Mon.Dec 20, 2021

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Moderna vaccine weaker against omicron, but third shot boosts protection

Bio Pharma Dive

As a result of new laboratory data, the biotech company is deemphasizing more complex "multivalent" booster shots in favor of further study of its existing formulation and an omicron-specific version.

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Value-based healthcare can help reduce costs

World of DTC Marketing

According to the Kaiser Family Foundation (KFF), in 2021, the average cost of employee health insurance premiums for family coverage increased by 4% from the previous year to $22,221. The average annual premiums for an individual’s plan also increased 4% to $7,739 this year. Why haven’t more employers addressed the rising costs of employee healthcare with value-based care?

Drugs 209
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Bluebird hit with another hold for sickle cell gene therapy

Bio Pharma Dive

Study enrollment and treatment of sickle cell patients under 18 will be paused for safety reasons, another hurdle in a series of setbacks for the company.

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PDUFA VII: Implications for Developers of Cell and Gene Therapies

Camargo

One of the biopharmaceutical industry’s most closely watched forthcoming regulatory developments is the FDA’s imminent reauthorization of the Prescription Drug User Fee Act (PDUFA). PDUFA VII , as the reauthorization is commonly known, will cover the fiscal years 2023-2027. Many of the advancements included in PDUFA VII are driven in large part by an increase in the development of innovative products such as cell and gene therapies.

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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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FDA OKs drugs from Amgen, Argenx, Intra-Cellular in year-end push

Bio Pharma Dive

The flurry of decisions from the regulator clears for market Amgen and AstraZeneca's asthma treatment Tezspire, Argenx's rare disease drug Vyvgart and Intra-Cellular's Caplyta for bipolar depression.

Drugs 284
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Bias in artificial intelligence impacts drug development: AiCure

Outsourcing Pharma

According to an expert from the clinical insights company, prejudice in AI can impact patient outcomes as well as the ability to develop effective treatments.

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Watch: DHC Roundtable Discussion

Pharma Marketing Network

R.J. Lewis, Founder and CEO of eHealthcare Solutions and Tap Native and the Chief Collaborator at Pharma Marketing Network, moderated a deep dive discussion on the topic of physician-level data (PLD) with a focus around drivers for the tool, its usage, and successes learnings about its function in pharma, and the where it’s heading. Guests of the panel included experts from GSK, Ispen, BioPharm Communications, and CMI, who all spoke to the importance of incorporating and leveraging PLD ins

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Here’s What You Need to Know About Coca-Cola’s Recall

XTalks

Last Friday, The Coca-Cola Company issued a recall of some of its beverages because the affected products may contain pieces of metal bolts, washers or other foreign objects. First reported by Food Safety News , the recall includes 59-ounce refrigerated cartons of select Minute Maid drinks, including its Berry Punch, Strawberry Lemonade and Fruit Punch, along with 12-ounce cans of select Coca-Cola and Sprite products.

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Biogen takes axe to Aduhelm price in a bid to drive take-up

pharmaphorum

Biogen has cut the list price of its Alzheimer’s disease therapy in half from $56,000 to $28,200 a year, before the outcome of an ongoing reimbursement review of the drug by the US government. The price reduction for Aduhelm (aducanumab) comes into play from 1 January and comes on the back of the “feedback of our stakeholders,” said the biotech’s chief executive Michel Vounatsos. “Too many patients are not being offered the choice of Aduhelm due to financial conside

Drugs 97
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How Will the Food Trends in 2021 Shape the Future of Food Innovation?

XTalks

2021 has been a year affected by the pandemic, but unlike 2020, it was filled with innovation and news in the food industry. Some of the stories we covered at Xtalks revolve around plant-based foods, the future of agriculture and the various ways to save the planet by combating food waste. Xtalks spoke with experts from the food industry to discuss how their companies played a significant role in catering to these food trends.

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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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Positive CHMP opinion for finerenone as new treatment for chronic kidney disease and type 2 diabetes

Pharma Times

It is estimated that chronic kidney disease affects more than 160 million people with type 2 diabetes worldwide.

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WHO Grants Novavax’s COVID-19 Vaccine Covovax Emergency Use Listing

XTalks

The World Health Organization (WHO) has backed Novavax’s COVID-19 vaccine, Covovax (NVX-CoV2373), by granting it an emergency use listing (EUL). The company is awaiting on authorization of its vaccine from regulatory health bodies around the world, including the US Food and Drug Administration (FDA) and Health Canada. It has also applied for regulatory licensing in the UK, European Union (EU), Australia, Singapore, India, United Arab Emirates (UAE), New Zealand and Japan.

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PPPL unravels a puzzle to speed the development of fusion energy

Scienmag

Researchers at the U.S. Department of Energy’s (DOE) Princeton Plasma Physics Laboratory have developed an effective computational method to simulate the crazy-quilt movement of free electrons during experimental efforts to harness on Earth the fusion power that drives the sun and stars. The method cracks a complex equation that can enable improved control of the […].

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‘Reassuring’: Moderna booster increases antibodies against Omicron

BioPharma Reporter

A booster shot of Modernaâs COVID-19 vaccine increases neutralizing antibody levels against Omicron approximately 37-fold compared to pre-boost levels, according to data released by the company today.

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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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Desert shrubs cranked up water use efficiency to survive a megadrought. It may not be enough.

Scienmag

Shrubs in the desert Southwest have increased their water use efficiency at some of the highest rates ever observed to cope with a decades-long megadrought. That’s the finding of a new study from University of Utah researchers, who found that although the shrubs’ efficiency increases are unprecedented and heroic, they may not be enough to […].

