Thu.Sep 10, 2020

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The voice of the customer, and how pharma can respond

Bio Pharma Dive

ZS surveyed more than 500 physicians, 500 patients and 30 healthcare administrators to gather their current thoughts on care delivery, telemedicine and pharma's potential role during the COVID-19 pandemic.

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How Can Nursing Homes Protect Themselves from COVID-19?

Pharma Mirror

There is an ongoing pandemic that has been proven to harm and even kill many people. Researchers have found that the elderly are particularly susceptible to the COVID-19 virus that caused the epidemic. This is because they often have weaker immune systems, so they can’t fight off a viral infection easily. This new situation puts. The post How Can Nursing Homes Protect Themselves from COVID-19?

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Sanofi's hemophilia drug comes into focus as delays hit a key competitor

Bio Pharma Dive

With BioMarin's gene therapy sidelined, attention is turning to other drugs, including one Sanofi acquired when it paid $11.6 billion for Bioverativ.

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Non-vaccine nasal spray could protect against COVID-19

pharmaphorum

Two UK biotechs – Destiny Pharma and Sporegen – have joined forces to develop a nasal spray that they say could serve as a first line of defense against coronavirus infections. The nasal spray could provide protection from infection within a few days of administration, and would be easy to make in bulk at a low cost, say the partners. The programme is still in the early stages of development, but if it works in trials would provide another approach to prevent transmission of SARS-CoV-2, the viru

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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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FDA wants more details on Sarepta gene therapy, potentially delaying final test

Bio Pharma Dive

A new request from the regulator could tighten the race between Sarepta and Pfizer to prove out a gene therapy for Duchenne muscular dystrophy.

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Europe lines up agreement with BioNTech-Pfizer for supply of coronavirus vaccine

BioPharma Reporter

The European Commission has concluded exploratory talks with BioNTech-Pfizer to purchase up to 300 million doses of a potential vaccine against COVID-19.

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How companies can encourage more diversity and inclusion in pharma

pharmaphorum

September is Global Diversity and Inclusion month – David Peacock, managing director of MSD in the UK shares with us his insights on why diversity and inclusion is so important and why it is critical to the future success of the life sciences sector. Taking diversity and inclusion seriously, supported by robust policies and accountability for implementation, creates success for everyone, fostering happy, healthy and invested employees, new ways of thinking and opportunities for growth, learning

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Catalent to invest $130M in gene therapy plant near Baltimore airport

Bio Pharma Dive

The contract manufacturer is riding a boom in demand for both its gene therapy and vaccine manufacturing services.

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Pfizer, BioNTech could supply EU with 300m doses of SARS-CoV-2 vaccine

Pharma Times

The proposed deal covers the initial supply of 200 million doses and an option to purchase an additional 100 million, with deliveries starting by the end of 2020, if the vaccine is approved

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Pandemic Schmandemic – Intouchers Keep Creativity, Company Culture Alive

Intouch Solutions

In this post, we showcase just a few of Intouch's talented employees who are making the most of the pandemic. From content creation to painting, plant-raising and house-flipping, and more, there's something for everyone! The post Pandemic Schmandemic – Intouchers Keep Creativity, Company Culture Alive appeared first on Intouch Solutions.

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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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After a Vaccine – What? The Shift from Research and Discovery to Communications

Eye on FDA

Vaccines for COVID-19 are the focus of the moment – politically and scientifically speaking. On the political front, there has not only been jockeying to try to squeeze the square peg of a vaccine development timeline into a round hole of political convenience, there is also skepticism expressed by a wary public that the process has become politicized – an unfortunate impression to be sure.

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How companies can encourage more diversity and inclusion in pharma

pharmaphorum

September is Global Diversity and Inclusion month – David Peacock, managing director of MSD in the UK shares with us his insights on why diversity and inclusion is so important and why it is critical to the future success of the life sciences sector. Taking diversity and inclusion seriously, supported by robust policies and accountability for implementation, creates success for everyone, fostering happy, healthy and invested employees, new ways of thinking and opportunities for growth, learning

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Daxor research battles military injuries

Outsourcing Pharma

The company is delving into clinical research partnerships geared toward saving the lives of soldiers, eventually translating findings to civilian care.

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Stem cell function may explain higher colon cancer rate in males

Scienmag

Credit: Yu et al Colon cancers have a higher incidence in males, which is in part related to much higher androgen levels in males compared to females. Scientists have now discovered a link between androgens and stem cells that could contribute to colon cancer. Some cancers in the intestine are thought to arise from intestinal […].

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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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Survey Finds Decline in E-Cigarette Use Among Youth as FDA Issues Warnings to Unauthorized Sellers

XTalks

Partnering with the Centers for Disease Control and Prevention (CDC), the US Food and Drug Administration (FDA) released new data yesterday from the 2020 National Youth Tobacco Survey (NYTS) , which shows that electronic cigarette (e-cigarette) use has significantly declined among youth in the US. At the same time, the FDA also issued warning letters to companies who sell or distribute unauthorized e-cigarettes or other electronic nicotine delivery systems (ENDS) products to remove them from the

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Dietary changes could produce big offsets to carbon emissions

Scienmag

Credit: Oregon State University CORVALLIS, Ore. – Eating less meat and dairy products in favor of plant-based proteins like those found in grains, legumes and nuts could make a huge difference in how much carbon dioxide reaches the atmosphere, research by Oregon State University shows. Published Monday in Nature Sustainability, the findings by OSU’s William […].

