Mon.May 17, 2021

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FDA approval sets stage for a showdown between Alexion and Apellis

Bio Pharma Dive

Apellis' newly approved drug, known as Empaveli, will compete against the blockbuster Soliris and Ultomiris franchises in the treatment of a rare and life-threatening blood disease.

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Time to rethink the objective of DTC marketing

World of DTC Marketing

QUICK READ: Only someone who is fooling themselves believes that life will go back to normal after the pandemic. The pandemic has affected healthcare dramatically as searches for health information beyond COVID, have skyrocketed and patients have become used to virtual health visits. DTC marketing needs to evolve if it’s to remain relevant as part of the brand objectives.

Marketing 155
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6 tips to deliver information that matters using print communications

Bio Pharma Dive

As remote work continues, print is as important as ever for biopharmaceutical companies when it comes to reaching a varied audience that may include patients, doctors' offices, researchers, and internal staff.

Doctors 246
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Artificial intelligence can elevate pharma manufacturing

Outsourcing Pharma

According to a leader from industrial AI specialist AspenTech, AI can help avoid costly maintenance interruptions by predicting when upkeep is needed.

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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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Biopharma Execs Address the Challenges of a Post-Pandemic Workplace

BioSpace

If these companies are any indication, it appears that the biopharma industry will be a hybrid of virtual and physical workforces, and with this comes a whole new set of risks.

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World first concept for rechargeable cement-based batteries

Scienmag

Credit: Yen Strandqvist/Chalmers University of Technology Imagine an entire twenty storey concrete building which can store energy like a giant battery. Thanks to unique research from Chalmers University of Technology, Sweden, such a vision could someday be a reality. Researchers from the Department of Architecture and Civil Engineering recently published an article outlining a new […].

More Trending

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Chicago emerging as a life science and biopharma hub

BioPharma Reporter

Many turn to Boston and North Carolinaâs Research Triangle to set up life science companies, but Chicago is now also fast becoming a draw in this respect. The city is emerging as a life science and biopharma hub and seems poised for even further growth, in CGT in particular.

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How a New AI Algorithm Could Help in the Early Detection of Heart Disease

XTalks

An AI algorithm developed by researchers at the Mayo Clinic through its newly formed health technology company Anumana Inc. , can assess for low ejection fraction through routine electrocardiograms (ECG, or also called EKG). The ECG-based AI-powered clinical decision support tool can enable diagnosis of low ejection fraction, especially in its earliest stages to facilitate more prompt diagnosis and treatment of the heart condition.

Trials 87
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Double ransomware attack targets Irish healthcare system

pharmaphorum

Criminals have launched a ransomware attack against the Department of Health in Ireland, shortly after a similar cyberattack shut down much of the IT infrastructure at the Health Service Executive (HSE). . The Irish government confirmed the latest attempt yesterday, two days after the HSE was hit by a new variant of the Conti ransomware virus – thought to be run by Russia-based criminal group Wizard Spider – that was able to evade its security protocols.

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Uninsured cancer patients 60-64 face worse outcomes than Medicare beneficiaries aged 66-69

Scienmag

MUSC Hollings Cancer Center researcher finds lack of insurance leads to worse cancer survival across the 16 most common cancers Credit: MUSC MUSC Hollings Cancer Center lung cancer researcher Gerard Silvestri, M.D., found that a lack of insurance leads to worse cancer survival than for those with Medicare, in a paper published in the May […].

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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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From representation to empowerment: Putting patients at the centre of medicine reimbursement

pharmaphorum

Experts from Vynamic discuss their vision for a future where patients are at the heart of medicine reimbursement in Europe – and provide actionable steps for achieving this. This article appears in full in our digital magazine Deep Dive: Market Access 2021. Read below for a sneak-peak: The reimbursement landscape in Europe is complex. There are different models, medicines are evaluated in different ways and the timelines for approval vary widely.

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Stanford study reveals new biomolecule

Scienmag

Credit: Ryan Flynn Stanford researchers have discovered a new kind of biomolecule that could play a significant role in the biology of all living things. The novel biomolecule, dubbed glycoRNA, is a small ribbon of ribonucleic acid (RNA) with sugar molecules, called glycans, dangling from it. Up until now, the only kinds of similarly sugar-decorated […].

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Biogen’s inherited eye disease gene therapy misses primary endpoint

Pharma Times

Company maintained, however, that the study showed ‘positive trends’ across a number of prespecified secondary endpoints

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‘We’re playing Moneyball with building assets’

Scienmag

New tool uses AI to target smarter repairs with limited funds Researchers have developed a tool to help governments and other organizations with limited budgets spend money on building repairs more wisely. The new tool uses artificial intelligence (AI) and text mining techniques to analyze written inspection reports and determine which work is most urgently […].

