Mon.Jan 03, 2022

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The most significant threat to American healthcare

World of DTC Marketing

The estimated numbe r of annual deaths attributable to obesity among U.S. adults is approximately 280,000 based on H.R.s from all subjects and 325,000 based on H.R.s from only nonsmokers and never-smokers. As the N.Y. Times recently reported, estimates of the medical cost of adult obesity in the United States (U.S.) range from $147 billion to nearly $210 billion per year.

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5 HIPAA Compliance Tips For Healthcare Professionals

Pharma Mirror

Healthcare professionals who comply with the Health Insurance Portability and Accountability Act (HIPAA) will benefit by removing the risk of breaching the HIPAA rules. Their patients would feel secure with them. They won’t be at risk of losing their license. They will also benefit from the continued business they’ll get from hospitals that require compliant professionals.

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Biogen and Eisai move forward with investigational Alzheimer's therapy

BioPharma Reporter

Lecanemab, an investigational anti-amyloid beta (AÎ) protofibril antibody for the treatment of early Alzheimer's disease, has been granted Fast Track designation by the US Food and Drug Administration (FDA).

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Accidental tree wound reveals novel symbiotic behavior

Scienmag

One afternoon, during the early days of the COVID-19 pandemic in Panama, a bored teenager with a slingshot and a clay ball accidentally shot entry and exit holes in a Cecropia tree trunk. These are “ant-plant” trees, which famously cooperate with fierce Azteca ants; the trees provide shelter and food to the ants, and in […].

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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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Integrated development models key to supply chain success: Lonza

Outsourcing Pharma

An R&D leader from the explains its proactive approach to staying on top of supply chain challenges, including a new dedicated manufacturing line in China.

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Mini but mighty: WVU researchers seek to better understand role of individual soil microorganisms

Scienmag

One of the largest reservoirs of carbon and home to billions of microorganisms, soil is a highly complex ecosystem that is essential to a healthy climate. Credit: WVU Illustration/Chansotheary Dang One of the largest reservoirs of carbon and home to billions of microorganisms, soil is a highly complex ecosystem that is essential to a healthy […].

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Study finds reduced microbial diversity in guts of wild bears that eat human food

Scienmag

A recent study suggests that eating human food has a pronounced effect on the microbiome of black bears. Specifically, researchers from North Carolina State University and Northern Michigan University found that wild bears who consumed a lot of processed foods had far less diversity in the microbial ecosystems of their guts. Credit: Tom Gillman A […].

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Applied Therapeutics slumps as FDA seeks more data on lead drug

pharmaphorum

Shares in Applied Therapeutics slumped today after it said it would have to delay a US filing for its lead drug programme AT-007, following an FDA request for more data. The New York-based biopharma company had been hoping to file AT007 in its lead indication galactosaemia in the third quarter of last year, but said it will now have to wait for results from an ongoing phase 3 trial.

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Researchers gain insights into how ultrasmall bacteria from the environment have adapted to live inside humans

Scienmag

The microbes that live inside our mouths, collectively known as the oral microbiome, impact our overall health in many ways that are not yet fully understood. Some bacteria cause inflammation, leading to periodontitis and other systemic diseases, such as cardiovascular disease and diabetes. Other oral organisms have been associated with certain types of cancer.

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Biologics and vaccines focused CDMO sees investment from Piramal Pharma

BioPharma Reporter

Indian multinational, Piramal Pharma Limited (PPL), has taken a minority stake in Yapan Bio, a CDMO, based in Hyderabad, with expertise in biologics and vaccines.

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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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OSU research finds way to scrub carbon dioxide from factory emissions, make useful products

Scienmag

Credit: Steve Lundeberg, OSU Journal Journal of Materials Chemistry A Method of Research Experimental study Subject of Research Not applicable Article Title Lanthanide Metal-Organic Frameworks for the Fixation of CO2 Under Aqueous-rich and Mixed-gas Conditions Article Publication Date 24-Dec-2021.

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Lottery-Based Incentives and COVID-19 Vaccination Rates in the US

JAMA Internal Medicine

This cohort study examines changes in COVID-19 vaccination rates across US states with lottery-based vaccine incentives.

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Study finds sexual minority communities disproportionately engage in behaviors to reduce medication costs

Scienmag

Individuals from sexual minority populations, including members of the lesbian, gay, bisexual and queer communities, are more likely than heterosexual individuals to engage in behaviors to reduce medication costs such as using alternative therapies, skipping medication doses or delaying prescription refills, according to study published in JAMA. Researchers with Vanderbilt University’s Department of Medicine, Health, […].

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Lessons learned can help advance the future of DCTs: ObvioHealth

Outsourcing Pharma

A leader from the clinical trial technology company says that insights gained during the recent pandemic could be helpful in realizing future improvements.

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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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Predicting uncertain futures for tropical landscapes

Scienmag

The Government of Panama and other tropical countries supported resolutions passed during the recent UN Climate Change Conference (COP26), which highlighted the critical importance of curtailing deforestation and restoring tropical ecosystems. But how much carbon dioxide is released into the atmosphere when tropical forests are destroyed? How much carbon is stored as they recover?

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All Too Few (Two Year Version) or Where Have All the COVID Tests Gone?* A Review of FDA’s Policies

FDA Law Blog

By Jeffrey N. Gibbs & Gail H. Javitt — As we approach our third year of COVID, one of the major questions from March 2020 eerily echoes today: where are all the COVID tests? The situation now, of course, is very different and much more favorable than two years ago. Unlike March 2020, numerous tests by multiple manufacturers have been reviewed by FDA and are being distributed.

