Thu.May 19, 2022

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Trial setback casts doubt on a biotech's respiratory virus drug

Bio Pharma Dive

As vaccines for respiratory syncytial virus progressed, Enanta used its hepatitis C know-how to develop an antiviral pill. Yet data in lower-risk patients raise questions of whether it can work.

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?Sharing Passion and Purpose on International Clinical Trials Day

Worldwide Clinical Trials

At Worldwide Clinical Trials, we are passionate about the work we do every day and its impact on countless patients and their families around the world. For International Clinical Trials Day 2022, take a moment to learn more about what it means to be part of a Contract Research Organization (CRO) – and how you can join our global team of experts. We have opportunities for all types of professionals from various industries and backgrounds.

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Google hires away former FDA digital health official Patel

Bio Pharma Dive

Bakul Patel, who helped establish the regulator's digital health center of excellence, said he will work in his new role to build a unified regulatory strategy at the tech giant.

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Moderna’s HIV vaccine prepped for trials in Africa

pharmaphorum

Moderna has joined forces with non-profit organisation IAVI on a third phase 1 trial of its candidate HIV vaccine in Africa, where the burden of the virus is still being keenly felt. IAVI (the International AIDS Vaccine Initiative) has started screening subjects to be included in the study, called IAVI G003, at centres in Rwanda and South Africa, said the biotech.

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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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Cancer drug startup draws former Vertex CEO to board

Bio Pharma Dive

Jeffrey Leiden will team up again with biotech entrepreneur Gary Glick, this time as board chairman of Glick's new company, the recently launched Odyssey Therapeutics.

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Large UK study suggests vaccination helps treat long COVID

pharmaphorum

An observational study in the UK has found evidence that COVID-19 vaccination can help alleviate the lingering symptoms that afflict some people who contract the virus, often referred to as ‘long COVID’ There have been persistent anecdotal reports that vaccines can help people with persistent symptoms get better, but the study published in the British Medical Journal is the first to explore the connection in large numbers of patients.

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Bacteriophage producer Locus Biosciences raises $35m in financing

BioPharma Reporter

Locus Biosciences says the US$35m in funding it has raised from a mix of old and new investors is further validation of its novel approach to treating bacterial diseases.

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Beckley adds digital element to its psychedelic drug trials

pharmaphorum

Phase 2 trials of Beckley Psytech’s psychedelic drug candidates will make use of digital technologies for patient monitoring, thanks to a new partnership with Empatica. The Oxford, UK-based drug developer said it will make use of Empatica’s wearable devices and software in its studies to enrich the data it can harvest from them and hopefully improve patient outcomes and safety.

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Mars Recalls Select Skittles, Starbust and Life Saver Gummies over Possible Metal Contamination

XTalks

Mars Wrigley announced a voluntary recall of various candy products after consumers reported thin metal strands in the candy itself or loose in the bag. The products, which were recalled in the US, include Starburst, Skittles and Life Savers gummies. According to the company, products were manufactured by a third party and subsequently distributed across North America.

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Targeted Radiopharmaceuticals Summit US (TRP US)

pharmaphorum

The inaugural Targeted Radiopharmaceuticals Summit US will bring together a worldwide community of specialists to address long-standing challenges in radiopharmaceutical development at all stages, from bench to bedside. Join them in Boston this July as they reveal the most important strategies for maximizing the value of their medications, not just to make them more financially feasible but also to increase the number of patients who will benefit from them.

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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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WHO validates 11th COVID-19 vaccine

BioPharma Reporter

The World Health Organization (WHO) has today issued an emergency use listing (EUL) for Convidecia, a vaccine manufactured by CanSino Biologics, bringing the total number of COVID-19 vaccines validated by the organisation to 11.

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Possible discovery of mechanism behind mysterious COVID-19 symptoms

Scienmag

In patients with serious and long-term COVID-19, disturbed blood coagulation has often been observed. Now, researchers at Linköping University (LiU), Sweden, have discovered that the body’s immune system can affect the spike protein on the surface of the SARS-CoV-2 virus, leading to the production of a misfolded spike protein called amyloid. The discovery of a possible […].

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Seeking Pills, Young People Head to Social Media, With Deadly Results

NY Times

The soaring drug fatalities in the U.S. are being fueled partly by fentanyl-tainted pills bought by teenagers and young adults on Snapchat, Instagram, TikTok and other social media apps.

Drugs 93
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Oncotarget | Anti-cancer drug profiling with CancerOmicsNet

Scienmag

BUFFALO, NY- May 19, 2022 – A new research paper was published in Volume 13 of Oncotarget, entitled, “CancerOmicsNet: a multi-omics network-based approach to anti-cancer drug profiling.” Credit: Oncotarget.com BUFFALO, NY- May 19, 2022 – A new research paper was published in Volume 13 of Oncotarget, entitled, “CancerOmicsNet: a multi-omics network-based approach to anti-cancer drug […].

Drugs 91
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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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Industry pros thankful, hopeful on Clinical Trials Day 2022

Outsourcing Pharma

Experts and organizations are honoring the occasion (designed to celebrate research accomplishments and achievements) with insights, education, and more.

