May, 2024

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Investors put $400M into biotech licensing obesity drugs from China

BioPharma Drive: Drug Pricing

The biotech, tentatively named Hercules CM Newco, has rights to three incretin drugs discovered by Jiangsu Hengrui Pharmaceuticals, two of which are in clinical testing.

Licensing 142
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Stomach Paralysis Risk May Rise in People Taking Ozempic and Similar Drugs

Drugs.com

MONDAY, May 20, 2024 -- New, real-world research confirms that the blockbuster weight-loss drugs that millions of Americans have been taking to shed pounds can trigger stomach paralysis in some patients.“Although these drugs do work and should be.

Drugs 133
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AI systems are already skilled at deceiving and manipulating humans

Science Daily: Pharmacology News

Many artificial intelligence (AI) systems have already learned how to deceive humans, even systems that have been trained to be helpful and honest. Researchers describe the risks of deception by AI systems and call for governments to develop strong regulations to address this issue as soon as possible.

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On National Cancer Survivors Day, celebrating the power of research

Antidote

This Sunday, June 2, is National Cancer Survivors Day , designed to be a celebration for those who have survived cancer and an inspiration for those recently diagnosed. Since 1991, the national cancer death rate has dropped by 33% , partially due to advancements in treatment, early detection, and reduced smoking rates.

Research 119
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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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Your Idea Factory – Quality Innovation from Quantity

Perficient: Drug Development

Quality innovation is not for the weak at heart! Innovation myths may have you thinking it is for the lucky or the extremely talented – that’s not true. Pablo Picasso said, “Inspiration exists, but it has to find you working.” Thomas Edison quipped, “Opportunity is missed by most people because it is dressed in overalls and looks like work.” In this blog post, I want to focus on a different quote with the same intent.

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#ScienceSaturday: May 4, 2024

KIF1A

#ScienceSaturday posts share exciting scientific developments and educational resources with the KAND community. Each week, Dr. Dylan Verden of KIF1A.ORG summarizes newly published KIF1A-related research and highlights progress in rare disease research and therapeutic development. KIF1A-Related Research Clinical and Genetic Characterization of a Cohort of Brazilian Patients With Congenital Ataxia KAND is a rare disorder, but each new patient makes it slightly less so.

Science 116

More Trending

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Plant-Based Diets Lower Risk of Heart Trouble, Cancer and Death

Drugs.com

THURSDAY, May 16, 2024 -- Following a vegetarian or vegan diet might just buy you a longer, healthier life, a new review finds.Staying away from meat was tied to a reduced risk of heart disease, cancer and early death, researchers reported in a.

Disease 130
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Scientists map networks regulating gene function in the human brain

Science Daily: Pharmacology News

A consortium of researchers has produced the largest and most advanced multidimensional maps of gene regulation networks in the brains of people with and without mental disorders. These maps detail the many regulatory elements that coordinate the brain's biological pathways and cellular functions. The research used postmortem brain tissue from over 2,500 donors to map gene regulation networks across different stages of brain development and multiple brain-related disorders.

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Who decides whether you get into a clinical trial?

Antidote

One may choose to participate in a clinical trial for many reasons. Volunteering often has multiple benefits, from advancing medical research to gaining access to cutting-edge medical care. However, deciding to enroll in a clinical trial is only one part of the process.

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When Worlds Collide: The Theory of Real-World Evidence Meets Reality

FDA Law Blog: Biosimilars

By Jeffrey N. Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). Extolling RWE, FDA has said “RWE can be leveraged to bring new products to market, evaluate the safety and effectiveness of existing products for new uses, and assess the continued performance and safety of products once on the market.

FDA 111
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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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Navigating Trust and Data in Healthcare Marketing

Perficient: Drug Development

In the ever-evolving landscape of healthcare, trust reigns supreme. As consumers increasingly rely on data to inform their decisions, the healthcare industry faces a pressing need to not only meet but exceed expectations. With disruptive forces emerging from various corners, healthcare organizations find themselves in a race to create personalized experiences that foster lasting engagement and trust.

