Fri.Oct 16, 2020

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Early signs of survival benefit raise optimism around a small biotech's ALS drug

Bio Pharma Dive

Newly published data show that, after joining a clinical trial, patients who were given a drug from Amylyx Pharmaceutcials lived a median 6.5 months longer than those who didn't.

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Pfizer to apply for COVID-19 vaccine EUA after mid-November safety data milestone

BioPharma Reporter

Pfizerâs CEO says the company will apply for Emergency Use Authorisation (EUA) for its COVID-19 vaccine candidate âsoon afterâ a safety milestone is reached in the third week of November.

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5 questions ahead of next week's FDA meeting on coronavirus vaccines

Bio Pharma Dive

Normally staid affairs, next Thursday's advisory committee meeting could be historic and set expectations for how the FDA will approach any future vaccine approval.

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Boehringer, Yale trial digital tech in heart failure

pharmaphorum

Patients with heart failure often have a dismal prognosis as the condition usually worsens over time, but a new study aims to see if digital health technologies can improve their prospects. The trial – run by Boehringer Ingelheim and Yale University – will test a smart bathroom scale device that has cardiac monitoring built in, as well as an app to help patients improve their diet and lose weight and a digital assistant designed to motivate them to actively manage their health.

Trials 118
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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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Pfizer won't seek FDA clearance of coronavirus vaccine until mid-November, CEO says

Bio Pharma Dive

An unusual letter from Pfizer chief Albert Bourla confirms that the drugmaker won't file for an approval of its experimental shot, assuming positive results, before the U.S. presidential election.

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World Food Day 2020: How to Eliminate Hunger by Reducing Food Waste

XTalks

Each year, World Food Day falls on October 16, serving as a reminder that 821 million people worldwide — or one in nine — experience hunger. The pandemic has not only highlighted the ongoing need for nutritious food but also shed light on the fragility of food supply chains internationally. Some people experienced long lines at grocery stores, while others couldn’t buy food at all.

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Rare diseases, repurposing and the role of AI

pharmaphorum

In the age of artificial intelligence, no trial data should be going to waste. Findacure’s Rick Thompson looks at how these technologies could bring us closer to treatments for underserved rare diseases. The repurposing of drugs is becoming more common, especially in the field of rare diseases. In the past, repurposing has mostly been driven by academics looking for new possibilities in generics.

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Plant genetic engineering to fight ‘hidden hunger’

Scienmag

International research team including University of Göttingen explains advantages of molecular breeding methods Credit: M Qaim More than two billion people worldwide suffer from micronutrient malnutrition due to deficiencies in minerals and vitamins. Poor people in developing countries are most affected, as their diets are typically dominated by starchy staple foods, which are inexpensive sources […].

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Sanofi preps trials of second COVID-19 shot, as Russia approves another

pharmaphorum

Sanofi will shortly start human trials of a second coronavirus vaccine, developed with US biotech Translate Bio, after reporting that it stimulated antibodies against SARS-CoV-2 in preclinical testing. The French drugmaker’s Sanofi Pasteur vaccines division says it is planning a phase 1/2 trial of the mRNA-based vaccine, called MRT5500, before the end of the year.

Trials 98
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Membranes for capturing carbon dioxide from the air

Scienmag

Researchers in I2CNER, Kyushu University suggest the potential of the advanced gas separation membranes for CO2 extraction from ambient air Credit: Kyushu University Climate change caused by emissions of greenhouse gases into the atmosphere is a most important issue for our society. Acceleration of global warming results in catastrophic heatwaves, wildfires, storms and flooding.

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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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CQC assessment is a ‘wake-up call’ to government, says NHS Confed chief exec

Pharma Times

Latest reports highlights need for improved access to mental health care

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Internet connectivity is oxygen for research and development work

Scienmag

Credit: College of ACES, University of Illinois. URBANA, Ill. – Fast and reliable internet access is fundamental for research and development activity around the world. Seamless connectivity is a privilege we often take for granted. But in developing nations, technological limitations can become stumbling blocks to efficient communication and cause significant disadvantages.

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Drug May Extend A.L.S. Patients’ Lives by Several Months, Study Finds

NY Times

The two-drug combination invented by college students is one of many potential therapies being tested for this paralyzing fatal condition.

Drugs 88
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Gel instrumental in 3D bioprinting biological tissues

Scienmag

Credit: Ozbolat Lab at Penn State The eventual creation of replacement biological parts requires fully three-dimensional capabilities that two-dimensional and three-dimensional thin-film bioprinting cannot supply. Now, using a yield stress gel, Penn State engineers can place tiny aggregates of cells exactly where they want to build the complex shapes that will be necessary to replace […].

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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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Gilead’s COVID-19 drug Veklury falls short in WHO’s global trial

pharmaphorum

Gilead’s Veklury (remdesivir) has failed to produce an effect on hospital stay and mortality in COVID-19 patients in a large global trial, casting doubt on previous supportive study findings. The results from the World Health Organization’s large Solidarity trial are yet to be peer reviewed but were posted online on a preprint server. Interim findings from Solidarity, which involved more than 11,000 patients in more than 30 countries, contradict those from the manufacturer in a US study.

