October, 2023

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Companies Seek To Increase Life Span By A Decade Or More

Forbes: Drug Truths

But keep in mind that it’s going to be a long while before such drugs are actually available.

Drugs 325
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Vertex, CRISPR therapy for sickle cell passes FDA panel test

BioPharma Drive: Drug Pricing

The high-profile meeting focused on the theoretical risks of CRISPR gene editing, as both the FDA and its advisory committee appeared convinced by the efficacy of the companies’ exa-cel treatment.

FDA 133
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Phase III is Coming!

Drug Hunter

With initial signs of efficacy and tolerability, Drug Hunter is launching into Phase III! To address your helpful feedback, we’ve rebuilt the platform from scratch to support new features and enhancements. In a few days, you’ll see the changeover to the new version go live. Show Me the Molecules! Fig. 1. The new homepage, which you can preview at v2.drughunter.com.

Trials 247
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New patient-partnered research project will study heart disease and diabetes risk in South Asian populations

Broad Institute

New patient-partnered research project will study heart disease and diabetes risk in South Asian populations By Corie Lok October 23, 2023 Breadcrumb Home New patient-partnered research project will study heart disease and diabetes risk in South Asian populations The OurHealth study aims to increase representation of people of South Asian ancestry in cardiometabolic research.

Disease 145
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Humans are disrupting natural 'salt cycle' on a global scale, new study shows

Science Daily: Pharmacology News

A new paper revealed that human activities are making Earth's air, soil and freshwater saltier, which could pose an 'existential threat' if current trends continue. Geologic and hydrologic processes bring salts to Earth's surface over time, but human activities such as mining and land development are rapidly accelerating this natural 'salt cycle.

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Plasmids 101: Choosing an Antibiotic Resistance Gene

addgene Blog

Plasmids need antibiotic resistance genes so that you can specifically isolate bacteria containing your constructs of interest. But does it matter which antibiotic resistance gene you select? In this blog, we’ll break down the mechanism of action of the most common antibiotic resistance genes and which applications are best (or worst) for each antibiotic.

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More Trending

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A decade later, biotech’s CRISPR revolution is still going strong

BioPharma Drive: Drug Pricing

Once the specialty of a few select drugmakers, CRISPR gene editing is now an essential technology for a growing group of biotechs, many led by former students of the field's pioneering scientists.

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Bagged, Precut Onions Tied to Salmonella Illnesses in 22 States

Drugs.com

WEDNESDAY, Oct. 25, 2023 – Federal regulators are investigating a salmonella outbreak linked to packaged, diced onions that has sickened at least 73 people across 22 states. Fifteen of the illnesses were so bad that people required.

Packaging 122
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A research team searches for every gene that helps tumors evade immunotherapy

Broad Institute

A research team searches for every gene that helps tumors evade immunotherapy By Allessandra DiCorato October 11, 2023 Breadcrumb Home A research team searches for every gene that helps tumors evade immunotherapy Efforts to probe the entire genome of cancer cells in animals have led to potential new drugs — now in early-stage clinical trials — that could make cancer immunotherapy more effective for more patients.

Research 137
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Climate report: 'Uncharted territory' imperils life on Earth

Science Daily: Pharmacology News

An international coalition of climate scientists says that the Earth's vital signs have worsened beyond anything humans have yet seen, to the point that life on the planet is imperiled.

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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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Understanding primary sclerosing cholangitis symptoms

Antidote

Primary sclerosing cholangitis (PSC) is an autoimmune disease that mainly targets bile ducts in the liver. PSC is a rare condition, impacting about 1 in 10,000 people worldwide , and it is diagnosed twice as frequently in men as it is in women.

Disease 122
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Microbiotica: transforming medicine with microbiome magic

Drug Target Review

Live Bacterial Products (LBPs) will provide patients with a desirable, credible, safe and effective treatment option. The human microbiome, a complex ecosystem of microorganisms residing within our bodies, has emerged as a promising frontier in the quest for innovative medical treatments. Microbiotica, a pioneering company that has developed a Discovery Platform that has paved the way for the creation of Live Bacterial Products (LBPs).

Treatment 122
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Verve gets FDA green light to run base editing study in US

BioPharma Drive: Drug Pricing

The trial, which is ongoing in the U.K. and New Zealand, has been on hold in the U.S. since late last year as the FDA sought more details on Verve’s in vivo treatment for heart disease.

FDA 136
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Using Rendering Parameters on a XM Cloud component

Perficient: Drug Development

What about Rendering Parameters? I recently did a POC using rendering parameters in a component in XM Cloud. In this blog i will describe my approach, issues faced and how i overcame them. Adding a rendering to a component, is relatively straight forward in Sitecore development, i.e.( [link] ). However, there are some circumstances where things are a little bit more complex (than they need to be).

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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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Broad Clinical Labs established to expand clinical services

Broad Institute

Broad Clinical Labs established to expand clinical services By Leah Eisenstadt October 3, 2023 Breadcrumb Home Broad Clinical Labs established to expand clinical services Formerly the Clinical Research Sequencing Platform, the cutting-edge laboratory at the Broad Institute is poised to further accelerate clinical genomics. By Broad Communications October 3, 2023 The Broad's Clinical Research Sequencing Platform is now Broad Clinical Labs.

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FDA Issues Warning on Dangers of Probiotic Products for Preemie Babies

Drugs.com

FRIDAY, Oct. 27, 2023 -- Federal regulators have sent warning letters to two companies for illegally selling probiotic products for use in preterm infants. The U.S. Food and Drug Administration also sent a letter to health care providers warning of.

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Health Literacy Month: How industry communication can impact patient health literacy

Antidote

Since 1999, October has been designated as Health Literacy Month , a month dedicated to promoting patient-centricity in healthcare communications across the industry. Health literacy refers to a person’s ability to find, understand, and use health-related services and make informed decisions for themselves and others.

