Tue.Aug 18, 2020

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A cure for hemophilia is closer than ever. For many patients, it could be just out of reach.

Bio Pharma Dive

Approval of BioMarin's Roctavian, should it come as expected this week, would deliver on decades of unfulfilled hopes for a gene therapy fix to one of the earliest identified inherited diseases.

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Pharma improves HCP engagement during COVID-19 – report

pharmaphorum

Pharma companies have improved how they engage with healthcare providers as a result of COVID-19, according to a new survey of HCPs. This has resulted in pharma companies being more relevant and providing more value in closing the care gap, the report says. The Accenture survey of 720 general practitioners, oncologists, cardiologists and immunologists globally found that this is in turn helping HCPs better serve patients.

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Gilead expands Tango alliance, continuing a busy year of cancer deals

Bio Pharma Dive

A $145 million payment to broaden a partnership with Tango Therapeutics is the latest in a series of deals Gilead has made to grow its oncology business.

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Could AI avert a future coronavirus pandemic?

pharmaphorum

Could AI prevent future pandemics by developing an armoury of drugs that work against all coronaviruses? This is a question that a consortium of European pharma companies hopes to answer as it aims to rapidly develop new therapies to combat the pandemic. The Corona Accelerated R&D in Europe (CARE) has been hastily set up by Europe’s Innovative Medicines Initiative (IMI), focusing on tackling the pandemic that has wreaked so much havoc across the world this year.

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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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Lilly doubles down on Innovent cancer drug in immunotherapy push

Bio Pharma Dive

The Indianapolis pharma paid $200 million to gain most of the rights to Tyvyt, a checkpoint blocker that could help it compete with Merck, Roche and others.

Drugs 258
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Takeda Continues to Shed OTC Business Offerings with $2.3 Billion Deal

BioSpace

Takeda continues to divest its over-the-counter business operations and has struck a deal for its U.S. offerings with The Blackstone Group, a U.S.-based investment fund valued at $2.37 billion.

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More Trending

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Roche’s Enspryng approved for Neuromyelitis Optica Spectrum Disorder

Pharma Times

Enspryng is the first approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology

Antibody 117
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Regeneron and Roche Partner to Increase Supply of COVID-19 Antibody Cocktail

BioSpace

Regeneron will distribute REGN-COV-2 in the U.S. and Roche will handle distribution outside the U.S.

Antibody 136
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Computer scientist makes big data more accessible

Scienmag

UTA researcher working to make data more usable and accessible Credit: UT Arlington A computer science professor at The University of Texas at Arlington is working with researchers to develop a process by which data points in multiple graph layers of a very large dataset can be connected in a way that is both highly […].

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Novateur Ventures: Overlooked Generic Drug Strategy May Prevent COVID-19’s Cytokine Storm

BioSpace

Two generic anti-inflammatory drugs typically used in asthma treatments are being proposed for use with COVID-19 because of their potential to dampen disease progression and severity.

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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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Calculating hadrons using supercomputers

Scienmag

Antoni Woss earned JSA’s 2019 Thesis Prize for exploring the theory underpinning the properties of subatomic particles and how they can decay Credit: Antoni Woss Hadrons are elusive superstars of the subatomic world, making up almost all visible matter, and British theoretical physicist Antoni Woss has worked diligently with colleagues at the U.S.

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Study confirms link between SABA inhalers and asthma exacerbations

Pharma Times

High SABA inhaler use was associated with around twice the number of exacerbations, the SABINA study found

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Machine learning unearths signature of slow-slip quake origins in seismic data

Scienmag

Results provide insight into fundamental earthquake physics and suggest slow-slip earth rupture might be predictable Credit: Galyna Andrushko/Shutterstock.com LOS ALAMOS, N.M., Aug. 18, 2020–Combing through historical seismic data, researchers using a machine learning model have unearthed distinct statistical features marking the formative stage of slow-slip ruptures in the earth’s crust months before tremor or GPS […].

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Yale-NBA Partnership Results in FDA Approval for COVID-19 SalivaDirect Test

XTalks

SalivaDirect, a saliva-based COVID-19 test that was tested among players of the National Basketball Association (NBA), has been given emergency use authorization (EUA) by the US Food and Drug Administration (FDA). The test has been developed by researchers at the Yale School of Public Health and is being touted as a game changer for fast and easy COVID testing.