Marketing 111
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Ajax, aiming for a better JAK drug, raises $95M to begin first tests

BioPharma Drive: Drug Pricing

Goldman Sachs and Eli Lilly are among those backing the startup, which claims its prospect could be more potent than the myelofibrosis therapies that have come to market in recent years.

Therapies 131
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There's a New Set of COVID Variants Called FLiRT: What You Need to Know

Drugs.com

WEDNESDAY, May 8, 2024 -- The virus behind COVID has mutated again, this time producing variants nicknamed FLiRT, the U.S. Centers for Disease Control and Prevention (CDC) has reported.The variants are appearing in wastewater sampling, the CDC.

Virus 130
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Participants of pioneering CRISPR gene editing trial see vision improve

Science Daily: Pharmacology News

About 79% of clinical trial participants experienced measurable improvement after receiving experimental, CRISPR-based gene editing that is designed to fix a rare form of blindness, according to a new article.

Trials 134
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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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Understanding colon cancer screening guidelines

Antidote

Colorectal cancer, often shortened just to colon cancer, is the third most commonly diagnosed cancer in the United States aside from skin cancers. While there are treatments available, including radiation and chemotherapy, the most important aspect of successful treatment is early detection — which is why knowing the colon cancer screening guidelines is essential.

Treatment 119
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How CDISC SDTM Improves Cost & Quality in ISS/ISE in 2024

Quanticate

When investigating the efficacy and safety of a new drug/device it is sometimes necessary to combine the research from multiple clinical trials for your analysis. In such cases, it is important to consider the cost and quality of producing integrated summaries and how CDISC SDTM (Clinical Data Interchange Standards Consortium Study Data Tabulation Model) can aid in reducing costs and improving quality for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) submissions.

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Handling Not Allowed Reflection Method in Sitecore

Perficient: Drug Development

Recently, to meet project requirements, we customized and expanded the functionality of the “General Link” feature by incorporating a new “Telephone Link” feature. Everything was working correctly on our local project instance, but we got the below-listed error when the changes were deployed on the higher environment. Exception: Sitecore.Exceptions.AccessDeniedException Message: Calling Fieldtypes.ExtendedGeneralLink.ExtendedGeneralLinkForm.OnModeChange method through ref

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Drug patents protect pharma profits. Track when they’ll expire here.

BioPharma Drive: Drug Pricing

Intellectual property is the foundation of the drug industry’s business model. This database will track key patent expiry dates for 30 top-selling medicines.

Drugs 133
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Ozempic Lowers Odds for Death, Illness in People With Kidney Disease and Type 2 Diabetes

Drugs.com

FRIDAY, May 24, 2024 -- Ozempic provides a wide variety of health benefits for people with kidney disease and type 2 diabetes, a major clinical trial has found. The drug significantly reduces the risk of severe kidney events, heart problems and.

Disease 124
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Stretchable e-skin could give robots human-level touch sensitivity

Science Daily: Pharmacology News

A stretchy electronic skin could equip robots and other devices with the same softness and touch sensitivity as human skin, opening up new possibilities to perform tasks that require a great deal of precision and control of force.

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Can a Device Be Found Not Substantially Equivalent Because of Cybersecurity Risks? A Review of FDA’s Draft Guidance on Cybersecurity in Medical Devices

FDA Law Blog: Biosimilars

By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance. The draft guidance provides recommendations on what is required to meet cybersecurity obligations under section 524B of the Food, Drug and Cosmetic Act (FD&C).

FDA 105
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Antidote to be announced as Corporate Honoree at MSAA Improving Lives Benefit

Antidote

We are thrilled to be honored as the Multiple Sclerosis Association of America’s Corporate Honoree at their 10th annual Improving Lives Benefit on May 15! This inspiring event supports MSAA’s free programs and services and honors key players in the MS research space.

