Tue.May 25, 2021

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Moderna, with new results, set to seek vaccine clearance for young teens

Bio Pharma Dive

The biotech's shot was strongly protective against COVID-19 in a study of 12- to 17-year-olds, a finding that could soon make it the second vaccine available for adolescents in the U.S.

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Pfizer explores co-administration of pneumococcal vaccine with COVID-19 booster shot

BioPharma Reporter

Pfizer has enrolled the first subjects in a study exploring the co-administration of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate following a booster dose of the Pfizer-BioNTech COVID-19 vaccine.

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ICER, vocal critic of drug company pricing, turns scrutiny to insurers

Bio Pharma Dive

The watchdog group plans to examine how cost sharing can hurt access to care, but it won't assess some of the most controversial insurer practices.

Drugs 257
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How to Prove You Can Effectively Work Remotely on Your Resume

BioSpace

If you’ve never worked from home or had a flexible schedule, how do you portray to a recruiter or hiring manager that you have what it takes to be productive outside of the traditional office?

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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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Racemases: The hunt for drugs to neutralise these critical enzymes

Scienmag

Scientists from the University of Bath in the UK explore racemases and propose strategies for finding drugs that target these important enzymes. Credit: University of Bath Scientists from the UK’s University of Bath explore racemases – an important type of enzyme that is linked to certain cancers and other life-threatening diseases while also being critical […].

Drugs 98
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Takis Disrupt the Salty Snack Category by Introducing Five New Products

XTalks

Takis, a chip company, known for its spicy rolled tortilla chip, announced that they are expanding their brand by introducing five new snacks with their signature Fuego flavor and a new brand look. The company is looking to disrupt the market by entering the salty snack category and placing itself as the most intense snack brand in the world. The brand came to the US in 2001 and they have been known since then to provide consumers with the spice they wanted.

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AbbVie in Hot Water Over Patent Abuses and Price Hikes to Block Humira Biosimilar Competition

XTalks

AbbVie (NYSE:ABBV) continues to face heat over complaints of patent exploitation and price hikes of its world’s best-selling drug Humira (adalimumab) to build a market monopoly and block out Humira biosimilar competition. A recent congressional probe provided confirmation of the claims. Overpatenting and overpricing Humira has been a part of AbbVie’s strategy to prevent biosimilars of the blockbuster drug from entering the market.

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Nanoparticle based shot could boost efficacy, accelerate production of seasonal flu vaccines

BioPharma Reporter

Seasonal flu vaccines typically work 40-60% of the time, according to the US Centers for Disease Control and Prevention (CDC). An experimental recombinant protein nanoparticle vaccine that stimulates a strong immune response is hoping to address that inefficiency.

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Innovation pioneers score world first for sustainable construction with graphene concrete

Scienmag

First commercial pour of engineered graphene concrete takes place in UK using Manchester technology Credit: The University of Manchester/Nationwide Engineering Manchester innovation pioneers score world first for sustainable construction with graphene concrete. Construction firm Nationwide Engineering will make a piece of history on Tuesday 25 May, as it completes the laying of the world’s first […].

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Engine and Giiant Scoop Up Fresh Funding for Cancer and IBD

BioSpace

Engine is ready to drive its lead program into clinical trials by 2023 while Giiant’s preclinical program will target moderate-to-severe ulcerative colitis.

Engineer 101
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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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Probing deeper into origins of cosmic rays

Scienmag

Simulation model provides first step in developing algorithms to enhance detection methods. Credit: Salvatore Buonocore WASHINGTON, May 25, 2021 — Cosmic rays are high-energy atomic particles continually bombarding Earth’s surface at nearly the speed of light. Our planet’s magnetic field shields the surface from most of the radiation generated by these particles.

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Emergent Enjoys Some Good News, Posting Positive Results for Chikungunya Vaccine

BioSpace

Emergent said the vaccine candidate against the mosquito-borne illness showed an increase in immune response as measured by anti-chikungunya virus SNA.

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Odd angles make for strong spin-spin coupling

Scienmag

Rice physicists’ RAMBO reveals magnetic phenomenon useful for quantum simulation and sensing Credit: Illustration by Motoaki Bamba/Kyoto University HOUSTON – (May 25, 2021) – Sometimes things are a little out of whack, and it turns out to be exactly what you need. That was the case when orthoferrite crystals turned up at a Rice University […].

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Straight after its first cancer bispecific OK, J&J highlights two more at ASCO

pharmaphorum

With the ink barely dry on the FDA’s approval of Johnson & Johnson’s Rybrevant, its first bispecific antibody for cancer, the drugmaker is already showcasing others in its pipeline. . Two of its earlier-stage bispecifics – both in development for the blood cancer multiple myeloma – will feature at the American Society of Clinical Oncology (ASCO) congress, which kicks off in a few days’ time.

