Mon.Apr 18, 2022

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Imara to reduce staff by 83% amid biotech shakeout

Bio Pharma Dive

The planned job cuts were announced days after Imara — one of three spinouts from the drug accelerator Cydan Development, stopped development of its top medicine.

Medicine 321
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RoboBurger: America’s First Burger Vending Machine

XTalks

Newark, New Jersey-based RoboBurger claims to have created America’s first burger vending machine and is now looking to expand. The startup aims to bring its burger vending machines to the Philadelphia area within the year after launching its first outpost at the Newport Centre Mall in North Jersey last month. So, how does the unusual vending machine work?

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Bristol Myers scraps $2B Nektar partnership after trial failures

Bio Pharma Dive

The companies have halted testing in kidney and bladder cancer, one month after ending a skin cancer study. Nektar executives are now preparing plans to conserve cash.

Trials 306
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BioNTech Partners with Matinas BioPharma to Develop New Delivery Technology for mRNA Vaccines

XTalks

Top COVID-19 mRNA vaccine maker BioNTech is setting out to explore new and improved delivery technologies for mRNA vaccines, recently announcing a collaboration with New Jersey-based lipid nanocrystal developer Matinas BioPharma. The $2.75 million deal will allow BioNTech to tap into Matinas’ Lipid Nanocrystal (LNC) Delivery Platform Technology to develop novel vaccine formulations, including a potential oral solution.

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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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Troubling data leads a biotech to pull its prized drug from market and FDA review

Bio Pharma Dive

Early analysis of a key clinical trial showed a potentially increased risk of death in cancer patients who received a combination treatment that included TG Therapeutics' approved medicine, Ukoniq.

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Extreme genetic drift in the Maniq hunter-gatherers of southern Thailand

Scienmag

Residing in the hills of southern Thailand, the Maniq comprise one of the last hunter-gatherer communities in the world. Although the Maniq are geographically isolated, they share many cultural features with the Semang peoples, most of whom live over the border in Malaysia. Due to the complex relationships among the various communities in mainland Southeast […].

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New insights into fermentation enzyme will lower the chemical industry’s carbon footprint

Scienmag

Researchers from the University of Tsukuba have obtained atomic-level insights into the structure of the phosphoketolase enzyme, which will help researchers optimize this enzyme for chemical feedstock synthesis Tsukuba, Japan—Pharmaceuticals, plastics, and other industries use enzymes to help synthesize molecular feedstocks. Enzymes taken straight from microbes such as bacteria are often not optimal for industrial […].

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Scientists Question Data Behind an Experimental Alzheimer’s Drug

NY Times

Studies linked to Cassava Sciences, once a stock market favorite, have been retracted or challenged by medical journals.

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UT gardens program administrator receives national horticultural therapy award

Scienmag

Derrick Stowell, administrator for the University of Tennessee Gardens’ Education and Horticultural Therapy Program, is the recipient of the 2022 American Horticultural Society’s Horticultural Therapy Award. Credit: UTIA Derrick Stowell, administrator for the University of Tennessee Gardens’ Education and Horticultural Therapy Program, is the recipient of the 2022 American Horticultural Society’s Horticultural Therapy Award.

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Contract CRA vs. Permanent CRA

ECRG Media's Clinical Research Podcast

Contract CRA vs Permanent CRA Don't forget to Subscribe for new content! Merch: [link] [link] eliteclinicalgroup@gmail.com Podcast: [link] [link] eliteclinicalgroup@gmail.com Watch: » Industry News: [link] All Videos: [link] Interview Recaps: [link] Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education Elite Clinical Research Group or ECRG for short is a content creating conglomer

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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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Microplastics in the food chain

Scienmag

Plastic rubbish is everywhere and now broken-down microplastics have been found in variable concentrations in blue mussels and water within the intertidal zone at some of southern Australia’s most popular and more remote beaches. Credit: Flinders University Plastic rubbish is everywhere and now broken-down microplastics have been found in variable concentrations in blue mussels and […].

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Core eTMF Features and Practices

Cloudbyz

On April 13th, Cloudbyz hosted a webinar covering Core eTMF Features and Practices. Our in-house experts, Medha Datar and Reeshav Mittal explained in detail what an eTMF is, the benefits and core features of an eTMF, compliance requirements, as well as how to choose the right eTMF vendor. The Cloudbyz eTMF solution offers a cloud-based repository of all your clinical trial documents including files, images, information, etc.

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Solar technology and community engagement team up to help low-income farmers in India

Scienmag

Involving people who will directly benefit from technology research is critical to sustainable development, as researchers have experienced by working with chili farmers in India for more than four years. Credit: Courtesy of Michael Machala Involving people who will directly benefit from technology research is critical to sustainable development, as researchers have experienced by working […].

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Contract CRA vs. Permanent CRA

ECRG Media's Clinical Research Podcast

Contract CRA vs Permanent CRA. Don't forget to Subscribe for new content! Merch: [link] [link] eliteclinicalgroup@gmail.com Podcast: [link] [link] eliteclinicalgroup@gmail.com Watch: » Industry News: [link] All Videos: [link] Interview Recaps: [link] Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education.

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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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Automated CAST-R system helps to identify best antimicrobials to fight acute blood infections

Scienmag

When treating acute infections in patients, health care providers must be able to quickly and accurately identify the best antibiotics for fighting the infection. Credit: LIU Yang When treating acute infections in patients, health care providers must be able to quickly and accurately identify the best antibiotics for fighting the infection. A research team led […].

