Sun.Jan 29, 2023

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Hypertension Drug Shown to Extend Lifespan And Slow Aging in Animals

AuroBlog - Aurous Healthcare Clinical Trials blog

The hypertension drug rilmenidine has been shown to slow down aging in worms, an effect that in humans could hypothetically help us live longer and keep us healthier in our latter years. Rilmenidine was picked for this latest study because past research has shown it mimics the effects of caloric restriction on a cellular level.

Drugs 202
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China’s NMPA conditionally approves two oral drugs for Covid-19

Pharmaceutical Technology

The National Medical Products Administration (NMPA) of China has granted conditional approval for two domestically developed oral drugs to treat Covid-19. Simcere Pharmaceutical Group and Shanghai Junshi Biosciences’ subsidiary have submitted the applications for the two drugs Xiannuoxin (SIM0417) and VV116, respectively. The anti-SARS-CoV-2 drug candidate Xiannuoxin has been co-developed by Simcere Group, along with Shanghai Institute of Materia Medica (SIMM) and Wuhan Institute of Virology (WI

Drugs 162
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COVID flashback: Here's how NPR reported on the coronavirus at a turning point

NPR Health - Shots

On Jan. 30, 2020, the World Health Organization declared the "novel coronavirus" sweeping through China to be a global health emergency. Here's how NPR covered the story at that point in time.

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STAT+: Inside the fall of star MIT scientist David Sabatini

STAT News

The 7 a.m. Acela out of South Station in Boston trembled along the rails toward Manhattan. David Sabatini sat alone on the left side of the train. He had brought along a science paper to work on, but had a lot on his mind. He kept his Wordle streak alive on his phone, and stared out at the picturesque Connecticut coastline. His clothing hung loose from recent weight loss,   presumably   from stress.

Scientist 105
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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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9 diseases that keep epidemiologists up at night

NPR Health - Shots

Thinking about the next pandemic is job number one for many researchers around the world. Here's a look at the World Health Organization's current list of pathogens with pandemic potential.

Research 111
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Why we need to support healthcare’s vital acceleration

pharmaphorum

What do I mean by vital acceleration? With the population ageing, the need for healthcare is growing fast: between 2015 and 2050, the proportion of the world’s population over 60 years old will nearly double from 12% to 22%, according to the World Health Organization. Keeping our elderly population healthy will prove a major challenge in years to come.

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Effect of Moderate and Vigorous Aerobic Exercise on Incident Diabetes in Adults With Obesity

JAMA Internal Medicine

This randomized clinical trial assesses the long-term effect of vigorous and moderate exercise on incident diabetes over a 10-year follow-up after a 12-month exercise intervention.

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Targeted therapy momelotinib provides significant symptom and anemia improvements in patients with myelofibrosis

Medical Xpress

Patients with myelofibrosis had clinically significant improvement in disease-related symptoms, including anemia and spleen enlargement, when treated with the targeted therapy momelotinib, according to results from the international Phase III MOMENTUM trial led by researchers at The University of Texas MD Anderson Cancer Center.

Trials 98
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How Black people can cope with the trauma of witnessing repeated death and violence against them

NPR Health - Shots

NPR's Ayesha Rascoe speaks to Dr. Alisha Moreland-Capuia about coping with the trauma Black people may feel after horrific events like the killing of Tyre Nichols.

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World-first guidelines created to help prevent heart complications in children during cancer treatment

Medical Xpress

The world's first international clinical guidelines to help prevent and treat heart complications in children undergoing cancer treatment have been created.

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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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Trial sets up earlier use of J&J’s Carvykti in myeloma

pharmaphorum

One of the Johnson & Johnson’s top clinical trial readouts for 2023 just generated results, which bode very well for the future prospects of multiple myeloma CAR-T Carvykti. BCMA-directed cell therapy Carvykti (ciltacabtagene autoleucel) has seen sluggish growth since it was first approved by the FDA in March 2022 as a fifth-line or later therapy for multiple myeloma, but the CARTITUDE-4 study could see it used earlier on in the treatment pathway.

Trials 64
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Experts urge better opioid rescue drug access to save lives

Medical Xpress

Jessie Blanchard started small nearly five years ago, just trying to get enough of the rescue drug naloxone that reverses opioid overdoses to keep her daughter from dying from an overdose.

Drugs 81
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Chest Pain Management Using Prehospital Point-of-Care Troponin and Paramedic Risk Assessment

JAMA Internal Medicine

This economic evaluation uses cost-minimization analysis to estimate the cost savings of paramedic risk stratification of adult acute chest pain and point-of-care troponin testing.

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An FDA Inspector’s Knock Will More Likely Be Followed by FDA’s Enforcement Hammer

FDA Law Blog

By Douglas B. Farquhar & Aisha T. Evans* — A recent analysis of statistics on FDA’s website, prepared for a presentation at a good manufacturing practices (GMP) conference in San Diego next week, shows a dramatic increase in the percentage of FDA drug manufacturing facility inspections that result in an “Official Action Indicated” classification.

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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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Lilly breaks new ground for BTK class with Jaypirca approval

pharmaphorum

Eli Lilly has picked up an FDA approval for its non-covalent BTK inhibitor Jaypirca in relapsed mantle cell lymphoma (MCL) patients who relapse after treatment with current drugs in the class. The accelerated approval covers adults MCL patients who have previously been treated with at least two lines of systemic therapy, including a covalent BTK inhibitor.

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8 Insights From 9,000+ Real Clinical Trial Participant Surveys

Velocity Clinical Research

Clinical trials — especially high-volume trials — are primarily designed to collect quantitative data. Collecting and reviewing qualitative data and experiential feedback from trial participants is rarely prioritized. Before being acquired by Velocity Clinical Research, Meridian Clinical Research built an in-house surveying system to elevate the participant’s voice.

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Help Researchers Explore Alternative Treatments for Type 2 Diabetes!

Trialfacts

Contents About the Study Why Participate? Your Rights Who Can Participate? More Study Details About the Research Center: Location Research Center: Joslin Diabetes Center Location: 1 Joslin Pl, Boston, MA 02215, USA Lead Researcher: Osama Hamdy, MD, PhD IRB: This study has been reviewed and approved by the Joslin’s Committee on Human Studies (CHS) About the Study Approximately 1 in 10 Americans have Diabetes, with over 90% of people having Type 2 Diabetes.

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EMA reviewing Novartis’ Adakveo after phase 3 miss

pharmaphorum

The EMA’s human medicines committee has started a review of Novartis’ sickle cell disease (SCD) therapy Adakveo, shortly after the company reported that it failed to show efficacy in a phase 3 trial. On Friday, Novartis said that the phase 3 STAND trial of Adakveo (crizanlizumab) found no statistically significant difference between the drug and placebo on annualised rates of vaso-occlusive crises (VOCs) – the excruciatingly painful attacks that intermittently affect patients with SC

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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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Which pharmaceutical companies have the most emulsion dosed drugs?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most emulsion dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most emulsion dosed drugs… The post Which pharmaceutical companies have the most emulsion dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Utah's governor has signed a bill banning gender-affirming care for transgender youth

NPR Health - Shots

The ban, signed Saturday by Republican Gov. Spencer Cox, prohibits transgender surgery for youth and disallows hormone treatments for minors who have not yet been diagnosed with gender dysphoria.

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