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UTSA professor awarded $150K from Air Force for semiconductor research

Scienmag

The Air Force Research Laboratory’s Minority Leaders Research Collaborative Program (ML-RCP) has awarded a two-year, $150,000 award to Ethan Ahn, an assistant professor of the UTSA Electrical and Computer Engineering Department. Ahn, UTSA’s inaugural recipient of the ML-RCP award, will use the money to fund his research to develop a new class of semiconducting materials for high […].

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New Smart Stent Platform for Wireless Vascular Monitoring Developed by Georgia Tech Researchers

XTalks

Cardiovascular diseases are the number one cause of death in the world. According to the World Health Organization (WHO), almost 18 million people died from cardiovascular diseases in 2019 , which was 32 percent of all deaths globally. Cardiovascular stents are expandable, small mesh tubes that are usually put inside a coronary artery to support and open arteries that are weakened or narrowed due to atherosclerosis.

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Thermal insulation for quantum technologies

Scienmag

Thermal insulation is not only important for buildings, but also in quantum technologies. While insulation panels around a house keep the heat inside, quantum devices require insulation against heat from the outside world, as many quantum effects are only stable at low temperatures. What is needed are materials with extremely low thermal conductivity that are […].

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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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The Baillie Gifford Pandemic Science Hub launched to fight lung disease

Pharma Times

Gifford is supporting the launch with a philanthropic donation of £14.

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Webb Telescope nearly set to explore the solar system

Scienmag

As NASA’s James Webb Space Telescope moves through the final phases of commissioning its science instruments, we have also begun working on technical operations of the observatory. While the telescope moves through space, it will constantly find distant stars and galaxies and point at them with extreme precision to acquire images and spectra. However, we also plan […].

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AGC Biologics adds new viral vector suspension capabilities at US cell & gene facility

BioPharma Reporter

AGC Biologics will add viral vector suspension technology and capacity for the development and manufacturing of gene therapies at its commercial-grade campus in Longmont, Colorado.

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Scientists devise method to prevent deadly hospital infections without antibiotics

Scienmag

A hospital or medical clinic might be the last place you’d expect to pick up a nasty infection, but approximately 1.7 million Americans do each year, resulting in nearly 100,000 deaths from infection-related complications and roughly $30 billion in direct medical costs. Credit: Amir Sheikhi/Penn State A hospital or medical clinic might be the last […].

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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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Five Themes to Consider for Your Strategic Planning 

Intouch Solutions

Around here, we start thinking about strategic planning season… well, it’s a bit like the Macy’s Thanksgiving Day parade in New York: We start working toward the next year’s event the day after we finish this year’s! Really, it’s even sooner than that. We’re always at it, always looking out for, catching hold of, and creating, the fresh ideas that will change the game for our clients.

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DAP array casts a wide net to fix mutations

Scienmag

HOUSTON – (May 19, 2022) – A genome-editing strategy developed at Rice University can correct dozens of errors at the same time with high precision and efficiency, a possible breakthrough for those who suffer from diseases caused by a combination of mutations. Credit: Qichen Yuan/Rice University HOUSTON – (May 19, 2022) – A genome-editing strategy […].

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Strategy&’s 2022 Global CDMO Study of Pharmaceutical Operations

Pharma Business Blog

How to gain a competitive advantage in a fast-changing pharmaceutical supply ecosystem. The global Covid-19 pandemic as well as geopolitical tensions and trade restrictions have drawn attention to profound geographical, technical, and structural shifts in pharmaceutical supply chains. Treatments are increasingly produced by highly capable contract development and manufacturing organizations (CDMOs).

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Biocompatible binary hologram with drug-elution capabilities

Scienmag

Holographic devices are used for security enhancement, entertainment, 3D display technologies and augmented reality but not limited to them. Due to their high information capacity, the ability to track ongoing external processes by assessing changes in the diffraction pattern, as well as well-established and simple methods for their production from various materials, holograms are finding […].

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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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New patent for Cubist Pharms drug ZERBAXA

Drug Patent Watch

Annual Drug Patent Expirations for ZERBAXA Zerbaxa is a drug marketed by Cubist Pharms Llc and is included in one NDA. It is available from one supplier. There are thirteen…. The post New patent for Cubist Pharms drug ZERBAXA appeared first on DrugPatentWatch - Make Better Decisions.

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The state of China’s climate in 2021: A new temperature high and abnormal precipitation

Scienmag

Weather and climate are important factors that affect economic and social development. The National Climate Center (NCC) of China releases an annual climate report every year, which comprehensively reflects the achievements and progress in climate system monitoring and climate impact assessment in China. This series of reports has been published in Atmospheric and Oceanic Science […].

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New patent expiration for Alexza Pharms drug ADASUVE

Drug Patent Watch

Annual Drug Patent Expirations for ADASUVE Adasuve is a drug marketed by Alexza Pharms and is included in one NDA. There are seven patents protecting this drug. Drug patent litigation…. The post New patent expiration for Alexza Pharms drug ADASUVE appeared first on DrugPatentWatch - Make Better Decisions.

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Lost or extinct? Study finds the existence of more than 500 animal species remains uncertain

Scienmag

An international study provides the first global evaluation of all terrestrial vertebrate species that have not been declared extinct and identifies more than 500 species considered to be ‘lost’—those that haven’t been seen by anyone in more than 50 years. Credit: Credit: Panji Akbar An international study provides the first global evaluation of all terrestrial […].

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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.