Sat.Oct 17, 2020 - Fri.Oct 23, 2020

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CRISPR Therapeutics reports remissions, one death in cancer cell therapy study

Bio Pharma Dive

The biotech is one of several attempting to develop "off-the-shelf "CAR-T therapies. While trial results show potential, high-dose treatment was paused following a patient's death.

Trials 334
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10 Trends for online health seekers

World of DTC Marketing

IN SUMMARY: Online health seekers are using the Internet differently since the pandemic. Treatment options are researched more, and people are using, but not relying, on social media to gather information on what’s best for THEM. I’ve spent the last three months gathering information on how online health seekers are using the Internet. My research points were Google, Twitter, and various websites that provide metrics on a variety of topics.

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Using Behavioral Science in A Digital World

Pharma Mirror

By Rotem Shor, Medisafe Chief Technology Officer Technology and health have experienced a convergence in the last few years, leading to a new state of digital health that is transforming how we live and work. But there is a greater science behind it that analyzes tremendous amounts of data to shape and personalize our health. The post Using Behavioral Science in A Digital World appeared first on Pharma Mirror Magazine.

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IBM and Pfizer Believe Machine Learning Can Predict Alzheimer’s Risk

BioSpace

Researchers with Pfizer and IBM developed an artificial intelligence (AI) model that they claim can predict eventual onset of Alzheimer’s disease with 71% accuracy based on a language sample. They published the research today in The Lancet eClinicalMedicine.

Research 143
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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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Biogen is running out of safety nets

Bio Pharma Dive

Third quarter earnings underscore just how vital it is that Biogen secure approval of its experimental Alzheimer's drug, given the challenges elsewhere in its business.

Drugs 337
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Pharma still doesn’t understand transparency

World of DTC Marketing

As development towards a COVID-19 vaccine continue so do the number of people who have said they won’t get vaccinated. The only way to get people on board with a vaccination is complete transparency about the product yet both J&J and Pfizer remain silent. Pausing clinical trials for any drug is normal when a participant gets sick. There has to be a complete investigation as to why the patient suffered ill effects including the possibility that he/she had a known or unknown health condi

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Vanquishing COVID-19 by Decreasing Viral Inoculum

BioSpace

Dr. Monica Gandhi, MD, an infectious diseases doctor and professor of medicine at UC San Francisco, poses the hypothesis that masks and other social distancing measures may reduce the viral inoculum – or amount – of the SARS-CoV-2 we contract.

Doctors 134
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Gilead's Veklury becomes first FDA-approved drug for COVID-19

Bio Pharma Dive

The U.S. regulator granted a full approval after allowing emergency use earlier this year. New results from an WHO study, however, raise questions about the drug's ultimate effectiveness.

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Pharma managers too far removed from patients

World of DTC Marketing

As people move up the pharma ladder, their work often revolves around internal management issues, training, and endless meetings to motivate their employees rather than focus on patients. Pharma likes to believe its own propaganda that everything they do is patient-focused, but that’s a canard. Pharma’s own internal processes and endless meetings are slowly draining the life out of employees and lead to a culture where people are promoted to navigate the system rather than help peopl

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Toxic positivity and grief: The reality of living through cancer

pharmaphorum

Cancer doesn’t end when treatment stops – it’s a lifelong journey and people need support throughout, says patient advocate Megan-Claire Chase. No one gets through cancer unscathed. People are usually left with a mixture of treatment aftereffects, toxic positivity, and lingering anger to deal with. Megan-Claire Chase , a fierce patient advocate who has been blogging about her experiences since she was diagnosed with breast cancer in 2015, said the disease never went away.

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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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What cold lizards in Miami can tell us about climate change resilience

Scienmag

Credit: Photo courtesy Day’s Edge Productions It was raining iguanas on a sunny morning. Biologist James Stroud’s phone started buzzing early on Jan. 22. A friend who was bicycling to work past the white sands and palm tree edges of Key Biscayne, an island town south of Miami, sent Stroud a picture of a 2-foot […].

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Roche joins the COVID-19 antiviral drug race, betting $350M on a startup

Bio Pharma Dive

A deal with Atea Pharmaceuticals gives Roche rights to an oral antiviral for coronavirus disease that would compete with emerging therapies from Pfizer and Merck.

Drugs 336
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Projections on pharma digital ad spending wrong

World of DTC Marketing

GOOD MORNING: eMarketer is promoting a report on pharma’s projected digital ad spending in the coming year, and from my conversations with pharma insiders, it’s wrong. There will be an investment in new digital platforms but display and search spending, I believe, are going to decline. There is no doubt that more people are turning to the Internet to help sort through the conflicting health information but that does not translate into more online ads.

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How real human experiences can power a healthier future

pharmaphorum

As part of our series of opinion pieces from leaders at Janssen, the company’s Maria Raad looks at how we can embrace tech and data science to overcome increasing pressures on healthcare systems. For the next generation born in the western world, living to be 100 will be the norm. While this seems like a desirable aspiration for our grandchildren, it adds new pressures on our healthcare systems.

