amyloid clearance and reduced clinical decline. Phase III trials demonstrated cognitive benefits with potential adverse events. Full FDA approval was granted for lecanemab due to its ability to eliminate toxic brain amyloids. However, longer trials are needed to assess its efficacy a

National Comprehensive Cancer Network Guideline Recommendations of Cancer Drugs With Accelerated Approval.

IMPORTANCE: Many cancer drugs are approved under the US Food and Drug Administration (FDA) accelerated approval pathway based on preliminary evidence. It is unclear how this limited evidence is integrated into the National Comprehensive Cancer Network (NCCN) guidelines, which are common references for clinicians and are used by public and private payers to determine reimbursement for oncology treatments. OBJECTIVE: To analyze the NCCN guidelines' assessments for cancer drug indications that received FDA accelerated approval compared with cancer drug indications that received FDA regular appro

Repurposing FDA-approved drugs as HIV-1 integrase inhibitors: an in silico investigation.

The Human Immunodeficiency Virus (HIV) infection is a global pandemic that has claimed 33 million lives to-date. One of the most efficacious treatments for naïve or pretreated HIV patients is the HIV integrase strand transfer inhibitors (INSTIs). However, given that HIV treatment is life-long, the emergence of HIV strains resistant to INSTIs is an imminent challenge. In this work, we showed two best regression QSAR models that were constructed using a boosted Random Forest algorithm (r2 = 0.998, q210CV = 0.721, q2external_test = 0.754) and a boosted K* algorithm (r2 = 0.987, q210CV = 0.721, q2

Olanzapine/Samidorphan: New Drug Approved for Treating Bipolar I Disorder and Schizophrenia.

OBJECTIVE: To describe the approval of olanzapine/samidorphan, compare the clinical trial data, and summarize key findings, with a focus on … ant English-language studies conducted in humans were considered. Primary use of Phase III clinical drug approval trials preferred; supplementary trial analysis evaluated to provide context. DATA SYNTHESIS: In June 2021, the Food and Drug Administration (FDA) approved Lybalvi® (olanzapine/samidorphan) for indications including treatment of adults with schizoph …

Network model-based screen for FDA-approved drugs affecting cardiac fibrosis.

Cardiac fibrosis is a significant component of pathological heart remodeling, yet it is not directly targeted by existing drugs. Systems pharmacology approaches have the potential to provide mechanistic frameworks with which to predict and understand how drugs modulate biological systems. Here, we combine network modeling of the fibroblast signaling network with 36 unique drug-target interactions from DrugBank to predict drugs that modulate fibroblast phenotype and fibrosis. Galunisertib was predicted to decrease collagen and α-SMA expression, which we validated in human cardiac fibroblasts. I

Trends and strategies to combat viral infections: A review on FDA approved antiviral drugs.

The infectious microscopic viruses invade living cells to reproduce themselves, and causes chronic infections such as HIV/AIDS, hepatitis B and C, flu, etc. in humans which may lead to death if not treated. Different strategies have been utilized to develop new and superior antiviral drugs to counter the viral infections. The FDA approval of HIV nucleoside reverse transcriptase inhibitor, zidovudine in 1987 boosted the development of antiviral agents against different viruses. Currently, there are a number of combination drugs developed against various viral infections to arrest the activity o