Mon.Mar 29, 2021

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5 FDA approval decisions to watch in the second quarter

Bio Pharma Dive

A long-awaited reckoning for Biogen’s Alzheimer’s drug and the review of AstraZeneca’s coronavirus vaccine are among the top FDA decisions expected before the end of June.

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What’s the call to action on DTC?

World of DTC Marketing

TEASER: What DTC marketers and consumers do as the result of seeing a relevant DTC ad differs by a wide margin. DTC marketers would like to think that patients ask for the advertised drug when visiting their doctor, but that’s largely untrue. Online searches for health information remain brisk, according to Google. Many people are going online for health information as the Internet has become cluttered with misinformation.

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UniQure says hemophilia gene therapy likely not cause of study volunteer's cancer

Bio Pharma Dive

The determination, made by UniQure and an independent lab, could ease safety concerns spurred by the patient's diagnosis in December.

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Akili’s gaming therapy improves attention in ADHD kids

pharmaphorum

Akili has published data backing the efficacy of its childhood attention-deficit hyperactivity disorder (ADHD) video game therapy EndeavorRx in the peer-review journal Nature Digital Medicine. . The results come from the STARS-Adjunct trial, an open-label study of EndeavorRx (AKL-T01) that supported approval of the app and video game combination in the US and Europe last year.

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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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A year with COVID-19: The impact of data on pharma marketing

Bio Pharma Dive

Learn how three pharma brands used data to validate and adjust their promotional spend in 2020.

Branding 334
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Cytiva diagnostics design lab goes live in China

BioPharma Reporter

Cytiva has opened a new diagnostics design lab in Tonglu, its manufacturing site close to Shanghai in East China, where it has been making filtration products for many years.

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Webcam Tips for Your Next Webinar Presentation

XTalks

Are you getting used to seeing yourself on a webcam more often lately? As most businesses shifted from the office to working from home, professionals are getting used to using webcams for work-related meetings every day. The webcam experience is paramount for professionals from all spheres. The importance of actually looking clear, professional and sharp when using a webcam is critical.

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Wave to Discontinue Lead Huntington’s Programs After Disappointing Clinical Data

BioSpace

Disappointing data from two Phase Ib/IIa trials for both lead Huntington’s disease antisense candidates have pushed Wave Life Sciences to shelve the assets and focus on its next generation of therapies.

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New Study Suggests Pregnant Women Should Avoid Caffeine Altogether. Here’s Why

XTalks

According to a study by researchers at the National Institutes of Health (NIH), moderate caffeine intake could lead to small babies. The study found that pregnant women who consumed even as little as half a cup a day had babies that were overall lower in size compared with women who did not drink any coffee. The research found that even consumption of less than the recommended moderate amount of 200 mg of caffeine per day for adults, which is about two cups of coffee, posed an increased risk to

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Detecting for carpal tunnel syndrome with a smartphone game

Scienmag

Early diagnosis enabled by identifying syndrome based on thumb movements through machine leaning Credit: Yuta Sugiura A Japanese research group combined motion analysis that uses smartphone application and machine learning that uses an anomaly detection method, thereby developing a technique to easily screen for carpal tunnel syndrome. Carpal tunnel syndrome is common amongst middle-aged women. […].

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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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New patent for Vanda Pharms drug HETLIOZ

Drug Patent Watch

Annual Drug Patent Expirations for HETLIOZ Hetlioz is a drug marketed by Vanda Pharms Inc and is included in two NDAs. It is available from one supplier. There are fifteen…. The post New patent for Vanda Pharms drug HETLIOZ appeared first on DrugPatentWatch - Make Better Decisions.

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Faster and less-invasive atomic force microscopy for visualizing biomolecular systems

Scienmag

Credit: Kanazawa University High-speed atomic force microscopy (HS-AFM) is an imaging technique that can be used for visualizing biological processes, for example the activity of proteins. Nowadays, typical HS-AFM frame rates are as high as 12 frames per second. In order to improve the capabilities of the method, so that it can be applied to […].

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Rare-disease researchers face unique obstacles: Minoryx

Outsourcing Pharma

A representative of the rare-disease specialist firm outlines the unique obstacles of orphan CNS disease research, and how professionals can overcome them.

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New computational models to understand colon cancer

Scienmag

Credit: Steven Offer Although the development of secondary cancerous growths, called metastasis, is the primary cause of death in most cancers, the cellular changes that drive it are poorly understood. In a new study, published in Genome Biology, researchers at the University of Illinois Urbana-Champaign have developed a new modeling approach to better understand how […].

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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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Omega Raises $126 Million to Unlock Potential of Epigenomic Controller Candidate

BioSpace

Omega Therapeutics secured $126 million in a Series C financing round that will be used to advance the company’s lead epigenomic controller candidate, OTX-2002, a potential treatment for hepatocellular carcinoma, as well as other next-generation pipeline assets.

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Procedures identify Barrett’s esophagus patients at risk for cancer progression

Scienmag

Credit: Elizabeth Cook A combination of esophageal brushing and extensive genetic sequencing of the sample collected can detect chromosome alterations in people with Barrett’s Esophagus, identifying patients at risk for progressing to esophageal cancer, according to a new study by researchers at the Johns Hopkins Kimmel Cancer Center and Case Western Reserve University.