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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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Funding News: Three Biopharmas Score a Combined $261 Million to Advance Pipelines

BioSpace

Three companies on different continents raised more than $250 million to advance their scientific visions of supporting and developing new therapies for life-threatening diseases.

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Scientists explore Tesla roads not taken — and find new potential present-day utility

Scienmag

Study tests viability of 100-year old patented device by inventor Credit: NYU’s Applied Mathematics Laboratory A valve invented by engineer Nikola Tesla a century ago is not only more functional than previously realized, but also has other potential applications today, a team of researchers has found after conducting a series of experiments on replications of […].

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Sanofi, GSK’s COVID-19 vaccine achieves positive Phase II results

Pharma Times

Companies previously delayed vaccine programme after Phase I/II study results found a low immune response in older adults

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Successful start of dark energy spectroscopic instrument follows record-setting trial run

Scienmag

International collaboration aims for 3D map of the universe, unraveling of mysterious ‘dark energy’ Credit: DESI collaboration and DESI Legacy Imaging Surveys A five-year quest to map the universe and unravel the mysteries of “dark energy” is beginning officially today, May 17, at Kitt Peak National Observatory near Tucson, Arizona.

Trials 63
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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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Vedere Bio is Bypassing What’s Broken to Create Light in Vision Loss

BioSpace

The robust $77 million Series A was led by Octagon Capital and the leadership and research team behind the original Vedere Bio.

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Study shows early preterm births can be decreased with DHA supplementation

Scienmag

Early preterm births may be dramatically decreased with docosahexaenoic acid (DHA) supplements, with a dose of 1000 mg more effective for pregnant women with low DHA levels than the 200 mg found in some prenatal supplements, according to a study led by researchers from the University of Kansas and the University of Cincinnati and published […].

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New Study Identifies Brain Proteins Predictive of Future Dementia

BioSpace

A new study from Johns Hopkins University Bloomberg School of Public Health suggests the development of dementia is associated with abnormal levels of plasma proteins, and these proteins may be predictive of dementia up to five years before a patient receives a diagnosis.

Protein 58
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Linguistic and biological diversity linked

Scienmag

Credit: Larry Gorenflo, Penn State Cultural diversity — indicated by linguistic diversity — and biodiversity are linked, and their connection may be another way to preserve both natural environments and Indigenous populations in Africa and perhaps worldwide, according to an international team of researchers. “The punchline is, that if you are interested in conserving biological […].

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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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Designing HCP engagement for the next normal

pharmaphorum

Life sciences companies’ engagement with HCPs has changed significantly in the past 12 months, as the COVID-19 pandemic struck. Restrictions to in-person face-to-face interactions have resulted in increased use of remote and digital channels. Many life sciences companies have begun 2021 by reviewing how they respond to the longer-term impact of this change, and its impact on field teams is a major topic.

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Insulin is necessary for repairing olfactory neurons

Scienmag

Findings point to possible treatment for smell loss Credit: Monell Chemical Senses Center, eNeuro PHILADELPHIA (May 17, 2021) – Researchers have known for some time that insulin plays a vital role in regeneration and growth in some types of neurons that relay environmental sensory information to our brains, such as sight. However, they know relatively […].

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Keytruda wins NICE backing in MSI-H/dMMR colorectal cancer

Pharma Times

Immunotherapy recommended for use in patients with MSI/dMMR biomarkers

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Slow research to understand fast change

Scienmag

Forty years of experiments, observation, modeling and theory may be just what’s needed to see where the world is headed Credit: Barbara Van Slyke, Konza LTER. CC-BY 4.0. In a world that’s changing fast, the Long Term Ecological Research (LTER) Network can seem almost an anachronism. Yet the patience and persistence that have generated 40 […].

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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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Irish health service hit with ‘significant’ ransomware attack

Pharma Times

Minister Ossian Smyth said the attack is "possibly the most significant cybercrime attack on the Irish State"

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Bird data from Ethiopia fills in baseline data gaps

Scienmag

Credit: Ça?an ?ekercio?lu/University of Utah One of the projected effects of a warming climate for species living on mountain slopes is moving their distributions upslope as their habits shift upwards. Eventually, since mountains have a limit to their elevation, a species may have no more habitat to move up to and therefore go extinct. Tracking […].

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Tamasek-Backed G2 Bio Companies Will Accelerate Gene Transfer Technologies

BioSpace

Temasek has committed $200 million to launch The G2 Bio Companies which focuses on the development of potential next-generation gene therapies.

Gene 61
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New epigenetic regulatory mechanisms involved in multiple myeloma growth

Scienmag

Expectations for the development of therapies targeting KDM5A Credit: Associate Professor Hiroto Ohguchi An international team of researchers from Japan, the US and the UK has analyzed the function of the histone demethylase KDM5A in multiple myeloma, one of the three major hematological cancers, and clarified the mechanism by which it promotes myeloma cell proliferation. […].

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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.