Wed.Mar 31, 2021

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FDA advisers reassert case against approval of Biogen's Alzheimer's drug

Bio Pharma Dive

In a new editorial, three of the agency's advisers reiterated that they see "no persuasive evidence to support approval of aducanumab at this time.

Drugs 312
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Azelis releases ‘Action 2025’, confirming sustainability as a key driver in growth strategy

Pharma Mirror

Azelis, an innovation service provider, is excited to release its sustainability strategy, ‘Action 2025’, reinforcing its commitment to become the world-leading provider of sustainable solutions and services in the specialty chemicals and food ingredients distribution industry. Through its sustainability program and strategy, Azelis wants to turn the sustainability aspirations of its principals and customers into innovative sustainable solutions.

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Pfizer, BioNTech's vaccine protects 12- to 15-year-olds from COVID-19 in study

Bio Pharma Dive

The positive finding should pave the way for broader use of the vaccine among adolescents, an important step for reaching herd immunity against the virus.

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CPhI Discover: connecting global pharma & pre-qualifying partners ahead of in person events

Pharma Mirror

Informa Markets is launching an annual dedicated online platform for pharma in May (17-28th), CPhI Discover – designed to encourage suppliers and customers to source, meet and discover – providing the industry with a new synergistic offering to sit alongside CPhI’s portfolio of in person events. In the last year, the pharma industry has adapted its approach to meeting new partners and existing customers, with wider pools of suppliers now needed, putting greater pressure on resources to find and

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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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FTC challenges Illumina's $7B Grail buyout amid new scrutiny of life science deals

Bio Pharma Dive

The commission said the union will "harm competition in the U.S. market" for early cancer detection tests as it signals a tougher stance toward life sciences acquisitions.

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Pfizer and BioNTech ramp up COVID-19 vaccine production to 2.5 billion doses

BioPharma Reporter

Pfizer and BioNTech expect to expand COVID-19 vaccine manufacturing capacity to up to 2.5 billion doses by the end of 2021, thanks to the optimization of production processes and the recent initiation of production in Marburg, Germany.

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Germany and Canada restrict AZ vaccine again over blood clot fears

pharmaphorum

Germany and Canada have both slapped restrictions on the AstraZeneca vaccine, recommending its use only in older patients, because of concerns over a link with blood clots. The moves come after the country’s medicines regulator found 31 cases of a rare type of blood clot known as cerebral venous sinus thrombosis (CVST) in people who had received the vaccine produced by AZ.

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AbbVie Receives NDA for Atogepant, Aims to Stop Migraines in Their Tracks

BioSpace

AbbVie won the NDA on the strength of definitive results in a Phase III ADVANCE trial, where atogepant met all six secondary endpoints at the 30-60 mg dose range, proving statistically significant in heading off migraines in nearly 2500 adult participants who experience them between 4-14 days per.

Trials 101
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Mmmly: The Newest Plant-Based, Functional Cookie Brand

XTalks

Mmmly, a new cookie brand based in Westchester, New York, is on a mission to change cookies for the better. Unlike most cookie brands that focus on flavor over nutrition, Mmmly aimed to use clean and functional ingredients in its plant-based, organic, keto and gluten-free cookies. The brand features innovative ingredients including tigernut flour, root vegetables, fruits, prebiotic fibers and healthy fats — ingredients not traditionally found in cookies.

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Novartis builds radio-oncology pipeline with iTheranostics deal

pharmaphorum

Novartis has added to its pipeline of radiopharmaceuticals pipeline once again, licensing a series of agents from iTheranostics that can be used to show where tumours are located in the body. . The diagnostic imaging agents all target fibroblast activation protein (FAP), a molecule that is only expressed at low levels on healthy cells but is found much more abundantly in solid tumours.

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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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Factory Mix-Up Ruins Up to 15 Million Vaccine Doses From Johnson & Johnson

NY Times

A manufacturing subcontractor in Baltimore mixed ingredients from the coronavirus vaccines of Johnson & Johnson and AstraZeneca, setting back U.S. production of the “one-and-done” shot.

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A statistical solution to processing very large datasets efficiently with memory limit

Scienmag

Scientists develop a statistical randomness-based framework to optimally classify extremely large datasets without needing large memories Credit: Ryo Maezono from JAIST. Ishikawa, Japan – Any high-performance computing should be able to handle a vast amount of data in a short amount of time — an important aspect on which entire fields (data science, Big Data) […].

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GSK on COVID and vaccine development: the pharmaphorum podcast

pharmaphorum

In the latest episode of the podcast Dominic Tyer speaks with GlaxoSmithKline’s Philip Cruz about the discovery and commercialisation of new vaccines in the light of the pandemic. Philip who is vaccines medical director for the UK and Ireland, and a paediatrician by training, tackles the clear pre- and post-COVID differentiation seen in approaches to vaccines.

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A Skoltech method helps model the behavior of 2D materials under pressure

Scienmag

Credit: ACS Nano (2021). DOI: 10.1021/acsnano.0c10609 Scientists from the Skoltech Center for Energy Science and Technology (CEST) have developed a method for modeling the behavior of 2D materials under pressure. The research will help create pressure sensors based on silicene or other 2D materials. The paper was published in the ACS Nano journal. Silicene, which […].

