AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 11, 2022
A ping from the pizza company. A couple of pings from your socials. Ping, ping, ping from your family WhatsApp group trying to organize a weekend barbecue. With all those smartphone notifications, it’s no wonder you lose focus on what you’re trying to do do. Your phone doesn’t even need to ping to distract you. […].
Pharmaceutical Technology
DECEMBER 11, 2022
Richter’s transformation (RT) is a rare blood cancer arising in up to 10% of patients with chronic lymphocytic leukemia (CLL) and presenting as aggressive lymphoma, typically as diffuse large B-cell lymphoma (DLBCL). Due to the rarity of the disease, no FDA-approved therapy exists specifically for RT, and these patients are treated using regimens derived from the DLBCL treatment paradigm and other small-scale clinical trials.
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pharmaphorum
DECEMBER 11, 2022
Digital transformation in pharma is not a singular endeavour. It can mean everything from patient-facing disease management apps and wearables to background AI dramatically altering drug discovery or radiological imaging. So, when a life sciences company embarks on a project of digital transformation or innovation, it’s really embarking on multiple projects that span the wide world of pharmaceutical operations.
Pharmaceutical Technology
DECEMBER 11, 2022
Mantle cell lymphoma (MCL) is a type of B-cell non-Hodgkin’s lymphoma (B-NHL), typically aggressive but often with an indolent presentation. For young patients with MCL, the standard of care (SOC) is a rituximab-based chemotherapy regimen such as R-CHOP/DHAP, followed by an autologous stem cell transplant (ASCT). BTK inhibitors such as AbbVie’s /Janssen’s Imbruvica (ibrutinib) are SOC for relapsed/refractory (R/R) MCL patients, and previous data from the Phase III SHINE study in older MCL patien
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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
NPR Health - Shots
DECEMBER 11, 2022
The CDC is advising people to practice indoor masking in nearly a tenth of U.S. counties, as three highly contagious respiratory viruses sweep the country.
Medical Xpress
DECEMBER 11, 2022
Researchers from the University of Pennsylvania's Abramson Cancer Center presented preliminary results of an ongoing Phase I clinical trial demonstrating successful re-treatment with CAR T cell therapy for patients whose cancers relapsed after previous CAR T therapy at the 2022 American Society of Hematology (ASH) Annual Meeting.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
STAT News
DECEMBER 11, 2022
NEW ORLEANS — An antibody treatment developed by the Belgian drugmaker Argenx raised platelet counts and stopped bleeding episodes in patients with a rare autoimmune disorder that causes the body to attack and destroy its own blood-clotting platelets. The clinical trial results represent a potentially new and more effective way of treating adults with primary immune thrombocytopenia (ITP), a debilitating condition that, when severe and uncontrolled, can force patients to have their spleen
BioSpace
DECEMBER 11, 2022
Teaming up with a recruiter can be a smart move in a tight job market or for job seekers looking for a specialized role. To help you in your job search, we've outlined how to get the best out of recruiters.
Medical Xpress
DECEMBER 11, 2022
When people are injured severely enough to require treatment at the hospital and they are either intoxicated or have an alcohol use disorder, they have a fivefold increased risk of dying in the next year, according to a new study in the Journal of Studies on Alcohol and Drugs.
BioSpace
DECEMBER 11, 2022
Combinations including Ibrutinib stood out in hard-to-treat hematological cancers at the 64th American Society of Hematology (ASH) annual meeting.
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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
Medical Xpress
DECEMBER 11, 2022
A patient with relapsed T cell leukaemia has been given base-edited T-cells in a world-first use of a base-edited cell therapy, in a 'bench-to-bedside' collaboration between UCL and Great Ormond Street Hospital for Children (GOSH).
BioSpace
DECEMBER 11, 2022
As 2022 comes to its conclusion, the FDA has a handful of Prescription Drug User Fee Amendments still to wrap up. Here’s a look at that and more.
Medical Xpress
DECEMBER 11, 2022
The AustralaSian COVID-19 Trial (ASCOT) has pinpointed the most efficient level of blood thinning treatment needed for patients hospitalized with COVID-19, in a study published in the New England Journal of Medicine Evidence and presented at the American Society for Hematology conference today.
