Bio Pharma Dive
JANUARY 6, 2023
The agency’s approval comes months after a large clinical trial showed the drug, called Leqembi, could slow the disease’s progression. Yet experts have raised concerns about its safety.
Pharmaceutical Technology
JANUARY 6, 2023
While the treatment options for multiple sclerosis (MS) patients are growing each year with the approval of new agents, all of the currently marketed treatments only slow the disease’s progression and sometimes carry risks of severe side effects, such as liver failure or the development of viral infections. However, new mechanisms of action (MoAs) are in constant development, with some of the more innovative ones utilizing cell-based therapies.
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Bio Pharma Dive
JANUARY 6, 2023
The pharma set the average annual cost of it and Biogen’s newly approved medicine Leqembi to $26,500, below the cost of the companies’ earlier drug Aduhelm but above one estimate of cost effectiveness.
Pharmaceutical Technology
JANUARY 6, 2023
Danish biotech company Adcendo has entered into a licence agreement with Duality Biologics on the next-generation antibody-drug conjugates (ADC) platform. Under the deal, the company will be granted a licence to Duality’s Duality Immune Toxin Antibody Conjugates (DITAC) linker/payload platform for its lead uPARAP-ADC mesenchymal cancers programme. The platform has been designed for producing ADCs with better safety profiles, payload delivery sustainably and release in tumours, and destroying ant
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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
Bio Pharma Dive
JANUARY 6, 2023
The cuts at Fate, Century Therapeutics and TCR2 Therapeutics signal a longer road in the companies’ plans to develop next-generation cell therapies for cancer.
NPR Health - Shots
JANUARY 6, 2023
An Alzheimer's drug that removes the substance amyloid from the brain has received a conditional approval from the FDA. A large study found the drug decreased the loss of thinking and memory by 27%.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
NPR Health - Shots
JANUARY 6, 2023
RSV and the flu appear to be receding in the U.S., but COVID is on the rise, new data suggests, driven by holiday gatherings and an even more transmissible omicron subvariant that has become dominant.
Bio Pharma Dive
JANUARY 6, 2023
The Takeda-backed biotech revealed it’s raised $85 million in new funding alongside announcing the acquisition of gene editing startup Twelve Bio.
pharmaphorum
JANUARY 6, 2023
Google and DeepMind have developed an artificial intelligence-powered chatbot tool called Med-PaLM designed to generate “safe and helpful answers” to questions posed by healthcare professionals and patients. The tool is an example of a large language model or LLM, which are designed to understand queries and generate text responses in plain language, drawing from large and complex datasets – in this case, medical research.
Bio Pharma Dive
JANUARY 6, 2023
The drugmaker said it is considering licensing out some assets to shorten development timelines, and will stop work on early viral-based gene therapies.
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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
JANUARY 6, 2023
Scientists from The University of Texas Health Science Center at San Antonio (UT Health San Antonio) today reported that an inflammatory trigger like one present during viral infections is elevated in Alzheimer's disease and progressive supranuclear palsy, a rare brain disorder.
NPR Health - Shots
JANUARY 6, 2023
A newborn was surrendered recently under a program that lets people give up an unwanted infant anonymously. There are dozens of baby boxes scattered across the U.S., but the practice is controversial.
Medical Xpress
JANUARY 6, 2023
A new USC Leonard Davis School of Gerontology study challenges existing ideas of how buildup of a protein called amyloid beta (Aβ) in the brain is related to Alzheimer's disease.
NPR Health - Shots
JANUARY 6, 2023
For the more than 350,000 Americans each year who suffer cardiac arrest outside of a hospital, the prognosis is not always an optimistic one. But quick action with CPR and a defibrillator can be key.
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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.
STAT News
JANUARY 6, 2023
Now that the U.S. Food and Drug Administration has granted accelerated approval to the widely anticipated Alzheimer’s drug from Eisai and Biogen, a key question is the extent to which payers — private and public — will cover the treatment. Such decisions are based on myriad factors, starting with the average $26,500 price tag. But there are other considerations, including the quality of the clinical trial data, side effect concerns, the patient population for which the medic
pharmaphorum
JANUARY 6, 2023
The UK has formed an partnership with German biotech BioNTech to provide up to 10,000 patients with access to personalised cancer therapies, in another example of the country embracing the mRNA technologies that underpinned COVID-19 vaccines. The cancer immunotherapies will mainly be provided in the context of clinical trials over the alliance, which extends out to 2030, but also covers supply of commercial therapies if approved in the interim.
