Fri.Aug 28, 2020

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BioMarin's hemophilia gene therapy could have warranted a record price tag, ICER finds

Bio Pharma Dive

A draft report from the drug pricing watchdog concluded that, under the right conditions, Roctavian may be cost-effective at a price of $2.5 million.

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What Is the Difference Between Oxygen Generators and CPAP?

Pharma Mirror

A CPAP machine is a device that can replace or improve human breathing, increase lung ventilation, and improve respiratory function. It is generally used for lung failure or airway obstruction to breathing normally to help the patient complete the breathing process of inhalation and exhalation. It has a variety of breathing modes (various ways in. The post What Is the Difference Between Oxygen Generators and CPAP?

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CanSino said to seek early authorization of coronavirus vaccine

Bio Pharma Dive

The reported talks between CanSino and several countries highlight the urgency with which governments are operating to secure supply of experimental coronavirus vaccines.

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Two P.R. Experts at F.D.A. Have Been Ousted After Blood Plasma Fiasco

NY Times

The agency’s chief spokeswoman, Emily Miller, was removed from her position just 11 days into the job. And the contract was terminated of a consultant who had advised the F.D.A. chief to correct misleading claims about plasma’s benefits.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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New data from J&J, Arrowhead mark latest step in RNAi's hepatitis B race

Bio Pharma Dive

The Arrowhead drug, which J&J licensed in 2018, is one of four rival programs in clinical testing aiming for a 'functional cure' for chronic infections.

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The Blanc Mask for COVID-19 and Beyond: A New Generation of PPE

XTalks

To help address the continued need for personal protective equipment (PPE) in the current COVID-19 pandemic, a group of entrepreneurs and PPE specialists have developed a modular full-face mask called Blanc; it is being marketed by their new company that goes by the same name. Xtalks spoke to one of the co-founders of Blanc, Philipp Egorov, to learn more about the mask.

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Which Companies Will Dominate the Plant-Based Meat Market by 2030?

XTalks

The food industry will face its fair share of challenges over the next decade and it’s difficult to imagine what it will look like in 2030, according to a new report. In “ The Future of Food & Drink 2030 ,” a World Global Style Network report, the authors wrote that the food and beverage industry is resilient and “will always rise to the situation.” One of the ways it will do this is keeping up with the growing demand for plant-based protein alternatives.

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US approves Roche's new pan-tumour liquid biopsy test

Pharma Times

FoundationOne Liquid CDx analyses more than 300 cancer-related genes and multiple genomic signatures to help inform treatment decisions for all solid tumour cancers

Genome 83
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For the First Time, Researchers Find New Form of Brain Analysis that Engages the Whole Brain

XTalks

Scientists from Duke University found a new method of brain imaging analysis that engages the whole brain. This method could improve the effectiveness of non-invasive brain stimulation treatment for Alzheimer’s disease, obsessive compulsive disorder (OCD), depression and other neurological conditions. The method identifies brain areas that exert the most control on network function.

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Researchers find potential to make brain cancers in children respond better to treatment

Scienmag

Small molecule compound that can activate the Wnt pathway in non-Wnt subtypes of medulloblastoma identified Credit: Branavan Manoranjan Hamilton, ON (August 28, 2020) – Brain cancer in children is always a devastating diagnosis, but McMaster University researchers may have found a way to have the most serious types of pediatric brain cancer respond better to […].

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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COVID-19’s lasting impact on digital communication in healthcare

pharmaphorum

The ongoing digital transformation of the healthcare and pharmaceutical industries has been greatly accelerated during the coronavirus pandemic. In The Medscape Professional Networks’ latest white paper, Healthcare’s New Normal: COVID Speeds Shift to Digital Communications , key opinion leaders and industry experts agree that in the post-pandemic world, even as lockdowns are lifted and restrictions relaxed, the emerging trends for an increase in digital communications will stay.

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COVID-19 has inspired Britons to take better care of their health

Pharma Times

A survey by GSK Consumer Healthcare and Ipsos MORI also signals a shift towards self-education and reducing the burden on the NHS

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Amazon enters health wearables market with Halo service

pharmaphorum

Amazon has launched a fitness band, app and subscription service – called Halo – that promises to look after both your body and mind. The e-commerce giant’s entry into the health wearables market combines monitoring of physical data such as activity levels, sleep patterns and body fat with artificial intelligence (AI) algorithms that listen for the emotion in a user’s voice.

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New book on sport marriages details systemic subordination of women

Scienmag

CORVALLIS, Ore. — In a new book based on nearly 30 years of study, Oregon State University researcher Steven M. Ortiz delves into the marital realities facing women married to professional athletes, including infidelity, sexism and a significant power imbalance in their relationships. “The Sport Marriage: Women Who Make It Work,” from the University of […].

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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Predicting pandemics with unconventional digital tools

pharmaphorum

The world is awash with data, and while retailers and TV subscription services have perfected the art of collection and curation, public health has been trailing behind. But the advent of COVID-19 is proving to be something of a coming of age for digital epidemiology, which has been putting data from disparate sources to global use for the last 15 years.

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New malaria transmission patterns emerge in Africa

Scienmag

An international study reveals how future climate change could affect malaria transmission in Africa over the next century. Malaria is a climate sensitive disease; it thrives where it is warm and wet enough to provide surface water suitable for breeding by the mosquitoes that transmit it. For more than two decades now, scientists have suggested […].

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Coronavirus: Winter plans revealed in leaked Sage report

The Pharma Data

Image copyright. PA Media. A leaked government report suggests a “reasonable worst case scenario” of 85,000 deaths across the UK this winter due to Covid-19. The document also says while more restrictions could be re-introduced, schools would likely remain open. But it says the report “is a scenario, not a prediction” and the data are subject to “significant uncertainty” However some are critical of the modelling and say some of it is already out of date.

