Fri.Nov 19, 2021

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FDA, aiming to curb another COVID-19 surge, clears Pfizer, Moderna boosters for all adults

Bio Pharma Dive

The decision comes as at least 10 states have already begun opening up booster dose eligibility, with cases remaining at high levels across the country.

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Global pharma industry gathers at CPhI Worldwide 2021 as surge in partnering expected in 2022

Pharma Mirror

Amsterdam, CPhI Worldwide (9-11 November, 2021), which held its first in-person event since 2019, hosted the global pharma community at the Fiera Milano, Milan, welcoming exhibitors and attendees from 146 countries. This year’s smart event was a combination of a three-day live exhibition, and a month-long online event featuring both the latest market insights through live and on demand content sessions and of course networking opportunities.

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A worrisome safety signal slows Merck's HIV ambitions

Bio Pharma Dive

After a study raised safety concerns, Merck has paused development of one of its experimental drugs and will keep a close eye on another that's critical to its plans in HIV.

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Respira Labs’ wearable device listens for lung diseases

pharmaphorum

US company Respira Labs has developed a device worn on the chest that uses tiny speakers and microphones to project sound into the lungs and listen for signals that could indicate serious lung diseases. The Sylvee wearable uses an artificial intelligence (AI) algorithm to interpret sounds that may indicate trapped air in the lungs, which can be a sign of ill health, using acoustic resonance – similar to the way an ultrasound machine creates visual images.

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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 seeking more information in investigation of Aduhelm patient's death

Bio Pharma Dive

A new report from an RBC investment analyst suggested the Alzheimer's drug played a role, adding to questions around the treatment's safety.

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NICE reaches a deal with Roche on access to oral SMA drug Evrysdi

pharmaphorum

Roche’s oral treatment Evrysdi for the rare genetic disease spinal muscular atrophy (SMA) will be made available on the NHS in England, after NICE reached a three-year access agreement with the company. The cost-effectiveness agency had turned down Evrysdi (risdiplam) in draft guidance published in June, saying it was too expensive, but after negotiations with Roche has reached a deal that will make the drug available to around 1,500 people in England.

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F.D.A. Authorizes Coronavirus Booster Shots for All Adults

NY Times

If the C.D.C. agrees, adults who received a second shot of the Pfizer or Moderna vaccine at least six months ago could be eligible by this weekend.

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Cystic fibrosis faithfully modeled in a human Lung Airway Chip

Scienmag

Cystic fibrosis faithfully modeled in a human Lung Airway Chip Credit: Wyss Institute at Harvard University Cystic fibrosis faithfully modeled in a human Lung Airway Chip First microfluidic organ-on-a-chip preclinical model of the cystic fibrosis lung airway could help bring new and much needed drugs, and personalized medicine approaches to patients By Benjamin Boettner (BOSTON) […].

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MHRA authorises Vumerity for multiple sclerosis patients

Pharma Times

Vumerity is a next-generation oral fumarate treatment for adults with relapsing-remitting multiple sclerosis

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COVID-19 case severity: How genetic differences leave immune cells at a disadvantage

Scienmag

LA JOLLA, CA—New research shows how genetic variations linked to severe cases of COVID-19 affect our immune cells. Credit: La Jolla Institute for Immunology LA JOLLA, CA—New research shows how genetic variations linked to severe cases of COVID-19 affect our immune cells. The study, led by scientists at La Jolla Institute for Immunology (LJI), is […].

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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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NICE recommends Inrebic for rare blood cancer

Pharma Times

Eligible adult patients with primary or secondary myelofibrosis will now be able to access the treatment on the NHS

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Suffering from psoriasis? Blame this trio of proteins

Scienmag

LA JOLLA—About 7.5 million Americans suffer from psoriasis, an autoimmune disease that shows up as patches of red, inflamed skin and painful, scaly rashes. Although there are effective treatments for psoriasis, not everyone responds to these therapies—and for many, the relief is temporary. Credit: Rinkesh Gupta, La Jolla Institute for Immunology LA JOLLA—About 7.5 million […].

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Pathway or Perish: The Two-Pronged Hurdle to Ensuring Access in Oncology

Drug Channels

Today’s guest post comes from Carolyn Zele, Senior Manager of Solution Enablement at MMIT. Carolyn describes how oncology pathways were developed to help standardize treatment and ensure quality care. She argues, however, that these pathways often shut manufacturers out of the market. Click here to learn more about MMIT's Pulse Analytics solution , which provides insight into payer- and pathway-driven barriers to access.

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Monkeys, guinea pigs and native English speakers have very similar brain responses to speech sounds

Scienmag

PITTSBURGH, November 19, 2021 – Speech sounds elicit comparable neural responses and stimulate the same region in the brain of humans, macaques and guinea pigs, a multidisciplinary group of University of Pittsburgh researchers reported in the journal eNeuro today. The finding could help pave the way for better understanding and diagnosis of auditory processing deficits. […].

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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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Canada Approves Pfizer Vaccine for Children 5 to 11

NY Times

The move adds more than 2.8 million young people to those eligible for a shot.

