Tue.Feb 22, 2022

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Copay accumulators, maximizers and the CMS best price rule: What you need to know now

Bio Pharma Dive

Copay accumulators, maximizers and best price concerns dominated the copay assistance landscape in 2021. Here is an update on the most prominent developments in this area over the last six months.

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Could Facebook monitoring predict sudden epilepsy death?

pharmaphorum

A study has suggested people with epilepsy may show patterns of activity and behaviour on social media that could serve as an early warning signal for sudden death – a rare but much feared complication of the disease. The study was carried out in six individuals who suffered sudden unexpected death in epilepsy (SUDEP), with the researchers analysing hundreds of Facebook posts for each subject in the six months leading up to their death, with the consent of surviving family members.

Genetics 113
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AstraZeneca, Daiichi press rivals with new results for breast cancer drug

Bio Pharma Dive

Positive study results for the companies' drug Enhertu in patients whose only remaining option is chemo could open up a new treatment use, pressuring competitors Roche and SeaGen.

Drugs 269
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NHS gene testing missing half of people at cancer risk

pharmaphorum

A study has revealed that current NHS guidelines on testing for genetic alterations linked to cancer could be missing around half of people carrying them, says a new study. The work by scientists at the Institute for Cancer Research (ICR) suggests that access to genetic testing should be made easier because the guidelines as drawn up “would have excluded many people who had ‘actionable’ genetic alterations that could raise their risk of cancer.” Cancer is not usually inhe

Gene 104
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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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Meso Scale Discovery (MSD): An immunoassay platform with varied applications in the biopharmaceutical industry

Bio Pharma Dive

Learn how MSD is a one stop immunoassay platform that could be a time- and cost-effective alternative to the regularly used bio-molecule detection technologies in the laboratory.

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Bia Care starts NHS trial of its digital menopause platform

pharmaphorum

A virtual menopause clinic service developed by Bia Care is starting a randomised clinical trial within the NHS that will not only test how well it performs, but also attempt to tackle inequalities in women’s health. The trial has been announced shortly after Bia Care was awarded additional funding from the NHS to extend the rollout of its digital platform, which helps women book an appointment, have a group online consultation with a doctor, get a personalised plan for managing menopause

Trials 103

More Trending

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Solving Regulatory Challenges: CSV for Cloud-based Clinical Applications

Cloudbyz

A comprehensive session exploring the regulatory challenges for clinical application. Rajendra Sadare, Head – Quality & Compliance from Cloudbyz goes deeper to explain the challenges, the expectation and the possible solutions.

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PANORAMIC view of World’s largest COVID study

Pharma Times

Study involving 10,000 patients will investigate a range of potentially ground-breaking oral antivirals

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Children eat what they like, but food intake driven more by what they dislike

Scienmag

It is often said that “children eat what they like,” but the results of a new study by Penn State nutritionists and sensory scientists suggests that when it comes to meals, it is more accurate and more relevant to say, “children do not eat what they dislike.” Credit: Penn State It is often said that […].

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Your roadmap to getting the most out of meetings

pharmaphorum

Oliver Stohlmann’s Corporate Survival Hacks series draws on his experiences of working in local, regional and global life science communications to offer some little tips for enjoying a big business career. In this post he reinforces good meeting practices to ensure productivity, avoid waste of time and resources and empower everyone to meet the desired business outcomes.

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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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Scientists identify neural disruptions underlying feeding, swallowing disorders in children

Scienmag

Every time you chew, talk, yawn, or sense the zap of a toothache, cranial nerve cells are shuttling electrochemical signals to your brain. Some of these neurons detect pain, while others sense facial muscle movements or sensations in the skin. Credit: Image courtesy of Anthony LaMantia lab. Every time you chew, talk, yawn, or sense […].

