Mon.Feb 08, 2021

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New data on AstraZeneca vaccine add to worries over coronavirus variant from South Africa

Bio Pharma Dive

South Africa will use other shots in its immunization campaign after AstraZeneca's offered "minimal protection" against the variant that's spread throughout the country.

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How CureVac is creating a ‘broad pipeline’ of both first and second generation COVID-19 vaccines

BioPharma Reporter

CureVac aims to bring together expertise from both its own company and other stakeholders to provide âbroader and faster protection against current and future viral threatsâ: through collaborations with the UK Government, Bayer and GSK all announced this month.

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Editas names new CEO in latest executive shakeup

Bio Pharma Dive

James Mullen, chair of Editas' board and a former Biogen CEO, will replace Cynthia Collins in a critical year for the gene editing biotech.

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Jazz Pharmaceuticals to acquire GW Pharma for $7.2bn

Pharma Times

Jazz will add GW's plant-derived cannabinoid treatment Epidiolex to its roster

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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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On target, on-time enrollment, even in a global pandemic

Bio Pharma Dive

Completing enrollment of a phase 3 trial on-time, even through the height of COVID-19

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BMS finally gets FDA OK for liso-cel, sets $410k launch price

pharmaphorum

Bristol-Myers Squibb finally has FDA approval for its CAR-T therapy liso-cel, which has been cleared by the US regulator as Breyanzi for certain forms of large B-cell lymphoma. The green light comes too late for holders of the contingent value right (CVR) BMS offered as a sweetener to its takeover of Celgene, which lapsed because liso-cel didn’t get approval by the deadline of 31 December.

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VPAS: Achievement so far on objectives for the economy and innovation

pharmaphorum

In the third part of this series taking stock of t he 2019 Voluntary Scheme for Branded Medicines Pricing and Access objectives, Leela Barham looks at the third VPAS objective that relates to the economy and innovation. The objectives for the economy and innovation are to: deliver a net benefit to the UK economy overall; and. support the life sciences industry across the UK and future innovation.

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Cancer Drug Fights COVID-19 Respiratory Deaths in Hospital Trial

BioSpace

Veru announced positive results from its Phase II trial of its VERU-111 compared to placebo in hospitalized patients at high risk for Acute Respiratory Distress Syndrome (ARDS) from COVID-19.

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EU industry group warns new export rules threaten COVID-19 vaccine production and supply

BioPharma Reporter

EU pharma industry representatives have expressed concern that the recently enacted EU export transparency mechanism could risk production delays or jeopardize the supply of COVID-19 vaccines in Europe.

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Cleaning Up the Mississippi River

Scienmag

Louisiana State University Boyd Professor tracks 100-year history Credit: LSU Louisiana State University College of the Coast & Environment Boyd Professor R. Eugene Turner reconstructed a 100-year record chronicling water quality trends in the lower Mississippi River by compiling water quality data collected from 1901 to 2019 by federal and state agencies as well as […].

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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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Uber to Acquire Drizly for $1.1 Billion

XTalks

Uber is acquiring Drizly for $1.1 billion, with plans for the apps to integrate and provide users with alcohol delivery. Drizly is an on-demand alcohol marketplace in the US and is available in more than 1,400 cities across the country. Drizly works with local merchants to provide consumers with beer, wine and spirits with competitive and transparent pricing, while being fully compliant with regulations.

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Kessler Foundation to study effects of MS disease-modifying therapy on cognitive fatigue

Scienmag

Dr. John DeLuca leads team in novel study of the effects of a MS disease-modifying agent on the symptoms of cognitive fatigue that adversely affect many individuals with multiple sclerosis Credit: Kessler Foundation East Hanover, NJ. February 8, 2021 – Kessler Foundation researchers have received support from Genentech, a member of the Roche Group, to […].

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Are Two Better Than One? Expert Weighs in on Double Masking

BioSpace

Ever since Dr. Fauci said he often double masks and that two masks “just makes common sense,” the medical community has been in somewhat of a debate with many in agreement, and some saying the opposite.

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Yes, allergy seasons are getting worse; blame climate change

Scienmag

Credit: William Anderegg If you live with seasonal allergies and feel like the pollen seasons feel longer and longer every year, you may be right. New research shows that pollen seasons start 20 days earlier, are 10 days longer, and feature 21% more pollen than in 1990–meaning more days of itchy, sneezy, drippy misery. Led […].

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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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Janssen Shows 35% Drop in Mortality with Prostate Cancer Drug

BioSpace

A final analysis of the Phase III TITAN study shows that Janssen’s ERLEADA®, when added to androgen deprivation therapy, significantly improved overall survival in patients with metastatic castration-sensitive prostate cancer (mCSPC) compared with placebo.

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Halt cell recycling to treat cancer

Scienmag

UC researchers found that stopping cell recycling in cancer cells could help treat a very aggressive form of breast cancer Credit: University of Cincinnati Recycling cans and bottles is a good practice. It helps keep the planet clean. The same is true for recycling within cells in the body. Each cell has a way of […].