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Understanding how pathogenic fungi build their carbohydrate armor

Scienmag

In a new study published in Nature Communications, Associate Professor Tuo Wang and his research team from the Department of Chemistry at Louisiana State University revealed the molecular architecture of fungal cell walls and the structural responses to stresses, aiding the development of antifungal drugs targeting cell wall components. Credit: Tuo Wang, LSU In a […].

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Inflation and Retirement: How to Protect Your Savings

NY Times

With prices rising at their fastest rate in decades, people in retirement or approaching it should take extra care to protect their savings.

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Research examines the role of psychotherapists in treatment effectiveness

Scienmag

New research at the University of Massachusetts Amherst shows that different psychotherapists use common treatment processes to varying benefits for patients. Credit: UMass Amherst New research at the University of Massachusetts Amherst shows that different psychotherapists use common treatment processes to varying benefits for patients. The findings, published in the Journal of Consulting and Clinical Psychology, ultimately […].

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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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Whats Next After CRA and Is It Easy Changing Jobs as a CRA

ECRG Media's Clinical Research Podcast

Whats Next After CRA and Is It Easy Changing Jobs as a CRA (Part 8) 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

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Atmospheric rivers may hasten Australia’s snow melt

Scienmag

The Australian Alps may suffer from a loss of snow and surrounding regions could endure flooding as climate change supercharges phenomena known as ‘atmospheric rivers’. Credit: Greg Brave The Australian Alps may suffer from a loss of snow and surrounding regions could endure flooding as climate change supercharges phenomena known as ‘atmospheric rivers’.

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Whats Next After CRA and Is It Easy Changing Jobs as a CRA

ECRG Media's Clinical Research Podcast

Whats Next After CRA and Is It Easy Changing Jobs as a CRA (Part 8). 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.

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Reading the mind of a worm

Scienmag

LA JOLLA—(November 19, 2021) It sounds like a party trick: scientists can now look at the brain activity of a tiny worm and tell you which chemical the animal smelled a few seconds before. But the findings of a new study, led by Salk Associate Professor Sreekanth Chalasani, are more than just a novelty; they […].

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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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WHY PM MODI ADDRESSED, INDIA AS THE PHARMACY OF THE WORLD

Pharma Tutor

WHY PM MODI ADDRESSED, INDIA AS THE PHARMACY OF THE WORLD. Recently, during inauguration of Global Innovation Summit of the pharmaceuticals sector Indian Prime Minister Shri Narendra Modi addressed, India as the Pharmacy of the world. He said that our definition of wellness is not limited by physical boundaries. We have exported life-saving medicines and medical equipment to over 150 countries during the initial phase of the pandemic.

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New microscopy method offers 3D tracking of 100 single molecules at once

Scienmag

Since its invention over 400 years ago, the microscope has continued to evolve, peering ever deeper into nature’s mysteries at the smallest scales. Credit: Adapted with permission from Three-Dimensional Tracking of Tethered Particles for Probing Nanometer-Scale Single-Molecule Dynamics Using a Plasmonic Microscope Copyright 2021 American Chemical Society.

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New patent for Eirgen drug RAYALDEE

Drug Patent Watch

Annual Drug Patent Expirations for RAYALDEE Rayaldee is a drug marketed by Eirgen and is included in one NDA. It is available from one supplier. There are thirteen patents protecting…. The post New patent for Eirgen drug RAYALDEE appeared first on DrugPatentWatch - Make Better Decisions.

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Urbanization not always bad for food and land use diversity

Scienmag

Widely accepted myths that urbanization negatively impacts food and land use biodiversity are incorrect, according to a team of researchers who developed a framework for evaluating this intersection. Their results could also affect nutrition and food insecurity in urban areas. Credit: Credit: Karl Zimmerer, GeoSyntheSES, Penn State Widely accepted myths that urbanization negatively impacts food […].

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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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New patent for Kadmon Pharms drug REZUROCK

Drug Patent Watch

Annual Drug Patent Expirations for REZUROCK Rezurock is a drug marketed by Kadmon Pharms Llc and is included in one NDA. The generic ingredient in REZUROCK is belumosudil mesylate. Additional…. The post New patent for Kadmon Pharms drug REZUROCK appeared first on DrugPatentWatch - Make Better Decisions.

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Can defects turn inert materials into useful, active ones?

Scienmag

Demonstrating that a material thought to be always chemically inert, hexagonal boron nitride (hBN), can be turned chemically active holds potential for a new class of catalysts with a wide range of applications, according to an international team of researchers. Credit: Elizabeth Flores-Gomez Murray, Yu Lei and Kazunori Fujisawa, Penn State Demonstrating that a material […].

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Airphysio Portable Mucus Removal Device For Atelectasis Symptom Relief Launched

BioTech 365

Airphysio Portable Mucus Removal Device For Atelectasis Symptom Relief Launched Airphysio Portable Mucus Removal Device For Atelectasis Symptom Relief Launched When diagnosed with an acute respiratory condition, even simple everyday tasks can be challenging.

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University of Guam awarded $715K for aquifer research using NASA technology

Scienmag

This November, University of Guam will start a $715,014 project that will use unmanned aerial systems (UAS), remote sensing, and NASA technology to closely examine the Northern Guam Lens Aquifer, which supplies 90% of the island’s drinking water, and produce critical data and tools for resource management. Credit: University of Guam This November, University of […].

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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.