Fri.Sep 22, 2023

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EU’s position as vaccines leader “at risk”, report reveals

Drug Discovery World

The EU has historically been a leader in vaccine research, development and manufacturing, but is now seeing a decline in vaccine research, according to data published by Vaccines Europe (VE). The EU has hosted approximately 20% of global vaccine clinical trials over the past two decades, as well as research facilities affiliated with the world’s largest vaccine companies.

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9 common misconceptions about clinical trial participation

Antidote

Connecting patients with clinical research opportunities is our mission here at Antidote, but often, we find that misconceptions can serve as barriers to achieving this goal. It’s important to carefully weigh the pros and cons of participating in a clinical trial but to do this effectively, it’s critical to have accurate information.

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This week in drug discovery (11-15 September)  

Drug Discovery World

News round-up for 18-22 September by DDW Digital Content Editor Diana Spencer. As we approach another autumn/winter season in the northern hemisphere, Covid-19 vaccines are once again making the headlines, but in the last week we have also reported on vaccine trials for a number of other conditions, including Nipah virus, rabies and lung cancer. The top stories: EU’s position as vaccines leader “at risk”, report reveals The EU has historically been a leader in vaccine research, development and m

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Many Americans Frustrated in Search for Low-Cost COVID Boosters

Drugs.com

FRIDAY, Sept. 22, 2023 -- Americans seeking out the new COVID boosters are finding themselves held back by insurance entanglements and supply delays. Some insurers have balked at covering the vaccines, with people arriving at shot appointments only.

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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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Specialised T cells could offer way to repair the gut barrier

Drug Discovery World

Researchers from the Francis Crick Institute, King’s College London and Guy’s and St Thomas’ NHS Foundation Trust in the UK have characterised a specialised type of immune cell, which plays a key role in protecting and repairing the cells in the healthy human gut. The researchers found that in healthy guts there was a specialised subset of gamma delta T cells (V-gamma-4 (Vg4) cells) that were significantly altered and often depleted in inflammatory bowel disease (IBD) samples.

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Scientists Spot Gene Mutation Linked to Esophageal Cancer

Drugs.com

FRIDAY, Sept. 22, 2023 -- Researchers have found a gene mutation linked to esophageal cancer, which could lead to better prevention and treatment strategies. Investigators from Case Western Reserve University in Ohio found the mutation, potentially.

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More Trending

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Newer Diabetes Meds Might Not Work as Well in Black Patients

Drugs.com

FRIDAY, Sept. 22, 2023 – New research suggests some newer diabetes treatments may not be as beneficial for Black patients, after earlier drug trials included small numbers of non-white people. Whether the medications -- called sodium-glucose.

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Novel Tank Diving Test with Zebrafish

biobide

Zebrafish ( Danio rerio ) has been used as a New Alternative Model (NAM) for the last 40 years. This organism conserves approximately 70% of gene homology with humans, in addition to having the benefit of possessing fast development, high fecundity, feasible maintenance, and ease of manipulation. This NAM complies with the 3Rs principle (Replacement, Reduction and Refinement), since it is possible to perform multiple assays on embryos.

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Medicaid Reinstated for Nearly 500,000 Children and Families: CMS

Drugs.com

FRIDAY, Sept. 22, 2023 – About 500,000 children and families have had their Medicaid reinstated after some states erroneously purged them because of a systems issue, the U.S. Centers for Medicare and Medicaid (CMS) said Thursday. The agency had.

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Jellyfish, with no central brain, shown to learn from past experience

Science Daily: Pharmacology News

Even without a central brain, jellyfish can learn from past experiences like humans, mice, and flies, scientists report for the first time. They trained Caribbean box jellyfish (Tripedalia cystophora) to learn to spot and dodge obstacles. The study challenges previous notions that advanced learning requires a centralized brain and sheds light on the evolutionary roots of learning and memory.

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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.

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In 22 U.S. States, More Than a Third of Adults Are Now Obese

Drugs.com

FRIDAY, Sept. 22, 2023 -- Obesity is on the rise across the United States. In 22 states, 35% of adults or more were obese last year, new data from the U.S. Centers for Disease Control and Prevention show. Just 10 years ago, there were no states that.

