Fri.Oct 08, 2021

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Relay's targeted cancer drug could be safer than its competitors. Is it more effective?

Bio Pharma Dive

Initial study results for Relay's experimental treatment offer some support for the biotech's protein motion technology, but raise some questions, too.

Protein 359
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Fungus-derived cancer killing drug by Oxford University shows promise

Pharma Times

A chemotherapy drug, NUC-7738, which is derived from a Himalayan fungus has been found to have 40 times greater potency in killing cancer cells than its original parent compound.

Drugs 141
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Twin Health raises $140m for “digital twin” diabetes reversal app

pharmaphorum

The developer of a toolkit that promises to create a “digital twin” of individuals with chronic metabolic diseases like diabetes to help model the impact of lifestyle changes has secured $140 million in funding to develop the technology. US and India-based Twin Health says the Whole Body Digital Twin platform uses Internet of Things (IoT) sensors and self-reported data within an artificial intelligence-driven software platform to generate a virtual copy of a person’s unique met

Insulin 143
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Medtronic Expands Two Insulin Pump Recalls, Including One Over Cybersecurity Concerns

XTalks

Medtronic has expanded a Class I recall of remote controllers used with the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps over potential cybersecurity risks. The affected remote controller models are MMT-500 and MMT-503. The medtech giant has also expanded another Class I recall of the retainer rings on its 600 series insulin pumps.

Insulin 128
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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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Poolbeg Pharma launches AI programme with Eurofins Genomics

Pharma Times

London-based infectious disease pharmaceutical company, Poolbeg Pharma, has announced their deal with testing and support specialist, Eurofins Genomics, according to Proactive Investors.

Genome 110
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World Egg Day 2021: What’s New in Egg Innovation?

XTalks

Held each year on the second Friday in October, World Egg Day is meant to celebrate the significance of eggs as one of the world’s oldest sources of protein. This year’s theme , “Eggs for all: Nature’s Perfect Package,” highlights eggs’ versatility and benefits to people at every stage of life. First observed in 1996, this year’s World Egg Day marks its 25 th anniversary.

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Conducting Patient Access in an Evolving Market

Drug Channels

Today’s guest post comes from Bill Dupere, Practice Lead and VP of Market Access Solutions and Eric Willis, VP of Operations Hub and Reimbursement Services at TrialCard. Bill and Eric discuss the complexities of digital patient support program technologies and introduce TrialCard’s integrated suite of solutions. To learn more, please contact Trialcard at sales@trialcard.com or visit them in booth #416 at the upcoming Asembia Specialty Pharmacy Summit from October 26 to 29, 2021.

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Oncotarget: Scent test to screen for early-stage pancreatic cancer

Scienmag

Oncotarget published “Scent test using Caenorhabditis elegans to screen for early-stage pancreatic cancer” which reported that although early detection and diagnosis are indispensable for improving the prognosis of patients with pancreatic cancer, both have yet to be achieved. Except for pancreatic cancer, other cancers have already been screened through scent tests using animals or microorganisms, including […].

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Enzyvant Receives FDA Approval for RETHYMIC® (allogeneic processed thymus tissue-agdc), a One-Time Regenerative Tissue-Based Therapy for Pediatric Congenital Athymia

BioTech 365

Enzyvant Receives FDA Approval for RETHYMIC® (allogeneic processed thymus tissue-agdc), a One-Time Regenerative Tissue-Based Therapy for Pediatric Congenital Athymia Enzyvant Receives FDA Approval for RETHYMIC® (allogeneic processed thymus tissue-agdc), a One-Time Regenerative Tissue-Based Therapy for Pediatric Congenital Athymia RETHYMIC is … Continue reading →

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TTUHSC researcher investigates ways to enhance neurolysin activity in the brain

Scienmag

Ischemic stroke, the second leading cause of death worldwide, occurs when a vessel to the brain is blocked, reducing blood flow to the brain and depriving it of critical supplies of oxygen and nutrients. This process leads to the death of brain cells and leaves the patient with a sudden loss of certain body functions. […].