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EU review extended for BioMarin's gene therapy Valrox

Pharma Times

The EMA has asked for full data from an ongoing Phase III study of the treatment in patients with severe haemophilia A

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FABP4: Preschool-aged biomarker discovered for autism spectrum disorder

Scienmag

Credit: RIKEN Researchers led by Takeo Yoshikawa at the RIKEN Center for Brain Science in Japan have discovered a biomarker that can detect autism spectrum disorder (ASD) in preschool-aged children. Published in Brain Communications, the new study found that levels of the protein FABP4 were much lower in four- to six-year-old children with ASD than […].

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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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Valisure Supports Drug Importation

Pharmacy Checkers

Valisure is a U.S. online pharmacy that actually tests the quality of medication it sends to patients and apparently, to my delight, they support drug importation as a policy to lower costs. Pretty cool. When people go online or to their local Walgreens to buy prescription drugs domestically, they are largely relying on the regulatory strength of the U.S.

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Coming up for air: Extinct sea scorpions could breathe out of water, fossil detective unveils

Scienmag

Credit: James Lamsdell Scientists have long debated the respiratory workings of sea scorpions, but a new discovery by a West Virginia University geologist concludes that these largely aquatic extinct arthropods breathed air on land. James Lamsdell dug into the curious case of a 340 million-year-old sea scorpion, or eurypterid, originally from France that had been […].

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AI could drive health system development in lower-income countries

pharmaphorum

Health systems in lower-income countries could overtake those in richer countries with artificial intelligence (AI)-enabled technologies, according to a report from Novartis Foundation and Microsoft. According to the report “Reimagining Global Health through Artificial Intelligence: The Roadmap to AI Maturity” , technologies such as mobile phone trading platforms, e-banking, e-commerce and blockchain applications have been adopted faster and more comprehensively in low- and middle-income countri

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How chemical diversity in plants facilitates plant-animal interactions

Scienmag

Credit: Bernadette Wynter Rigley. We aren’t the only beings who enjoy feasting on tasty fruits like apples, berries, peaches, and oranges. Species like bats, monkeys, bears, birds, and even fish consume fruits — and plants count on them to do so. Wildlife disperse their seeds by eating the fruit and defecating the seed elsewhere, thus […].

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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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ATTC Network gets further investment of £9.5m

Pharma Times

The UK government grant will support new and existing advanced therapy projects until March 2022

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High-precision electrochemistry: The new gold standard in fuel cell catalyst development

Scienmag

Credit: Argonne National Laboratory Vehicles powered by polymer electrolyte membrane fuel cells (PEMFCs) are energy-efficient and eco-friendly, but despite increasing public interest in PEMFC-powered transportation, current performance of materials that are used in fuel cells limits their widespread commercialization. Scientists at the U.S. Department of Energy’s (DOE) Argonne National Laboratory led a team to investigate […].

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F.D.A. Regulators Publish Rare Self-Defense Amid Rising Vaccine Pressure

NY Times

A group of career scientists at the Food and Drug Administration vowed that their work would continue unimpeded and independent of political influence.

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New Hubble data suggests there is an ingredient missing from current dark matter theories

Scienmag

Credit: NASA, ESA, G. Caminha (University of Groningen), M. Meneghetti (Observatory of Astrophysics and Space Science of Bologna), P. Natarajan (Yale University), the CLASH team, and M. Kornmesser (ESA/Hubble) Observations by the NASA/ESA Hubble Space Telescope and the European Southern Observatory’s Very Large Telescope (VLT) in Chile have found that something may be missing 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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Coronavirus: What are the challenges of mass testing?

The Pharma Data

Image copyright. Getty Images. Image caption. Boris Johnson described mass-testing plans as a “moonshot” The prime minister talked about his “Moonshot” plan, on Wednesday, to test millions of people every day using tests that can produce results in as little as 20 minutes. He said they “would allow people to lead more normal lives” by giving them the all clear to go to the theatre or a football match after a negative on-the-day test result.

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Researchers reveal safeguarding of key DNA sensor in innate immune system

Scienmag

Led by Qi Zhang and Robert McGinty, UNC-Chapel Hill scientists used cryo-electron microscopy technology to produce the first-ever high-resolution structure of the protein cGAS bound to the DNA packaging unit inside human cell nuclei Credit: UNC-Chapel Hill CHAPEL HILL, NC – September 10, 2020 – UNC-Chapel Hill researchers have, for the first time, determined the […].

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AZ’s Fasenra on target in nasal polyps trial

pharmaphorum

AstraZeneca’s Fasenra (benralizumab) injected drug cuts the size of nasal polyps and nasal blockage in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The company announced top-line results from the phase 3 OSTRO trial, which lasts for 56 weeks and compared Fasenra with placebo. Fasenra demonstrated a statistically significant improvement in the endoscopic total nasal polyp score and the nasal blockage score compared to placebo, in patients with severe disease who were still sym

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UNC researchers publish striking images of SARS-CoV-2 infected cells

Scienmag

The UNC School of Medicine lab of Camille Ehre, PhD, generated high-powered microscopic images showing startlingly high SARS-CoV-2 viral loads on human respiratory surfaces, ready to spread infection in infected individuals and to others Credit: Ehre Lab, UNC School of Medicine The UNC School of Medicine laboratory of Camille Ehre, PhD, Assistant Professor of Pediatrics, […].

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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.