Bio Pharma Dive
APRIL 29, 2022
Executives on Friday said that the company's three-drug therapy, a possible threat to Vertex's top-selling medicine Trikafta, didn't meet expectations in a key study. A new combination could start testing next year, however.
pharmaphorum
APRIL 29, 2022
An artificial intelligence-powered digital tool for diagnosing skin cancers developed by Skin Analytics has been cleared in the UK as a Class IIA medical device, setting up broader use of the technology in patient assessments. DERM is being deployed in pilot studies across five NHS Trusts, for example to see if it can support GPs in referring patients to the urgent two week skin cancer referral laid out in NICE guidelines.
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Scienmag
APRIL 29, 2022
Having understood the ill-effects if sick building syndrome and the need to better conserve energy by incorporating green features, architects are also utilizing certain elements of an architectural design system shown to reduce stress, improve sleep, promote physical and mental health, thereby improving the quality of life for its inhabitants. Credit: Maharishi International University Having […].
pharmaphorum
APRIL 29, 2022
AstraZeneca has revealed plans to set up a new strategic R&D hub in Cambridge, Massachusetts as it reported a massive increase in first-quarter revenues, driven by COVID-19 and oncology drugs and heart failure therapy Farxiga. The new site will be at Kendall Square and will serve as the new corporate headquarters for Alexion – which is currently based across the Charles River in Boston’s Seaport District – as well as housing around 1,500 R&D staff from AZ and Alexion in a new purpo
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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
Pharma Times
APRIL 29, 2022
NICE urges older people to stop routine painkiller use – over 10 million in the UK suffer a form of arthritis or other joint conditions
pharmaphorum
APRIL 29, 2022
For many patients with type 2 diabetes, having to inject basal insulin every day is a burdensome fact of life, but Novo Nordisk is trying to change that. The Danish drugmaker has reported the first phase 3 results with its new basal insulin product – insulin icodec – which backs up earlier data suggesting it could provide effective blood glucose control when injected just once a week.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
APRIL 29, 2022
Oliver Stohlmann’s Corporate Survival Hacks series draws on his experiences of working in local, regional and global life science communications to offer some little tips for enjoying a big business career. This post focuses on how poor managers frequently treat employees; it might hold some hints to support and retain strong talent – and benefit from their continued enthusiasm and drive for results.
Scienmag
APRIL 29, 2022
UPTON, NY—Biologists at the U.S. Department of Energy’s Brookhaven National Laboratory and their collaborators have discovered an aberrant protein that’s deadly to bacteria. In a paper just published in the journal PLOS ONE, the scientists describe how this erroneously built protein mimics the action of aminoglycosides, a class of antibiotics. The newly discovered protein could serve […].
Pharma Times
APRIL 29, 2022
InRange is the first worldwide multicentre RCT to compare second generation basal insulins
Scienmag
APRIL 29, 2022
BIRMINGHAM, Ala. – A novel therapy developed at the University of Alabama at Birmingham ameliorates obesity and Type 2 diabetes in mice fed a high-fat diet. The therapy acts through sustained release of nitric oxide, a gaseous signaling chemical whose most important function in the body is relaxing the inner muscles of blood vessels. Credit: […].
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Drug Channels
APRIL 29, 2022
Today’s guest post comes from Chris Harvey, Director of Solutions Engineering at Panalgo, and Carolyn Zele, Senior Manager of Solution Enablement at MMIT. Chris and Carolyn discuss the insights that health economics and outcomes research (HEOR) professionals bring to commercial teams. They explain how that pairing benefits both manufacturers and patients.
Scienmag
APRIL 29, 2022
Tokyo, Japan – Researchers from Tokyo Metropolitan University have identified key similarities between the behavior of granular materials and melting gels. They found that falling beds of sand share the same destabilization mechanism as melting gelatin as it is heated from below, particularly how key parameters scale with the thickness of the fluidized region.
Drug Discovery Today
APRIL 29, 2022
Nijmegen, the Netherlands April 27th, 2022 – Thirona, one of the leading companies specializing in artificial intelligence for medical image analysis, has signed a strategic partnership agreement with iCare, for the implementation of Thirona’s RetCAD™ artificial intelligence software into the iCare solutions for eye disease screening, in Europe. The partnership underpins both companies’ technological leadership in this field.
Scienmag
APRIL 29, 2022
FORT COLLINS, Colo., April 25—Protected areas — such as nature reserves, national parks, and wilderness areas — are essential to conserving biodiversity. New research published in Environmental Research Letters provides insights for developing climate-smart conservation strategies. The study looked at the global network of protected areas, evaluated potential for shifts in where plants and animals occur due to climate […].
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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.
The Pharma Data
APRIL 29, 2022
Operationally and strategically successful in 2021 / Dividend of 2.00 euros per share proposed / Very successful start to 2022. The Bayer Group was operationally and strategically successful in 2021. “ We achieved a lot, and there’s a lot of good news to report as regards our functional performance, invention power and sustainability. Bayer is on the right track,” said Werner Baumann, Chairman of the Board of Management, at the company’s virtual Annual Stockholders’Meeting in Leverkusen on
Scienmag
APRIL 29, 2022
TUCSON, Arizona — Robert C. Robbins, MD, president of the University of Arizona, and Kayse Shrum, DO, president of Oklahoma State University, today announced the two institutions’ academic medical centers have joined forces to combat the opioid crisis and chronic pain through research, treatment and education. The partnership will share institutional resources from three research centers […].