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Patient-derived organoids in disease modelling

Drug Target Review

These “patient in a dish” models, as explained by Molecular Devices, are three-dimensional (3D) cell structures cultivated from tissue samples that offer an opportunity to bridge the gap between traditional two-dimesion (2D) cell cultures and animal models. As we explore translatability, technological advancements and the integration of artificial intelligence (AI), we envision the potential role of PDOs throughout the entire medicine creation pipeline, from target identification to

Disease 122
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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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Pfizer to cut costs, lay off staff on waning demand for COVID products

BioPharma Drive: Drug Pricing

Sales of Pfizer's antiviral Paxlovid and shot Comirnaty have been slower than it anticipated, while a shift to the commercial market for the antiviral has been delayed.

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AI/ML-enabled Medical Devices Have Everyone’s Attention, Including FDA’s

FDA Law Blog: Biosimilars

By Gail H. Javitt & Steven J. Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. The first article—“Is the Eye the Window to Alzheimer’s?

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Cancer immunotherapy candidate provokes powerful dual response in cancer and immune cells

Broad Institute

Cancer immunotherapy candidate provokes powerful dual response in cancer and immune cells By Allessandra DiCorato October 4, 2023 Breadcrumb Home Cancer immunotherapy candidate provokes powerful dual response in cancer and immune cells The small molecule, now in clinical trials, increases activity of immune cells and sensitivity of tumors to immune attack.

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CVS Pulling Popular Cold Meds From Shelves After Report Deems Them to Be Useless

Drugs.com

FRIDAY, Oct. 20, 2023 -- CVS Health plans to pull cold medications that contain phenylephrine from its store shelves after federal regulators determined recently that the decongestant doesn’t work. Oral phenylephrine is an active ingredient.

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Empowering patients: How to match to clinical trials

Antidote

Clinical trials are an integral part of the medical industry, as they are required for any new treatment to be approved. Every medicine used today, whether prescription or over the counter, is a result of the rigorous research process that is a clinical trial — and for these trials to take place, volunteers are vital.

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AI Healthcare Use Cases

Perficient: Drug Development

Are you a Healthcare Business Leader stressing over how much you should use AI? Don’t be. I’m certain you have a roadmap with some bodacious goals on them. You want to increase engagement and access to high quality care and drive down healthcare costs, right? Although AI isn’t a magic wand, we can finally start to think bigger and shorten our roadmaps.

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Tracking the FDA’s meeting on Vertex, CRISPR’s sickle cell therapy

BioPharma Drive: Drug Pricing

Expert advisers are reviewing the companies’ case for approval of what could be the first medicine based on the gene editing technology. Follow their discussion here.

Therapies 131
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Stem cell therapy to slow progression of multiple sclerosis (MS)

Drug Target Review

Published in the Journal of Neurology Neurosurgery & Psychiatry. This innovative approach involves the extraction of a patient’s own stem cells from either their bone marrow or blood , followed by a course of chemotherapy and antibody treatment. While aHSCT has shown potential benefits for RRMS patients, it has not yet garnered widespread inclusion in national clinical guidelines.

Therapies 116
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Modeling patient insights to make the most of clinical trials

Fierce BioTech

Successful and worthwhile clinical trials rely on patient trust throughout the entire experience. | Greg Lever, Director within the IQVIA Applied Data Science Center, reveals how modeling technology is being used to unlock value and enhance the experience of trial participants.

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Ketamine Nasal Spray Shows Promise Against Tough-to-Treat Depression

Drugs.com

THURSDAY, Oct. 5, 2023 -- A nasal spray containing a ketamine derivative appears to beat one of the standard drugs used for people with difficult-to-treat depression, a new clinical trial has found. The trial, of nearly 700 people with.

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Key breast cancer facts for Breast Cancer Awareness Month

Antidote

Since 1985, Breast Cancer Awareness Month has been held every October with the goal of raising awareness about the importance of breast cancer screening and prevention. Catching breast cancer early is one of the best ways to increase a person’s prognosis — though one in 8 women in the United States will be diagnosed with breast cancer in their lifetime , when caught in early stages, the 5-year survival rate is 99%.

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Let’s Connect at the Puerto Rico CIO & IT Leadership Conference

Perficient: Drug Development

Let’s Connect at the Puerto Rico CIO & IT Leadership Conference From October 12, 2023 to October 13, 2023, we will have several Perficient colleagues at the Puerto Rico IT Cluster’s CIO & IT Leadership conference to support companies in the region as they continue to transform through digital technology. Our industry, technology, and strategy capabilities place Perficient at the forefront of the technology space, and we are excited to engage with our peers at this year’s conference

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Vertex gearing up for launch as sickle cell therapy review advances

BioPharma Drive: Drug Pricing

Executives at the biotech say they’re trying to get ahead of the payer and production challenges that will face their gene editing treatment exa-cel, which is now under FDA review.

Therapies 121
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My Love/Hate Relationship with Process

LifeSciVC

By Aoife Brennan, CEO of Synlogic, as part of the From The Trenches feature of LifeSciVC I remember vividly my first vacation with the man who would be my husband. In the days before Airbnb and on-line travel websites, he had all the books and had thoroughly researched each destination, every transport option, all the food venues. The guy clearly had process.

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New avenues for rare disease treatment

Drug Target Review

Almost every one of us will know someone with a neurodegenerative disease such as Alzheimer’s or Parkinson’s. Whether it is a friend, a family member or a work colleague, it is likely these conditions have touched your life in some way. It is less common to know someone with a rare genetic disease; but while individually rare, collectively they have an enormous impact.

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