Bio Pharma Dive
JUNE 10, 2022
The British drugmaker now plans to seek approval of what could be the first preventive shot for the common lung infection. However, Pfizer, Johnson & Johnson and Moderna are close behind.
pharmaphorum
JUNE 10, 2022
If you work in pharma, the chances are you’re no stranger to the United States Food and Drug Administration, or FDA, which regulates pharmaceuticals. But if you’re becoming more involved with the world of digital health, as many pharma companies are these days, you may find that your old FDA knowledge isn’t much help in knowing what will be required of you.
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Bio Pharma Dive
JUNE 10, 2022
By a 13-0 vote, the panel agreed the benefits of Bluebird’s beta thalassemia treatment outweigh its risks, one day after reaching a similar conclusion for another of the company’s drugs.
pharmaphorum
JUNE 10, 2022
Pharma’s evolving role in patient care. The digital revolution has already reshaped the commercial engine of biopharma companies. Pharma’s digital initiatives now routinely enable new channels that educate and market to patients, physician engagement that is more efficient and effective, and novel payment mechanisms and distribution models that improve access to therapies.
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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
JUNE 10, 2022
The European venture firm’s latest fund will open up a new source of investment at a time companies are struggling to go public or hold their value.
Pharmaceutical Commerce
JUNE 10, 2022
Proper control of type 1 and 2 diabetes can greatly reduce the personal impact and economic burden of this pervasive public health condition. To that end, stakeholders are exploring many parallel routes to help individuals and society maintain the upper hand, as the toll of diabetes continues to skyrocket.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
JUNE 10, 2022
Babies born to mothers who contracted COVID-19 during seem to be at slightly higher risk of neurodevelopmental delays, say US researchers, although they caution their findings are preliminary. Their retrospective study looked at more than 7,500 infants delivered during the pandemic, including 222 born to mothers with a positive COVID-19 test during pregnancy.
XTalks
JUNE 10, 2022
The European Parkinson’s Disease Association (EPDA) is Europe’s Parkinson’s umbrella organization that connects and engages with the Parkinson’s community in Europe and the world. The EPDA represents national Parkinson’s associations across Europe and advocates for the needs and rights of more than 1.2 million people living with Parkinson’s in Europe.
pharmaphorum
JUNE 10, 2022
The FDA may have safety concerns abut bluebird bio’s gene therapy for rare, fatal disease cerebral adrenoleukodystrophy (CALD), but its advisors believe its benefits far outweigh the risks. Members of the agency’s Cellular, Tissue and Gene Therapies advisory committee voted 15 to 0 in favour of approval of elivaldogene autotemcel – also known as eli-cel and Lenti-D – ahead of the FDA’s scheduled decision on the drug in September.
Olympian Clinical Research
JUNE 10, 2022
Atopic dermatitis is a form of eczema and is the most common chronic inflammatory skin disease. While this condition is often seen in children, around 16.5 million Americans suffer from this itchy skin condition. Although there is no cure for this condition, with the proper knowledge, treatments, and lifestyle changes, those with eczema may manage their symptoms and lead happy, healthy lives.
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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
JUNE 10, 2022
Credit: University of Chichester Drumming for 90 minutes each week helps autistic children overcome hyperactivity and attention deficit difficulties, report finds Learning musical patterns with tempo, volume and timing tunes brain connectivity in regions responsible for inhibitory control, action-outcome monitoring and self-regulation Scientists will use the novel findings to shape future studies in areas […].
Pharma Times
JUNE 10, 2022
The partnership will involve the optimised delivery of saRNA-based vaccines and therapeutics
Scienmag
JUNE 10, 2022
Whatever you are doing, whether it is driving a car, going for a jog, or even at your laziest, eating chips and watching TV on the couch, there is an entire suite of molecular machinery inside each of your cells hard at work. That machinery, far too small to see with the naked eye or […].
Pharma Times
JUNE 10, 2022
The company completes its enrolment in phase 3 trial evaluating ensifentrine for treatment of COPD
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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
JUNE 10, 2022
Even the most frugal among us upgrade our cell phones and laptops every now and again. They’re relatively easy to replace. Credit: Tom Cogill/University of Virginia School of Engineering and Applied Science Even the most frugal among us upgrade our cell phones and laptops every now and again. They’re relatively easy to replace. That’s not […].
pharmaphorum
JUNE 10, 2022
Takeda has reported positive new, long-term results in its pivotal trial of dengue fever vaccine TAK-003 that builds the case for the shot as regulators review marketing applications. The new data – coming after four-and-a-half years of follow-up – has revealed that TAK-003 cut dengue-related hospitalisations by 84%, with 61% protective efficacy against symptomatic dengue illness, with no serious safety issues.
