Bio Pharma Dive
APRIL 7, 2022
Treatment with Aduhelm would only be covered for patients enrolled in a clinical trial under the policy, which largely follows a draft proposal released in January.
Pharma Mirror
APRIL 7, 2022
Let’s face it, dealing with a terminal illness diagnosis will never be an easy task and there’s not much you can do to mitigate the pain. However, there are a few steps that you can take to make the whole ordeal a bit more manageable for the person diagnosed and those around them. There are a few emotional chapters you’ll need to close as well as some practical matters that you should get out of the way if you are diagnosed with a terminal illness.
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Bio Pharma Dive
APRIL 7, 2022
The layoffs come after safety concerns led the FDA to rebuff its anemia pill, similar to the agency's spurning of FibroGen's rival drug last year.
BioPharma Reporter
APRIL 7, 2022
US company Catalent is acquiring the UKâs Vaccine Manufacturing and Innovation Centre in Harwell: a facility which had been planned to support COVID-19 and wider vaccine production and which is still under construction.
Bio Pharma Dive
APRIL 7, 2022
The pharma company adds experimental RSV treatments to its pipeline through the deal, which is worth up to $525 million.
XTalks
APRIL 7, 2022
Each year, April 7 marks World Health Day, an initiative created by the World Health Organization (WHO) to spread awareness about health-related issues. While last year’s theme was “building a fairer, healthier world for everyone,” the theme for World Health Day 2022 is “our planet, our health,” which aims to direct global attention toward the well-being of our planet and the humans living on it.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Drug Patent Watch
APRIL 7, 2022
Annual Drug Patent Expirations for BAXDELA Baxdela is a drug marketed by Melinta and is included in two NDAs. It is available from one supplier. There are thirteen patents protecting…. The post New patent for Melinta drug BAXDELA appeared first on DrugPatentWatch - Make Better Decisions.
Outsourcing Pharma
APRIL 7, 2022
The US Department of Health and Human Serviceâs Office of Research Integrity has uncovered evidence that Toni Brand committed fraud in a number of reports.
Scienmag
APRIL 7, 2022
Chemists integrated computer functions into rolling DNA-based motors, opening a new realm of possibilities for miniature, molecular robots. Nature Nanotechnology published the development, the first DNA-based motors that combine computational power with the ability to burn fuel and move in an intentional direction. Credit: Salaita Lab, Emory University Chemists integrated computer functions into rolling DNA-based […].
Pharma Times
APRIL 7, 2022
NICE recommends avelumab as treatment for adults with locally advanced or metastatic urothelial cancer
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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
Scienmag
APRIL 7, 2022
Many people, especially the elderly, suffer from abnormal sleep. In particular, the deep sleep phases become shorter and shallower with age. Deep sleep is important for the regeneration of the brain and memory, and also has a positive influence on the cardiovascular system. Credit: Sleeploop Many people, especially the elderly, suffer from abnormal sleep.
Pharma Times
APRIL 7, 2022
Spin-off company will focus on developing therapies in areas of inflammation and immunometabolism
Scienmag
APRIL 7, 2022
FORT DAVIS, Texas — The world’s largest International Dark Sky Reserve is coming to Texas and Mexico, thanks to a partnership between The University of Texas at Austin’s McDonald Observatory, The Nature Conservancy, the International Dark-Sky Association (IDA) and many others. The designation, granted by the IDA, recognizes the commitment of organizations, governments, businesses and […].
Outsourcing Pharma
APRIL 7, 2022
Experts from the Decentralized Trials and Research Alliance and Rafael Pharmaceuticals discuss progress and possibilities during Clinical Development Advances.
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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
Scienmag
APRIL 7, 2022
The Mid-Infrared Instrument (MIRI) and other Webb instruments have been cooling by radiating their thermal energy into the dark of space for the bulk of the last three months. The near-infrared instruments will operate at about 34 to 39 kelvins, cooling passively. But MIRI’s detectors will need to get a lot colder still, to be […].
pharmaphorum
APRIL 7, 2022
It is too early to consider widespread use of a second COVID-19 vaccine booster dose, according to the European Centre for Disease Prevention and Control (ECDC) and EMA’s COVID-19 task force (ETF). The official word from the EU authorities is that for now a fourth dose of Pfizer/BioNTech’s Comirnaty or Moderna’s SpikeVax – the preferred booster vaccines in Europe – should only be used in adults aged 80 years and over and people with compromised immunity.
Scienmag
APRIL 7, 2022
Atmospheric dust plays a key role in Earth’s climate system. While it can have a positive impact, such as fertilizing the soils, dust can also have a negative impact on our planet’s ecosystems, affecting everything from the weather to global warming. For example, in the Four Corners region—which includes portions of Arizona, Colorado, Utah and […].