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4D Pharma to trial LBPs in patients with Parkinson’s disease: ‘We are continuing to expand clinical pathways for the microbiome field’

BioPharma Reporter

4D Pharma says the US Food and Drug Administration (FDA) has cleared its IND application for the first in-human trial to use Live Biotherapeutics (LBPs) for the treatment of Parkinsonâs disease.

Trials 77
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A revolution in learning

Scienmag

To understand a country, it helps to know its schools. To grasp Mexico, MIT historian Tanalís Padilla believes, that means learning about its rural “normales,” teacher-training schools with outsized historical influence on the country’s politics. Credit: Image: Photo by Bryce Vickmark To understand a country, it helps to know its schools. To grasp Mexico, MIT […].

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Are We Moving On From Covid?

Eye on FDA

Mask mandates are dropping like flies. Restrictions are being lowered. In my observation, it feels that they are going to the wayside not only because of dropping caseloads, but also because people are just more than ready to move on. There may be some complacence – a feeling that the ubiquitous Omicron has fostered a feeling of inevitability about exposure and eventual infection.

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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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City of Hope awarded $4.9 million from CIRM to train future leaders in stem cell biology and regenerative medicine

Scienmag

LOS ANGELES — City of Hope, one of the largest cancer research and treatment organizations in the United States and a leading research center for diabetes and other life-threatening illnesses, today announced that its Department of Stem Cell Biology and Regenerative Medicine received a $4.9 million grant to train the next generation of scientific leaders […].

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Available for Preorder: The 2022 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

Drug Channels

On March 15, 2022, Drug Channels Institute will release The 2022 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers. This report—our thirteenth edition—remains the most comprehensive, fact-based tool for understanding the entire U.S. drug pricing, reimbursement, and dispensing system. 12 chapters, 430+ pages, 216 exhibits, 800+ endnotes: There is nothing else available that comes close to this report.

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Evidence for exotic magnetic phase of matter

Scienmag

UPTON, NY—Scientists at the U.S. Department of Energy’s Brookhaven National Laboratory have discovered a long-predicted magnetic state of matter called an “antiferromagnetic excitonic insulator.” Credit: Various sources including *DESY, Marta Mayer. UPTON, NY—Scientists at the U.S. Department of Energy’s Brookhaven National Laboratory have discovered a long-predicted magnetic state of matter called an “antiferromagnetic excitonic insulator.” […].

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FDA expands use of Abbott’s heart sensor with new approval

pharmaphorum

The FDA has approved expanded labelling for Abbott’s CardioMEMS HF System, an implantable sensor that provides an early warning of worsening heart failure, that could make it an option for more than a million more patients. The new approval makes the CardioMEMS device – which was first approved in the US in 2014 – an option for earlier-stage patients, specifically those with New York Heart Association class II heart failure and a blood test that shows elevated levels of the biomarker natri

Doctors 62
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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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Vietnam English language assessment research to ensure fairness and inclusivity

Scienmag

FAIRNESS and inclusivity throughout Vietnam’s urban and rural regions in terms of their English language assessment practices is being brought to the fore following an international research collaboration, funded by the British Council, between the University of Huddersfield and one of Vietnam’s leading higher educational institutions. Credit: University of Huddersfield FAIRNESS and inclusivity throughout Vietnam’s urban […].

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Synairgen slumps as inhaled COVID drug fails pivotal test

pharmaphorum

UK biotech Synairgen saw the value of its shares crater after its inhaled interferon beta therapy SNG001 was found to provide no benefit to people hospitalised with COVID-19. The drug – originally developed for asthma – missed both primary and secondary efficacy measures in the 623-patient SPRINTER trial , including a failure to reduce the time it took for patients to be discharged from hospital or recover from COVID-19 compared to placebo.

Drugs 57
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First-of-its-kind live imaging leads to major discovery in how cells pattern in tissues

Scienmag

The ability of cells to self-organize into specific patterns in tissues that serve a function is a universal feature of life. The stripes of a zebra, our eyelashes, the spiral of seeds in a sunflower and the maze patterns of snakeskins are just a few examples. Credit: Northwestern University The ability of cells to self-organize into specific patterns in tissues that […].

