Fri.May 21, 2021

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Bluebird's next gene therapy gets backing from European regulator

Bio Pharma Dive

The treatment, for a progressive, often deadly brain disease, could soon become Bluebird's third approved product and one of only a handful of marketed gene therapies in the world.

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Experts state contract services sector the big winner of pandemic at CPhI Discover

Pharma Mirror

Contract services experts at this week’s CPhI Discover – (17-28th May, 2021) – the largest ever online pharma event featuring content in the opening week and networking in week two – point to pandemic contracts delivering a significant boon to the CDMO sector, but forewarn of exacerbated shortages for viral vector manufacturing. In a dedicated session three experts – Peter Shapiro Senior Director of Drugs and Business Fundamentals, PharmSource, a GlobalData Company; Eric Langer, President and Ma

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What is a Webcast? Learn the Differences Between Webcasts vs Webinars

XTalks

Webcast or webinar? These two terms are often used interchangeably by various organizations. Ultimately, webcasts and webinars offer the same goal — they give hosts a virtual space to present content with an audience while keeping track of webinar registrations. . When push comes to shove, webcasts and webinars can be differentiated. We will take a thorough look at the definitions of these two terms, then clarify the similarities and differences, which might often be overlooked by most.

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Ashfield Engage acquires Nuvera to enhance Patient Solutions offering

Pharma Mirror

Nuvera are experts in optimizing the design and build of seamless patient and HCP treatment experiences. This expertise will enhance Ashfield Engage’s Patient Solutions capabilities and create an end-to-end strategic offering across their client’s product lifecycles. Following the acquisition, Ashfield Engage and Nuvera will offer integrated specialist support and services including late-phase clinical trial experience, implementation and post-commercialization satisfaction benchmarking and serv

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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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Listening to ultra-rare disease communities

pharmaphorum

When it comes to ultra-rare diseases, the smaller the patient population, the bigger the challenges. As a global commercial biopharmaceutical company pioneering therapies for ultra-rare diseases, PTC Therapeutics is familiar with the challenges. The company prides itself on a patient-centric approach to treatment but there can be significant hurdles in patients accessing potentially life-changing treatments.

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Positive interim Phase 2 results for COVID-19 vaccine from Medicago and GSK

BioPharma Reporter

Canadian biotechnology company, Medicago, announced positive interim Phase 2 results this week for its plant-derived COVID-19 vaccine, which has been tested in combination with GSKâs pandemic adjuvant.

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Virtual Reality – FDA and AdComms

Eye on FDA

Vaccination has been robust. Cities are opening up. Plans are underway for back-to-school. Travel is robust. Offices are cautiously re-opening. There are multiple hallmarks that, whatever the consequences, we are going back to normal. The age of COVID-19 will likely continue, but with the emergence of a significant proportion of the population with vaccines pumped into them, we headed back on almost every level.

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New patent for Indivior Inc drug SUBLOCADE

Drug Patent Watch

Annual Drug Patent Expirations for SUBLOCADE Sublocade is a drug marketed by Indivior Inc and is included in one NDA. It is available from one supplier. There are ten patents…. The post New patent for Indivior Inc drug SUBLOCADE appeared first on DrugPatentWatch - Make Better Decisions.

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Reify, SubjectWell partner to elevate trial recruitment

Outsourcing Pharma

The two tech-focused firms are joining forces to work on technology solutions aimed at improving patient recruitment and enrollment for various studies.

Trials 105
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Pandemic paleo: A wayward skull, at-home fossil analyses, a first for Antarctic amphibians

Scienmag

Credit: Christian Sidor Paleontologists had to adjust to stay safe during the COVID-19 pandemic. Many had to postpone fossil excavations, temporarily close museums and teach the next generation of fossil hunters virtually instead of in person. But at least parts of the show could go on during the pandemic — with some significant changes. “For […].

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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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NHS England funds first national metastatic breast cancer audit

Pharma Times

UK-based charity Breast Cancer Now ‘proud’ of milestone after campaigning for improved data collection

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Robot enables communication between people isolated due to COVID-19 and their relatives

Scienmag

It is designed to facilitate the work of professionals in nursing homes and hospitals Credit: University of Malaga Researchers of the Integrated Systems Engineering Group of the University of Malaga (UMA) have designed a telepresence robot that enables people suffering from COVID-19 to talk to their loved ones. Although this scientific team has been working […].

Nurses 96
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Lilly’s tirzepatide achieves superior A1C reductions versus insulin glargine

Pharma Times

Investigational therapy also led to superior body weight reductions in adults with type 2 diabetes

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Finer touch for tuning stem cell “fate” with substrates of varying stiffness

Scienmag

Quantitative control over localization of key proteins in mesenchymal stem cells Credit: Tokyo Metropolitan University Tokyo, Japan – Researchers from Tokyo Metropolitan University have been quantifying how different batches of mesenchymal stem cells respond to the mechanical stiffness of their environments. They focused on how certain proteins were “localized” in cell nuclei and found key […].

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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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EU secures 1.8 billion additional doses of Pfizer/BioNTech’s COVID-19 jab

Pharma Times

Pfizer/BioNTech said all doses earmarked for the European Commission are planned to be manufactured in the European Union

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3D visualization of oxytocin and vasopressin circuits with unprecedented resolution

Scienmag

Alterations in these circuits may underlie mental disorders characterized by deficits in social interaction, such as autism, social anxiety and aggression, or schizophrenia. Credit: IN-CSIC-UMH The work, carried out by Pilar Madrigal and Sandra Jurado, from the UMH-CSIC Neurosciences Institute in Alicante, a joint center of the Spanish National Research Council and Miguel Hernández University, […].