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Nurses burned out and want to quit

Scienmag

Sophia Antipolis, France – 28 Aug 2020: A survey of nurses caring for children with heart problems has revealed that more than half are emotionally exhausted. The analysis, presented today at ESC Congress 2020, also found that good working environments were linked with less burnout.1 “Nurses’ wellbeing is central to ensuring the best outcomes for […].

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The New Age of Decentralized Clinical Trials

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.

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Coronavirus: Children's role in spread puzzles scientists

The Pharma Data

Image copyright. Getty Images. Children can carry coronavirus in their noses for up to three weeks, according to a study from South Korea. Earlier studies have found the vast majority of children with the virus have mild or no symptoms. But these findings shed light on the unresolved question of how likely children are to spread the virus to others.

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Study finds that sleep restriction amplifies anger

Scienmag

DARIEN, IL – Feeling angry these days? New research suggests that a good night of sleep may be just what you need. This program of research comprised an analysis of diaries and lab experiments. The researchers analyzed daily diary entries from 202 college students, who tracked their sleep, daily stressors, and anger over one month. […].

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Korea approves Celltrion’s Phase 1 trial of COVID-19 antiviral antibody treatment

The Pharma Data

U.S. Air Force photo by Staff Sgt. Omari Bernard. Celltrion Group has announced that the Korean Ministry of Food and Drug Safety has approved the company’s Investigational New Drug application for a Phase 1 trial for their coronavirus antiviral antibody treatment candidate. Celltrion has already begun trials of the treatment, called CT-P59, in July following their clinical trial authorisation application from the UK’s Medicines and Healthcare products Regulatory Agency.

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Experiment contradicts assumptions about sleep loss and criminal interrogations

Scienmag

DARIEN, IL – An experimental study suggests that sleep restriction may hinder information disclosure during criminal interviews, contradicting widespread assumptions about the effectiveness of sleep deprivation as an interrogation tool. Preliminary results show that even mildly sleep-restricted participants provided around 7% less information during their initial disclosure.

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Accelerating Clinical Supply Through Integrated Drug Development

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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First clinical trial for MDMA and LSD combination set to go ahead

The Pharma Data

Coaster420. Researchers are set to investigate a combined dose of LSD and MDMA to treat patients undergoing psychotherapy. The Phase 1 trial will be conducted by MindMed later this year and will be the first to investigate what happens when you mix the two drugs to work as a therapy. The study will assess 24 subjects who will undergo four different experimental sessions which will see the patients either being dosed with 100 micrograms of LSD mixed with a placebo, 100 milligrams of MDMA with a p

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Canada renews support for UN University Institute in Hamilton addressing world water issues: $10M

Scienmag

Research organization is at forefront of pressing global water challenges; New funding coincides with World Water Week and UN’s 75th anniversary UNU-INWEH works to bridge the gap between the wealth of evidence and research that exists on water resources, and the practical needs of political leaders and decision makers, particularly those… view more HAMILTON – Canada […].

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US approves Roche's new pan-tumour liquid biopsy test

The Pharma Data

FoundationOne Liquid CDx analyses more than 300 cancer-related genes and multiple genomic signatures to help inform treatment decisions for all solid tumour cancers. US regulators have approved Roche’s new pan-tumour liquid biopsy test for patients with solid tumours, offering a potentially more convenient option and an alternative for patients unable to have tissue biopsy.

Genome 52
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Natural disasters must be unusual or deadly to prompt local climate policy change

Scienmag

Credit: Oregon State University CORVALLIS, Ore. — Natural disasters alone are not enough to motivate local communities to engage in climate change mitigation or adaptation, a new study from Oregon State University found. Rather, policy change in response to extreme weather events appears to depend on a combination of factors, including fatalities, sustained media coverage, […].

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How Machine Learning Drives Clinical Trial Efficiency

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.

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COVID-19 has inspired Britons to take better care of their health

The Pharma Data

A survey by GSK Consumer Healthcare and Ipsos MORI also signals a shift towards self-education and reducing the burden on the NHS. Britons are increasingly self-educating and acting to boost their everyday health, from visiting pharmacists instead of the GP to staying at home when ill to avoid transmission, indicates new research from GSK Consumer Healthcare and Ipsos MORI.

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Announcing the 2020 British Ecological Society award winners

Scienmag

Credit: British Ecological Society The British Ecological Society (BES) announced today the winners of its annual awards and prizes, recognising eleven distinguished ecologists whose work has benefited the scientific community and society in general. This year, honorary membership, the highest honour given by the society, has been awarded to three distinguished ecologists: Mike Begon, Sandra […].

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Top Ten most popular articles on Pharmafile.com this week

The Pharma Data

The top 10 news stories this week are focused on coronavirus vaccines and treatments, as China is set to move ahead with human testing of a potential vaccine that has been created using insect cells, while AstraZeneca has started a clinical trial of its antibody treatment designed to prevent and also treat symptoms of coronavirus. In other news, the FDA has approved a request from American Gene Technologies to begin a clinical study of its HIV gene therapy and a 75-year-old woman from Nottingham

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NASA-NOAA satellite nighttime imagery tracks Tropical Depression Laura over US

Scienmag

Credit: NASA Worldview, Earth Observing System Data and Information System (EOSDIS) A new animation of nighttime imagery from NASA-NOAA’s Suomi NPP satellite followed the path of former Hurricane Laura from its landfall in southwestern Louisiana to its movement over the Mississippi Valley. As Laura tracks across the eastern U.S., it is generating heavy rain and […].

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.