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NICE methods and process review aims to create fertile ground for innovation

pharmaphorum

The way NICE reviews new medicines is about to go through its biggest change in years – but what do the proposals mean for the future of drug development in the UK? Amanda Barrell spoke to Dr Paul Catchpole, director of value and access policy at the ABPI, to find out. From COVID-19 and Brexit, to the emergence of patient-centric drug development and personalised medicine, the life sciences sector has experienced a complete transformation in recent years.

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UIC researchers to test new groundwater decontamination technology

Scienmag

$1 million grant advances research from College of Engineering Credit: Brian Chaplin and Shafigh Mehraeen/UIC Researchers at the University of Illinois Chicago who have developed a reactive electrochemical membrane that can adsorb toxins and degrade them are now testing their technology in the field. They hope their technology will be an effective tool for removing […].

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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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CHMP backs Celltrion’s regdanvimab antibody for COVID-19

pharmaphorum

The EU looks set to approve emergency use of a third antibody therapy for COVID-19 after its human medicines committee backed use of Celltrion’s regdanvimab at its March meeting. . Regdanvimab (CT-P59) – which is currently under a rolling review at the EMA – can be used for the treatment of COVID-19 in adults who don’t need oxygen therapy but are at high risk of progressing to severe COVID-19, according to the CHMP.

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Inflammation-fighting protein could improve treatment of rheumatoid arthritis

Scienmag

Credit: Photo by Cori Kogan, Washington State University Health Sciences Spokane SPOKANE, Wash. – New research led by scientists at Washington State University has found that a protein known as GBP5 appears to play a key role in suppressing inflammation in rheumatoid arthritis, a potentially debilitating disease in which the immune system mistakenly attacks the […].

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TCR2 Therapeutics Leases Manufacturing Space in Maryland, Autolus Backs Out of U.S. Expansion

BioSpace

After Autolus Therapeutics’ backed out of its plan to establish a manufacturing center in Rockville, Maryland, Massachusetts-based TCR2 Therapeutics has stepped up to the plate to build an 85,000 square-foot cell therapy manufacturing facility in Rockville.

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Genetic sleuthing reveals endangered river dolphins in Asia as different species

Scienmag

Tissue collection at NOAA Fisheries lab helps reveal genetic distinction Credit: Mansur/WCR Bangladesh New genetic analysis and years of painstaking research has revealed that one of the world’s most endangered marine mammals is actually two species rather than one, as scientists had long assumed. Scientists spent about two decades crossing Asia and Europe in pursuit […].

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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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Clinical innovation webinar to feature award-winning technology

Outsourcing Pharma

An expert speaking at the April 6 Clinical Development Innovations event will discuss an app that matches patients with clinical research opportunities.

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The truth about Christ lies in contradiction, philosopher finds

Scienmag

Credit: University of Notre Dame While the quest to explain how Christ can be both fully human and fully divine enjoys a long, fascinating history, Jc Beall, the O’Neill Family Professor of Philosophy at the University of Notre Dame, believes that the quest should end. Beall is an expert in logic, the philosophy of logic […].

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Novartis UK signs digital partnership with Cievert for chronic disease management

Pharma Times

Initiative is aiming to support NHS patient care in rheumatology and dermatology

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The Protein Society announces its 2021 award recipients

Scienmag

Credit: The Protein Society The Protein Society, the premier international society dedicated to supporting protein research, announces the winners of the 2021 Protein Society Awards, which will be conferred at the 35th Anniversary Symposium (virtual), July 7 – 14, 2021. Plenary talks from award recipients will take place throughout the 6-day event.

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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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2021 Biopharma Update on the Novel Coronavirus: March 30

BioSpace

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 30, 2021.

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New drug to regenerate lost teeth

Scienmag

Antibody for USAG-1 shown to stimulate tooth growth Credit: Kyoto University/Katsu Takahashi Japan — The tooth fairy is a welcome guest for any child who has lost a tooth. Not only will the fairy leave a small gift under the pillow, but the child can be assured of a new tooth in a few months. […].

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VMLY&Rx appoints Nichole Davies as global chief strategy officer

pharmaphorum

VMLY&Rx, a comms agency dedicated to prescription pharmaceutical companies who are researching and developing breakthrough therapies, has hired Nichole Davies as global chief strategy officer. . Davies will lead a new global strategic practice to deliver and enable connected health strategies for clients. The team comprises specialists across a wide range of strategic expertise including brand, activation, innovation and medical.

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Scientists identify molecular pathway that helps moving cells avoid aimless wandering

Scienmag

Findings from Johns Hopkins Medicine study have potential implications for understanding cancer cell spread Credit: Deborah Andrew and JiHoon Kim, Johns Hopkins Medicine. Working with fruit flies, scientists at Johns Hopkins Medicine say they have identified a new molecular pathway that helps steer moving cells in specific directions. The set of interconnected proteins and enzymes […].

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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.