Thu.Nov 24, 2022

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WHO Ranks The Deadliest Pathogens, Including The Mysterious ‘Disease X’

AuroBlog - Aurous Healthcare Clinical Trials blog

The World Health Organization said on Monday it was thrashing out a new list of priority pathogens that risk sparking pandemics or outbreaks and should be kept under close observation. The WHO said the aim was to update a list used to guide global research and development (R&D) and investment, especially in vaccines, tests, and […].

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Biovac and IVI enter deal to develop oral cholera vaccine

Pharmaceutical Technology

South African bio-pharmaceutical firm Biovac and the International Vaccine Institute (IVI) in South Korea have signed a licencing and technology transfer agreement for developing and manufacturing an oral cholera vaccine (OCV). The deal will aid Biovac in establishing drug substance manufacturing expertise for producing the antigen/raw material required to make the vaccines.

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CDSCO approves four more medical device testing labs

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) has approved four more Medical Device Testing Laboratories (MDTL) to carry out tests or evaluation of a medical device on behalf of the manufacturers under the provisions of the Medical Devices Rules, 2017. With this, the total number of MDTLs approved by the regulator is 28 across the […].

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NICE recommends BMS’ combination therapy for gastroesophageal cancer

Pharmaceutical Technology

The National Institute for Health and Care Excellence (NICE) in the UK has recommended Bristol Myers Squibb ’s (BMS) nivolumab (Opdivo) plus chemotherapy as an option for patients with advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma. As per the final draft guidance issued by the health institute, the treatment is intended for usage in such untreated HER2-negative cancers and if the tumour expresses PD-L1.

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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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Bacteria that break down nicotine found in the guts of mice

Medical Xpress

A team of researchers affiliated with multiple institutions in China, working with a colleague in the U.S., has isolated a type of bacteria in the guts of mice that break down nicotine. In their paper published in the journal Nature, the group describes how they isolated the bacteria and why their finding could reduce incidences of fatty liver disease in humans.

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The Metaverse: Regulatory trends

Pharmaceutical Technology

The metaverse will make digital media experiences more immersive, inclusive, and accessible than today. However, it will raise social concerns ranging from data privacy to other forms of online harm. Listed below are the key regulatory trends impacting the metaverse theme , as identified by GlobalData. Net neutrality. Net neutrality refers to the concept that a telecom network should be a neutral gateway to the Internet rather than a gatekeeper with the power to decide what content is available

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The Metaverse: Macroeconomic trends

Pharmaceutical Technology

Gaming and social media companies are at the vanguard of metaverse development, but enterprises will lead the charge in the next three years. This shift will be driven by the future of work and digital transformation initiatives ongoing across sectors ranging from retail to healthcare and financial services. Big Tech is championing the metaverse, with Microsoft and Meta promoting it as the ideal environment to support hybrid working.

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New male contraceptive does not involve hormones

Medical Xpress

A team of researchers at a company called Contraline has developed a new kind of male contraceptive. Instead of using hormones to disrupt sperm production, the new technique involves placing a hydrogel called ADAM into the vas deferens to prevent sperm from making its way to the urethra. The new technique is not yet available for men seeking an alternative way to prevent pregnancy, however—it is currently undergoing a clinical trial in Australia.

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Xeris and Horizon enter partnership to develop teprotumumab

Pharmaceutical Technology

Xeris Biopharma and Horizon Therapeutics have sig n ed a research partnership and option agreement for developing a ready-to-use, highly-concentrated, subcutaneous injection of teprotumumab. Under the deal, Xeris will leverage XeriJect, its technology platform to develop the formulation of teprotumumab. Horizon will also hold an option to licence this technology of Xeris. .

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Experimental flu vaccine, developed using mRNA, seen as potential game changer

STAT News

An experimental influenza vaccine developed using messenger RNA technology appears capable of inducing what should be a protective immune response against all known subtypes of flu, at least in animals. If the work is translated into humans it could turn out to be a version of a long-sought universal vaccine. This would not be a vaccine that would block all flu infections, nor would it replace the need for an annual flu shot.

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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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Scientists develop 20-subtype mRNA flu vaccine to protect against future flu pandemics

Medical Xpress

An experimental mRNA-based vaccine against all 20 known subtypes of influenza virus has provided broad protection from otherwise lethal flu strains in initial tests, and thus might serve one day as a general preventative measure against future flu pandemics, according to researchers from the Perelman School of Medicine at the University of Pennsylvania.

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How masks became a habit in Mexico City

NPR Health - Shots

In Mexico City, the federal government has never issued a mask mandate. Even so, masks seem to have become a habit.

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Wild primate study ties importance of social environment to molecular markers of age in the brain

Medical Xpress

As people age, maintaining a positive and predictable social environment becomes more and more important. For instance, keeping close ties with friends and family has been identified as one of the key ingredients to healthy aging.

