Tue.Jan 19, 2021

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Lilly expands its cancer drug work with bet on dual-acting antibodies

Bio Pharma Dive

An alliance with Merus, a Dutch biotech, continues Lilly's push to revitalize its oncology research under the leadership of former Loxo Oncology executives.

Antibody 299
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Pharma’s move to digital Part 2 DTC Marketing

World of DTC Marketing

OPENING : DTC marketers have relied too much on TV advertising. Despite data that shows that people are watching more TV than usual during the pandemic , there has been an overall and steady decline in traditional TV viewing in the past few years. Just 59% of US consumers watched traditional TV on a weekly basis in 2020, compared to 83% who did so in 2017.

Marketing 180
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Cancer-focused biotech turns its tools to building a 2nd-generation coronavirus vaccine

Bio Pharma Dive

As worries about coronavirus mutations grow, Gritstone Oncology will work with the NIH to develop a shot capable of stimulating a broad immune response.

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Your NDA Preparation Should Have Started by Now: Planning and Managing Your NDA Submission

Camargo

Throughout our years of preparing and filing FDA submissions, Camargo has often encountered sponsors who cannot file an NDA or BLA within expected timeframes, most commonly due to a failure to start and complete prerequisite activities before the targeted filing date. In this post, we will highlight those requirements that seem to be the most misunderstood.

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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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Personalize your omnichannel marketing today and see the benefits tomorrow

Bio Pharma Dive

With virtual interactions here to stay, it's important that pharma marketers continue to embrace the digital world. Learn how a personalized, insights-led approach to marketing drives results.

Marketing 246
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Commonly Asked Questions About Practice Management Software

Pharma Mirror

The chances are that at some point in the last year when you’ve been talking to someone about how hard it’s been to keep track of and to keep on top of your workload when more and more people are working from home, and everything is so up in the air, that someone will have recommended a management software that they swear by. They will have told you that it has made their work-life immeasurably easier and that they cannot remember how they ever got by without it.

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Commonly Asked Questions About Practice Management Software

Pharma Mirror

The chances are that at some point in the last year when you’ve been talking to someone about how hard it’s been to keep track of and to keep on top of your workload when more and more people are working from home, and everything is so up in the air, that someone will have recommended a management software that they swear by. They will have told you that it has made their work-life immeasurably easier and that they cannot remember how they ever got by without it.

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Biohaven adds to a long list of Alzheimer's drug failures

Bio Pharma Dive

A study evaluating brain function in patients with mild to moderate Alzheimer's found no statistical difference between Biohaven's drug and a placebo.

Drugs 161
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Unlocking the potential in rare disease research with decentralised trials

pharmaphorum

A survey by rare disease patient network Raremark found that 86% of the community members asked were interested in taking part in clinical trials. CEO Jeremy Edwards looks at how decentralised trial models can solve some of the challenges for clinical trial recruitment in rare disease. With low and geographically dispersed patient populations in rare disease, deciding where best to place trial sites can be a headache for sponsors.

Trials 133
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The Future of Cancer Treatment Lies in Vaccines, Say These Pioneers

BioSpace

NEUVOGEN's official strategy revolves around covering the entire immune system so that the tumor cannot perform an “immune escape”. Past immune priming efforts have fallen short because they focus on only a handful of important targets that some tumor cells may not express, thereby allowing them.

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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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Genome editing to treat human retinal degeneration

Scienmag

Credit: Mary Ann Liebert, Inc., publishers New Rochelle, NY, January 19, 2021–Gene editing therapies, including CRISPR-Cas systems, offer the potential to correct mutations causing inherited retinal degenerations, a leading cause of blindness. Technological advances in gene editing, continuing safety concerns, and strategies to overcome these challenges are highlighted in the peer-reviewed journal Human Gene Therapy. […].

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Merck and Bayer Win FDA Approval for Heart Failure Drug

BioSpace

The U.S. Food and Drug Administration approved Merck and Bayer’s heart failure drug vericiguat, an orally administered soluble guanylate cyclase (sGC) stimulator, the pharma giants announced this morning.

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The FDA and Customs and Border Protection Bust Illegal E-Cigarette Shipment

XTalks

The US Food and Drug Administration (FDA) has announced that in an operation with the US Customs and Border Protection (CBP) officers at the Dallas Fort Worth International Airport, 33,681 units of e-cigarettes were seized with a manufacturer’s suggested retail price of $719,453. The raid was part of an ongoing joint operation between the CBP and the FDA to intercept counterfeit or other violative e-cigarettes.

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Breakthrough in understanding ‘tummy bug’ bacteria

Scienmag

Credit: University of Exeter Bioimaging Unit Scientists have discovered how bacteria commonly responsible for seafood-related stomach upsets can go dormant and then “wake up” Vibrio parahaemolyticus is a marine bacterium that can cause gastroenteritis in humans when eaten in raw or undercooked shellfish such as oysters and mussels. Some of these bacteria are able to […].

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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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3 Things We Have Learned About Work During the Pandemic

BioSpace

Collectively, we’ve lived through (and still are) a global pandemic. But that’s not to say that there aren’t lessons to pull from the huge shifts in society that occurred in 2020, including ones that are here to stay.