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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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Ajinomoto grows small-molecule capabilities in India

Outsourcing Pharma

The CDMO is expanding its small-molecule manufacturing capacity with a new 8,500-square-meter production facility at its Visakhapatnam, India site.

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Mylan Wins Approval for First Generic to Biogen's MS Drug Tecfidera

BioSpace

This morning, Mylan announced the launch of its new generic offering, dimethyl fumarate delayed-release capsules for the treatment of relapsing forms of multiple sclerosis.

Drugs 102
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Illingworth: mobile nursing can reduce trial patient burden

Outsourcing Pharma

A leader from home-based clinical services firm Illingworth Research Group talks about the evolution of mobile nursing and how it can keep trials going.

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3 Ways to Use Your Former Commute Time to Advance Your Career

BioSpace

Now that a majority of us are working remotely, and it may stay like that for the foreseeable future, one thing we’ve left behind is the commute to the office.

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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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Patients with recently discovered antibodies have more severe myasthenia gravis

Scienmag

Credit: Phil Jones, Senior Photographer, Augusta University A study of 181 patients at 16 sites across the country who test negative for two antibodies long known to cause muscle-weakening myasthenia gravis, found that about 15% test positive for one of two newly discovered antibodies that also attack the point of communication between nerves and muscle. […].

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Biopharma Update on the Novel Coronavirus: August 19

BioSpace

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 19, 2020.

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OCT-based technique captures subtle details of photoreceptor function

Scienmag

New instrument paves the way to earlier detection and treatment of diseases that cause blindness Credit: Mehdi Azimipour, UC Davis Eye Center. WASHINGTON — Researchers have developed a new instrument that has, for the first time, measured tiny light-evoked deformations in individual rods and cones in a living human eye. The new approach could one […].

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FDA Turns Down BioMarin's Hemophilia A Gene Therapy

BioSpace

The agency indicated that they had completed the review cycle for the application but the application was not ready for approval in its current form.

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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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AstraZeneca, J&J and Sanofi-GSK set to sell up to 1.1bn COVID-19 vaccines to EU

BioPharma Reporter

European Union lines up deals to source up to 1.1 billion doses of three COVID-19 vaccines.

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J&J Snaps Up Momenta Pharmaceuticals in $6.5 Billion All-Cash Deal

BioSpace

J&J said the acquisition will allow its subsidiary, Janssen Pharmaceutical, to broaden its leadership in immune-mediated diseases and drive further growth through expansion into autoantibody-driven disease.

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Doctors express concern over clearing NHS bottleneck

Pharma Times

The survey, by the British Medical Association, highlights the huge challenge in returning to a normal service as waiting lists grow

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Cold-weather accounts for almost all temperature-related deaths

Scienmag

Credit: UIC/Roberta Dupuis-Devlin With the number of extreme weather days rising around the globe in recent years due to global warming, it is no surprise that there has been an upward trend in hospital visits and admissions for injuries caused by high heat over the last several years. But cold temperatures are responsible for almost […].

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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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Hancock confirms replacement of Public Health England

Pharma Times

The National Institute for Health Protection (NIHP) will bring together the pandemic response work of PHE and NHS Test and Trace

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Green apple e-cigarette flavorant triggers reward-related behavior in the brain

Scienmag

Credit: Lead Author Skylar Cooper, PhD candidate, Marshall University HUNTINGTON, W.Va. – A common green apple vape flavor enhances nicotine reward, which could heighten reward and drug-seeking behavior, according to researchers at Marshall University. Of the more than 7,000 available flavored vape chemicals, only a handful have been studied. In a new study recently published […].

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IBRI Licenses Rapid-Testing Technology for Infectious Diseases

BioSpace

Point-of-care testing is a critical tool in the battle against COVID-19, and researchers in Indiana are working around the clock to deliver rapid tests with high specificity.

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Evolution in real-time: How bacteria adapt to their hosts

Scienmag

Some bacteria become increasingly infectious when they have to move from cell to cell in order to survive Credit: © Patrick Arthofer In the environment, they are often found inside unicellular organisms. A research team led by Matthias Horn at the Centre for Microbiology and Environmental Systems Science at the University of Vienna has made […].

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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.