Big Data 128
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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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Moderna Fully Enrolls 30,000-Person COVID-19 Vaccine Trial, Boosts Minority Participation

BioSpace

Moderna has fully enrolled its late-stage coronavirus disease 2019 (COVID-19) vaccine trial by hitting its target of 30,000 participants. More than one-third of this cohort includes minority participants.

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Sarepta, continuing its gene therapy push, helps launch a startup

Bio Pharma Dive

The biotech has joined a group of investors to form a new gene therapy developer led by one of its longtime executives and backed with $107 million.

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Fats fighting back against bacteria

Scienmag

Droplets of fat inside our cells are helping the body’s own defence system fight back against infection, University of Queensland researchers have discovered. Credit: Institute for Molecular Bioscience, University of Queensland Droplets of fat inside our cells are helping the body’s own defence system fight back against infection, University of Queensland researchers have discovered.

Bacteria 123
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Novartis launches digital health hub in Canada

pharmaphorum

Novartis is opening a new digital health innovation hub in Canada to help develop “scalable, digital solutions” for patients and healthcare providers. The Canadian Biome Digital Innovation Hub will be based in Montreal at the artificial intelligence research institute, Mila. The institute formed a strategic alliance with Novartis in 2019. Canada is the latest country to join a global network of hubs opened by Novartis.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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FDA Grants Full Approval to Remdesivir for COVID-19

BioSpace

Shares of Gilead Sciences are jumping in aftermarket trading following full approval for Veklury (remdesivir) as a treatment for COVID-19. The approval marks the first drug approved by the U.S. Food and Drug Administration as a treatment for the novel coronavirus.

Drugs 117
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Ex-Medivation team nets $500M to take their new cancer drugmaker to Wall Street

Bio Pharma Dive

Nuvation Bio, a large oncology startup run by former Medivation executives, is capitalizing on a boom in mergers with so-called special purpose acquisition company, or SPACs.

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CBD helps reduce lung damage from COVID by increasing levels of protective peptide

Scienmag

Credit: Kim Ratliff, Production Coordinator, Augusta University One way CBD appears to reduce the “cytokine storm” that damages the lungs and kills many patients with COVID-19 is by enabling an increase in levels of a natural peptide called apelin, which is known to reduce inflammation and whose levels are dramatically reduced in the face of […].

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Kite cues up first EMA okay for mantle cell lymphoma CAR-T

pharmaphorum

Gilead Sciences’ Kite Pharma unit is closing on approval of its second European approval for a CAR-T for cancer, after the CHMP backed its Tecartus therapy for mantle cell lymphoma. The EMA’s human drugs advisory committee recommended approval of Tecartus (brexucabtagene autoleucel; formerly KTE-X19 ) for relapsed or refractory MCL setting up a formal approval by the regulator in the coming weeks.

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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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RA Capital Closes $461 Million Investment Fund Aimed at Life Sciences Companies

BioSpace

The new fund, RA Capital Nexus Fund II, will serve as a companion fund to RA’s Nexus I fund, which closed last year with approximately $300 million in capital.

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Facing vaccine doubts, US grapples with building confidence in coronavirus shots

Bio Pharma Dive

The CDC, for example, doesn't support vaccine mandates for healthcare workers or essential employees, an agency official told experts convened by the FDA Thursday.

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WHO: remdesivir shows little effect on COVID-19

Outsourcing Pharma

The agencyâs Solidarity Therapeutics Trial examined a range of drugs repurposed for COVID-19 treatment, finding nearly no effect on patient mortality.

Trials 128
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How COVID-19 Popularized Contactless Food Delivery

XTalks

COVID-19 has given rise to a slew of new terms, namely “social distancing,” and drastically changed the context of wearing a mask and standing six feet away from others. But in the food and beverage industry, the rise of the term “contactless delivery” cannot be understated. To stay in business during the pandemic, foodservice enterprises — including fast-food chains, dine-in restaurants and grocery stores — have turned to take out and delivery to generate income.

Engineer 111
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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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Moderna CEO Says COVID-19 Vaccine Could Get Emergency Approval in December

BioSpace

Stephane Bancel, chief executive officer of Moderna, told analysts and journalists at a Wall Street Journal’s Tech Live event on Monday that the FDA requires enough safety and efficacy data, and he believes that they will have that in the later part of November.

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Moderna enrolls final volunteers into key coronavirus study

Bio Pharma Dive

Recruiting 30,000 participants for the late-stage trial took Moderna just three months, even after the company slowed enrollment to boost participation of people of color.

Trials 303
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HCP > MD: How Brands Can Help NPs and PAs Improve Healthcare

Intouch Solutions

Brands can help patients and physicians by building and strengthening their relationships with NPs and PAs. Engaging them helps the entire care team perform at a higher level. Learn how here! The post HCP > MD: How Brands Can Help NPs and PAs Improve Healthcare appeared first on Intouch Solutions.

Branding 111
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Coastal permafrost more susceptible to climate change than previously thought

Scienmag

Credit: Bayani Cardenas If you flew from the sea towards the land in the north slope of Alaska, you would cross from the water, over a narrow beach, and then to the tundra. From the air, that tundra would look like a landscape of room-sized polygonal shapes. Those shapes are the surface manifestations of the […].

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.