Tue.Feb 02, 2021

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Pfizer forecasts $15B sales boost from coronavirus vaccine orders

Bio Pharma Dive

The estimate for 2021 sales, which Pfizer splits with partner BioNTech, would make the vaccine one of the highest-selling medicines in the industry.

Sales 231
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Digital health exploding but dangers persist

World of DTC Marketing

SUMMARY : DigitalHealth.com, a British website, had a fascinating look at the use of health apps during the pandemic. Among their findings: Downloads of apps supporting consumers with mental health needs increased by nearly 200% from summer 2019 to summer 2020 Downloads of those supporting consumers with diets and weight loss rose by a massive 1294% from mid-2019 to mid-2020.

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Moderna planning to add doses to coronavirus vaccine vials

Bio Pharma Dive

The biotech aims to add five more vaccine doses to each vial — currently labeled to hold 10 each — but needs to secure FDA sign-off on the change.

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FDA Hit Record Drug and Biologic Approvals in 2020, Despite Ongoing Pandemic

BioSpace

For the pharmaceutical industry, the lack of face-to-face meetings caused the U.S. Food and Drug Administration to implement regulatory workarounds to stay on top of drug and biologics approvals.

Drugs 113
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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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Vertex comes to a crossroads

Bio Pharma Dive

The biotech's cystic fibrosis business is booming. But with a pipeline of risky, disjointed assets, some on Wall Street aren't sure what Vertex's next move is, or why it hasn't been spending its massive amounts of cash.

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DrugPatentWatch featured in Inc Magazine

Drug Patent Watch

DrugPatentWatch was featured in a recent article by Inc. Magazine. In their coverage of Mark Cuban’s new pharma company, they cited our published interview where Mark Cuban Sounds off on Drug Prices.…. The post DrugPatentWatch featured in Inc Magazine appeared first on DrugPatentWatch - Make Better Decisions.

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Study aims to break the chains of incarceration in African American males

Scienmag

Researchers develop ‘care’ approach for re-entry programs that addresses centuries of oppression and segregation Credit: Florida Atlantic University Over the last three decades, the United States prison population has exploded from 300,000 to more than 2 million. More than 1.1 million are African American men – the vast number of whom have returned within one […].

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Jazz Moves to Snap Up Cannabinoid Company, Bolster Neurology Pipeline

BioSpace

Jazz Pharmaceuticals will beef up its neurology pipeline with a $7.2 billion buyout of GW Pharmaceuticals, the only company yet to score U.S. regulatory approval for a cannabis-derived product.

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Warmer climate may make new mutations more harmful

Scienmag

Credit: Mareike Koppik A warmer global climate can cause mutations to have more severe consequences for the health of organisms through their detrimental effect on protein function. This may have major repercussions on organisms’ ability to adapt to, and survive in, the altered habitats of the future. This is shown in a new Uppsala University […].

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COVID-19 News: Vaxart Posts Phase I Data on Oral Vaccine, BMS Licenses mAb

BioSpace

The vast majority of COVID-19 vaccines on the market or in development are administered through an injection, but Vaxart is attempting to develop an oral vaccine.

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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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Some food contamination starts in the soil

Scienmag

Credit: Matt Limmer When most people hear “food contamination,” they think of bacteria present on unwashed fruits or vegetables, or undercooked meat. However, there are other ways for harmful contaminants to be present in food products. Angelia Seyfferth, a member of the Soil Science Society of America, investigates food contamination coming from the soil where […].

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GSK and CureVac Take Aim at COVID-19 Variants with Second-Generation mRNA Vaccine

BioSpace

The collaboration is valued at €150 million (approximately $180 million). The two companies already have a history of working together.

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More mammals are being struck by aircraft each year

Scienmag

Credit: Samantha Ball Investigators have published a global review of mammal strikes with aircraft, noting that events have been increasing by up to 68% annually. More mammals were struck during the landing phase of an aircraft’s rotation than any other phase, according to the article published in Mammal Review. By analyzing published information and mammal […].

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Amgen Q4 Report: Five Halted or Killed Cancer Programs, Revenue Up 7%

BioSpace

Amgen released its fourth-quarter and full-year 2020 results today and although there was good news financially, there was also news of five cancer programs that have either been halted or abandoned.

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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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‘Women and Leadership: Real Lives, Real Lessons’

Scienmag

New MIT press book is a powerful call to action for achieving equality in leadership Credit: Photo credit: The MIT PRESS, 2021. Women make up fewer than ten percent of national leaders worldwide, and behind this eye-opening statistic lies a pattern of unequal access to power. Through conversations with some of the world’s most powerful […].