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Lack of physical exercise during COVID-19 confinement may lead to a rise in mortality

Scienmag

In a review article published in Frontiers of Endocrinology, Brazilian researchers estimate a reduction of 35% in levels of physical activity and a rise of 28% in sedentary behavior in the initial months of confinement imposed by the pandemic Credit: Isabela Roque Marc Social distancing and working from home help prevent transmission of the novel […].

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Scotland backs Roche’s Rozlytrek for ROS1 lung cancer

pharmaphorum

The Scottish Medicines Consortium (SMC) has given a green light to Roche’s Rozlytrek for a rare form of lung cancer, almost seven months after NICE backed the drug in England. Rozlytrek (entrectinib) can now be used by the NHS in Scotland as a treatment option for ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.

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COVID-19 Brief: Pfizer-BioNTech Vaccine Prevents UK Variant and Other News

BioSpace

Pfizer and BioNTech announced that their COVID-19 vaccine was probably just as effective against the variant strain of the virus, B.1.1.7, found in the U.K.

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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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A clinical trial provides encouraging results on ivermectin for reducing mild COVID-19

Scienmag

Credit: ISGlobal/Clínica Universidad de Navarra. A small pilot study suggests that early administration of ivermectin can reduce viral loads and symptom duration in patients with mild COVID-19, which in turn could help reduce viral transmission. The study, which is part of the SAINT project and has been led by the University of Navarra Clinic and […].

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Biden CDC Head Says Science Will Be Heard Again On Her Watch

BioSpace

Rochelle Walensky, who most recently served as chief of the division of infectious diseases at Massachusetts General Hospital, will become the new head of the U.S. Centers for Disease Control and Prevention under the administration of Joe Biden.

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Constructing termite turrets without a blueprint

Scienmag

Researchers develop a mathematical model to explain the complex architecture of termite mounds Credit: (Image courtesy of Guy Theraulaz/Harvard SEAS) Following a series of studies on termite mound physiology and morphogenesis over the past decade, researchers at the Harvard John A. Paulson School of Engineering and Applied Sciences have now developed a mathematical model to […].

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Pharma digital transformation: customer data expected to play a pivotal role

pharmaphorum

A new survey highlights the importance of customer reference data to digital transformation and analyses ways pharma companies can improve the quality of their datasets. In a remote world, customer data is more foundational than ever, and Veeva’s 2020 European Customer Reference Data Survey found 91% of organisations view customer data as a global strategic asset, while 88% said it’s essential for new product launches or sales models.

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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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Aclaris Stock Jumps 200% As RA Drug Candidate Shows Durable Clinical Activity

BioSpace

An investigational oral MK2 inhibitor from Aclaris Therapeutics was safe and associated with promising reductions in inflammatory markers in a 12-week, Phase II a study of patients with moderate to severe rheumatoid arthritis.

Drugs 98
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Brain cell network supplies neurons with energy

Scienmag

Researchers identify important function of the so-called oligodendrocytes Credit: © Group Steinhäuser; from: Cerebral Cortex, January 2018;28: 213-222; doi: 10.1093/cercor/bhw368 The human brain has about as many neurons as glial cells. These are divided into four major groups: the microglia, the astrocytes, the NG2 glial cells, and the oligodendrocytes.

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2021 Biotech IPOs Get Off to a Roaring Start

BioSpace

Last year was a record number of IPOs in the biotech industry, with 81 raising $13.5 billion. With this kind of a start, 2021 may be scorching.

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NASA explores solar wind with new view of small sun structures

Scienmag

Credit: NASA/SDO/Uritsky, et al. Scientists have combined NASA data and cutting-edge image processing to gain new insight into the solar structures that create the Sun’s flow of high-speed solar wind, detailed in new research published today in The Astrophysical Journal. This first look at relatively small features, dubbed “plumelets,” could help scientists understand how and […].

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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.

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Lilly and Merus set to collaborate on cancer therapies

BioPharma Reporter

Loxo Oncology at Lilly, an R&D division of Eli Lilly and Co, and Merus, a Dutch clinical-stage oncology company, today announced a partnership to research and develop up to three CD3-engaging T-cell re-directing bispecific antibody therapies.

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College classrooms are still chilly for women, as men speak more

Scienmag

Gendered participation has a long way to go to reach equity Credit: Figure provided by Jennifer J. Lee and Janice McCabe. Men speak 1.6 times more often than women in college classrooms, revealing how gender inequities regarding classroom participation still exist, according to a Dartmouth study. By comparison, women are more hesitant to speak and […].

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Johns Hopkins Researchers Identify CRISPR Dimmer

BioSpace

A naturally occurring system for tuning CRISPR-Cas9 expressing in bacteria, identified in a study published in Cell, could have implications for gene editing therapies as well.

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New heat method kills pathogens with minimal damage to plants

Scienmag

Credit: William W. Turechek, Ole Myhrene, Janet Slovin, and Natalia A. Peres In the strawberry nursery industry, a nursery’s reputation relies on their ability to produce disease- and insect-free plants. The best way to produce clean plants is to start with clean planting stock. Many nurseries struggle with angular leaf spot of strawberry, a serious […].

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.