Research 105
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Women in Stem with Stefanie Flückiger-Mangual

Drug Target Review

Can you tell us about your journey in the field of STEM and the challenges you encountered along the way? My journey in STEM has been both challenging and immensely fulfilling. Early in my career, I had a bad experience in one of my first jobs, helping in the lab as a young student. My professor’s seeming support of my work quickly shifted into a more personal interest in me.

Science 105
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Biogen, Ionis shelve ALS drug following study failure

BioPharma Drive: Drug Pricing

While results indicated the drug works as intended, it didn’t have enough of an effect on a protein that’s become integral to many ALS research programs.

Drugs 127
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Costs, Side Effects Drive Folks to Quit New Weight-Loss Meds

Drugs.com

THURSDAY, May 23, 2024 -- Three months after starting one of the new GLP-1 weight-loss drugs, more than a quarter of patients have already quit the medications, and by a year from first use more than a third have stopped, new research shows.Reasons.

Research 124
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Birth of universe's earliest galaxies observed for first time

Science Daily: Pharmacology News

Researchers have now seen the formation of three of the earliest galaxies in the universe, more than 13 billion years ago. The sensational discovery contributes important knowledge about the universe.

Research 128
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Cell Line Services FAQ

Crown Bioscience

This post delves into some frequently asked questions about Omni Screen and its unique capabilities in providing compliant, large-scale cell line screening solutions that are not only cutting-edge but also aligned with industry standards and regulations. Whether you're a researcher, a biotech professional, or someone keen on understanding the nuances of cell line screening, this discussion will provide valuable insights into how Crown Bioscience can support your scientific endeavors.

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Advancing Clinical Data Management into a New Era

Quanticate

Innovative strategies paving the way for enhanced data quality, integrity and streamlined data validation and cleaning. The way we clean and validate data within clinical trials is continuously evolving, more than ever now with the advancements in technology that we are seeing across this industry year on year. These technological developments are reshaping the way data is handled, leading to improvements in the accuracy and efficiency of data.

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Perficient @ The 2024 Michigan Kidney Walk

Perficient: Drug Development

On Sunday, May 19th, 2024, 21 individuals consisting of Perficient employees and their family members, participated in the 2024 Michigan Kidney Walk at the Detroit Zoo. This annual event aims to raise funds for the National Kidney Foundation, an organization that provides critical support to those affected by kidney disease. A Tradition of Giving This year marked our third consecutive participation in the Kidney Walk.

Disease 98
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Orna, a circular RNA specialist, acquires a buzzy startup

BioPharma Drive: Drug Pricing

After laying off staff late last year, Orna is expanding through the purchase of ReNAgade Therapeutics, which was built around technology designed to more effectively deliver RNA-based medicines.

RNA 120
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Louisiana Votes to Make Abortion Pills Controlled Substances

Drugs.com

FRIDAY, May 24, 2024 -- Louisiana has become the first state to pass a law that designates abortion pills as dangerous controlled substances. Once Gov. Jeff Landry signs the bill into law, as he is expected to do, possession of the drugs.

Drugs 122
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'Vigorous melting' at Antarctica's Thwaites 'Doomsday' Glacier

Science Daily: Pharmacology News

Glaciologists show evidence of warm ocean water intruding kilometers beneath grounded ice at Thwaites Glacier in West Antarctica. The findings suggest that existing climate models are underestimating the impact of ocean and ice interactions in future sea level rise projections.

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New patent for Ferring Pharms drug NOCDURNA

Drug Patent Watch

Annual Drug Patent Expirations for NOCDURNA Nocdurna is a drug marketed by Ferring Pharms Inc and is included in one NDA. It is available from one supplier.

Drugs 105
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The democratisation of cell and gene therapy

Drug Discovery World

Marc Hummersone, Senior Director of Research and Development (R&D) at Astrea Bioseparations, shares insight on the challenges and opportunities in cell and gene therapy (CGT) with DDW’s Megan Thomas. Lack of standardisation According to Hummersone, the major challenge in the CGT space is a lack of throughput that’s due to a lack of alignment of processes.

Therapies 273