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A Clear Path to Education Affordability Requires Meeting Patients Where They Are

Drug Channels

Today’s guest post comes from Kristina Crockett, VP of Product Management at CoverMyMeds. Kristina shares the story of a patient who cut pills in half to extend her prescriptions. Unfortunately, this patient didn’t know about manufacturer affordability programs. In this article, Kristina reviews how brands can help patients make connections that address medication affordability challenges, whether at the prescriber’s office, the pharmacy, or at home.

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Astronomers find abundance of Milky Way-like Galaxies in early Universe, rewriting cosmic evolution theories

Science Daily: Pharmacology News

Galaxies from the early Universe are more like our own Milky Way than previously thought, flipping the entire narrative of how scientists think about structure formation in the Universe, according to new research.

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A Clear Path to Medication Affordability Requires Meeting Patients Where They Are

Drug Channels

Today’s guest post comes from Kristina Crockett, VP of Product Management at CoverMyMeds. Kristina shares the story of a patient who cut pills in half to extend her prescriptions. Unfortunately, this patient didn’t know about manufacturer affordability programs. In this article, Kristina reviews how brands can help patients make connections that address medication affordability challenges, whether at the prescriber’s office, the pharmacy, or at home.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Vaping Raises a Teen's Odds of Developing Asthma

Drugs.com

FRIDAY, Sept. 22, 2023 -- New research underscores the harms of e-cigarettes, showing that vaping increases the risk of asthma in teens who have never smoked cigarettes. Although e-cigarettes have fewer toxins than regular cigarettes, they still.

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Astronomers discover newborn galaxies with the James Webb Space Telescope

Science Daily: Pharmacology News

With the launch of the James Webb Space Telescope, astronomers are now able to peer so far back in time that we are approaching the epoch where we think that the first galaxies were created. Throughout most of the history of the Universe, galaxies seemingly tend to follow a tight relation between how many stars they have formed, and how many heavy elements they have formed.

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RSV Vaccine Given in Pregnancy to Help Shield Newborns Receives Full U.S. Approval

Drugs.com

FRIDAY, Sept. 22, 2023 -- Women may soon have a vaccine they can take during a pregnancy to help protect their newborn from respiratory syncytial virus (RSV). Following approval one month ago by the U.S. Food and Drug Administration, the Centers for.

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Migratory birds can be taught to adjust to climate change

Science Daily: Pharmacology News

One result of climate change is that spring is arriving earlier. However, migratory birds are not keeping up with these developments and arrive too late for the peak in food availability when it is time for breeding. By getting the birds to fly a little further north, researchers have observed that these birds can give their chicks a better start in life.

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Kids' ER Visits for Mental Health Crises Rise When School Term Begins

Drugs.com

FRIDAY, Sept. 22, 2023 -- While the start of the school year can give kids and teens the chance to reconnect with friends and enjoy school sports and activities, it can also trigger stressors that send many to the emergency room for mental health.

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Pollen analysis suggests peopling of Siberia and Europe by modern humans occurred during a major Pleistocene warming spell

Science Daily: Pharmacology News

A new study appearing in Science Advances compares Pleistocene vegetation communities around Lake Baikal in Siberia, Russia, to the oldest archeological traces of Homo sapiens in the region. The researchers use the 'remarkable evidence' to tell a compelling story from 45,000-50,000 years ago with new detail: how the first humans migrated across Europe and Asia.

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AstraZeneca and Daiichi’s next cancer medicine scores in breast tumors

BioPharma Drive: Drug Pricing

Results show that the medicine helped patients who progressed on earlier-line treatments live longer than those receiving chemotherapy without their disease getting worse, according to a Friday announcement.

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Why are you better at recognizing upright faces? Clues from a person who sees the world differently

Science Daily: Pharmacology News

When you see a familiar face upright, you'll recognize it right away. But if you saw that same face upside down, it's much harder to place. Now researchers who've studied Claudio, a 42-year-old man whose head is rotated back almost 180 degrees such that it sits between his shoulder blades, suggest that the reason people are so good at processing upright faces has arisen through a combination of evolution and experience.

