Fri.Nov 20, 2020

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Pfizer, BioNTech ask FDA for emergency approval of coronavirus vaccine

Bio Pharma Dive

The companies expect immunizations with their shot, if approved, could begin in high-risk groups by the middle to end of December.

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Lilly’s baricitinib granted US emergency use in COVID-19

pharmaphorum

Doctors in the US are to get another option to treat COVID-19 after the FDA granted an Emergency Use Authorization (EUA) for Eli Lilly’s baricitinib. Baricitinib is the active ingredient in Lilly’s rheumatoid arthritis drug Olumiant and is the latest example of a drug being repurposed to combat COVID-19. Most of the drugs attempt to tackle the inflammation that can cause complications in patients with severe disease.

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WHO recommends against Gilead's Veklury, in break with US guidelines

Bio Pharma Dive

The organization argues there's no evidence the antiviral saves lives or improves outcomes for COVID-19 patients, despite positive data on the latter point from a key U.S. study.

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What will the digital health ecosystem look like post-COVID?

pharmaphorum

COVID-19 has turned the world on its head and healthcare systems have had to respond rapidly to match the sudden changes created by lockdown. Digital health had already been building a presence before the pandemic, but the tools it offers have been essential to counter the disruption caused by the coronavirus, reports Richard Staines. COVID-19 isn’t going away any time soon but when, and if, this crisis subsides the healthcare systems that are left behind will have changed radically.

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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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Lilly dives into gene editing

Bio Pharma Dive

Through a deal with Precision Biosciences, the pharma aims to develop therapies for genetic disorders, including Duchenne muscular dystrophy.

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Some Amazon rainforest regions more resistant to climate change than previously thought

Scienmag

New observational study demonstrates that increasing air dryness does not reduce photosynthesis in certain very wet regions of the Amazon rainforest, contradicting Earth system models that show the opposite Credit: Xi Yang/University of Virginia New York, NY–November 20, 2020–Forests can help mitigate climate change, by taking in carbon dioxide during photosynthesis and storing it in […].

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Media means business

pharmaphorum

COVID-19 has left us more reliant on media than ever – both the pharma industry and society as a whole. Havas Lynx Group’s 2020 white paper provides a blueprint for pharma brands to inject meaning into their media. “Meaningful media experiences are made by connecting with the right people, in the contexts they spend their time, with content that drives impact.

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Science reveals secrets of a mummy’s portrait

Scienmag

Scientific analysis of an ancient portrait pigment reveals long-lost artistic details Credit: The Walters Art Museum. How much information can you get from a speck of purple pigment, no bigger than the diameter of a hair, plucked from an Egyptian portrait that’s nearly 2,000 years old? Plenty, according to a new study. Analysis of that […].

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Helixmith starts new trial of diabetic neuropathy gene therapy

pharmaphorum

Just over a year after its first phase 3 trial of its Engensis gene therapy for painful diabetic peripheral neuropathy (DPN) bombed, Helixmith has started dosing patients in a new study. The South Korean biotech says the DNA plasmid-based therapy has been administered to a patient at Innovative Research of West Florida. The aim is to enrol 152 DPN patients at 15 clinical sites across the US in the study, called REGAiN-1A.

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Improving quantum dot interactions, one layer at a time

Scienmag

Scientists have found a way to control an interaction between quantum dots that could lead to more efficient solar cells. Credit: DaeGwi Kim, Osaka City University Osaka City University scientists and colleagues in Japan have found a way to control an interaction between quantum dots that could greatly improve charge transport, leading to more efficient […].

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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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Pfizer/BioNTech prep US COVID-19 vaccine launch after emergency filing

pharmaphorum

Pfizer and BioNTech have filed for emergency use of their COVID-19 vaccine candidate in the US, paving the way for a launch before year-end. The announcement is no surprise as earlier this week, Pfizer’s CEO Albert Bourla said the company was preparing to file phase 3 data from the vaccine known as BNT162b2 with the FDA after gathering the required amount of safety data.

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Do neural networks dream visual illusions?

Scienmag

This is the question studied by researchers at the Department of Information and Communication Technologies, led by Marcelo Bertalmío together with Jesús Malo, a researcher at the University of Valencia. Credit: – Aconvolutional neural network is a type of artificial neural network in which the neurons are organized into receptive fields in a very similar […].

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Impact Assessment of Decentralized Clinical Trials (DCT)

VirTrial

Clinical research sites continually strive to improve patient recruitment and engagement practices for clinical trials in an effort to provide sponsors with the critical data they need to bring new medications to market safely. In addition, it is an ongoing challenge to retain the number of patients needed to successfully complete and validate the integrity of a study.

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From lab to industry? Ideally ordered porous titania films, made at scale

Scienmag

High-throughput double anodization to make ordered titania through-hole membranes Credit: Tokyo Metropolitan University Tokyo, Japan – Researchers from Tokyo Metropolitan University have realized high-throughput production of thin, ordered through-hole membranes of titanium dioxide. Titania layers were grown using anodization on mask-etched titanium before being crystallized.