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FDA Approves Merck KGaA's Tepmetko for Aggressive Lung Cancer

BioSpace

The U.S. Food and Drug Administration (FDA) granted Merck KGaA, Darmstadt, Germany’s Tepmetko (tepotinib) approval for adults with metastatic non-small cell lung cancer (NSCLC) who have a MET exon 14 skipping alteration.

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COVID-19 vaccine equity: Campaigners say onus on pharma companies to start sharing IP and to transfer technology

BioPharma Reporter

Rows about vaccine supply and threats of export blocks donât do anything to bring us closer to ending the COVID-19 pandemic, say campaigners pushing for vaccine equity on a global level.

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Biogen Ditches Parkinson’s Drug After Phase II Study Fails to Show Benefit

BioSpace

As the therapy “did not achieve proof-of-concept” and failed to provide benefit in this study, the development of the drug has been discontinued.

Drugs 84
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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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Will 2021 Be the Year of Hybrid Food Products?

XTalks

Only a month into the new year, hybrids are already taking food and beverage innovation by storm. The traditional meaning of a hybrid food is the crossing of two different varieties of a fruit or vegetable to create a new variety — one that is not found in nature. But the food and beverage industry has created its own spin on hybrid foods and there are already a variety of new products this year that exemplify it.

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Study Supports Delay of Second Dose of AstraZeneca's COVID-19 Vaccine

BioSpace

Although designed for two doses, primary analysis of AstraZeneca and the University of Oxford’s Phase III data for its COVID-19 vaccine found it to have 76% efficacy after the first dose.

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Tiny 3D structures enhance solar cell efficiency

Scienmag

Credit: Lutz Mühlenbein A new method for constructing special solar cells could significantly increase their efficiency. Not only are the cells made up of thin layers, they also consist of specifically arranged nanoblocks. This has been shown in a new study by an international research team led by the Martin Luther University Halle-Wittenberg (MLU), which […].

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EU approves Chiesi’s triple combination asthma therapy Trimbow

Pharma Times

European Commission has authorised treatment for uncontrolled asthma patients

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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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Gene mutations linked to worse outcomes from leukemia in Hispanic and Latino children

Scienmag

A new drug combo may help to address the disparity A combination of genetic mutations may explain the higher incidence of and poorer outcomes from pediatric leukemia in Hispanic and Latino children, according to Penn State College of Medicine researchers. They said a novel therapeutic drug combination – as well as testing for these mutations […].

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Neurocrine Terminates Parkinson's Deal with Voyager Following Clinical Hold

BioSpace

The two companies first partnered in 2019 to develop a gene therapy treatment for Parkinson’s disease, and other neurodegenerative disorders.

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Scientists uncover potential antiviral treatment for COVID-19

Scienmag

Researchers from the University of Nottingham have discovered a novel antiviral property of a drug that could have major implications in how future epidemics / pandemics – including Covid-19 – are managed. The study, published in Viruses*, shows that thapsigargin is a promising broad spectrum antiviral, highly effective against Covid-19 virus (SARS-CoV-2), a common cold […].

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Virtual trials and the next generation of pharma clinical research

pharmaphorum

Previously viewed as a ‘nice to have’ for the pharma industry, virtual trials were already moving from a theoretical to a practical proposition before COVID-19 accelerated their transition. Studies that follow a virtual, decentralised, hybrid or remote model can offer many patient recruitment benefits including improvements in terms of enabling a more diverse patient population to participate.

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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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People blame a vehicle’s automated system more than its driver when accidents happen

Scienmag

A new study looks at the public perception of blame and responsibility in semi-AV crashes Experts predict that autonomous vehicles (AVs) will eventually make our roads safer since the majority of accidents are caused by human error. However, it may be some time before people are ready to put their trust in a self-driving car. […].

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Money on the Move: January 27 – February 2

BioSpace

A recap of where life sciences cash has been flowing the past week.

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Biomedical basis of the Barker hypothesis uncovered

Scienmag

According to the Barker hypothesis (Hales and Barker 1992) (also referred to as “small baby syndrome”), infants with too low body weight have an increased risk of suffering from cardiovascular diseases, high blood pressure, diabetes and chronic kidney diseases in adulthood. According to this hypothesis, fetal protective mechanisms enable adaptation to unfavorable intrauterine conditions (chronic […].

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Algorithms and Equity: Banishing Bias in AI

Intouch Solutions

Employing artificial intelligence (AI) in healthcare can save lives. Bias in healthcare AI can cost them. The stakes are life and death. Learn what that looks like and how to avoid it. The post Algorithms and Equity: Banishing Bias in AI appeared first on Intouch Solutions.

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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.