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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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Intouch Group Wins Silver In Large Healthcare Network Of The Year

Intouch Solutions

KANSAS CITY, MO (Oct. 8, 2021) Intouch Group, a full-service global agency network serving the pharmaceutical industry, was named the Large Healthcare Network of the Year, Silver, at the 2021 MM+M Awards. The award was announced during a live gala on Oct. 7 in New York City. “We are honored to be recognized by MM+M as the Silver Winner of Healthcare Network of the Year,” said Faruk Capan, CEO of Intouch Group. “I want to thank all of our clients and employees for continuing t

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Georgia Tech researcher earns $12 million NSF grant to establish atmospheric measurement network

Scienmag

Georgia Institute of Technology Professor Nga Lee “Sally” Ng has earned a $12 million grant from the National Science Foundation (NSF) Mid-Scale Research Infrastructure program to provide high time-resolution (every 1 to 15 minutes), long-term measurements of the properties of atmospheric particulates known as aerosols, which have significant effects on health and climate change.

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Intouch Celebrates Intouchers With Pep Rallies in 4 Cities

Intouch Solutions

If you’ve read or seen much about Intouch, you’ll know that along with our purpose statement, No Challenge Too Big to Cure , we have a set of guiding values, and one of them is Build Lasting Relationships. Since the pandemic, we’ve become experts at building and maintaining strong, lasting relationships with our colleagues and clients … virtually.

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A rare feat: Material protects against both biological and chemical threats

Scienmag

A Northwestern University research team has developed a versatile composite fabric that can deactivate both biological threats, such as the novel coronavirus that causes COVID-19, and chemical threats, such as those used in chemical warfare. A material that is effective against both classes of threats is rare. Credit: Northwestern University A Northwestern University research team […].

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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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Next Generation CAR-TCR Summit

pharmaphorum

The cell therapy field is showing no signs of slowing down, with huge investment and excitement around next generation products and their clinical validation in solid tumour indications. Formerly CAR-TCR Europe , the new and improved Next Generation CAR-TCR Therapies Summit is now the only industry-dedicated forum focused on the 2.0, next generation innovations in cell therapies.

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Biblical burning

Scienmag

Could the biblical description of the destruction of Sodom be explained by an exploding meteor? Credit: Rhett Butler/East Carolina University Could the biblical description of the destruction of Sodom be explained by an exploding meteor? A research team including East Carolina University’s Dr. Sid Mitra, professor of geological sciences, has presented evidence that a Middle […].

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FDA halts Allogene CAR-T trial after safety scare

pharmaphorum

A phase 1 trial of Allogene’s of-the-shelf CAR-T for lymphoma has been placed on hold by the FDA, after a “chromosomal abnormality” was seen in a patient receiving the cell therapy. Shares in the California biotech were hit hard after the news emerged, losing more than a third of their value as investors fretted that the finding could jeopardise development of the ‘off the shelf’ CAR-T, designed to be cheaper and easier to use than current therapies.

Trials 52
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nTIDE September 2021 Jobs Report: Job numbers surpass pre-pandemic levels for people with disabilities

Scienmag

East Hanover, NJ – October 8, 2021 – Job numbers improved for people with disabilities, whose engagement with the labor market surpassed their pre-COVID-19 pandemic levels, according to today’s National Trends in Disability Employment – Monthly Update (nTIDE), issued by Kessler Foundation and the University of New Hampshire’s Institute on Disability (UNH-IOD).

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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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Preparing for a pandemic starts with creating a mentally resilient society

pharmaphorum

Janssen UK & Ireland’s managing director Gaëtan Leblay discusses the importance of maintaining the spotlight on our mental health post-pandemic, and why we must hone our mental resilience for possible future health crises. Our day-to-day life now looks significantly different compared to two years ago – without question, the pandemic has affected us all.

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Study examines diversifying STEM research for underrepresented students

Scienmag

The social, economic, and health impacts of the COVID-19 pandemic have disproportionately affected underserved populations in the United States, including racially minoritized students, lower-income students, and females. These populations have also been historically underrepresented and underserved in the science, technology, engineering, and mathematics (STEM) fields.