Trials 76
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Arctic Ocean sediments reveal permafrost thawing during past climate warming

Scienmag

Credit: Björn Eriksson Sea floor sediments of the Arctic Ocean can help scientists understand how permafrost responds to climate warming. A multidisciplinary team from Stockholm University has found evidence of past permafrost thawing during climate warming events at the end of the last ice age. Their findings, published in Science Advances, caution about what could […].

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Astellas to acquire iota Biosciences following R&D partnership

Pharma Times

Companies will develop ultra-small implantable medical devices

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Oncotarget: Induction of phenotypic changes in HER2-postive breast cancer cells

Scienmag

The cover for issue 30 of Oncotarget features Figure 4, “RNAseq results demonstrating differences between normal, cancer, and redirected cells,” by Frank-Kamenetskii, et al. which reported that the influence of breast cancer cells on normal cells of the m Credit: Correspondence to – Brian W. Booth – brbooth@clemson.edu The cover for issue 30 of Oncotarget […].

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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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New patent for Amicus Theraps drug GALAFOLD

Drug Patent Watch

Annual Drug Patent Expirations for GALAFOLD Galafold is a drug marketed by Amicus Theraps Us and is included in one NDA. There are twelve patents protecting this drug. This drug…. The post New patent for Amicus Theraps drug GALAFOLD appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 64
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A promising new tool in the fight against melanoma

Scienmag

An Edith Cowan University (ECU) study has revealed that a key blood marker of cancer could be used to select the most effective treatment for melanoma Credit: Edith Cowan University An Edith Cowan University (ECU) study has revealed that a key blood marker of cancer could be used to select the most effective treatment for […].

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Janssen’s psoriasis med Tremfya scores long-term safety and efficacy data

Pharma Times

Treatment demonstrated positive outcomes for nearly five years

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Researchers discover a uniquely quantum effect in erasing information

Scienmag

Credit: Professor Goold, Trinity College Dublin Researchers from Trinity College Dublin have discovered a uniquely quantum effect in erasing information that may have significant implications for the design of quantum computing chips. Their surprising discovery brings back to life the paradoxical “Maxwell’s demon”, which has tormented physicists for over 150 years.

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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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Sanofi's Sarclisa bags NICE recommendation

Pharma Times

Treatment is approved for relapsed/refractory multiple myeloma

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Zeptoseconds: new world record in short time measurement

Scienmag

Physicists from Frankfurt, Hamburg and Berlin track the propagation of light in a molecule Credit: Sven Grundmann, Goethe University Frankfurt FRANKFURT. In 1999, the Egyptian chemist Ahmed Zewail received the Nobel Prize for measuring the speed at which molecules change their shape. He founded femtochemistry using ultrashort laser flashes: the formation and breakup of chemical […].

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Los anticuerpos son la nueva esperanza contra el COVID-19

NY Times

Una red de científicos persigue el santo grial de la pandemia: un anticuerpo que no solo protege contra el virus, sino también contra patógenos relacionados que pueden amenazar a los humanos.

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Echo from the past makes rice paddies a good home for wetland plants

Scienmag

Geography before human land use impacts how well plant species are retained Credit: Tokyo Metropolitan University Tokyo, Japan – Researchers from Tokyo Metropolitan University studied the biodiversity of wetland plants over time in rice paddies in the Tone River basin, Japan. They found that paddies which were more likely to have been wetland before agricultural […].

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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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Bonus CRA Academy Session: How A Former Student Landed A Clinical Research Job

Clinical Trial Gurus

Monika Khatri is a former CRA Academy student who has succeeded in landing a promising job in clinical research. She is able to provide some much needed advice for all job seekers in the clinical research industry. One of the points she makes is to highlight any training that is most relevant to the new position, especially if it was self initiated and self funded.

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ctDNA may predict outcomes with first-line, but not second-line immunotherapy for melanoma

Scienmag

Bottom Line: Baseline levels of circulating tumor DNA (ctDNA) predicted responses to first-line, but not second-line, immune checkpoint inhibition in patients with melanoma. Journal in Which the Study was Published: Clinical Cancer Research, a journal of the American Association for Cancer Research Author: Elin Gray, PhD, an associate professor at Edith Cowan University in Australia […].

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Use of Common Meds Tied to Lower Lung Cancer Mortality

The Pharma Data

News. Professional. Use of Common Meds Tied to Lower Lung Cancer Mortality. FRIDAY, Oct. 16, 2020 — Use of aspirin , metformin , and statins is associated with a lower risk for lung cancer mortality, according to a study published online Sept. 17 in the Journal of Thoracic Oncology. Jihun Kang, M.D., from Kosin University Gospel Hospital in South Korea, and colleagues used data from 732,199 individuals who had undergone a national health check-up in 2002 to 2003.

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Catholic OB-GYNs can face moral dilemmas in issues of family planning

Scienmag

Faith limits what some provide while compelling others to provide more AURORA, Colo. (Oct. 16, 2020) – A study of Catholic obstetrician-gynecologists shows that many face moral dilemmas when dealing with issues of family planning and abortion due to their religious faith, according researchers at the University of Colorado Anschutz Medical Campus.

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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.