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Researchers reviewing nearly 300 top-tier ADHD drugtrials found that half skipped the rigorous, expert-led evaluations needed to rule out other conditions like depression or schizophrenia.
Meanwhile, Merck advanced its once-monthly PrEP pill into two late-stage trials. NHS England has agreed to reimburse Vertex's newest cystic fibrosis medicine.
A trial of an interactive game that trains people to alter their brain waves has shown promise as a treatment for nerve pain -- offering hope for a new generation of drug-free treatments.
MONDAY, June 9, 2025 — Prompt treatment with a drug combo can effectively manage chronic kidney disease in people with type 2 diabetes, a new clinical trial shows. Patients prescribed the combination of finerenone and empagliflozin.
Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management.
Clinical trials are expensive, slow and often limited by outdated design constraints. These digital twins are created for each trial participant using their baseline data – regardless of whether they are assigned to the placebo or treatment arm – and simulate how that individual would have responded under control conditions.
The Danish drugmaker, which is grappling with a share decline and competition from Eli Lilly, unveiled planned trials of an obesity medication that works differently than its popular Wegovy.
Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Actithera draws new investors to radiopharma drug pitch The four-year-old biotech raised about $75 million in a Series A round that involved nine venture capital firms.
FRIDAY, June 6, 2025 — A repurposed diabetes drug can be an effective tool against fatty liver disease, a new clinical trial has found. Dapagliflozin helped people reduce fat levels in their liver and avoid liver scarring that comes with the.
Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. But its impact goes far beyond research.
The scientists say that discovering the mechanism will support ongoing clinical trials, and could lead to the targeted use of aspirin to prevent the spread of susceptible types of cancer, and to the development of more effective drugs to prevent cancer metastasis.
Artificial intelligence (AI) has revolutionised many industries, yet its adoption in pharmaceutical drug development has been notably slower. For years, AI and machine learning (ML) were often dismissed as little more than advanced statistics with little practical value in drug development.
As clinical trials become increasingly complex, particularly in decentralized trials and rare disease studies, sponsors experience increased challenges in site selection, forecasting and resourcing, and patient recruitment and enrollment. Discover how AI is used to optimize key aspects of clinical trial management. Get in touch.
In the rapidly evolving field of cell and gene therapy (CGT), the ability to manage complex biological data, optimise manufacturing processes, and accelerate drug discovery is crucial. It involves a dynamic and often unpredictable process where every stage, from target identification to clinical trials, generates vast amounts of data.
However, as we note in that post, the design, timing of initiation, and timely conduct of confirmatory trials are also important considerations in FDAs determination of whether accelerated approval is appropriate. This blog post focuses on interpreting these new authorities with respect to timely conduct of confirmatory trials.
MONDAY, May 5, 2025 An experimental drug might help people with uncontrolled high blood pressure, according to early clinical trial results.People taking lorundrostat experienced twice the decline in their systolic blood pressure than people t.
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As the pharmaceutical industry continues to evolve, drug developers encounter new challenges and opportunities in their pursuit of innovation. From adapting to complex new trial designs to embracing cutting-edge technologies, staying ahead requires a deep understanding of the current landscape.
Sujeegar Jeevanandam, an expert with 13 years of experience in life sciences R&D, offers valuable insights into the current state and future trajectory of artificial intelligence in drug discovery. This breakthrough could fundamentally change how drugs are developed and tested.
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Launching a clinical trial in Europe is a complex but rewarding endeavor, requiring careful navigation of regulatory frameworks, ethical requirements, and submission processes.
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The journey of cell and gene therapies from preclinical discovery to clinical trials is complex and challenging, impacting every team member involved, from researchers in the lab to patients receiving treatment. These digital platforms are designed to manage and automate critical trial processes, especially related to drug management.
The presence of thienopyrimidine derivatives in several FDA-approved drugs and clinical trial candidates underscores their therapeutic potential and safety profile. The review elaborates on the primary approach for synthesis of thienopyrimidines, using thiophene derivatives or pyrimidine analogues.