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FDA panel backs Takeda’s CMV drug for transplant patients

pharmaphorum

Takeda is closing on a first FDA approval in the treatment of refractory cytomegalovirus (CMV) infections in organ transplant patients, after agency advisors voted unanimously in favour of its antiviral maribavir. Maribavir (TAK-620) should be approved for refractory CMV infections in people with solid organ transplants as well as haematopoietic stem cell transplants (HSCT), regardless of whether the CMV has been shown to have resistance to other drugs, said the advisory committee.

Drugs 52
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International refugees: From uncertain pasts to promising futures

Scienmag

A better knowledge of the Australian schooling system and a clear understanding of how parents can support their child’s education could ensure the academic success of thousands of refugee children, according to new research from University of South Australia. Credit: Shravan K Acharya, Unsplash A better knowledge of the Australian schooling system and a clear […].

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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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Consternation as NICE rejects Janssen MS drug Ponvory

pharmaphorum

NICE has delivered its first verdict on NHS funding of Janssen’s oral multiple sclerosis drug Ponvory, and it’s not good news for patients with the disease waiting for new treatment options. In a provisional decision, NICE has said Ponvory (ponesimod) should not be available routinely on the NHS in England and Wales for relapsing forms of MS with active disease, an indication approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) in August.

Drugs 52
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Sequencing the unknown made easy: Metaplatanus improves metagenome assembly

Scienmag

Metagenomics often involves sequencing DNA samples that can only be described as “tricky.” Such DNA shows high heterogeneity, which can cause interspecies misassemblies. These misassemblies threaten the very purpose of metagenome sequencing, which is to comprehensively study the gene pool, by generating multiple draft genomes in a given sample. This issue is further complicated by […].

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FDA Announces New Process for Requesting Release from Postmarketing Requirements (PMRs)

FDA Law Blog

By McKenzie E. Cato & Deborah L. Livornese — As surveyed in detail by our colleagues in an earlier blog post , FDA’s PDUFA VII goals letter , for fiscal years 2023-2027, is full of announcements and new agency initiatives. One of those announcements is a commitment to create a new process for reviewing sponsor-initiated requests for release from postmarketing requirements (PMRs).

Drugs 52
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Astrophysicists explain the origin of unusually heavy neutron star binaries

Scienmag

A new study showing how the explosion of a stripped massive star in a supernova can lead to the formation of a heavy neutron star or a light black hole resolves one of the most challenging puzzles to emerge from the detection of neutron star mergers by the gravitational wave observatories LIGO and Virgo. Credit: […].

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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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Don’t Rely On Protocol Deviation Logs To Assess Deviations As A Clinical Research Associate

Clinical Trial Gurus

It is a lazy habit and a disservice to the clinical research associate role to solely rely on the site’s protocol deviation log to discover any protocol deviations. Oftentimes, the site may be unaware of their deviations and this is why the clinical research associate role exists.

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Studies find mixed results from sage grouse hunting restrictions

Scienmag

A thorough review of the history of sage grouse hunting and populations across the Intermountain West shows that declines in the bird’s numbers have prompted significant reductions in hunting opportunities in recent decades — with mixed results for grouse populations. Credit: Jeff Beck A thorough review of the history of sage grouse hunting and populations […].

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Scopus BioPharma Announces Adjournment of Annual Meeting of Stockholders

BioTech 365

Scopus BioPharma Announces Adjournment of Annual Meeting of Stockholders Scopus BioPharma Announces Adjournment of Annual Meeting of Stockholders NEW YORK, Oct. 08, 2021 (GLOBE NEWSWIRE) — Scopus BioPharma Inc.

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NIST, collaborators develop sensitive new way of detecting transistor defects

Scienmag

Researchers at the National Institute of Standards and Technology (NIST) and collaborators have devised and tested a new, highly sensitive method of detecting and counting defects in transistors — a matter of urgent concern to the semiconductor industry as it develops new materials for next-generation devices. These defects limit transistor and circuit performance and can […].

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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.