Bio Pharma Dive
FEBRUARY 21, 2024
The full results spotlight cell therapy’s potential to treat lupus and other inflammatory conditions, but also the problems drug developers must solve first.
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 21, 2024
Approximately 1 in 26 people develop epilepsy, a condition in which someone experiences recurring and unprovoked seizures. But experiencing a seizure does not always mean a person has epilepsy. Seizures can be provoked by acute head injuries, alcohol withdrawal and high blood sugar, among other things.
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Bio Pharma Dive
FEBRUARY 21, 2024
One expert views Amtagvi’s approval as a catalyst for further investment in TIL therapies, akin to how Kymriah’s 2017 clearance buoyed CAR-T treatment.
Worldwide Clinical Trials
FEBRUARY 21, 2024
During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure.
Pharmaceutical Technology
FEBRUARY 21, 2024
Biora’s new smart pill represents a new treatment modality that may increase the efficacy of therapeutics for ulcerative colitis
Bio Pharma Dive
FEBRUARY 21, 2024
The biotech alleges that the agency is letting competitor Liquidia sidestep the rules by accepting an amendment to an application that’s involved in a patent dispute.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
FEBRUARY 21, 2024
The departure of Phil Pang, who played a key role in developing Vir’s COVID-19 antibody, comes amid a broader company restructuring.
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 21, 2024
Indian hospitals are keen to navigate roadblocks to cancer patient recovery with regular annual screening. While India excels in initial treatment and interventions, several challenges in post-treatment care hinder optimal recovery and long-term well-being. India has made significant strides in its medical care, showcasing technology, skilled professionals, and infrastructure.
Pharmaceutical Technology
FEBRUARY 21, 2024
The US FDA has approved Johnson & Johnson’s (J&J) reduced dosing frequency of TECVAYLI for relapsed or refractory multiple myeloma.
Bio Pharma Dive
FEBRUARY 21, 2024
The Danish company scrapped a vaccine in Phase 1 testing and will exit oncology altogether, focusing instead on infectious disease research.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
FEBRUARY 21, 2024
Bristol Myers Squibb (BMS) reported FDA acceptance of the sNDA for KRAZATI plus cetuximab to treat colorectal cancer for priority review.
Drug Discovery World
FEBRUARY 21, 2024
DDW Editor Reece Armstrong speaks to Dr Paul Song , MD, NKGen and Dr Vince DeOrchis , clinician, to find out more about the investigational natural killer therapy SNK01 and the benefit of using a patient’s own cells to treat Alzheimer’s. In October 2023, pharmaceutical company NKGen Biotech released data from its Phase I clinical trial on the use of its investigational natural killer therapy, SNK01, to treat patients with Alzheimer’s disease.
Pharmaceutical Technology
FEBRUARY 21, 2024
Contract development and manufacturing organisation Genezen has announced plans to license CSL’s Cytegrity lentivirus production system.
Fierce Pharma
FEBRUARY 21, 2024
On the heels of a turbulent 2023 in which Novavax’s very existence was at stake, the beleaguered vaccine maker has new reason to be optimistic about the future. | Novavax has reached a settlement with Gavi, the Vaccine Alliance ending arbitration tied to a 2021 advance purchase agreement around its prototype COVID-19 vaccine NVX-CoV2373. Had Novavax lost the arbitration, the company might have had to refund nearly $700 million.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Pharmaceutical Technology
FEBRUARY 21, 2024
A Phase I trial studying the therapy is underway after an FDA clinical hold was lifted last year, with initial data expected in 2024.
pharmaphorum
FEBRUARY 21, 2024
Clinical research involves trial and error as part of the drug development process. Learn more about how to optimise drug trials and the important role of participants in clinical research.
Pharmaceutical Technology
FEBRUARY 21, 2024
WuXi ATU received FDA approval to commence the analytical examination and production of Iovance’s Amtagvi at its Philadelphia site.
Pharmaceutical Commerce
FEBRUARY 21, 2024
Cabenuva (cabotegravir + rilpivirine) showed superior efficacy in maintaining viral load suppression in patients with HIV compared with standard of care daily oral antiretroviral treatment.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Pharmaceutical Technology
FEBRUARY 21, 2024
Polpharma’s biosimilar candidate PB106 showed non-inferiority to the reference therapy Takeda’s Entyvo in a Phase III trial.
XTalks
FEBRUARY 21, 2024
This episode features an interview with Amir Reichman, CEO of Scinai Immunotherapeutics , a biopharma company focused on developing cutting-edge biological treatments within the inflammation and immunology (I&I) sector, with a primary focus on addressing autoimmune and infectious diseases. Scinai Immunotherapeutics is working on developing nanosized antibodies from alpacas, known as VHH-antibodies or NanoAbs, which show promise as improved biological therapies for various illnesses.
Pharmaceutical Technology
FEBRUARY 21, 2024
Bavarian Nordic reported a preliminary revenue of $1bn for 2023, driven by sales of JYNNEOS, its moneypox/smallpox vaccine.
Outsourcing Pharma
FEBRUARY 21, 2024
Creating artificial intelligence to understand medical conditions, and not just the English language, sounds far-fetched, but this is what one CEO is achieving with an impressive foundational innovation.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Pharmaceutical Technology
FEBRUARY 21, 2024
Codeine linctus has been reclassified from a pharmacy-only medicine to a prescription-only medicine in the UK.
Fierce Pharma
FEBRUARY 21, 2024
In a year that started with more than two-thirds of biopharma companies posting | While Novo Nordisk and Eli Lilly continued to be the biopharma industry growth leaders in the fourth quarter of 2023, many other drugmakers also delivered big gains, including Daiichi Sankyo, Amgen, Teva, GSK and Novartis.
Pharmaceutical Technology
FEBRUARY 21, 2024
Sarilumab is under clinical development by Regeneron Pharmaceuticals and currently in Pre-Registration for Polyarticular Juvenile Idiopathic Arthritis (PJIA).
pharmaphorum
FEBRUARY 21, 2024
Explore the evolution of clinical research in the UK, including the role of NIHR and Direct Delivery Teams in embracing new delivery models. Join our informative webinar to learn more.
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Pharmaceutical Technology
FEBRUARY 21, 2024
Squaric acid dibutyl ester is under clinical development by Squarex Pharmaceutical and currently in Phase I for Herpes Labialis (Oral Herpes).
Drug Channels
FEBRUARY 21, 2024
Like many of you, I have believed that the Inflation Reduction Act of 2022 (IRA) will encourage Medicare Part D plans to adopt low-list-price products over their high-list/high-rebate counterparts, thereby popping the gross-to-net bubble. Actually, maybe not. Below, I explain why the IRA will encourage Part D plans to prefer high-list, high-rebate specialty drugs , even as the government and manufacturers will prefer a low-list-price version.
Pharmaceutical Technology
FEBRUARY 21, 2024
Apilimod mesylate is under clinical development by OrphAI Therapeutics and currently in Phase II for Amyotrophic Lateral Sclerosis.
pharmaphorum
FEBRUARY 21, 2024
Attention-deficit hyperactivity disorder (ADHD) in adults is not well understood and highly underdiagnosed, but the developers of a mobile game designed to raise awareness hope to shine a light on the struggles of people struggling with the condition.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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