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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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Actively Monitoring Remote Employees to Ensure Productivity Success

BioSpace

If employers genuinely want to ensure that their workers spend their valuable time on the clock working diligently, then they should consider implementing some of these productivity monitoring programs.

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1 in 5 Americans did not seek needed medical treatment during the pandemic due to cost

Scienmag

More than 46 million say they still could not afford medical care today Credit: West Health-Gallup WASHINGTON, DC – March 31, 2021 — Nearly 20% of Americans, or more than 46 million adults, say they did not seek treatment for a health problem in the last year due to cost, and an equal number say […].

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IRS Investigating Bristol Myers Squibb Over Tax Scheme Worth $1.4 Billion

BioSpace

In a statement, the company said, “Bristol Myers Squibb is in compliance with all applicable tax rules and regulations. We work with leading experts in this area and will continue to work cooperatively with the IRS to resolve this matter. Beyond that, we don’t comment on ongoing regulatory matters.

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New study supports the effectiveness of the ForsythKids school-based dental program for reducing untreated tooth decay

Scienmag

Credit: Forsyth Institute In a longitudinal study published earlier this month in the Journal of the American Dental Association, researchers analyzed untreated decay in a cohort of nearly 7,000 children enrolled in the ForsythKids preventive dentistry program. Over the course of six years, the percentage of children with untreated cavities in the program decreased from […].

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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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NHS extends ‘COVID-friendly’ at-home cancer care

Pharma Times

Funding for effective, 'less risky' treatments extended until summer 2021

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Leipizig University joins new DFG Priority Program on the fluvial anthroposphere

Scienmag

Collaboration between Leipzig University, the University of Tübingen and the Technical University of Darmstadt Credit: Christoph Zielhofer, Leipzig University Floodplains are exceptionally dynamic landscapes and key areas of Europe’s cultural and natural heritage. Strategies for land reclamation and risk minimisation, such as flood defence systems, have meant that up to 95 per cent of Central […].

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Disinformation Dozen: The Anti-Vaxxers Behind Most Social Media Misinformation

XTalks

A new report from the Center for Countering Digital Hate (CCDH) and Anti-Vax Watch has identified 12 individuals, dubbed the “Disinformation Dozen,” as being responsible for spreading up to 65 percent of all online anti-vaccine information. The Disinformation Dozen includes influential anti-vax leaders such as Robert F. Kennedy Jr., Joseph Mercola and Ty and Charlene Bollinger, among others.

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Chemo for glioblastoma may work better in morning than evening

Scienmag

Study indicates timing of chemotherapy could improve treatment for deadly brain cancer Credit: Washington University School of MEdicine An aggressive type of brain cancer, glioblastoma has no cure. Patients survive an average of 15 months after diagnosis, with fewer than 10% of patients surviving longer than five years. While researchers are investigating potential new therapies […].

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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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JLL Report Ranks Up-and-Coming Life Sciences Hubs

BioSpace

New markets are emerging, and a new report from the market research team at JLL pinpoints some of these growing areas.

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Caffeine Consumption in Pregnancy + Portable Neuromodulation Stimulator for MS – Xtalks Life Science Podcast Ep. 4

XTalks

In this episode of the Xtalks Life Science Podcast, Ayesha discusses the results of a new NIH study that suggest a link between moderate caffeine consumption during pregnancy and lower birth weight and reduced body size. Should pregnant women avoid caffeine altogether, or is this yet another restriction placed on expectant mothers that might not be necessary?

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Advancing Your Career in a Pandemic

BioSpace

The global COVID-19 pandemic may not seem like the best time to accelerate your career, but some characteristics of this unusual time actually lend themselves to career-boosting activities. Whether you are still working from home or are back in your workplace, this article offers suggestions for.

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Bluestar Genomics gains FDA Breakthrough Device designation for pancreatic can

Scienmag

Company accelerates commercialization efforts to address a million at-risk patients’ unmet needs Bluestar Genomics announces today it received U.S. Food and Drug Administration (FDA) Breakthrough Device designation for its proprietary noninvasive pancreatic cancer detection test in patients with new-onset diabetes. The FDA’s Breakthrough Device program accelerates the development of medical devices that have the potential […].

Genome 75
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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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CDC Ranks COVID-19 as Third Leading Cause of Death in 2020

BioSpace

Several new reports, two by the U.S. CDC, describe just how severely COVID-19 has affected mortality figures in the U.S., and around the world, as well as ripple effects that extended to other forms of death.

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Weight loss changes people’s responsiveness to food marketing: study

Scienmag

Obesity rates have increased dramatically in developed countries over the past 40 years — and many people have assumed that food marketing is at least in part to blame. But are people with obesity really more susceptible to food marketing? And if they are, is that a permanent predisposition, or can it change over time? […].

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Global Roundup: Astellas Eyes European Approval of Urothelial Cancer Drug

BioSpace

Biopharma and life sciences companies from across the globe provide updates on their pipelines and businesses.

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The Lancet GH: COVID-19 pandemic worsened pregnancy outcomes for women and babies worldwide

Scienmag

Findings reveal overall increase in the chances of stillbirth and maternal death during the pandemic, but chances of pre-term birth decreased in high-income countries Review of 40 published studies from 17 countries offers first global assessment of the collateral impact of the COVID-19 pandemic on pregnancy outcomes. Findings reveal overall increase in the chances of […].

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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.