The Pharma Data
APRIL 29, 2022
Today, the U.S. Food and Drug Administration is announcing its plans to hold virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) in anticipation of complete submissions of emergency use authorization (EUA) requests in the coming months that have been publicly announced by COVID-19 vaccine manufacturers. It is important to note that the dates below are tentative as none of the submissions are complete.
Scienmag
APRIL 29, 2022
Humans have developed four different IgG antibody subclasses that orchestrate protection against invading pathogens. A molecular and cellular understanding of how these contribute to eradication of viral infections may guide design of “super-antibodies” that can become important therapeutic and prophylactic tools against emerging viruses and future pandemics but also for indications beyond infection diseases.
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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.
The Pharma Data
APRIL 29, 2022
Pfizer Inc. (NYSE: PFE) today shared top-line results from the Phase 2/3 EPIC-PEP ( E valuation of P rotease I nhibition for C OVID-19 in P ost- E xposure P rophylaxis) study evaluating PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for post-exposure prophylactic use. In this trial, compared to placebo, Pfizer observed risk reductions of 32% and 37% in adults who received PAXLOVID for five and ten days, respectively, to prevent infection.
Scienmag
APRIL 29, 2022
RIVERSIDE, Calif. — Understanding the molecular mechanisms that specify and maintain the identities of more than 200 cell types of the human body is arguably one of the most fundamental problems in molecular and cellular biology, with critical implications for the treatment of human diseases. Central to the cell fate decision process are stem cells […].
The Pharma Data
APRIL 29, 2022
SK bioscience and GSK announced submission of a biologics license application for SKYCovione™ a recombinant protein-based COVID-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant, to the Korean Ministry of Food and Drug Safety (KMFDS) following positive Phase III clinical data. SK bioscience conducted a Phase III clinical trial in 4,037 adults over 18-year-old across 6 countries (Thailand, Vietnam, New Zealand, Ukraine, the Philippines and South Korea).
Scienmag
APRIL 29, 2022
Plants rely on a process called carbon fixation – turning carbon dioxide from the air into carbon-rich biomolecules – for their very existence. That’s the whole point of photosynthesis, and a cornerstone of the vast interlocking system that cycles carbon through plants, animals, microbes and the atmosphere to sustain life on Earth. Credit: H. DeMirci […].
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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.
Drug Patent Watch
APRIL 29, 2022
Annual Drug Patent Expirations for EDURANT Edurant is a drug marketed by Janssen Prods and is included in one NDA. It is available from one supplier. There are four patents…. The post New patent for Janssen Prods drug EDURANT appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
APRIL 29, 2022
Reston, VA—The Society of Nuclear Medicine and Molecular Imaging (SNMMI), European Association of Nuclear Medicine (EANM), and the International Atomic Energy Agency (IAEA) have created a new guide for the creation of dedicated theranostics centers. Focusing on safety protocols and operational procedures, the guide provides a framework that highlights best practices that can be applied […].
Drug Patent Watch
APRIL 29, 2022
Annual Drug Patent Expirations for EMPAVELI Empaveli is a drug marketed by Apellis Pharms and is included in one NDA. There are seven patents protecting this drug. This drug has…. The post New patent for Apellis Pharms drug EMPAVELI appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
APRIL 29, 2022
Researchers at the Kennedy Institute, University of Oxford, led by Professor Jagdeep Nanchahal have demonstrated the efficacy of the anti-TNF drug adalimumab for patients with early stage Dupuytren’s disease. Credit: Emma Jackson Researchers at the Kennedy Institute, University of Oxford, led by Professor Jagdeep Nanchahal have demonstrated the efficacy of the anti-TNF drug adalimumab for […].
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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.
Drug Patent Watch
APRIL 29, 2022
Annual Drug Patent Expirations for VUITY Vuity is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. There is one patent…. The post New patent for Abbvie Inc drug VUITY appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
APRIL 29, 2022
LA JOLLA, CA—Scientists at Scripps Research have invented a way to image, across different tissues and with higher precision than ever before, where drugs bind to their targets in the body. The new method could become a routine tool in drug development. Credit: Scripps Research LA JOLLA, CA—Scientists at Scripps Research have invented a way […].
pharmaphorum
APRIL 29, 2022
In the latest episode of the pharmaphorum podcast, editor in chief Jonah Comstock speaks with Dr Colin Banas, chief medical officer at DrFirst. They discuss out of control drug pricing, especially in the United States, that has led to nonadherence and care rationing. While the world waits for systemic and policy solutions, Banas’s company is developing digital tools that can help ease the burden for patients in the meantime by getting them the lowest prices available through generics, coupons, a
Scienmag
APRIL 29, 2022
This study is led by Prof. Zhong-Shuai Wu (Dalian Institute of Chemical Physics (DICP) of the Chinese Academy of Sciences (CAS)), and Prof. Hui-Ming Cheng (Institute of Metal Research of CAS). MXenes, a family of 2D transition metal carbides and nitrides with over 30 species, are emerging as high-performance electrode materials. However, MXene electrode is […].
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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.
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