Scienmag
JULY 18, 2021
NIA grant will fund user-centered design to create and test Helping the Helpers app Credit: Regenstrief Institute INDIANAPOLIS — Most of the six million people in the U.S. who live with Alzheimer’s disease and related dementias rely on informal caregivers, usually family or friends, to help manage their medications. Researchers from Regenstrief Institute, Indiana University […].
BioSpace
JULY 18, 2021
Genentech’s Hemlibra showed no new safety signals and continued to deliver consistent bleeding control in the final analysis of a long-term, late-stage hemophilia A study.
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Scienmag
JULY 18, 2021
The Oncotarget authors found that AIM2 inflammasome is at the crossroad between COPD and lung cancer in that its higher presence is correlated to lower survival rate of smoking COPD adenocarcinoma patients Credit: Correspondence to – Rosalinda Sorrentino – rsorrentino@unisa.it Oncotarget published “Caspase-11 and AIM2 inflammasome are involved in smoking-induced COPD and lung adenocarcinoma” which […].
Pharma Times
JULY 18, 2021
Healthcare providers will offer the flu vaccine to over 35 million people from September 2021
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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
JULY 18, 2021
Credit: ESO / L. Calçada New models of neutron stars show that their tallest mountains may be only fractions of millimetres high, due to the huge gravity on the ultra-dense objects. The research is presented today at the National Astronomy Meeting 2021. Neutron stars are some of the densest objects in the Universe: they weigh about as […].
Pharma Times
JULY 18, 2021
Studies showed immunosuppression appeared to weaken immune responses to COVID-19 vaccines
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
JULY 18, 2021
?Frontier Medicines will support the continued development of the company’s chemoproteomics drug discovery program, including lead asset, an inhibitor of KRASG12C.
Scienmag
JULY 18, 2021
These Oncotarget results show that a degree of chemotherapeutic drug effects on biomechanical and biophysical properties of cancer cells is distinguishable in normoxia and hypoxia` Credit: Correspondence to – Yongki Choi – yongki.choi@ndsu.edu Oncotarget published “Dynamic cellular biomechanics in responses to chemotherapeutic drug in hypoxia probed by atomic force spectroscopy” which reported that by exploiting […].
BioSpace
JULY 18, 2021
The CDC Advisory Committee on Immunization Practices is planning a meeting in October to recommend the vaccine’s use in adults.
Scienmag
JULY 18, 2021
New study in the Journal of the Academy of Nutrition and Dietetics indicates interventions of specific relevance to COVID-19, including expanded food assistance services, are needed to improve the accessibility of healthy food for young adults Credit: Journal of the Academy of Nutrition and Dietetics Philadelphia, July 19, 2021 – University of Minnesota School of […].
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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
BioSpace
JULY 18, 2021
The firm would be moving forward to Phase III for the treatment of hypertrophic cardiomyopathy, which is expected to commence before the end of 2021.
Scienmag
JULY 18, 2021
Together these Oncotarget results describe the first ever CAC case with a BRCAness genetic background Credit: Correspondence to – Juha K. Rantala – rantala@misvik.com Oncotarget published “Ex vivo analysis of DNA repair targeting in extreme rare cutaneous apocrine sweat gland carcinoma” which reported a rare metastatic case with a PALB2 aberration identified previously as a […].
BioSpace
JULY 18, 2021
There are two PDUFA dates on the U.S. Food and Drug Administration’s calendar for this week. Here’s a look.
Scienmag
JULY 18, 2021
WHAT: In a perspective published in Neuropsychopharmacology, leaders from the National Institutes of Health address how using appropriate language to describe mental illness and addiction can help to reduce stigma and improve how people with these conditions are treated in health care settings and throughout society. The authors define stigma as negative attitudes toward people […].
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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.
BioSpace
JULY 18, 2021
BioNTech indicates the acquisition will add production capacity in support of U.S. clinical trials.
Scienmag
JULY 18, 2021
The climate crisis will lead to changes in distribution and habitat loss of stony corals in the tropical Atlantic, shows a new study published by the open access publisher Frontiers. The loss of such coral species could have devastating consequences for the marine ecosystems they inhabit. The results of the study highlight an urgent need […].
BioSpace
JULY 18, 2021
With these latest results, AB Science has further established the sweet spot for masitinib in ALS.
JAMA Internal Medicine
JULY 18, 2021
This cohort study investigates the association between time spent cycling and all-cause and cardiovascular disease mortality among persons with diabetes.
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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.
BioSpace
JULY 18, 2021
It was a moderately busy mid-summer week for clinical trial news. Here’s a look.
JAMA Internal Medicine
JULY 18, 2021
This cohort study assesses the association between consumption of common caffeinated products and the risk of arrhythmias using data from the UK Biobank.
BioSpace
JULY 18, 2021
With billions of dollars at stake in potential legal liabilities, the life sciences giant is exploring a possible solution – bankruptcy of a sort.
Scienmag
JULY 18, 2021
Researchers are using computer models to simulate COVID-19 infections on a cellular level – the basic structural level of the human body. The models allow for virtual trials of drugs and vaccines, opening the possibility of pre-assessment for drug and vaccine efficacy against the virus. The research team at the University of Waterloo includes Anita […].
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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
JULY 18, 2021
On Friday, the agency approved belumosudil as a new treatment option for anyone over 12 with cGVHD after two prior lines of therapy have failed.
The Pharma Data
JULY 18, 2021
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that the U.S. Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in January 2022.
BioTech 365
JULY 18, 2021
Special Needs Dentist Grand Prairie Dallas TX Updates Services Special Needs Dentist Grand Prairie Dallas TX Updates Services Disability Dental (+1-972-296-0101) have launched updated treatments for special needs patients in Grand Prairie, Arlington, Irving, Duncanville and the wider Dallas-Fort Worth … Continue reading →
The Pharma Data
JULY 18, 2021
Clinical Data Supporting Approval Demonstrated Non-Inferior Immune Responses for the Serotypes Shared with PCV13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). VAXNEUVANCE Elicited Superior Immune Responses for Serotypes 3, 22F and 33F Compared to PCV13, Which Are Major Causes of Disease. (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S.
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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.
Pharma in Brief
JULY 18, 2021
The Government of Canada has proposed a series of amendments to the Patent Rules intended to keep Canada compliant with its obligations under the Canada-United States-Mexico Agreement ( CUSMA ) and the Patent Cooperation Treaty ( PCT ). As part of the proposal, the Canada Gazette published a Regulatory Impact Analysis Statement on July 3, 2021, summarizing the changes and their anticipated impact.
JAMA Internal Medicine
JULY 18, 2021
I have measured out my life with coffee spoons…T.S. Eliot, The Love Song of J.
NY Times
JULY 18, 2021
Boosters may make it to market whether they are critical for vaccinated people or not.
Scienmag
JULY 18, 2021
To prepare for the next pandemic and provide a coordinated approach to vaccination across the country, Canada should create Canadian Immunization Services based on the Canadian Blood Services model, authors propose in CMAJ (Canadian Medical Association Journal). The authors, including a leading health policy and immunization expert, a blood system expert and a former federal […].
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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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