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Valneva revives Scottish vaccine manufacturing plans

BioPharma Reporter

Valneva has been awarded up to Â20m ($27m) in R&D funding from Scottish Enterprise: which will be used to revive its plans to increase vaccine manufacturing in Scotland.

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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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Malware research will create more secure online environment

Scienmag

A University of Texas at Arlington computer scientist is using a three-year grant worth nearly $500,000 from the National Science Foundation to create virtual “sandbox” environments that allow computer security professionals to analyze Android malware without being detected by the code or its creators. Credit: UT Arlington A University of Texas at Arlington computer scientist […].

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AMGEN ISSUES INAUGURAL GREEN BOND TO ADVANCE ESG GOALS

The Pharma Data

Amgen (NASDAQ:AMGN) today announced the issuance of its inaugural $750 million green bond, with a 3.000% semi-annual coupon and maturing in 2029, to advance the environmental goals that are part of Amgen’s environmental, social and governance (ESG) framework. The green bond is part of a $4 billion underwritten public offering of senior notes that were issued on February 22, 2022 and the use of proceeds from the green bond is aligned with the Company’s Green Financing Framework.

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Smoking before and after conception is linked to delayed embryonic development

Scienmag

Smoking by mothers during the period immediately before and after conception is linked to a delay in embryonic development, smaller foetuses at the time of the 20-week ultrasound scan, and lower birth weight. Credit: Dr Anton Koning Smoking by mothers during the period immediately before and after conception is linked to a delay in embryonic […].

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Lilly Announces the Institute for Genetic Medicine and $700 Million investment in Boston Seaport Site

The Pharma Data

State-of-the-art facility will headquarter research efforts in Boston and New York to accelerate the development of RNA and DNA-based medicines. Eli Lilly and Company (NYSE: LLY) today announced the launch of the Lilly Institute for Genetic Medicine and an investment of approximately $700 million to establish a state-of-the-art facility at a new site in the Boston Seaport.

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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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Existing water quality guidelines fail to protect lake ecosystems

Scienmag

Irvine, Calif., Feb. 22, 2022 – In a new paper, an international team of researchers have established that water quality guidelines in North America and Europe do not protect lakes from human-induced salinization, which can have a negative impact on the abundance of freshwater organisms and lake food webs. The increase in salinity of lakes […].

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Sanofi’s Board of Directors proposes the appointment of Carole Ferrand, Emile Voest and Antoine Yver as independent Directors

The Pharma Data

At its meeting on February 22, 2022, Sanofi’s Board of Directors has decided to propose, on the occasion of its next General Shareholder Meeting to be held on May 3, 2022, the renewal of the mandates of Paul Hudson, Christophe Babule, Patrick Kron and Gilles Schnepp and the appointment of Carole Ferrand, Emile Voest and Antoine Yver as independent Directors.

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WashU engineering faculty, alumna named AIMBE fellows

Scienmag

Three faculty members and one alumna of the McKelvey School of Engineering at Washington University in St. Louis have been named fellows of the American Institute for Medical and Biological Engineering (AIMBE). According to AIMBE, its College of Fellows is limited to the top 2% of medical and biological engineers and comprises those who are […].

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New Drug Application to U.S. FDA for cariprazine (VRAYLAR®) for the Adjunctive Treatment of Major Depressive Disorder

The Pharma Data

– Submission is based on clinical trial results that include findings showing clinically and statistically significant improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score in patients with major depressive disorder (MDD) treated with cariprazine (VRAYLAR®) and an antidepressant – If approved, this milestone will be the fourth indication for cariprazine (VRAYLAR®) joining approvals for the treatment of adults with schizophrenia, the acute treatment of manic

Drugs 52
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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.