The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. Regulatory Authority: Pharmaceuticals and Medical Devices Agency (PMDA) The PMDA is the primary regulatory authority responsible for overseeing the drug approval process in Japan.
Collaboration aims to reduce animal use in drug safety testing By Leah Eisenstadt July 29, 2025 Breadcrumb Home Collaboration aims to reduce animal use in drug safety testing OASIS consortium is evaluating omics tools in cells, including Cell Painting and transcriptomics, to predict liver toxicity of potential new medicines and agrochemicals.
Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. In this comprehensive guide, we’ll explore the intricacies of identifying such drugs and leveraging them for successful in-licensing opportunities.
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Drug development is plagued by complex challenges, but multimodal AI is unlocking new opportunities. By integrating diverse data sources – from genomics to clinical insights – this approach is accelerating drug discovery, improving patient stratification and boosting success rates.
Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
The review provides a comprehensive analysis of non-hydroxamate inhibitors for IspC, an enzyme crucial in the MEP pathway, highlighting its structural diversity and improved drug development potential.
4c00622 The STAT family of transcription factors are important signaling hubs, with several of them, particularly STAT3, being emerging oncotargets already investigated in clinical trials. Keserű ACS Medicinal Chemistry Letters 2025 16 (6), 991-997 DOI: 10.1021/acsmedchemlett.4c00622
Recent drug discovery efforts culminating from work during the past decade have resulted in two FDA-approved inhibitors, sotorasib and adagrasib, which target the KRASG12C mutant allele. One agent in late-stage clinical trials, divarasib, has demonstrated robust overall response rates, in some cases greater than currently approved agents.
This intersection is where pharmacognosy meets drug patents, creating a unique landscape that shapes the future of medicine. But what exactly is pharmacognosy, and how does it relate to the complex world of drug patents? This approach has led to the discovery of numerous potential drug candidates. What is a Drug Patent?
MONDAY, May 5, 2025 — An experimental drug might help people with uncontrolled high blood pressure, according to early clinical trial results. People taking lorundrostat experienced twice the decline in their systolic blood pressure than.
Primary Endpoint and Clinical Results The HYPERION trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the risk of time to clinical worsening (TTCW). The treatment was generally well tolerated, and adverse events aligned with the known effects of the drug class and prior studies.
A Next-Generation Antibody-Drug Conjugate Targeting B7-H3 Ifinatamab deruxtecan is a potential first-in-class antibody-drug conjugate (ADC) specifically engineered to target B7-H3 , a surface protein overexpressed in many solid tumors, including prostate cancer.
Biogen Reports Promising Interim Phase 1 Results for Salanersen in Spinal Muscular Atrophy, Prepares for Registrational Trials Biogen has announced encouraging topline results from its Phase 1 clinical trial evaluating salanersen (BIIB115/ION306) , an investigational antisense oligonucleotide (ASO) therapy for spinal muscular atrophy (SMA).
This partnership brings together Altasciences’ extensive expertise in preclinical research and early clinical development with VoxCell’s groundbreaking tissue engineering technology, promising to deliver a more human-relevant, predictive, and efficient drug development paradigm.
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The past few years have seen a boom in the market for protein- and peptide-based drugs, with the global market for peptide-based drugs expected to reach approximately $80 billion by 2032. 1 The primary reason is that peptide-based drugs can be highly effective, 2 leading to fewer off-target interactions and excellent biocompatibility.
These structures hold the promise of reducing the high failure rate seen in clinical trials by providing more accurate preclinical testing, thus potentially saving time and resources while enhancing patient safety.
These structures hold the promise of reducing the high failure rate seen in clinical trials by providing more accurate preclinical testing, thus potentially saving time and resources while enhancing patient safety.
Asahi Kasei Pharma Initiates Phase III Clinical Trial of ART-123 to Combat Chemotherapy-Induced Peripheral Neuropathy Asahi Kasei Pharma Corporation has officially commenced drug administration in a pivotal Phase III clinical trial of ART-123, a recombinant human thrombomodulin (rTM), in Japan.
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