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Myth Busting: Master Protocol Edition

Cytel

Interest and appetite for master protocols is growing as sponsors consider opportunities in various therapeutic areas beyond oncology. During initial discussions, most quickly recognize the potential operational and inferential benefits of a master protocol; however, as sponsors dive deeper into the details, doubt creeps in and there are a multitude of reasons expressed for not moving forward with a master protocol.

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Carbon source found on surface of Jupiter's moon Europa

Science Daily: Pharmacology News

Astronomers using data from NASA's James Webb Space Telescope have identified carbon dioxide in a specific region on the icy surface of Europa.

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Latest trial win further supports expanded use of Bristol Myers’ Opdivo in lung cancer

BioPharma Drive: Drug Pricing

The drug, which is already cleared as a neoadjuvant lung cancer treatment, could further compete with Merck’s Keytruda if it gains approval in the adjuvant setting for patients with the non-small cell form of the disease.

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Brain Trauma Could Help Trigger Heart Troubles

Drugs.com

FRIDAY, Sept. 22, 2023 -- While the neurological impact of a traumatic brain injury (TBI) has long been studied, new research suggests TBIs are also hard on the heart.

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Seagen’s cancer drug succeeds in ‘must-win’ trial

BioPharma Drive: Drug Pricing

Compared to chemotherapy, a combination of Seagen’s Padcev and Merck’s Keytruda was significantly better at keeping bladder cancer patients alive longer and their disease from progressing.

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New patent for Mallinckrodt Ard drug ACTHAR GEL

Drug Patent Watch

Annual Drug Patent Expirations for ACTHAR+GEL Acthar Gel is a drug marketed by Mallinckrodt Ard and is included in one NDA. It is available from one supplier. The generic ingredient… The post New patent for Mallinckrodt Ard drug ACTHAR GEL appeared first on DrugPatentWatch - Make Better Decisions.

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Article FDA: Following a 2018 draft framework, FDA unveils long-awaited PDURS draft guidance

Agency IQ

Following a 2018 draft framework, FDA unveils long-awaited PDURS draft guidance A long-awaited draft guidance on Prescription Drug Use-Related Software (PDURS) outlines when information from digital health tools could be represented on prescription drug labeling. Per the new draft guidance, key considerations include where the software gets its data inputs and what the expected benefit of the tool’s use could be.

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New patent for Albireo drug BYLVAY

Drug Patent Watch

Annual Drug Patent Expirations for BYLVAY Bylvay is a drug marketed by Albireo and is included in one NDA. It is available from one supplier. There are eight patents protecting… The post New patent for Albireo drug BYLVAY appeared first on DrugPatentWatch - Make Better Decisions.

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Article Periodic: France finds unclear disinfectant labeling to blame for chemical burns in children

Agency IQ

France finds unclear disinfectant labeling to blame for chemical burns in children The French environment and safety agency (ANSES) has identified a pattern of chemical incidents, reporting more than one hundred cases of schoolchildren sustaining chemical burns in recent years. It appears the issue is largely the result of unclear labeling for biocidal disinfectants, an aspect French regulators may flag in future market authorization evaluations for these products.

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New patent for Arcutis drug ZORYVE

Drug Patent Watch

Annual Drug Patent Expirations for ZORYVE Zoryve is a drug marketed by Arcutis and is included in one NDA. It is available from one supplier. There are four patents protecting… The post New patent for Arcutis drug ZORYVE appeared first on DrugPatentWatch - Make Better Decisions.

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Healthcare & Life Sciences Takeaways from Dreamforce 2023

Perficient: Drug Development

Dreamforce has come and gone, and our team proudly attended this year’s conference for a front-row seat to hear Salesforce’s latest innovations. These announcements ranged from AI-centric innovations to new Data Cloud features and everything in between. With a highly skilled team of Salesforce consultants and developers with Healthcare and Life Sciences (HLS) experience, Perficient is especially interested in this year’s announcements for the vertical.

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Clinical trial to test immune modulation strategy for hospitalized COVID-19 patients begins

SCIENMAG: Medicine & Health

A clinical trial has launched to test whether early intensive immune modulation for hospitalized COVID-19 patients with relatively mild illness is beneficial. The placebo-controlled study, part of the global clinical trials consortium known as Strategies and Treatments for Respiratory Infections and Viral Emergencies (STRIVE), will enroll approximately 1,500 people at research sites around the world.