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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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Sosei Heptares’ COVID-19 programme advances promising molecules

Pharma Times

R&D programme is focused on developing small molecules against SARS-CoV-2 virus

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After more than a decade, ChIP-seq may be quantitative after all

Scienmag

Credit: Courtesy of Van Andel Institute GRAND RAPIDS, Mich. (Nov. 20, 2020) — For more than a decade, scientists studying epigenetics have used a powerful method called ChIP-seq to map changes in proteins and other critical regulatory factors across the genome. While ChIP-seq provides invaluable insights into the underpinnings of health and disease, it also […].

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Greek health insurer partners with dacadoo to launch health app

pharmaphorum

A Greek health insurance firm has released a new platform to encourage members to adopt a healthier lifestyle. Generali Hellas is the sixth largest insurance company in Greece and has had a presence there since 1886. With its new platform, My Health IQ, the company aims to improve the wellbeing of customers by encouraging their active involvement in the adoption of a healthier lifestyle.

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Plant evolves to become less visible to humans

Scienmag

Credit: Yang Niu A plant used in traditional Chinese medicine has evolved to become less visible to humans, new research shows. Scientists found that Fritillaria delavayi plants, which live on rocky slopes of China’s Hengduan mountains, match their backgrounds most closely in areas where they are heavily harvested. This suggests humans are “driving” evolution of […].

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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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Pfizer Applies for Emergency F.D.A. Approval for Covid-19 Vaccine

NY Times

A large team of regulators at the agency will take about three weeks to review an application spanning thousands of pages.

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A long distance connection: polar climate affects trade wind strength in tropics

Scienmag

Credit: Joe Mastroianni, National Science Foundation The impact of sea surface temperature variations in the tropical Pacific on global climate has long been recognized. For instance, the episodic warming of the tropical Pacific during El Niño events causes melt of sea ice in far-reaching parts of the Southern Ocean via its effect on the global […].

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Novartis secures rights to Mesoblast’s remestemcel-L for ARDS

Pharma Times

Drug is currently being evaluated in a phase III COVID-19-related ARDS study

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New report projects severe coral bleaching globally in this century

Scienmag

Lead author is a scientist with NOAA’s Cooperative Institute of Marine and Atmospheric Science Credit: Marti Colognoli, Coral Guardian | Coral Reef Image Bank MIAMI–The United Nations recently released a new report projecting future coral reef bleaching globally. The lead author of the report, Ruben van Hooidonk, is a scientist with NOAA’s Cooperative Institute of […].

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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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Amazon launches online pharmacy in the US

Pharma Times

Service also offers price comparison on generic and branded drugs

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Zebra finches amazing at unmasking the bird behind the song

Scienmag

The spirited songbirds can rapidly memorize the signature sounds of at least 50 different members of their flock Credit: Image courtesy of Frederic Theunissen If songbirds could appear on “The Masked Singer” reality TV competition, zebra finches would likely steal the show. That’s because they can rapidly memorize the signature sounds of at least 50 […].

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Alnylam's RNAi therapeutic Oxlumo gets EU green light

Pharma Times

Treatment approved to treat primary hyperoxaluria type 1

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New type of ultrahigh piezoelectricity in hydrogen-bonded ferroelectrics

Scienmag

Credit: ©Science China Press Prevalent piezoelectric materials like barium titanate (BaTiO3) and lead zirconate titanate (PZT) possess high piezoelectric coefficients 20-800 pC/N, which are also ferroelectric. The Curie temperature of those ferroelectrics are mostly far above room temperature, so the change of polarization ?P upon a strain at room temperature is approximately the same as […].

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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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American College of Rheumatology, Nov. 5-9

The Pharma Data

The annual meeting of the American College of Rheumatology was held virtually this year from Nov. 5 to 9 and attracted participants from around the world, including rheumatology specialists, physicians, scientists, and other health professionals. The conference featured presentations focusing on the latest advances in the diagnosis and treatment of arthritis as well as other rheumatic and musculoskeletal diseases.

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Accelerator makes cross-country trek to enable laser upgrade

Scienmag

Jefferson Lab ships its final accelerator section for a project to upgrade the world’s brightest X-ray laser Credit: DOE’s Jefferson Lab Today, the U.S. Department of Energy’s Thomas Jefferson National Accelerator Facility has shipped the final new section of accelerator that it has built for an upgrade of the Linac Coherent Light Source (LCLS).

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Prescient Announces Recent Appointments to its Senior Team

pharmaphorum

Prescient hires three new senior members to expand its expertise and keep pace with the company’s growth. LONDON, November 3, 2020 – Prescient , a biopharma product and portfolio strategy partner, announces the recent appointment of three new senior members: Gordon Gochenauer, Dr. Priya Kar and Dr. Cameron Mackenzie. They join the existing leadership team, which shapes the competitive strategies of Prescient’s clients through dynamic decision support.

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TTUHSC scientist takes next step in search for bone disease treatment

Scienmag

Das study indicates KLF2 induction in DPSCs can promote osteoblast Credit: TTUHSC For more than a decade, Hiranmoy Das, Ph.D., has been investigating how Kruppel-like Factor 2 (KLF2), a gene that codes protein into a specific human chromosome, influences the development of bone and musculoskeletal diseases such as rheumatoid arthritis and osteoporosis.

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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.