Fri.May 20, 2022

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AbbVie asks FDA to approve Parkinson's treatment

Bio Pharma Dive

The company believes the treatment, which uses prodrug versions of two commonly used Parkinson's medications, could be a longer-lasting option for patients and blockbuster product for AbbVie.

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Why I Fight | A message from Jim Eamma

Worldwide Clinical Trials

Life after cancer is about more than just survival. It’s not just the length of life that matters, but also the quality of that life. Join us as we celebrate cancer research awareness month and clinical trials awareness month. The Patient Experience. The thing that really motivates me in cancer research is seeing how, in the last couple of decades, the landscape has evolved to where we’re not only focusing on curative intent but also on improving the patient’s experience with the illness.

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PTC's first gene therapy gains European regulator's backing

Bio Pharma Dive

The brain-infused treatment for a rare neurological disease would be one of only three gene therapies commercially available in the EU. PTC plans to ask for FDA approval later this year.

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?The Current State of Advanced Therapeutics

Worldwide Clinical Trials

The past few years we’ve had exciting opportunities to work on more cell and gene therapy programs for our sponsors. The industry is just at the tip of the iceberg for exploring the potential of these therapies in revolutionizing how we treat disease, and as the approvals start to trickle in, the pipeline only grows. (For a full look at the cell and gene therapy landscape, check out our webinar titled: “ Changing Times, Changing Therapies: Keeping Up with Advancements in Cell and Gene Therapy.”)

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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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Bayer backs out of Atara cell therapy deal

Bio Pharma Dive

The German drugmaker will hand back rights to two CAR-T cell therapies it was developing with Atara, which said it would reassess its strategy for the programs.

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Sleepio app for insomnia backed by NICE

pharmaphorum

After a non-committal appraisal of Big Health’s Sleepio app for insomnia last November in draft guidance from NICE, the cost-effectiveness agency has come out in favour of the digital therapy. The earlier draft guidance showed that NICE was uncertain whether Sleepio would save money for the NHS, but its latest document recommends the app as a cost-saving option for treating insomnia in primary care “for people who would otherwise be offered advice about sleep hygiene or sleeping pill

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Coalition aims to improve cancer drug access in poorer nations

pharmaphorum

Several of the top pharmaceutical companies have joined a new coalition that aims to improve access to cancer medicines in low- and lower-middle-income countries (LLMICs). The new initiative – called ATOM (Access to Oncology Medicines) – pledges to tackle the issue that fewer than 50% of the cancer medicines on the World Health Organization’s essential medicines list are available in developing nations around the world.

Drugs 111
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Clinical Scientist Jobs: The Steps to Succeed in This Role

XTalks

Do you possess laboratory skills, an analytical mindset and a penchant for research? If you enjoy working with biological samples and are enthusiastic about healthcare, a career as a clinical scientist might be just right for you. To start applying to clinical scientist jobs today, head over to the Xtalks Job Search platform. Who is a Clinical Scientist?

Scientist 105
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EU imposes Horizon funding block on UK scientists

pharmaphorum

UK scientists are being denied from joining the €95 billion Horizon research funding programme as a dispute over the trade border in Northern Ireland gets increasingly acrimonious. The UK’s involvement in the Horizon Europe programme as an associate member was included in the Brexit ‘divorce’ deal with EU, but has not been finalised.

Scientist 105
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Birmingham research shows promise for spinal cord injury patients

Pharma Times

Scientists demonstrated that AZD1236 halts oedema while reducing spinal cord breakdown at site of injury

Scientist 122
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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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Study links thalamus inhibition in adolescence to long-lasting cortical abnormalities

Scienmag

A team of Columbia University researchers has reported new evidence that cognitive abnormalities seen in neuropsychiatric disorders such as schizophrenia may be traceable to altered activity in the thalamus during adolescence, a time window of heightened vulnerability for schizophrenia. Credit: Columbia University A team of Columbia University researchers has reported new evidence that cognitive abnormalities […].

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On Clinical Trials Day, CVS shares lessons learned from one year providing trial services

pharmaphorum

CVS Health has come a long way from its humble beginnings as a health and beauty products store in 1963. In recent years the retail pharmacy chain has begun to delve more and more deeply into the healthcare sector – by constantly expanding the basic healthcare services offered at their instore Minute Clinics, and by buying into the health insurance insurance space with their $69 billion purchase of Aetna in 2017.

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Designers find better solutions with computer assistance, but sacrifice creative touch

Scienmag

From building software to designing cars, engineers grapple with complex design situations every day. ‘Optimizing a technical system, whether it’s making it more usable or energy-efficient, is a very hard problem!’ says Antti Oulasvirta, professor of electrical engineering at Aalto University and the Finnish Center for Artificial Intelligence.

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It’s Time to Put Innovative Contracts Under Warranty

Drug Channels

Today’s guest post comes from Jane Barlow, Chief Clinical Officer, and Susan Raiola, President of Real Endpoints. Jane and Susan discuss the mechanism and benefits of warranties in the realm of value-based contracts. To learn more about payer-pharma warranty contracts and whether these agreements can solve issues that limit the utility of more traditional value-based contracts, sign up for Real Endpoints’ free June 9 webinar: Putting Innovative Contracts Under Warranty.