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Xeris Biopharma’s glucagon injection becomes available in UK

Pharma Times

Tetris Pharma’s Ogluo is the first ready-to-use, pre-mixed and pre-measured glucagon injection.

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Light the E-beacon: Method may lead to faster, more accurate test for coronavirus

Scienmag

BINGHAMTON, N.Y. — You’re worried that you may have been exposed to the coronavirus, so you decide to take a test. But which do you choose? You can grab a rapid test at the local pharmacy and get your results in 15 minutes — but there’s a chance those results won’t be accurate. Or you […].

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Green light for Novavax COVID-19 vaccine in the EU

BioPharma Reporter

The European Commission has granted conditional marketing authorisation to Novavax for its COVID-19 vaccine: making it the first protein-based COVID-19 vaccine in the EU.

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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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Children’s Hospital Colorado first pediatric hospital to treat patients using 3D intracardiac echocardiography catheter

Scienmag

Children’s Hospital Colorado (Children’s Colorado) is the first pediatric hospital in the world to use a 3D intracardiac echocardiography (ICE) catheter in the treatment of congenital heart disease in the Cardiac Catheterization Lab. The live, 3D image guidance provided by the recently FDA-approved technology from Phillips allows cardiac interventionalists to better navigate complex procedures, which is […].

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Frontiers Health Digital Innovators: Aptar’s Sai Shankar

pharmaphorum

Continuing his Frontiers Health Digital Innovator’s series, pharmaphorum’s founder, Dr Paul Tunnah, speaks with president of Digital Health Sai Shankar. At Frontiers Health conference live in Milan , Sai discusses the history and broad reach of Aptar in the pharmaceutical space and its recent acquisition of Voluntis. Aptar continues to look for valuable partnerships to develop and expand its portfolio, and Sai relays the importance of synergies between digital health applications and Aptar

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Air bubbles in Antarctic ice point to cause of oxygen decline

Scienmag

HOUSTON – (Dec. 20, 2021) – An unknown culprit has been removing oxygen from our atmosphere for at least 800,000 years, and an analysis of air bubbles preserved in Antarctic ice for up to 1.5 million years has revealed the likely suspect. Credit: Photo courtesy of Yuzhen Yan HOUSTON – (Dec. 20, 2021) – An […].

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Aducanumab rejected in the EU: Biogen to ask EMA to re-examine application

BioPharma Reporter

Biogen will ask the European Medicines Agency (EMA) to re-examine its Alzheimerâs drug application, following the agencyâs recommendation to refuse authorization of the drug in the EU.

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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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Does Holiday Heart Syndrome, which affects the atria, extend to the ventricles?

Scienmag

Philadelphia, December 21, 2021 — The relationship between alcohol and atrial fibrillation has long been referred to as the Holiday Heart Syndrome. An extensive study of the relationship between total alcohol consumption and cardiovascular disease determined that this phenomenon is not associated with ventricular arrhythmias (VAs). It appears in Heart Rhythm, the official journal of […].

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Blow for Novartis as ligelizumab can’t top Xolair in phase 3

pharmaphorum

Novartis’ big-selling IgE inhibitor Xolair has been a mainstay of treatment for chronic spontaneous urticaria (CSU) for many years, but with biosimilars looming the company has been looking to follow-up ligelizumab to defend the franchise. That hope now look decidedly faint, as ligelizumab was able to match Xolair (omalizumab) but not improve on it in a pair of phase 3 trials in CSU, although it did perform better than placebo.

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Rise of alternative data could be a boon, not a bust, for hedge funds, says study

Scienmag

Toronto – Whether it’s satellite images or social media activity, alternative data has become hot property as hedge funds and other large asset managers hunt for new ways to gain a competitive edge in their trading strategies. Credit: Rotman School of Management Toronto – Whether it’s satellite images or social media activity, alternative data has […].

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Biogen Slashes Price of Alzheimer’s Drug Aduhelm, as It Faces Obstacles

NY Times

A group of Alzheimer’s experts and health advocates called on the F.D.A. to withdraw its approval of the drug, the latest of several setbacks for the treatment.

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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.

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News media amplified rather than rectified misleading health information from TV personality Dr. Oz

Scienmag

Consumers’ choices about health products are influenced heavily by public information. A new study analyzed how media outlets responded to the endorsement of weight-loss products by TV personality Dr. Oz. The study found that media tended to amplify rather than rectify misleading information, resulting in the further spread of misinformation. The authors call for government […].

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AstraZeneca and Amgen’s asthma biologic approved in the US

BioPharma Reporter

AstraZeneca and Amgenâs Tezspire (tezepelumab-ekko) has been approved in the US for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

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Changes in the brain hinder addiction recovery in people who are HIV-positive

Scienmag

Researchers with the Del Monte Institute for Neuroscience at the University of Rochester are studying how the brain puts the ‘brakes’ on behavior. That may be different in individuals recovering from cocaine addiction and who are also HIV-positive. “Scientists have long known that drug abuse can cause damage to the brain. We also know HIV […].

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Meal Delivery For A Busy CRA

ECRG Media's Clinical Research Podcast

Meal Delivery for a Busy CRA Don't forget to Subscribe for new content! Merch: [link] [link] eliteclinicalgroup@gmail.com Podcast: [link] [link] eliteclinicalgroup@gmail.com Watch: » Industry News: [link] All Videos: [link] Interview Recaps: [link] Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education Elite Clinical Research Group or ECRG for short is a content creating conglomera

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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.