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Computer model of blood enzyme may lead to new drugs for cardiovascular disease

Scienmag

Membrane-associated proteins play a vital role in a variety of cellular processes, yet little is known about the membrane-association mechanism. Lipoprotein-associated phospholipase A2 (Lp-PLA2) is one such protein with an important role in cardiovascular health, but its mechanism of action on the phospholipid membrane was unknown. To address this, researchers at University of California San […].

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All Too Few (Two Year Version) or Where Have All the COVID Tests Gone?* A Review of FDA’s Policies

FDA Law Blog

By Jeffrey N. Gibbs & Gail H. Javitt — As we approach our third year of COVID, one of the major questions from March 2020 eerily echoes today: where are all the COVID tests? The situation now, of course, is very different and much more favorable than two years ago. Unlike March 2020, numerous tests by multiple manufacturers have been reviewed by FDA and are being distributed.

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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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Online parenting communities pulled closer to extreme groups spreading misinformation during COVID-19 pandemic

Scienmag

WASHINGTON (Jan. 3, 2022) — Parenting communities on Facebook were subject to a powerful misinformation campaign early in the COVID-19 pandemic that pulled them closer to extreme communities and their misinformation, according to a new study published by researchers at the George Washington University. Credit: Anastasia Shuraeva WASHINGTON (Jan. 3, 2022) — Parenting communities on […].

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G42 and Mubadala to establish biopharma manufacturing campus in Abu Dhabi

BioPharma Reporter

The agreement between the Abu Dhabi-based entities, sovereign wealth fund, Mubadala Investment Company, and AI and cloud computing specialist, G42, is aimed at bolstering biopharma linked innovation, R&D and manufacturing capabilities in the region.

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More insight into how vision works

Scienmag

PSI scientists have shed light on an important component of the eye: a protein in the rod cells of the retina which helps us see in dim light. Acting as an ion channel in the cell membrane, the protein is responsible for relaying the optical signal from the eye to the brain. If a genetic […].

Protein 73
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Evotec receives €7.5m grant to develop COVID-19 therapeutic

BioPharma Reporter

Evotec SE has received a â7.5m ($8.5m) grant from the German Federal Ministry of Education and Research (BMBF) for the development of EVT075, a potential immunomodulatory therapy against COVID-19.

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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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New epoch of miniaturized Cherenkov detectors

Scienmag

Cherenkov radiation refers to the photon emission from the swift charged particle moves with the velocity greater than the phase velocity of light in the surrounding materials. Ever since its experimental observation by a Soviet physicist P.A. Cherenkov in 1934, Cherenkov radiation has been widely explored and applied in many research fields ranging from cosmology […].

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Relievant Medsystems Announces New Category I CPT Codes for Intracept® Procedure

BioTech 365

Relievant Medsystems Announces New Category I CPT Codes for Intracept® Procedure Relievant Medsystems Announces New Category I CPT Codes for Intracept® Procedure MINNEAPOLIS, Jan.

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Choline during pregnancy impacts children’s sustained attention

Scienmag

ITHACA, N.Y. — Seven-year-old children performed better on a challenging task requiring sustained attention if their mothers consumed twice the recommended amount of choline during their pregnancy, a new Cornell study has found. The study, which compared these children with those whose mothers had consumed the recommended amount of choline, suggests that the recommended choline intake […].

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Vivoryon Therapeutics N.V.: Vivoryon Therapeutics N.V. to Participate in Upcoming Investor Conferences

BioTech 365

DGAP-News: Vivoryon Therapeutics N.V. / Key word(s): Conference 04.01.2022 / 07:00 The issuer is solely responsible for the content of this announcement. Vivoryon Therapeutics N.V.

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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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CSU researchers launch $1.9 million project for water treatment and reuse using biochar

Scienmag

Every day, hundreds of billions of gallons of a precious, dwindling natural resource, fresh water, is used for agricultural irrigation, energy extraction and more. The demand for novel sources of clean water, in the face of a growing population and a warming planet, is at crisis levels. Colorado State University researchers have been given the […].

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Relief Reports that its U.S. Collaboration Partner has Announced the Filing of a Provisional Patent Application for Stable Compositions of Aviptadil Suitable for Human Use

BioTech 365

RELIEF THERAPEUTICS Holding AG / Key word(s): Patent 04-Jan-2022 / 07:00 CET/CEST Release of an ad hoc announcement pursuant to Art. 53 LR The issuer is solely responsible for the content of this announcement. Relief Reports that its U.S.

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New Geology articles published online ahead of print in December

Scienmag

Boulder, Colo., USA: Article topics and locations include methane seeps as refugia; silver sources of Roman coinage; early Earth zircons; the southwestern Laurentide Ice Sheet; the Siljan impact structure, Sweden; the importance of oxbow lakes in the floodplain storage of pollutants; joint earthquake ruptures of the San Andreas and San Jacinto faults; contemporary and future […].

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Sensorion appoints Aniz Girach as Independent Board Member

BioTech 365

Sensorion appoints Aniz Girach as Independent Board Member Sensorion appoints Aniz Girach as Independent Board Member MONTPELLIER, France–(BUSINESS WIRE)–Regulatory News: Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN), a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, … Continue reading →

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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.