Pharmaceutical Technology

JANUARY 2, 2023

South Korean biotechnology company Alteogen has signed an exclusive license agreement with Swiss company Sandoz to develop and market biosimilar products that are enabled by the former’s Hybrozyme technology. Under the terms of the agreement, Sandoz will have the global rights to use Alteogen’s novel hyaluronidase, ALT-B4, for the development and commercialisation of a subcutaneous version of a biosimilar product.

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Deltaclinical

JANUARY 2, 2023

To ensure successful study outcomes, we take a collaborative approach to providing the highest standard of clinical trial support. We understand that establishing a good relationship is essential, so through our clinical trials service we provide support and guidance on every step of the journey to ensure success. .

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Pharmaceutical Technology

JANUARY 2, 2023

The China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has recommended priority review for Everest Medicines’ new drug application (NDA) of Nefecon to treat primary immunoglobulin A nephropathy (IgAN). The regulatory support for the accelerated approval of Nefecon is to treat IgAN in adult patients who are at risk of rapid disease progression.

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Medical Xpress

JANUARY 2, 2023

Adults who stay well-hydrated appear to be healthier, develop fewer chronic conditions, such as heart and lung disease, and live longer than those who may not get sufficient fluids, according to a National Institutes of Health study published in eBioMedicine.     Using health data gathered from 11,255 adults over a 30-year period, researchers analyzed links between serum sodium levels—which go up when fluid intake goes down—and various indicators of health.

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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

Clinical Research

NPR Health - Shots

JANUARY 2, 2023

An investigation finds that corrections officers in Pennsylvania use physical force on people who may be unable to comply with orders due to a mental health condition.

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Medical Xpress

JANUARY 2, 2023

People with a condition known as dry eye disease are more likely than those with healthy eyes to suffer injuries to their corneas. Studying mice, researchers at Washington University School of Medicine in St. Louis have found that proteins made by stem cells that regenerate the cornea may be new targets for treating and preventing such injuries.

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Medical Xpress

JANUARY 2, 2023

Researchers at UCSF have developed a novel, potentially life-saving approach that may prevent antibodies from triggering immune rejection of engineered therapeutic and transplant cells.

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Pharmaceutical Technology

JANUARY 2, 2023

Danicamtiv is under clinical development by Bristol-Myers Squibb and currently in the Phase I and Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

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BioPharma Reporter

JANUARY 2, 2023

Last week saw Opus Genetics announce it had acquired the rights to two preclinical-stage adeno-associated virus (AAV)-based gene therapy product candidates for inherited retinal diseases (IRDs) from Iveric Bio.

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Pharmaceutical Technology

JANUARY 2, 2023

Lifirafenib maleate is under clinical development by BeiGene and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

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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

Clinical Trials

Medical Xpress

JANUARY 2, 2023

Vaccination and boosting, especially when recent, helped to limit the spread of COVID-19 in California prisons during the first omicron wave, according to an analysis by researchers at UC San Francisco that examined transmission between people living in the same cell.

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NPR Health - Shots

JANUARY 2, 2023

As we dive into another new year of resolutions, managing time is the key to success. And learning to organize our time around our goals may mean saying 'no' to activities that don't align.

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Medical Xpress

JANUARY 2, 2023

UK medical bodies on Monday said patients were dying due to inadequate care and urged the government to act as Britain's health service grapples with a winter crisis of strikes and soaring demand.

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NPR Health - Shots

JANUARY 2, 2023

If you think that African countries have nothing to contribute to the global food supply, Ndidi Nunweli would like you to think about what you eat daily.

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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.

Clinical Supply

Drug Patent Watch

JANUARY 2, 2023

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

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NPR Health - Shots

JANUARY 2, 2023

For the past three decades, the Centenarians of Oklahoma volunteers have made it their mission to celebrate as many centenarians as they can. To date, they've honored more than 2,700 and counting. (Image credit: Michael Noble Jr.

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Medical Xpress

JANUARY 2, 2023

Around a dozen countries have slapped fresh travel regulations on travellers from China, as the world's most populous nation faces a surge in COVID cases following its decision to relax strict virus restrictions.

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NPR Health - Shots

JANUARY 2, 2023

Many feel tethered to a water bottle, having heard that hydration is key to being healthy. Here's what the science says about how much water to drink and when.

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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.

Clinical Trials

Medical Xpress

JANUARY 2, 2023

Schools in Malawi's two largest cities are to remain closed until further notice due to a worsening cholera outbreak, the government said on Monday.

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NPR Health - Shots

JANUARY 2, 2023

The main library in Boulder, Colorado, had been receiving increased reports of drug use in the bathrooms over a four-week span. It has been closed since late December.

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Medical Xpress

JANUARY 2, 2023

Children and adults with a rare type of soft tissue cancer will now have a new treatment option that could have a big impact.

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JAMA Internal Medicine

JANUARY 2, 2023

This quasi-experimental study determines whether peer relationships between primary care physicians and specialists formed during training motivate improved specialist care for patients.

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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.

Clinical Supply

Medical Xpress

JANUARY 2, 2023

Wearing proper gear, watching out for snow and ice hazards, and "walking like a penguin" are just some of the tips that can help prevent winter accidents, one medical expert says.

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Fierce Pharma

JANUARY 2, 2023

Acasti, seeking to expand use of old steroid, posts clinical data on oral spray in rare disease. ntaylor. Tue, 01/03/2023 - 01:49.

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Medical Xpress

JANUARY 2, 2023

When children have autism, it's possible to recognize the symptoms as early as when they are 18 months old.

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FDA Law Blog

JANUARY 2, 2023

Hosted by American Conference Institute, the FDA Boot Camp returns for its 40th iteration with the continued intent of providing an essential working knowledge of core FDA concepts, and real-world examples that will help you to excel in your everyday practices. This year’s conference co-chairs include Stacy Cline Amin (Partner, Morrison Forester) and Kurt R.

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Clinical Trials Clinical Trials Drugs Production 59

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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.

Clinical Trials

Medical Xpress

JANUARY 2, 2023

Keeping allergies and asthma in check in the new year is a resolution worth keeping.

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Allergies 97

JAMA Internal Medicine

JANUARY 2, 2023

This case report describes a patient in their 50s with recurrent abdominal pain and syncope after drinking alcohol.

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Pharma Tutor

JANUARY 2, 2023

Computational Analysis of HCV Entry Inhibitors for Hepatitis C Treatment – A Molecular Docking Approach. admin. Mon, 01/02/2023 - 20:35. About Author: Karthika M. Postgraduate in Bioinformatics. Bharathiar University m.karthika1@gmail.com.

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BioPharma Reporter

JANUARY 2, 2023

As the new year begins, we look at recent agreements in the global antibody drug conjugate (ADC) technology licensing space.

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Licensing Licensing Antibody Drugs 52

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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.

Clinical Trials