Drug Discovery World

MAY 8, 2024

Fiona Maini , Senior Director Global Compliance & Strategy, at Medidata looks at the rise of artificial intelligence (AI) and machine learning (ML) within life sciences and the applications for the technology in clinical trials. The benefits that AI and machine learning (ML) can bring to society and their potential to radically change the world we live in can sometimes feel a little intangible, futuristic or even far-fetched.

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Clinical Trials Trials Regulations Compliance 163

Science Daily: Pharmacology News

MAY 8, 2024

When old food packaging, discarded children's toys and other mismanaged plastic waste break down into microplastics, they become even harder to clean up from oceans and waterways. These tiny bits of plastic also attract bacteria, including those that cause disease. Researchers describe swarms of microscale robots (microrobots) that captured bits of plastic and bacteria from water.

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Packaging Disease Research 118

Chemical Biology and Drug Design

MAY 2, 2024

Simultaneous inhibition of EGFR and VEGFR2 may improve the efficacy of cancer treatment. Understanding the macromolecular structures, activation mechanism, and pharmacophore features of both kinase inhibitors and their selectivity is essential in designing dual inhibitors of EGFR and VEGFR2. Abstract Epidermal growth factor receptor (EGFR) and vascular endothelial growth factor 2 (VEGFR2) are known as valid targets for cancer therapy.

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Therapies Treatment Research Drugs 100

Drugs.com

MAY 6, 2024

MONDAY, May 6, 2024 -- A new combination therapy appears to boost the response rate for liver cancer patients receiving immunotherapy, according to results from a phase 2 clinical trial.The combo therapy involves bavituximab, a drug that.

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Therapies Drugs 112

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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.

Clinical Trials

FDA Law Blog: Biosimilars

MAY 6, 2024

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).

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Drug Discovery World

MAY 8, 2024

The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. The ongoing innovation and development in the drug discovery sector relies on a number of moving parts, one of which is financial support and backing.

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BioPharma Drive: Drug Pricing

MAY 2, 2024

The funding will help Reunion pay for a mid-stage study testing its most advanced medicine — essentially a synthetic version of the hallucinogenic psilocin — in women with postpartum depression.

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Drugs 114

Drugs.com

MAY 6, 2024

MONDAY, May 6, 2024 -- An injectable gene therapy caused measurable improvements in vision among a small group of people with inherited blindness, an early-stage clinical trial says.Researchers recruited 14 people with Leber Congenital Amaurosis.

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Therapies Clinical Trials Trials 111

Drug Target Review

MAY 6, 2024

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.

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Science Therapies Small Molecule Clinical Trials 98

Drug Discovery World

MAY 8, 2024

A plant-based medication called cytisinicline may be an effective therapy to help them stop vaping, according to the ORCA-V1 trial results in the Journal of the American Medical Association (JAMA) Internal Medicine. Cytisinicline, also known as cytisine, baptitoxine, or sophorine, is an alkaloid that occurs naturally in several plant genera and has been used medically in relation to smoking cessation.

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Clinical Trials Compliance Trials Drugs 148

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Clinical Trials

Science Daily: Pharmacology News

MAY 3, 2024

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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BioPharma Drive: Drug Pricing

MAY 8, 2024

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.

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Drugs 94

Drugs.com

MAY 8, 2024

WEDNESDAY, May 8, 2024 -- Calls to U.S. poison centers regarding so-called synthetic cannabis jumped 88% between 2021 and 2022, as use of these legally sold products rose, research shows.Synthetic cannabis contain varying forms of the active.

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Production Research 99

Quanticate

MAY 2, 2024

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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Clinical Trials Trials 105

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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

Clinical Trials

Drug Discovery World

MAY 8, 2024

Calliditas Therapeutics has announced data from the proof-of-concept Phase II trial evaluating setanaxib, its lead NOX enzyme inhibitor, in combination with pembrolizumab, in patients with squamous cell carcinoma of the head and neck (SCCHN). The analysis showed statistically significant improvements in progression-free survival (PFS), as well as in overall survival (OS), with statistically significant changes in tumour biology consistent with the mechanism of action of setanaxib.

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Trials Clinical Trials Treatment Disease 148

Science Daily: Pharmacology News

MAY 8, 2024

Researchers may have detected atmospheric gases surrounding 55 Cancri e, a hot rocky exoplanet 41 light-years from Earth. This is the best evidence to date for the existence of any rocky planet atmosphere outside our solar system.

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Research 106

BioPharma Drive: Drug Pricing

MAY 3, 2024

The company said data for its Wegovy competitor was promising enough to move the drug into late-stage testing, triggering a stock jump that added billions to Amgen’s market value.

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Drugs.com

MAY 6, 2024

MONDAY, May 6, 2024 -- Worries over health-related costs are plaguing the minds of older Americans of all backgrounds, a new poll suggests.Five of the six health-related issues that most people found very concerning had to do with health care.

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KIF1A

MAY 4, 2024

#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.