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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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Vectura Group Undergoes $1.36 Billion Takeover by Global Investment Firm

BioSpace

On Wednesday morning, the company announced that it would be undergoing a $1.36 billion takeover by global investment firm The Carlyle Group.

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National Foundation for Cancer Research announces 2021 Salisbury Award Competition Winners

Scienmag

The program is designed to catalyze and advance promising cancer research innovations onto a path of commercialization and patient impact Credit: National Foundation for Cancer Research, RadioMedix, TanoMed, Tel Aviv University, Libera Bio ROCKVILLE, MD – The National Foundation for Cancer Research (NFCR) announced winners of the 2021 Salisbury Award Competition for Entrepreneurial Translational Research, […].

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Opdivo plus Yervoy moves closer to EU approval for dMMR/MSI-H colorectal cancer

Pharma Times

CHMP recommended EU approval for combination treatment in its May decisions

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Lyell Plans $150 Million IPO to Advance Cell Therapies for Solid Tumors

BioSpace

The company, which isn’t expected to enter the clinic until possibly in 2022, is working to make cell therapies work in solid tumors.

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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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Geology helps map kidney stone formation from tiny to troublesome

Scienmag

Credit: Image courtesy of Mayandi Sivaguru, University of Illinois CHAMPAIGN, Ill. — Advanced microscope technology and cutting-edge geological science are giving new perspectives to an old medical mystery: How do kidney stones form, why are some people more susceptible to them and can they be prevented? In a new paper published in the journal Nature […].

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Money on the Move: May 19-25

BioSpace

Drug development requires solid funding. Here's who's standing on higher ground this week with fresh investment dollars.

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Hurricane Matthew storm surge data wins NHERI DesignSafe Dataset Award 2021

Scienmag

Data assimilation method improves NOAA forecasts of coastal flooding Credit: FEMA News Photos Hurricane storm surge is one of the most hazardous and difficult parts of a hurricane to forecast. Researchers at the University of North Carolina, Chapel Hill (UNC) have developed a data assimilation method for improving multi-day forecast of coastal water levels.

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How Women Can Have a Feminist Menopause

NY Times

Women often experience the hormonal transition of midlife in a shroud of misinformation and shame. We deserve better.

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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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Harnessing next generation sequencing to detect SARS-CoV-2

Scienmag

…and prepare for the next pandemic Credit: Peter Duchek Researchers at the Vienna BioCenter designed a testing protocol for SARS-CoV-2 that can process tens of thousands of samples in less than 48 hours. The method, called SARSeq, is published in the journal Nature Communications and could be adapted to many more pathogens. The COVID-19 pandemic […].

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Despite Advances in Drug Development, HIV Fight Falters During Pandemic

BioSpace

When the pandemic hit, many companies diverted resources aimed at HIV to COVID-19, which ended up pausing some research efforts.

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Building a better LED bulb

Scienmag

UH researchers’ new prototype LED lightbulb emits less of that troublesome blue light LED lightbulbs offer considerable advantages over other types of lighting. Being more efficient, they require much less electricity to operate. They do not give off unwanted heat the way old-school incandescent bulbs do, and the best of them long outlast even fluorescent […].

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FDA Places Hold on Friedreich’s Ataxia Candidate After Nonhuman Primate Deaths

BioSpace

This is after Larimar reported deaths in the highest dose levels of a nonhuman primate toxicology study.

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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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Researchers seek deeper understanding on how cells in the body operate

Scienmag

An interdisciplinary team seeks to better understand how the mechanical properties of cells operate in the body and how pathologies can disrupt these processes. Cells sense and respond to the mechanical properties of the cellular microenvironment in the body. Changes in these properties, which occur in a number of human pathologies, including cancer, can elicit […].

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CytoReason and Ferring Pair Up, Using AI to Improve IBD Drug Options

BioSpace

The purpose is to develop cell-based disease models to accelerate drug discovery and reduce development costs.

Drugs 93
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Association between bitter taste receptor types, clinical outcomes among patients with COVID-19

Scienmag

What The Study Did: This study evaluates the association between bitter taste receptor types (supertasters who experience greater intensity of bitter tastes; tasters; and nontasters who experience low intensity of bitter tastes or no bitter tastes) and outcomes after infection with SARS-CoV-2. Authors: Henry P. Barham, MD, Sinus and Nasal Specialists of Louisiana in Baton Rouge, […].

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Finalists announced for the 2021 International Clinical Researcher of the Year

Pharma Times

Find out which individuals and teams have earned their spot in the head-to-head virtual finals day.

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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.