Drugs 86
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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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Long-hypothesized ‘next generation wonder material’ created for first time

Scienmag

For over a decade, scientists have attempted to synthesize a new form of carbon called graphyne with limited success. That endeavor is now at an end, though, thanks to new research from the University of Colorado Boulder. Credit: Yiming Hu For over a decade, scientists have attempted to synthesize a new form of carbon called […].

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NICE recommends app-based treatment for insomnia over sleeping pills

Pharma Times

Thousands usually prescribed sleeping pills could be offered app-based treatment

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Electrons in a crystal exhibit linked and knotted quantum twists

Scienmag

As physicists delve deeper into the quantum realm, they are discovering an infinitesimally small world composed of a strange and surprising array of links, knots and winding. Some quantum materials exhibit magnetic whirls called skyrmions — unique configurations described as “subatomic hurricanes.” Others host a form of superconductivity that twists into vortices.

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Sidekick and Pfizer prep launch of DTx for atopic dermatitis

pharmaphorum

A long-running partnership between digital therapeutics (DTx) developer Sidekick Health and Pfizer has resulted in a new app to support patients with atopic dermatitis, which will start rolling out in Europe and Japan later this year. Sidekick specialises in developing gamified digital health apps. Its alliance with Pfizer has already led to the launch of a series of medication management and lifestyle software programmes aimed at five chronic diseases.

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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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Machine learning radically reduces workload of cell counting for disease diagnosis

Scienmag

The use of machine learning to perform blood cell counts for diagnosis of disease instead of expensive and often less accurate cell analyzer machines has nevertheless been very labor-intensive as it takes an enormous amount of manual annotation work by humans in the training of the machine learning model. However, researchers at Benihang university have […].

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Conducting successful commercial research in a primary care setting

pharmaphorum

The primary care setting has garnered significant attention from industry stakeholders due to its promise in commercial research. Not only do these sites offer a wide array of patient knowledge and medical expertise, but they can also have great benefits for clinical trial recruitment. Primary care providers frequently have ongoing relationships with patients, giving them an in-depth understanding of which patients would be most well suited to certain clinical trials.

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Engineers evaluate the factors behind battery performance at low temperatures

Scienmag

Energy storage with rechargeable battery technologies powers our digital lifestyles and supports renewable energy integration into the power grid. However, battery function under cold conditions is an ongoing challenge, motivating research on improving low temperature performance of batteries. Aqueous batteries (in a liquid solution) do better than non-aqueous batteries in terms of rate capability (a […].

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Help With Medicare Costs: What You Need to Know

NY Times

Low-income Americans on Medicare can get assistance paying their premiums and other expenses. Several states have allowed more people to qualify.

Drugs 63
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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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Research brings hope for spinal cord injury treatment

Scienmag

Scientists from the University of Birmingham have shown an existing drug may reduce damage after spinal cord injury, by blocking the inflammatory response in the spinal cord. Their research, published today in Clinical and Translational Medicine, demonstrates that AZD1236, a drug developed by AstraZeneca, can significantly reduce ‘secondary damage’ caused by the body’s response to […].

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“Erase the Line” Campaign Chosen for Prestigious D&AD Future Impact Short List 

Intouch Solutions

Design & Art Direction (D&AD), an international nonprofit design and advertising organization, has chosen our “Erase the Line” campaign for The Chrysalis Initiative for its Future Impact short list. This honor is given “ for early-stage designs and initiatives recognized for their potential to drive change ” – and it’s far more than just an award!

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Snake trade in Indonesia is not sustainable enough — but it could be

Scienmag

Wildlife trade is a multi-million dollar industry. While some animals are traded legally, in compliance with legislation that aims to protect populations, wildlife trafficking continues to thrive in many places, threatening precious species with extinction. Credit: Tontan Travel Wildlife trade is a multi-million dollar industry. While some animals are traded legally, in compliance with legislation […].

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New patent for Parapro Llc drug NATROBA

Drug Patent Watch

Annual Drug Patent Expirations for NATROBA Natroba is a drug marketed by Parapro Llc and is included in one NDA. It is available from two suppliers. There is one patent…. The post New patent for Parapro Llc drug NATROBA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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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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Research sheds light on crimean-congo hemorrhagic fever disease process

Scienmag

Army scientists determined that the body’s own natural immune response contributes to disease severity in mice infected with Crimean-Congo hemorrhagic fever virus (CCHFV), which causes a widespread tick-borne viral infection in humans. Their work, published May 19, 2022 in PLoS Pathogens, provides a deeper understanding of how the virus causes disease and forms a basis […].

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New patent for Genentech Inc drug XOFLUZA

Drug Patent Watch

Annual Drug Patent Expirations for XOFLUZA Xofluza is a drug marketed by Genentech Inc and is included in two NDAs. It is available from two suppliers. There are seven patents…. The post New patent for Genentech Inc drug XOFLUZA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Haptics device creates realistic virtual textures

Scienmag

Technology has allowed us to immerse ourselves in a world of sights and sounds from the comfort of our home, but there’s something missing: touch. Credit: Shihan Lu Technology has allowed us to immerse ourselves in a world of sights and sounds from the comfort of our home, but there’s something missing: touch. Tactile sensation […].

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New patent for Janssen Pharms drug SPRAVATO

Drug Patent Watch

Annual Drug Patent Expirations for SPRAVATO Spravato is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. There are four patents…. The post New patent for Janssen Pharms drug SPRAVATO appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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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.