Wed.May 19, 2021

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FDA seeking more consistency from cell, gene therapy developers, top official says

Bio Pharma Dive

A number of drugmakers have recently faced development delays after the FDA's asked for more information on how they measure the potency of their products.

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Three ways to combat stress in a remote working healthcare team

World of DTC Marketing

The pandemic has been uniquely stressful for healthcare teams. With some parts of the sector shifting to remote work, that stress tended to build, having a real impact on mental health. It can be hard to manage a remote team, even more so to take care of their mental health, but there are a few steps that every employer can take. #1 Set up a Digital Helpdesk.

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Rashedi Hassan takes over Sales & Marketing management of Telstar’s subsidiary in Bangladesh

Pharma Mirror

Terrassa (Barcelona). Azbil Telstar announces the appointment of Rashedi Hassan as a Sales & Marketing Manager of the subsidiary of the company in Dhaka, Bangladesh. From 14th February 2021, Rashedi Hassan focuses his responsibility on developing extensive marketing and sales plan to strengthen the Telstar brand position in the local pharmaceutical market and to promote the presence and distribution of Telstar branded Life Sciences service & product solutions in the region, particularly

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Bristol Myers details data for closely watched cancer immunotherapy

Bio Pharma Dive

Study results presented ahead of the year's biggest cancer meeting show, for the first time, that a drug blocking the protein LAG-3 improves on the benefit of another immunotherapy.

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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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AbbVie CEO looks like a fool before Congress

World of DTC Marketing

SUMMARY: “You’re spending all this money to make sure you make money rather than spending money to… help patients,” the California congresswoman told AbbVie’s, Richard Gonzalez. “ That was pretty brutal, but to was right on target by Rep Katie Porter. While AbbVie is a poster for everything wrong with pharma, what they have done doesn’t apply to ALL pharma companies.

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FDA delays a biotech's cancer cell therapy once again

Bio Pharma Dive

Iovance, which now plans to submit its melanoma treatment to the FDA next year, separately disclosed that its CEO Maria Fardis will resign.

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Janssen inks inflammatory disease collaboration with Mestag Therapeutics

Pharma Times

Collaboration will utilise Mestag’s specialist fibroblast subpopulation biology platform to identify novel therapeutic targets

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Centivax Drives Next-Generation COVID-19 Antibody into the Clinic

BioSpace

“The virus will not be eradicated through vaccination alone. That means. we need our medicines. That was a failure of 2020 that doesn’t get enough emphasis,” Jake Glanville, chief executive officer of Bay Area-based Centivax, told BioSpace in an interview.

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Healthcare bills to pay? Let hi.health pick up the tab

pharmaphorum

Just over a year ago, hi.health launched an app that takes the legwork out of submitting reimbursement claims to private health insurers. Now, the startup has taken another leap forward, settling users bills immediately. . Fredrik Debong. The addition to the hi.health app acts as a digital health expense account, according to the company’s co-founder and chief scientific officer Fredrik Debong, who was a co-founder of diabetes management app mySugr.com, which was snapped up by Roche in 201

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White shark population is small but healthy off the coast of Central California

Scienmag

Credit: Scot Anderson NEWPORT, Ore. – The population of white sharks that call the Central California coast their primary home is holding steady at about 300 animals and shows some signs of growth, a new long-term study of the species has shown. Between 2011 and 2018, researchers were able to identify hundreds of individual adult […].

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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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Leo Pharma’s Tralokinumab News: What You Need to Know

BioSpace

While waiting for further updates, here’s everything you need to know about this highly-anticipated atopic dermatitis treatment.

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Researchers shed light on the evolution of extremist groups

Scienmag

Findings suggest new strategies to limit the growth of groups like the Boogaloo and ISIS Credit: Neil Johnson/GW WASHINGTON (May 19, 2021)–Early online support for the Boogaloos, one of the groups implicated in the January 2021 attack on the United States Capitol, followed the same mathematical pattern as ISIS, despite the stark ideological, geographical and […].

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4 Ways Career Assessments Can Help You Find Your Dream Job

BioSpace

If you’re struggling to find your dream job or unsure of what your next career move should be, a career assessment might be the next right step.

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Tree species diversity is no protection against bark beetle infestation

Scienmag

Credit: aerial photos by K. R. Kovach, Sixtoothed spruce bark beetle photo by U. Schmidt In recent years, foresters have been able to observe it up close: First, prolonged drought weakens the trees, then bark beetles and other pests attack. While healthy trees keep the invaders away with resin, stressed ones are virtually defenseless. Freiburg […].

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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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ASCO 2021: Watch for Sanofi/Sloan Kettering, Incyte, Exelixis and AstraZeneca

BioSpace

Companies have already begun their announcements of new clinical studies for various treatment settings in preparation for ASCO 2021.

