Worldwide Clinical Trials
APRIL 15, 2024
As the clinical research landscape continually evolves, the choice of a Contract Research Organization (CRO) partner can significantly impact the success of drug development programs. In fact, recent industry dynamics indicate a considerable shift in preference towards midsize CROs, driven by the need for more personalized, agile, and cost-effective partnerships.
Bio Pharma Dive
APRIL 15, 2024
Treatment appeared to result in functional and cognitive gains in people with the neurological disorder. Three participants experienced lower extremity weakness, however.
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Pharmaceutical Technology
APRIL 15, 2024
Discover ImmunityBio Inc's groundbreaking patent for a cross-reactive SARS-CoV2 vaccine targeting multiple variants. Learn how this innovative method boosts immune response and memory cells for enhanced protection.
Bio Pharma Dive
APRIL 15, 2024
Because live cell and tissue products are extremely sensitive to contamination from microorganisms, viral particles or other airborne impurities, research and manufacturing involving these materials needs to be conducted in a cleanroom environment.
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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
APRIL 15, 2024
Discover Genzyme Corp's innovative method for detecting anti-drug antibodies in human body fluids. Learn how their patented process reduces interference in drug assays effectively.
Bio Pharma Dive
APRIL 15, 2024
Learn about why access to robust biomarkers such as cfHPV-DNA is pivotal in determining eligibility, assessing treatment response and detecting recurrence early to improve patient outcomes.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
APRIL 15, 2024
The results could give Roche’s Columvi an edge over a rival medicine from AbbVie and Genmab, while Regeneron awaits an approval of its own therapy.
Pharmaceutical Technology
APRIL 15, 2024
Discover the innovative patent by Zydus Lifesciences Ltd for a pharmaceutical composition in oral suspension form, enhancing stability and palatability for immunosuppressive agents.
Bio Pharma Dive
APRIL 15, 2024
Shares of the biotech dipped by double digits following disclosure the FDA had paused an early-stage study of Neumora’s muscarinic-targeting drug.
Pharmaceutical Technology
APRIL 15, 2024
Discover the groundbreaking patent by Arena Pharmaceuticals for treating atopic dermatitis with a specific compound in a standard dose. Learn how (R)-2-(7-(4-cyclopentyl-3-(trifluoromethyl)benzyloxy)-1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl)acetic acid can revolutionize dermatological treatments.
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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
Bio Pharma Dive
APRIL 15, 2024
While corporate venture arms are commonplace among pharmaceutical companies, the new fund announced Monday is Regeneron’s first.
Pharmaceutical Technology
APRIL 15, 2024
Discover a groundbreaking pharmaceutical composition with patented bacteriophages targeting E. coli strains in treating inflammatory bowel disease. Explore the innovative approach to combatting infections caused by adherent-invasive E. coli.
pharmaphorum
APRIL 15, 2024
Psychedelic treatments for conditions like PTSD using substances like MDMA are on the brink of approval, but there are still unanswered questions surrounding their effectiveness and potential risks. Learn more here.
Pharmaceutical Technology
APRIL 15, 2024
Optimize and distribute predictively processed data in medical software applications with Allscripts Healthcare Solutions Inc's patented resource management system. Enhance operational capabilities and capacities for improved performance.
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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.
pharmaphorum
APRIL 15, 2024
Regeneron has formed a corporate venture capital unit with $100 million a year to invest over the next five years in “biopharmaceutical, healthcare, and health technology” start-ups.
Pharmaceutical Technology
APRIL 15, 2024
Discover a groundbreaking method to treat renal disorders with AVEO Pharmaceuticals Inc's patented anti-GDF15 antibody. Learn how this innovative approach targets hyperuricemia and CKD for improved renal function.
Fierce Pharma
APRIL 15, 2024
A Novartis drug with "pipeline in a pill" potential, according to one analyst group, has delivered on that promise once again. | In a phase 3 trial, treatment with Fabhalta led to a statistically significant 38.3% reduction of proteinuria (protein in the urine) in patients with IgA nephropathy, Novartis said on Monday.
Pharmaceutical Technology
APRIL 15, 2024
The future development of IV ganaxolone will be determined by results from the Phase III RAISE study, expected in summer 2024.
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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.
Fierce Pharma
APRIL 15, 2024
After nearly two years of legal back and forth, Pfizer and its German partner BioNTech have won a brief reprieve in their patent fight against mRNA rival Moderna. | In a docket entry dated Friday, Massachusetts federal judge Richard G. Stearns granted a stay on Moderna's COVID-19 vaccine patent infringement lawsuit against Pfizer and BioNTech. The move will give the Patent Trial and Appeal Board more time to review challenges against two of the three relevant patents in the litigation.
Pharmaceutical Technology
APRIL 15, 2024
Soligenix’s Marburg virus vaccine demonstrated 100% protection in non-human primates in a clinical study.
pharmaphorum
APRIL 15, 2024
Shah Capital has fired a broadside at the management team of Novavax, seeking a change in leadership at the vaccine company and the appointment of two handpicked directors to the board. In an open letter, the hedge fund accuses Novavax’s leadership of squandering its “many significant competitive advantages and sizeable market opportunity” due to “self-inflicted problems” under the current team led by chief executive John Jacobs.
Pharmaceutical Technology
APRIL 15, 2024
Pharmaceutical innovations require an extra layer of precision and care in the supply chain process.
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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.
pharmaphorum
APRIL 15, 2024
Roche’s CD20xCD3 bispecific antibody Columvi has improved survival when used as a second-line therapy for diffuse large B-cell lymphoma (DLBCL) in a phase 3 trial, setting up regulatory filings for earlier use of the drug in the treatment pathway.
Pharmaceutical Technology
APRIL 15, 2024
Discover how Atrium Health's groundbreaking patent revolutionizes cancer treatment with targeted antibodies and cytotoxic cells, enhancing immune response and improving patient outcomes.
Pharma Times
APRIL 15, 2024
Affecting over 500,000 people in the UK, IBD comprises Crohn’s disease and ulcerative colitis
pharmaphorum
APRIL 15, 2024
The advancement of medicine is dependent on secure pharmaceutical supply chains. Discover why ensuring the security of these chains is crucial for the development and distribution of life-saving medications.
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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.
Intouch Solutions
APRIL 15, 2024
At SXSW 2024, amidst a confluence of marketing, technology, AI, and design, one word seemed to echo through every conversation, panel, and workshop: authenticity. It’s fascinating, isn’t it? The idea of being genuine, real, and true — qualities so deeply sought after in everything we do, yet so complex and rich when we pause to unpack them. Among the minds at EVERSANA INTOUCH, with leaders spanning the spectrum from Strategic Planning to Creative Direction, and from Experience Design to Customer
pharmaphorum
APRIL 15, 2024
Life sciences service provider (and pharmaphorum parent company) Eversana has completed the integration of Healthware Group, the Italy-based global agency and consultancy it acquired in October. The group will now be known as Eversana Intouch Healthware and will operate as Eversana’s sixth full-service affiliate.
BioSpace
APRIL 15, 2024
Novartis on Monday shared late-stage data for its potential multibillion-dollar drug Fabhalta, in what the company contends is first and only Phase III study to demonstrate significant proteinuria reduction by targeting the complement system in IgA nephropathy patients.
pharmaphorum
APRIL 15, 2024
Up to one in six people in eight industrialised nations could be suffering from chronic kidney disease (CKD) by 2032, with dire consequences for “patients, [the] planet, and economies,” says a new study.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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