Bio Pharma Dive
OCTOBER 26, 2023
Executives at the biotech say they’re trying to get ahead of the payer and production challenges that will face their gene editing treatment exa-cel, which is now under FDA review.
Pharmaceutical Technology
OCTOBER 26, 2023
The potential for using gene therapies to treat sickle cell disease is high, but their durability and high price point invite scrutiny.
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Bio Pharma Dive
OCTOBER 26, 2023
The partners announced the trial had succeeded weeks after Moderna disclosed positive results from a study of its similar combination vaccine.
Pharmaceutical Technology
OCTOBER 26, 2023
The EC announced new initiatives to tackle critical medicine shortages in winter, introducing more flexibility to strengthen supplies.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 26, 2023
Many tiny organisms including bacteria, fungi and viruses normally live on our bodies, and even inside us. These are called the microbiome. The large number of these organisms living in the gastrointestinal tract are collectively known as the gut microbiome.
Pharmaceutical Technology
OCTOBER 26, 2023
A pivotal Phase III trial will be initiated in the coming months to further evaluate the lead formulations of the combination vaccine.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 26, 2023
The Indian Council of Medical Research (ICMR) has invited proposals to establish Ayush-ICMR Advanced Centre for Integrative Health Research (AI-ACIHR) at the All India Institute of Medical Sciences (AIIMS) under Extramural Programme. This is following a Memorandum of Agreement (MoA) signed between the Union Ministry of Ayush and the ICMR at an inter-ministerial level.
Bio Pharma Dive
OCTOBER 26, 2023
Backed by like Atlas, Cormorant and OrbiMed, Triveni is developing an antibody drug for eczema and asthma that takes aim at a different kind of target.
Pharmaceutical Technology
OCTOBER 26, 2023
Covid-19 and its mutations have prompted numerous studies to assess the impact of ventilation on transmission rates. New research examines the effectiveness of activated carbon cartridges in air-handling units for the filtration of bacteria and viruses.
Bio Pharma Dive
OCTOBER 26, 2023
Company shares fell Thursday as the company adjusted its medium-term guidance for sales of new products like Reblozyl, Camzyos and Abecma.
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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
OCTOBER 26, 2023
The Series A funds will go towards the clinical development of TRIV-509, with plans for a proof-of-concept atopic dermatitis study.
Rethinking Clinical Trials
OCTOBER 26, 2023
Speakers Rachael L. Fleurence, PhD, MSc Senior Advisor National Institutes of Health Joshua M. Sharfstein, MD Vice Dean for Public Health Practice and Community Engagement Director, Bloomberg American Health Initiative Professor of the Practice in Health Policy and Management Slides Keywords Hepatitis C, NIH, PCORnet Key Points The advances in Hepatitis C drugs is one of the greatest successes in clinical research in the last 20 years, yet Hepatitis C is a public health crisis in th
Pharmaceutical Technology
OCTOBER 26, 2023
Sanguinate is under clinical development by Prolong Pharmaceuticals and currently in Phase II for Sickle Cell Disease With Vaso-Occlusive Crisis.
Pharma Times
OCTOBER 26, 2023
Thousands of patients with heart failure are set to benefit from the expansion - News - PharmaTimes
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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
OCTOBER 26, 2023
The ACIP of the US Centers for Disease Control and Prevention recommended routine use of Bavarian Nordic’s mpox vaccine, Jynneos, in adults.
BioSpace
OCTOBER 26, 2023
Following an FDA rejection and a previous discontinuation in psoriasis, Eli Lilly’s anti-IL-23 antibody has finally won an approval in ulcerative colitis, joining a crowded inflammatory bowel disease market.
Pharmaceutical Technology
OCTOBER 26, 2023
GSK plans to submit the data to regulatory agencies to support label expansion for Arexvy in the younger adult patient population in 2024.
BioSpace
OCTOBER 26, 2023
The company’s blockbuster cancer asset Keytruda brought in more than $6.3 billion in the third quarter, a 17% increase from the same period last year, while bolstering its antibody-drug conjugate portfolio.
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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
OCTOBER 26, 2023
The FDA has approved Tofidence as the first biosimilar referencing the IL-6 receptor antagonist tocilizumab for rheumatoid arthritis
Fierce Pharma
OCTOBER 26, 2023
Novartis believes a former employee of its Egyptian affiliate made off with thousands of files before jumping ship to Takeda. | Novartis believes a former employee of its Egyptian affiliate made off with thousands of files before jumping ship to Takeda. Now, the Swiss pharma giant wants a peek at Takeda’s business records to find out whether its confidential information has been used improperly.
Pharmaceutical Technology
OCTOBER 26, 2023
MK-1942 was in two Phase II trials for the treatment of Alzheimer’s disease and major depressive disorder.
Fierce Pharma
OCTOBER 26, 2023
With concerns growing over the burden Leqembi could impose on healthcare infrastructure, Eisai and Biogen have trotted out data for an under-the-skin version of the Alzheimer’s disease drug that ma | Eisai and Biogen have trotted out data for a subcutaneous version of the Alzheimer’s disease drug Leqembi. The self-injected version showed an encouraging efficacy result but a seemingly increased risk of ARIA, which analysts said shouldn't be too much of a concern.
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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
OCTOBER 26, 2023
Zenith Epigenetics and Cencora have signed an agreement for expediting the commercialisation of the former’s ZEN-3694 programme.
BioSpace
OCTOBER 26, 2023
The French drugmaker’s shares dropped more than 15% Friday morning on the announcement that it has abandoned its goal of a 32% operating profit margin for 2025, focusing on long-term profitability.
Pharmaceutical Technology
OCTOBER 26, 2023
NKTR-255 is under clinical development by Nektar Therapeutics and currently in Phase III for Diffuse Large B-Cell Lymphoma.
BioSpace
OCTOBER 26, 2023
New platforms are emerging to help biopharma companies fill their human studies more efficiently, but barriers remain to their successful implementation.
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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
OCTOBER 26, 2023
Appili Therapeutics has received additional funding of $6.6m from the US Air Force Academy to develop ATI-1701.
BioSpace
OCTOBER 26, 2023
Santhera Pharmaceuticals and partner Catalyst Pharmaceuticals got the FDA’s greenlight for their Duchenne muscular dystrophy drug Agamree, which is expected to launch in the first quarter of 2024.
Pharmaceutical Technology
OCTOBER 26, 2023
Setbacks for Exkivity and Alofisel mean Takeda has adjusted its profit outlook; full-year revenue not affected.
Pharma Times
OCTOBER 26, 2023
The two projects will be awarded $1m each to support their clinical investigations - News - PharmaTimes
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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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