Scienmag
JUNE 10, 2022
On a beautiful fall day in 2019, Miranda Sinnott-Armstrong was walking down Pearl Street in Boulder, Colorado when something caught her eye: a small, particularly shiny blue fruit, on a shrub known as Lantana strigocamara. While its tiny clusters of pink, yellow and orange flowers and blue berries commonly adorn the pedestrian mall in spring, […].
Pharmaceutical Commerce
JUNE 10, 2022
A conversation with EY life sciences leaders Jim Welch and Jay Welsh.
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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
JUNE 10, 2022
Understanding how brain areas communicate is one of the oldest questions in neuroscience. Researchers at the Sainsbury Wellcome Centre at UCL used causal techniques to uncover how two neocortical areas in the brain communicate with one another and found that their influence on each other changes over much faster-timescales than previously thought. Credit: © SAINSBURY […].
Intouch Solutions
JUNE 10, 2022
You may have noticed that we had some big news this week! We unveiled our new brand – EVERSANA INTOUCH – and had celebrations across many of our offices to mark the occasion with some fun and cameraderie! The afternoons were full of food, drinks, activities, games, prizes, and connecting with coworkers. From workshops on creating floral arrangements, to cocktails, to personalized scents, we had some creative fun; a little healthy competition; and got to laugh and smile with colleague
Scienmag
JUNE 10, 2022
BIRMINGHAM, Ala. – A new study that analyzed protein levels in 2,002 primary tumors from 14 tissue-based cancer types identified 11 distinct molecular subtypes, providing systematic knowledge that greatly expands a searchable online database that has become a go-to platform for cancer data analysis by users worldwide. Credit: UAB BIRMINGHAM, Ala. – A new study […].
pharmaphorum
JUNE 10, 2022
Around 425,000 people in England and Wales with cardiovascular disease who are at risk of a secondary stroke or heart attack, could be eligible for treatment with Amarin’s Vazkepa, following a NICE recommendation. In draft guidance, the health technology assessment (HTA) organisation has recommended Vazkepa (icosapent ethyl) as a treatment option for adult patients with high-risk cardiovascular disease and elevated levels of triglycerides in their blood who are already taking statins.
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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.
Scienmag
JUNE 10, 2022
BIRMINGHAM, Ala. – All of the newly diagnosed glioblastoma multiforme patients enrolled in a Phase 1 clinical trial at the University of Alabama at Birmingham have exceeded both their median and expected progression-free survivals. Two patients, to date, have exceeded their expected overall survival. Glioblastoma multiforme is the most aggressive type of cancer originating in […].
Pharmaceutical Commerce
JUNE 10, 2022
Pharma supply chain management will be one of the earliest beneficiaries of the Fourth Industrial Revolution, and the potential of ‘networks of networks’.
Scienmag
JUNE 10, 2022
For years, scientists have warned that monarch butterflies are dying off in droves because of diminishing winter colonies. But new research from the University of Georgia shows that the summer population of monarchs has remained relatively stable over the past 25 years. Credit: U.S. Fish & Wildlife Service For years, scientists have warned that […].
Pharmaceutical Commerce
JUNE 10, 2022
The packaging and shipping of dangerous goods (DG) adds further challenges. to the distribution pressures brought about by the pandemic.
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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
JUNE 10, 2022
As the world’s appetite for carbon-based materials like graphite increases, Ohio University researchers presented evidence this week for a new carbon solid they named “amorphous graphite.” Credit: Ohio University As the world’s appetite for carbon-based materials like graphite increases, Ohio University researchers presented evidence this week for a new carbon solid they named “amorphous graphite.” […].
Pharmaceutical Commerce
JUNE 10, 2022
Click the title above for a link to open the Pharmaceutical Commerce June 2022 issue in an interactive PDF format.
Scienmag
JUNE 10, 2022
Extreme weather phenomena are on the rise worldwide, including frequent droughts and fires. Floods are also a clear consequence of climate change. For agriculture, a flooded field means major losses: about 15 percent of global crop losses are due to flooding. As part of a collaboration between Freiburg, Utrecht in the Netherlands, and other institutes, […].
Pharmaceutical Commerce
JUNE 10, 2022
Why ‘real-time-all-the-time’ supply chain operations are fundamental to biopharma success.
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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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