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Pharma M&A rumour mill grinds out Mirati’s name again

pharmaphorum

Mirati Therapeutics is the subject of takeover speculation in the biopharma sector once again, as it waits for the FDA’s decision on its KRAS inhibitor adagrasib in non-small cell lung cancer (NSCLC). A Bloomberg report published ahead of the Thanksgiving holiday in the US suggested that potential buyers are waiting for the results from a phase 2 trial of the drug in combination with Merck & Co’s PD-1 inhibitor Keytruda (pembrolizumab) in patients with previously-untreated KRASG1

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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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Study sheds new light on the link between oral bacteria and diseases

Medical Xpress

Researchers at Karolinska Institutet in Sweden have identified the bacteria most commonly found in severe oral infections. Few such studies have been done before, and the team now hopes that the study can provide deeper insight into the association between oral bacteria and other diseases. The study is published in Microbiology Spectrum.

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Can Europe become a major player in cell and gene therapy?

Drug Discovery World

With European life sciences R&D investment at a 20-year low, biopharmaceutical associations and MEPs are calling on the EU to modernise its policies. DDW’s Diana Spencer asks what will be needed for Europe to compete in the growing global market for advanced therapies. . A new report by Charles River Associates for the European Federation of Pharmaceutical Industries and Associations (EFPIA has revealed that Europe is falling behind the US and Asia in its pharmaceutical R&D investment,

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Hope for first blood test to detect deadly heart inflammation

Medical Xpress

The first blood test to diagnose inflammation of the heart muscle (myocarditis) could be in use in as little as a year, following the discovery of a molecular signal in the blood by Queen Mary University of London researchers. The research, published today in the journal Circulation, offers hope of a quick and cheap way of diagnosing the condition.

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Storm doses first patient with solid tumour drug candidate

Pharma Times

Candidate is first molecule targeting an RNA methyltransferase enzyme to enter development

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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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Artificial sweeteners found to kill off antibiotic-resistant bacteria

Medical Xpress

Sugar substitutes found in many supermarket foods have been shown to kill off antibiotic-resistant bacteria that cause pneumonia and sepsis. Three artificial sweeteners used in products such as diet drinks, yogurts and desserts dramatically halt the growth of multidrug-resistant priority pathogens.

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Multi-drug precision medicine cancer trial begins

Pharma Times

Patients on the trial will have one of the particular genetic mutations among rare cancers

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Researchers explain how lipids can control immune response

Medical Xpress

When we consume fats (also called lipids) in our diet, they can be metabolized or stored to provide energy for the body. But they are also involved in regulating the genes expressed within—and the signaling between—cells. Lipids influence how our cells behave and function, which affects many processes in the body including the immune system.

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FDA approves first gene therapy for hemophilia B

BioPharma Reporter

CSLâs Hemgenix (etranacogene dezaparvovec-drlb) becomes the first treatment to offer patients freedom from regular ongoing infusions.

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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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Digital divide poses exclusion risk for people with mental illness

Medical Xpress

A stark digital skills deficit among people with severe mental illness means they struggle to access key services which are increasingly online, according to research by scientists at the University of York.

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LifeArc commits £10m to fund repurposed chronic respiratory infection therapies

pharmaphorum

Following the launch of LifeArc’s £100 million programme, Chronic Respiratory Infection Translational Challenge (CRI TC) – for the acceleration of the development of new clinical solutions to tackle chronic lung conditions – the medical research charity has now announced that it is committing £10 million to fund up to five collaborative projects to repurpose existing therapies as new treatments for bronchiectasis and cystic fibrosis.

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First pandemic young people's mental health review says service demand will rise

Medical Xpress

The first comprehensive study to evaluate research on the mental health of children and young people using evidence that spanned before and during COVID-19 has found an impact on mental health that could result in an increased demand for support services.

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Co-crystallization in drug development ~ Exploring the benefits of co-crystals ~

Drug Discovery Today

Over the last decade, co-crystallization has become an attractive alternative to improve the physiochemical properties of drugs without affecting their pharmacology. As a result of the pharmaceutical benefits co-crystals exhibit, industrial interest is on the rise. Here Dr. Thomas Kendall, application specialist at crystallization and solid-state specialist Technobis Crystallization Systems, gives a perspective on the benefits of co-crystals and explains how they can be screened.

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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.

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Ayahuasca: Just how safe is this psychoactive brew?

Medical Xpress

Psychedelic drugs are experiencing something of a renaissance. It's no longer a case of turning on, tuning in and dropping out, as the hippy mantra went in the 1960s. Tripping—whether on magic mushrooms, LSD or psychedelic toads—is now part of the global wellness industry. It's a way to "find yourself" or deal with a mental health or spiritual crisis.

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$12 million awarded for the development of antiviral therapies

Drug Discovery World

Three institutions have received a share of $12 million for the development of antiviral therapies to treat diseases caused by viruses with pandemic potential. . The money was awarded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. NIAID may award approximately $61.5 million total over five years if all contract options are exercised. .

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China's daily COVID cases highest since pandemic began

Medical Xpress

China's daily COVID cases have climbed to the highest since the pandemic began, official data showed Thursday, despite the government persisting with a zero-tolerance approach involving grueling lockdowns and travel restrictions.

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Fujifilm expands cell culture media manufacturing

Drug Discovery World

Fujifilm Corporation has announced a $188 million investment to establish a cell culture media manufacturing facility in Research Triangle Park (RTP), North Carolina, USA. . The new site will be operated by Fujifilm Irvine Scientific, a manufacturer of cell culture solutions for life science research, bioproduction, cell therapy manufacturing, and medical applications. .

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.