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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

While the approval pathway for biosimilar products was established 12 years ago, there are still misconceptions about how biosimilars are approved, biosimilarity versus interchangeable status and which patients can be treated with biosimilars. In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options.

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Study seeks to better understand how COVID-19 and cancer intersect

Scienmag

MUSC Hollings Cancer Center researchers join nationwide study to examine long-term outcomes of cancer patients diagnosed with COVID-19 Credit: MUSC Hollings Cancer Center Researchers at MUSC Hollings Cancer Center have joined a nationwide study to look at the long-term outcomes of cancer patients who have been diagnosed with COVID-19. The study, which is led by […].

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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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NeuroRX/Relief Therapeutics' COVID-19 Respiratory Distress Drug Significantly Reduces Hospital Stay

BioSpace

ZYESAMI is intended to block the replication of SARS-CoV-2 in the ATII cell, as well as cytokine synthesis, thereby relieving respiratory distress. It is the only treatment in development that targets these ATII cells, and if approved, would be the first drug on the market for COVID-19 patients c.

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Bernese researchers create sophisticated lung-on-chip

Scienmag

Credit: Pauline Zamprogno, ARTORG Center for Biological Engineering Research The lung is a complex organ whose main function is to exchange gases. It is the largest organ in the human body and plays a key role in the oxygenation of all the organs. Due to its structure, cellular composition and dynamic microenvironment, is difficult to […].

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Top Five Fastest-Growing Beverage Brands

XTalks

The beverage industry encompasses far more than just what comes to mind when we think of famous beverage brands, going beyond soft drinks, juices and bottled water. It is typically divided into two subcategories, alcoholic and non-alcoholic, with many brands venturing into both segments to appeal to a wider consumer base. While some beverage brands have a more focused approach with a core product category, other typically larger and more established brands have a large portfolio of beverage prod

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How rocks rusted on Earth and turned red

Scienmag

Important phenomenon could help assess future climate change Credit: NPS How did rocks rust on Earth and turn red? A Rutgers-led study has shed new light on the important phenomenon and will help address questions about the Late Triassic climate more than 200 million years ago, when greenhouse gas levels were high enough to be […].

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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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China approves Sinovac’s coronavirus vaccine

pharmaphorum

China’s national regulator has approved Sinovac Biotech’s COVID-19 vaccine for use by the general public. This is the second vaccine approved by China’s National Medical Products Administration (NMPA). Both of the vaccines, along with another experimental vaccine from Sinopharm, have been used in China’s vaccination programme. More than 31 million doses have been administered, mainly targeting groups at higher infection risks, while a fourth experimental vaccine from CanSino Biologics has been g

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Early Indian monsoon forecasts could benefit farmers

Scienmag

Seasonal forecasts for Indian summer monsoon accurate in India’s major agricultural regions Credit: Amulya Chevuturi/University of Reading Farmers in India should be provided with early forecasts of expected variations in the monsoon season in order to reduce crop losses, scientists say. Researchers at the University of Reading and the European Centre for Medium-range Weather Forecasts […].

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AZ’s Imfinzi fails to improve overall survival in head and neck cancer again

Pharma Times

Immunotherapy has previously failed in this therapy area

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Ophiura from Russky Island might make photodynamic therapy more affordable

Scienmag

Credit: FEFU press office An unusual biologically active porphyrin compound was isolated from seabed dweller Ophiura sarsii. The substance might be used as an affordable light-sensitive drug for innovative photodynamic therapy and for targeted treatment of triple-negative breast cancer and some other cancers. Researchers from the School of Biomedicine of Far Eastern Federal University (FEFU) […].

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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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Push Doctor partners with Well Pharmacy on UK’s first ‘pharmacy-first’ digital service

Pharma Times

Over 50,000 patients will have direct access to local community pharmacists

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1918 pandemic second wave had fatal consequences

Scienmag

Credit: Archive of the History of Medicine, University of Zurich In the event of a pandemic, delayed reactions and a decentralized approach by the authorities at the start of a follow-up wave can lead to longer-lasting, more severe and more fatal consequences, researchers from the universities of Zurich and Toronto have found. The interdisciplinary team […].

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Lonza to Sell Specialty Ingredients Division for $4.7 Billion, Pivot to Pharma

BioSpace

Lonza has been in the process of separating LSI into a standalone unit since 2019.

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Personal data, fodder for cyberwarfare? New models for stepping up cybersecurity

Scienmag

Although organizations invest in resources to protect their data, many fail to acknowledge the dangers of poorly managing the digital world More awake to this issue than most, Regner Sabillon, a doctoral student at the Universitat Oberta de Catalunya (UOC), dissects these models in his thesis, Digital Forensics Assessment, Cyberlaw Review and Cybercrime Analysis to […].

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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.