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Drug Discovery World

MAY 7, 2024

DDW Editor Reece Armstrong speaks to David Chau , Global Bioprocess Application Specialist, Separation and Purification Sciences Division, 3M, about challenges in producing monoclonal antibodies (mAbs) and how single-use technologies can simplify processes. RA: What are some of the current limitations for producing mAbs? DC: For the past few decades, there have been many advancements in the biotechnology space.

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Production Engineering Packaging DNA 148

Science Daily: Pharmacology News

MAY 8, 2024

A tiny, flexible electronic device that wraps around the spinal cord could represent a new approach to the treatment of spinal injuries, which can cause profound disability and paralysis. A team of engineers, neuroscientists and surgeons developed the devices and used them to record the nerve signals going back and forth between the brain and the spinal cord.

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Engineering Treatment 104

BioPharma Drive: Drug Pricing

MAY 6, 2024

A 12-year-old boy in the Washington, D.C., area is set become the first patient treated with Lyfgenia since its U.S. approval last December.

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Therapies 112

Drugs.com

MAY 3, 2024

FRIDAY, May 2, 2024 -- Folks struggling to quit smoking might need a bump up on the dose of medication they’re using to help them stop, according to new clinical trial results.Patients are more likely to successfully quit if the dose of their.

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Clinical Trials Trials 111

Covalent Modifiers

MAY 5, 2024

Giulia Alboreggia, Parima Udompholkul, Carlo Baggio, Kendall Muzzarelli, Zahra Assar, and Maurizio Pellecchia Journal of Medicinal Chemistry 2024 DOI: 10.1021/acs.jmedchem.4c00277 Several novel and effective cysteine targeting (Cys) covalent drugs are in clinical use. However, the target area containing a druggable Cys residue is limited. Therefore, methods for creating covalent drugs that target different residues are being looked for; examples of such ligands include those that target the resi

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Research Drugs 84

Drug Discovery World

MAY 6, 2024

Thanks to a prestigious academic legacy, Europe has long been a dominant region for life sciences. In this article, DDW’s Diana Spencer highlights several prominent hotspots that are taking the lead on advancing European drug discovery and development. Europe is traditionally a life sciences powerhouse, with a strong tradition in pharmaceutical discovery.

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Drugs Molecular Biology Science Clinical Trials 148

Science Daily: Pharmacology News

MAY 6, 2024

Astronomers observed the elusive starlight surrounding some of the earliest quasars in the universe. The findings may shed light on how the earliest supermassive black holes became so massive despite having a relatively short amount of cosmic time in which to grow.

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BioPharma Drive: Drug Pricing

MAY 7, 2024

Pfizer said the patient, a young boy who was treated earlier last year, had died suddenly. The company is working with trial researchers to investigate further.

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Therapies Trials Research 92

Drugs.com

MAY 6, 2024

MONDAY, May 6, 2024 -- A potentially dangerous spike in blood pressure known as preeclampsia can occur in 1 in every 25 pregnancies, but an accurate test to spot those women at highest risk has remained elusive.Now, Canadian researchers at.

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Research 98

Drug Channels

MAY 2, 2024

Today’s guest post comes from Chris Dowd, Senior VP of Market Development at ConnectiveRx. Chris explains how the Inflation Reduction Act of 2022 (IRA) will impact hub, patient assistance programs (PAP), and affordability programs. He discusses steps manufacturers can take to accommodate the anticipated budget reductions while maintaining access and affordability for patients.

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Marketing Drugs 83

Drug Discovery World

MAY 8, 2024

The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. The ongoing innovation and development in the drug discovery sector relies on a number of moving parts, one of which is financial support and backing.

Disease 130

Disease Research Drugs 130

Science Daily: Pharmacology News

MAY 3, 2024

Researchers uncovered compelling evidence that Earth's magnetic field was in a highly unusual state when the macroscopic animals of the Ediacaran Period -- 635 to 541 million years ago -- diversified and thrived. Their study raises the question of whether these fluctuations in Earth's ancient magnetic field led to shifts in oxygen levels that may have been crucial to the proliferation of life forms millions of years ago.

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Research 121

BioPharma Drive: Drug Pricing

MAY 2, 2024

The $1 billion dollar acquisition will add to Novartis’ pipeline of the targeted radiation drugs, giving it a potential lung cancer treatment.

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Treatment Drugs 108

Drugs.com

MAY 6, 2024

MONDAY, May 6, 2024 -- Pets and pet owners who come into contact with Bausch & Lomb's "Project Watson" dog eye wipes could be at risk for infection if the products come from certain lots.The wipes are used to clean a dog's eyelids, but two.

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Production 98

addgene Blog

MAY 2, 2024

FITS In vitro CRISPR screens in immune cells have identified many putative regulators of immunity. However, in vitro screens cannot faithfully model the complex spatial, cellular, metabolic, and cytokine microenvironment that exists in vivo. Over the past five years, in vivo CRISPR screens have been used to interrogate T cells, an important immune cell type, in more complex and physiological microenvironments.

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Regulations 77