NY Times
APRIL 7, 2022
Officials cited data showing the new Alzheimer’s drug has serious safety risks and may not help patients.
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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.
Scienmag
APRIL 7, 2022
Currently, AI services spread rapidly in daily life and in all industries. These services are enabled by connecting AI centers and terminals such as mobile devices, PCs, etc. This method, however, increases the burden on the environment by consuming a lot of power not only to drive the AI ??system but also to transmit data. […].
Antidote
APRIL 7, 2022
Two of the most critical components of any clinical trial recruitment campaign are patient-centricity and trust. Antidote has a robust Contact Center with personable and knowledgeable agents that walk patients through the prescreening process and answer any questions along the way. We spoke with our Contact Center Operations Manager, Andy Schulz, about why he joined the team, what his team’s day-to-day looks like, why it is so important to provide patients with a positive experience during their
Scienmag
APRIL 7, 2022
Asian and Hispanic communities experience significantly more air pollution from economic activity compared to predominantly white neighborhoods across the state of California, according to new research from the University of California San Diego’s School of Global Policy and Strategy. Credit: UC San Diego Asian and Hispanic communities experience significantly more air pollution from economic activity […].
The Pharma Data
APRIL 7, 2022
This unprecedented CMS decision effectively denies all Medicare beneficiaries access to ADUHELM ® (aducanumab-avwa), the first and only FDA-approved therapy in a new class of Alzheimer’s drugs. It may also limit coverage for any future approved treatment in the class. These coverage restrictions, including the distinction between accelerated approval and traditional approval, have never been applied to FDA-approved medicines for other disease areas.
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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.
Scienmag
APRIL 7, 2022
A combined study of genetics and skeletal remains show that the switch from primarily hunting, gathering and foraging to farming about 12,000 years ago in Europe may have had negative health effects as indicated by shorter than expected heights in the earliest farmers, according to an international team of researchers. Credit: Marija Stojkovic A combined […].
The Pharma Data
APRIL 7, 2022
Dupixent is the only biologic indicated in the European Union for severe asthma with type 2 inflammation, characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide Approval based on Phase 3 data showing Dupixent significantly reduced severe asthma attacks and also improved lung function and health-related quality of life for children Data reinforce well-established safety profile of Dupixent.
Scienmag
APRIL 7, 2022
A new study has shown how fish influence ocean ecosystems in coastal regions, revealing for the first time how they circulate nutrients and oxygen around the waters when they spawn. This process is key to keeping the ecosystems running. Credit: Remedios project A new study has shown how fish influence ocean ecosystems in coastal regions, […].
The Pharma Data
APRIL 7, 2022
A grim milestone has been crossed today in the war in Ukraine – more than 100 attacks on health care verified by WHO since the start of the war on February 24. The attacks so far have claimed 73 lives and injured 51. Of the current total of 103 attacks, 89 have impacted health facilities and 13 have impacted transport, including ambulances. “We are outraged that attacks on health care are continuing.
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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.
Scienmag
APRIL 7, 2022
A new artificial intelligence-based approach can predict, significantly more accurately than a doctor, if and when a patient could die of cardiac arrest. The technology, built on raw images of patient’s diseased hearts and patient backgrounds, stands to revolutionize clinical decision making and increase survival from sudden and lethal cardiac arrhythmias, one of medicine’s deadliest […].
Intouch Solutions
APRIL 7, 2022
Perhaps the strangest point in my career was when I concurrently marketed a major candy brand and a novel diabetes medication. Yes, I recognize the irony. Interestingly, people seemed more impressed that I marketed chocolate than pharmaceuticals. After all, if you ask people to tell you their favorite ads, few are likely to name a pharmaceutical one.
Scienmag
APRIL 7, 2022
GAINESVILLE, Fla. — With any highly infectious disease, time can be a killer. Credit: Photo courtesy of Houndstoothe Analytics. GAINESVILLE, Fla. — With any highly infectious disease, time can be a killer. It is crucial to get a test result for a pathogen quickly, lest someone continue in their daily lives infecting others. And delays […].
XTalks
APRIL 7, 2022
While the plant-based food industry has experienced rapid growth in recent years, how much have sales in the sector grown since 2018? In this episode of the Xtalks Food Podcast, Sydney talks about the massive growth of plant-based food sales in the US, which hit $7.4 billion in 2021, growing by a whopping 54 percent since 2018. This data was released in a report from the Good Food Institute (GFI), which also pointed out that dollar sales of products in categories including plant-based milk, meat
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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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