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Digital experience impacts clinical trial success: Medallia

Outsourcing Pharma

A representative from the digital experience management firm discusses how improving the quality of tech interactions with patients can elevate results.

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Railway infrastructure susceptible to greater damages from climate change

Scienmag

$2.06 billion/year can be saved by keeping warming to 1.5 °C instead of 3 °C for Chinese railway Credit: Kai Liu Just half a degree Celsius less warming would save economic losses of Chinese railway infrastructure by approximately $0.63 billion per year, according to a new paper published by a collaborative research team based in […].

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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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Under-pressure GSK sells stake in respiratory diseases partner Innoviva

pharmaphorum

GlaxoSmithKline has sold its entire stake in its respiratory partner Innoviva, raising $392 million and simplifying its business ahead of a split into two. GSK is pushing ahead with a split into an innovative drugs business and a consumer healthcare firm, while the spectre of activist investor Elliott Management hangs over it. The fund run by billionaire Paul Singer has bought a significant stake in GSK and is notorious for demanding and often enforcing significant changes in the companies it in

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University of Montana students lead prescribed wildfire burn on university ranch

Scienmag

University of Montana leads prescribed wildfire burn Credit: University of Montana MISSOULA – In mid-April on the University of Montana-owned Bandy Ranch in neighboring Powell County, the snow was still visible on the surrounding Garnet Mountains, geese were honking overhead and Cottonwood Creek was beginning to ripple. But there would be a greater sound of […].

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Vinehealth earns CE marks for cancer management apps

pharmaphorum

UK digital health firm Vinehealth has won a CE mark for a mobile app that helps cancer patients manage their medications and care, as well as a sister web-based app aimed at clinicians. . The Vinehealth Cancer Companion – originally developed by neurologist Dr Rayna Patel and Georgina Kirby, the company’s co-founders – uses behavioural science and artificial intelligence to help cancer patients track, manage and understand their care.

Nurses 59
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How human cells and pathogenic shigella engage in battle

Scienmag

Credit: Justin M. Hansen DALLAS – May 21, 2021 – One member of a large protein family that is known to stop the spread of bacterial infections by prompting infected human cells to self-destruct appears to kill the infectious bacteria instead, a new study led by UT Southwestern scientists shows. However, some bacteria have their […].

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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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MSD’s pneumococcal vaccine candidate shows promise in paediatric studies

Pharma Times

Investigational 15-valent pneumococcal conjugate vaccine consists of pneumococcal polysaccharides from 15 serotypes

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Researchers create world’s most power-efficient high-speed ADC microchip

Scienmag

Analag-to-digital converters are a key component of nearly every piece of electronic equipment Credit: BYU Photo To meet soaring demand for lightning-quick mobile technology, each year tech giants create faster, more powerful devices with longer-lasting battery power than previous models. A major reason companies like Apple and Samsung can miraculously pull this off year after […].

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Gamma Biosiences takes majority stake in Mirus Bio

BioPharma Reporter

Gamma Biosciences has taken a controlling investment in Mirus Bio, an innovator and developer of biomimetic, cell-adaptive lipid-polymer nanocomplexes (LPNCs) for nucleic acid delivery based in Wisconsin in the US.

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Superficial relationship: Enzymes protect the skin by ignoring microbes and viruses

Scienmag

UC San Diego School of Medicine researchers identify how the body regulates and prevents constant skin inflammation The human body is constantly exposed to various environmental actors, from viruses to bacteria to fungi, but most of these microbial organisms provoke little or no response from our skin, which is charged with monitoring and protecting from […].

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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 expiration for Sanofi Aventis drug NICODERM CQ

Drug Patent Watch

Annual Drug Patent Expirations for NICODERM+CQ Nicoderm Cq is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from one supplier. There is…. The post New patent expiration for Sanofi Aventis drug NICODERM CQ appeared first on DrugPatentWatch - Make Better Decisions.

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Smart toilet may soon analyze stool for health problems

Scienmag

Artificial intelligence tool can be used for long-term tracking and management of chronic gastrointestinal ailments Bethesda, MD (May 22, 2021) — An artificial intelligence tool under development at Duke University can be added to the standard toilet to help analyze patients’ stool and give gastroenterologists the information they need to provide appropriate treatment, according to […].

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New patent for Otsuka Pharm drug ABILIFY MAINTENA KIT

Drug Patent Watch

Annual Drug Patent Expirations for ABILIFY+MAINTENA+KIT Abilify Maintena Kit is a drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. It is available from one supplier.…. The post New patent for Otsuka Pharm drug ABILIFY MAINTENA KIT appeared first on DrugPatentWatch - Make Better Decisions.

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Green light on gold atoms

Scienmag

Credit: Nicolas Antille, www.nicolasantille.com Because individual atoms or molecules are 100 to 1000 times smaller than the wavelength of visible light, it is notoriously difficult to collect information about their dynamics, especially when they are embedded within larger structures. In an effort to circumvent this limitation, researchers are engineering metallic nano-antennas that concentrate light into […].

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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.