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Pfizer and Moderna COVID-19 Vaccines Found to Induce Robust T Cell Responses Against Variants

XTalks

As vaccinations continue to ramp up worldwide in the fight against COVID-19 amidst uncertainties over variants of concern, early data from a lab study shows that the mRNA COVID-19 vaccines from Pfizer and Moderna are effective against some of the variants. In a small study conducted by researchers from the University of California and the Gladstone Institute of Virology in San Francisco, it was found that both vaccines elicited immune responses, particularly robust T cell responses, against the

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House Subcommittee Interrogates Emergent Execs Over Vaccine and Money Mess

BioSpace

The House Select Subcommittee on the Coronavirus Crisis questioned executives from Emergent BioSolutions as part of a congressional probe.

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Recruiting participants to the first European Red list of insect taxonomists

Scienmag

Contributors will enable the EU to take action to plug in the essential scientific knowledge to address insect declines Credit: Royal Belgian Institute of Natural Sciences The ‘Red List of Taxonomists’ initiative, funded by the European Union, launches its registration portal, where professionals and citizen scientists are called to register on.

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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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Voyager Therapeutics CEO and CMO Resign as Company Undergoes Strategic Shift

BioSpace

Shares of Voyager Therapeutics fell in aftermarket trading after its CEO and CMO announced plans to depart the company following clinical setbacks with a Parkinson’s disease program.

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New FAST discoveries shed light on pulsars

Scienmag

Credit: NAOC Using the Five-hundred-meter Aperture Spherical radio Telescope (FAST), a research team led by Prof. HAN Jinlin from National Astronomical Observatories of Chinese Academy of Sciences (NAOC) has discovered 201 pulsars, including many very faint pulsars, 40 millisecond pulsars (MSPs), and 16 pulsars in binaries. These discoveries were published in Research in Astronomy and […].

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NAO report finds UK was ‘not as prepared for pandemic as it could have been’

Pharma Times

NHS Confederation chief exec Danny Mortimer said report ‘re-emphasises’ long-term health and social care issues

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HAYA, RenBio Launch with Sights Set on Clinic

BioSpace

Two different companies, cardiac fibrosis RNA company HAYA Therapeutics and COVID-19 bispecific player RenBio, launched today with funding rounds designed to push them toward the clinic.

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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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Long search finds grain of hope in the glume

Scienmag

Credit: John Innes Centre Researchers have found the elusive genetic element controlling the elongated grains and glumes of a wheat variety identified by the renowned botanist Carl Linnaeus more than 250 years ago. The findings relating to Polish wheat, Triticum polonicum, could translate into genetic improvements and productivity in the field. Wheat, in bread, pasta, […].

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Global Roundup: Russia-Developed RA Drug Shows Significant Promise in Phase III Study

BioSpace

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

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Penn nursing-led Philly team awarded $1.4 million NIH grant to expand COVID-19 outreach

Scienmag

Collaboration includes Penn Medicine, Annenberg School for Communication, The City of Philadelphia department of public health, and Philly Counts Credit: Penn Nursing PHILADELPHIA (May 19, 2021) – José A. Bauermeister, PhD, and Antonia M. Villarruel, PhD, are leading one of 10 new research teams from across the country that received National Institutes of Health (NIH) […].

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10 Things You Should Know Before Jumping into a Freelance Career

BioSpace

Along with the growing trends of working from home and online, freelancing is becoming a more and more popular career path.

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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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Study shows sharp decrease in Texas childhood vaccination rates during pandemic

Scienmag

Texas A&M researchers found the declines were greatest for 5-month-olds and 16-month-olds, but no decrease was seen in vaccines given at birth Credit: Texas A&M University Despite expert recommendations that children continue to get regularly scheduled vaccines during the pandemic, vaccination rates have decreased in several states. A new study by researchers from the Texas […].

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How to improve payer engagement with tailored value communication

pharmaphorum

Pharmaceutical drug success rests on being able to achieve market access. Brands are facing increasing pressure to demonstrate strong value propositions in increasingly crowded therapeutic areas. However, value can mean different things to different payers. In this article, Cecilie Alstad, senior analyst at Research Partnership, discusses how an approach established in the world of marketing and commercial strategy could be the key to significantly improving pharma’s payer engagement.

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A rapid antigen test for SARS-CoV-2 in saliva

Scienmag

Credit: Shinichi Fujisawa Scientists from Hokkaido University have shown that an antigen-based test for quantifying SARS-CoV-2 in saliva samples is simple, rapid, and more conducive for mass-screening. More than a year into the COVID-19 pandemic, the RT-PCR test remains the gold standard for detection of the SARS-CoV-2 virus. This method requires trained personnel at every […].

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Lilly's Tirzepatide Significantly Reduces A1C, Body Weight Versus Insulin Glargine

BioSpace

Eli Lilly's SURPASS-4 trial program shows tirzepatide, significantly reduced blood glucose levels and body weight better than insulin glargine in adult patients with type 2 diabetes.

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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.