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Epygen Biotech and Dyadic advance low-cost COVID-19 vaccine candidate

BioPharma Reporter

Dyadic licensee, Epygen Biotech, has received funding from the Government of India to advance a low-cost COVID-19 vaccine through Phase 1 and 2 clinical trials in India, using Dyadicâs C1 protein production platform.

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Introducing SQuRo, a novel small-sized robotic rat with high movement agility

Scienmag

Legged robots are very promising for use in real-world applications, but their operation in narrow spaces is still challenging. Large quadruped robots like BigDog and ANYmal have shown excellent adaptability and load capacity but cannot enter narrow spaces, while micro quadruped robots such as sub-2g robots could enter the narrow spaces but failed to perform […].

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AMGEN ANNOUNCES POSITIVE TOP-LINE RESULTS FROM PHASE 3 STUDY OF ABP 654, BIOSIMILAR CANDIDATE TO STELARA® (USTEKINUMAB)

The Pharma Data

Primary Efficacy Analysis Demonstrates no Clinically Meaningful Differences Compared to STELARA. Amgen (NASDAQ:AMGN) today announced preliminary results from a Phase 3 study evaluating the efficacy and safety of ABP 654 compared to STELARA ® (ustekinumab) in adult patients with moderate to severe plaque psoriasis. The study met the primary efficacy endpoint, demonstrating no clinically meaningful differences between ABP 654 and STELARA.

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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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It’s all in the hiPS

Scienmag

Osaka, Japan – Many people have experienced the struggles of dealing with low back pain. A common cause of this pain is degeneration of intervertebral disks (IVDs), which are located between the vertebrae and help give the spinal column its flexibility. Thus, IVD degeneration can lead to more serious conditions such as spinal deformity. In […].

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Takeda Announces Approval of Nuvaxovid® COVID-19 Vaccine for Primary and Booster Immunization in Japan

The Pharma Data

– Nuvaxovid Intramuscular Injection, containing Matrix-M TM adjuvant, is the first recombinant protein-based COVID-19 vaccine approved for use in Japan – Approval for primary and booster immunization is based on efficacy and safety data from Japan and international clinical studies – Takeda is manufacturing Nuvaxovid at its Hikari facility and will begin distribution in Japan as soon as possible .

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About 30% of COVID patients develop “Long COVID,” UCLA research finds

Scienmag

FINDINGS Credit: Pixabay FINDINGS New UCLA research finds that 30% of people treated for COVID-19 developed Post Acute Sequelae of COVID-19 (PASC), most commonly known as “Long COVID.” People with a history of hospitalization, diabetes, and higher body mass index were most likely to develop the condition, while those covered by Medicaid, as opposed to […].

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New patent expiration for Allergan drug COMBIGAN

Drug Patent Watch

Annual Drug Patent Expirations for COMBIGAN Combigan is a drug marketed by Allergan and is included in one NDA. It is available from two suppliers. There are eleven patents protecting…. The post New patent expiration for Allergan drug COMBIGAN appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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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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Appointment of new JST President, Dr. Kazuhito Hashimoto

Scienmag

Michinari Hamaguchi, President of the Japan Science and Technology Agency (JST), will retire from his position on March 31, 2022, and Kazuhito Hashimoto, President of the National Institute for Materials Science (NIMS), will assume the position of President of JST on April 1, 2022. Credit: JST Michinari Hamaguchi, President of the Japan Science and Technology […].

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New patent expiration for The Medicines drug IONSYS

Drug Patent Watch

Annual Drug Patent Expirations for IONSYS Ionsys is a drug marketed by The Medicines Co and is included in one NDA. There are nine patents protecting this drug. This drug…. The post New patent expiration for The Medicines drug IONSYS appeared first on DrugPatentWatch - Make Better Decisions.

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Neural network model helps predict site-specific impacts of earthquakes

Scienmag

In disaster mitigation planning for future large earthquakes, seismic ground motion predictions are a crucial part of early warning systems and seismic hazard mapping. The way the ground moves depends on how the soil layers amplify the seismic waves (described in a mathematical site “amplification factor”). However, geophysical explorations to understand soil conditions are costly, […].

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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 nineteen…. The post New patent for Vanda Pharms drug HETLIOZ 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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Taylor Swift, the millipede: Scientists name a new species after the singer

Scienmag

Taylor Swift, U.S. singer-songwriter known for hits such as “Shake It Off” and “You Belong With Me”, has earned a new accolade—she now has a new species of millipede named in her honor. Credit: Dr Derek Hennen Taylor Swift, U.S. singer-songwriter known for hits such as “Shake It Off” and “You Belong With Me”, has […].

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New patent for Vanda Pharms drug HETLIOZ LQ

Drug Patent Watch

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

Drugs 52
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AF2Complex: Researchers leverage deep learning to predict physical interactions of protein complexes

Scienmag

From the muscle fibers that move us to the enzymes that replicate our DNA, proteins are the molecular machinery that makes life possible. Credit: (Photo: Jess Hunt-Ralston / Georgia Tech) From the muscle fibers that move us to the enzymes that replicate our DNA, proteins are the molecular machinery that makes life possible. Protein function […].

Protein 79
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Eversana, UpScriptHealth ally on digital patient platform

pharmaphorum

UpScriptHealth has joined forces with Eversana on a digital platform that aims to improve patient access to therapies, and the experience that goes with it. The alliance pairs UpScriptHealth’s telehealth and remote prescribing with Eversana’s commercialisation platform that provides drugmakers with services like patient support, digital engagement, dispensing and distribution, and data/analytics.

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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.