STAT News
JANUARY 6, 2023
WASHINGTON — Members of Congress, state legislators, regulators, and legal advocates are calling on prisons to explain their poor hepatitis C treatment rates, after a STAT investigation revealing that more than 1,000 people had died from complications of the curable disease. In South Dakota and Oklahoma, lawmakers have written to their respective departments of corrections about STAT’s reporting.
Medical Xpress
JANUARY 6, 2023
German pharmaceutical company BioNTech, which developed a trailblazing COVID-19 vaccine, will trial a cancer treatment in Britain using the same mRNA technology, the company said on Friday.
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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.
STAT News
JANUARY 6, 2023
The pharmaceutical industry has been slow to adopt a business practice that is faster, safer, and more efficient than its current way of operating; that the FDA has been encouraging the industry to implement more widely for years; and that has been used effectively in other industries for decades. I’m talking about continuous manufacturing. Continuous manufacturing produces a drug product from start to finish through a nonstop, integrated assembly.
Medical Xpress
JANUARY 6, 2023
Neurodegenerative diseases affect millions of people worldwide and as our life expectancy increases, more individuals are expected to be affected in the coming decades. Tauopathies such as Alzheimer's disease are a class of neurodegenerative disorders involving an accumulation of tau proteins, which eventually results in massive loss of brain cells.
STAT News
JANUARY 6, 2023
When Michael Odell, an intensive care nurse, died by suicide a year ago this month, it thrust attention on all that nurses had endured during the pandemic. Odell’s death also motivated his friends in the field as well as other nurses to build on that attention and his legacy. In the year since, they’ve been advocating for health care worker well-being and calling for health systems to offer more support for nurses, historically a group that’s received less consideration than
pharmaphorum
JANUARY 6, 2023
With the US economy teetering on a recession, sales and marketing budgets are expected to take a hit among businesses across sectors. The pharmaceutical industry is no exception. When any organisation looks to slash its budget, the old adage about acquiring new customers costing five times as much as retaining existing customers becomes an alluring data point.
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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.
STAT News
JANUARY 6, 2023
The Food and Drug Administration on Friday approved a new Alzheimer’s disease treatment that moderately slows cognitive decline in people with early-stage disease. The drug, called Leqembi, was developed by Eisai , the Japanese pharmaceutical company that also developed the first symptomatic treatment for Alzheimer’s 25 years ago.
Medical Xpress
JANUARY 6, 2023
In a new Imperial College London study involving three volunteers, skin scars began to behave more like uninjured skin after they were treated with hair follicle transplants. The scarred skin harbored new cells and blood vessels, remodeled collagen to restore healthy patterns, and even expressed genes found in healthy unscarred skin.
STAT News
JANUARY 6, 2023
The Environmental Protection Agency announced on Friday more aggressive air quality standards for particulate matter, pollutants small enough to be inhaled and cause respiratory illness and other disease. The agency’s new rules would help clean the nation’s air and bring it more in line with the past decade of research on the harmful effects of particulate matter.
Medical Xpress
JANUARY 6, 2023
Newly published research from the University of Cincinnati finds that people with latent tuberculosis infection (LTBI) have more inflammation and could be at a higher risk for cardiovascular disease.
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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.
STAT News
JANUARY 6, 2023
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.
Medical Xpress
JANUARY 6, 2023
The US Food and Drug Administration on Friday approved a highly anticipated new drug designed to slow cognitive decline in patients in the early stages of Alzheimer's disease.
pharmaphorum
JANUARY 6, 2023
pharmaphorum is proud to announce its inaugural “The World Without Disease Summit”: a high quality, two-day event bringing together key global leaders and innovators to explore the potential of disease interception in future health. The event has been conceived in partnership with an established industry leader in this space, Ben Wiegand, Founding Partner at CWWDA (The Connected World Without Disease Accelerator) and former senior executives at UnitedHealth and Janssen.
Medical Xpress
JANUARY 6, 2023
The mpox virus is closely related to the smallpox virus (variola virus), which caused large, deadly outbreaks before it was eradicated by vaccination at the end of the 1970s. While the smallpox virus led to very severe disease progression with a death rate of about 30%, mpox is milder. Nevertheless, the mortality rate is still about 3%.
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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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