BioSpace
DECEMBER 11, 2022
Merck initiated a tender offer Monday to buy all outstanding shares of Imago Biosciences. This follows the November announcement of the buyout.
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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.
Medical Xpress
DECEMBER 11, 2022
Coronavirus-related hospital admissions are climbing again in the United States, with older adults a growing share of U.S. deaths and less than half of nursing home residents up to date on COVID-19 vaccinations.
BioSpace
DECEMBER 11, 2022
Affimed will not seek accelerated approval for AFM13 as a monotherapy in advanced-stage relapsed/refractory peripheral T cell lymphoma.
Medical Xpress
DECEMBER 11, 2022
One of China's top health experts has warned of a surge in COVID-19 cases, state media said Sunday, in the wake of the government's decision to abandon its hardline coronavirus strategy.
BioSpace
DECEMBER 11, 2022
Amgen confirmed Monday it will acquire rare disease giant Horizon Therapeutics for $26.4 billion.
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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.
Medical Xpress
DECEMBER 11, 2022
A CAR-T-cell therapy known as axicabtagene ciloleucel (axi-cel) is safe and shows encouraging signs of efficacy in a small pilot trial involving patients with lymphoma of the brain and/or spinal cord, Dana-Farber Cancer Institute investigators report at the 64th American Society of Hematology (ASH) Annual Meeting.
NPR Health - Shots
DECEMBER 11, 2022
China will drop a travel tracing requirement as part of an uncertain exit from its strict "zero-COVID" policies that have elicited widespread dissatisfaction.
BioSpace
DECEMBER 11, 2022
Wall Street is no longer enamored with NASH drug developers.
Roots Analysis
DECEMBER 11, 2022
Cancer is known to be one of the leading causes of deaths worldwide. In fact, as per the WHO, close to 10 million cancer related deaths were reported in 2020. Further, it is estimated that, by the end of 2040, 27.5 million new cancer cases will be added to the global numbers , exerting tremendous physical, emotional and financial strain on affected individuals, their families, communities and national health systems.
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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.
BioSpace
DECEMBER 11, 2022
Clovis Oncology officially files for Chapter 11 bankruptcy.
Roots Analysis
DECEMBER 11, 2022
Antibody drug conjugates (ADCs) are an upcoming class of targeted therapeutic agents that have garnered the attention of pharmaceutical companies, and academic / research institutions across the world. Fundamentally, these complex biotherapeutic entities represent the combination of the target specificity of an antibody and the therapeutic features of a chemotherapy / cytotoxic drug.
Drug Patent Watch
DECEMBER 11, 2022
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Roots Analysis
DECEMBER 11, 2022
Cancer is one of the leading causes of mortality, accounting for 0.6 million deaths in 2021, in the US alone. As per the International Agency for Research on Cancer (IARC), by 2040, there are likely to be 27.5 million new cases and 16.3 million deaths related to cancer, annually. Although cancer therapeutics continue to be one of the most active areas, in terms of drug development, there is still a significant unmet need in this domain.
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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.
Drug Patent Watch
DECEMBER 11, 2022
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Pharmaceutical Technology
DECEMBER 11, 2022
The US Food and Drug Administration (FDA) has granted Fast Track designation for Pfizer and BioNTech’s messenger ribonucleic acid (mRNA)-based combination vaccine candidate against Covid-19 and influenza. The vaccine is intended to prevent two respiratory ailments through a single injection. In November, the companies announced plans for a Phase I clinical trial of the combined vaccine candidate in healthy adult subjects.
Drug Patent Watch
DECEMBER 11, 2022
This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Sweden. SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating…. The post Which pharmaceutical companies have the most SPCs in Sweden? appeared first on DrugPatentWatch - Make Better Decisions.
STAT News
DECEMBER 11, 2022
NEW ORLEANS — For some patients suffering with certain blood cancers, CAR-T therapy can offer the tantalizing chance to end their disease with a single treatment. But the immunotherapy takes time to manufacture, and patients often have to wait weeks to actually receive an infusion once they’re eligible. For some patients with especially aggressive cancer, they can die while waiting for the therapy to arrive.
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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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