Mon.Mar 11, 2024

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Orphan Drug Designation for first-in-class autotaxin cancer therapy

Drug Discovery World

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to iOnctura for its autotaxin inhibitor cambritaxestat for the treatment of pancreatic cancer. After assessing its novel chemical and biological properties, including an attractive non-clinical safety and efficacy profile, the FDA has granted Orphan Drug Status, conferring certain benefits during development and commercialisation.

Therapies 174
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Biotech stock fundings headed for best quarter in 3 years, Jefferies says

BioPharma Drive: Drug Pricing

Publicly traded companies raised nearly $10 billion in follow-on stock offerings in January and February, a financing surge that’s driving a “sector recovery,” the investment bank said.

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New DDW Highlights podcast: 11 March 2024

Drug Discovery World

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. It was antibodies hitting the headlines this week, with the discovery of antibodies with potential against a new influenza target, the launch of a Phase I trial to investigate a novel type of bispecific antibody, and the announcement that the FDA will delay approval of donanemab to hold

FDA 148
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Investigating the effect of polymerase inhibitors on cellular proliferation: Computational studies, cytotoxicity, CDK1 inhibitory potential, and LC?MS/MS cancer cell entrapment assays

Chemical Biology and Drug Design

Polymerase inhibitor (daclatasvir; DLT) does not induce cell proliferation in variable cell lines. DLT exhibited a superior antiproliferative and anti-CDK1 potential over the nucleoside analogues, especially in the HepG2. This supports the claim that a reduction in HCC development in patients treated with a DAA. Abstract Directly acting antivirals (DAAs) are a breakthrough in the treatment of HCV.

Treatment 100
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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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Elsevier and Iktos partner to launch AI-powered drug discovery database

Drug Discovery World

Elsevier and Iktos have partnered to strengthen Elsevier’s chemistry solution, Reaxys, by combining the company’s chemistry data with synthetic planning AI technologies developed by Iktos. The partnership aims to support R&D organisations to decrease the time required to complete Design-Make-Test-Analyse cycles of small molecules, thus reducing the length and cost of early-stage drug discovery.

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Amylyx CEOs look for a path forward following major setback

BioPharma Drive: Drug Pricing

Justin Klee and Joshua Cohen spoke to BioPharma Dive about the next steps for their company, which is considering pulling its only product from market after the drug failed a confirmatory study in ALS.

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Poor Trial Results May Prompt Maker to Pull ALS Drug, Relyvrio, From Market

Drugs.com

MONDAY, March 11, 2024 -- Following disappointing trial results, the maker of a controversial ALS drug may pull the medication off the market. In a statement issued Friday, Amylyx Pharmaceuticals said that Relyvrio failed to help patients in a.

Marketing 115
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Nasa’s Webb, Hubble telescopes affirm universe’s expansion rate, puzzle persists

Science Daily: Pharmacology News

When you are trying to solve one of the biggest conundrums in cosmology, you should triple check your homework. The puzzle, called the 'Hubble Tension,' is that the current rate of the expansion of the universe is faster than what astronomers expect it to be, based on the universe's initial conditions and our present understanding of the universe's evolution.

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Boehringer, Sosei Heptares team up in schizophrenia drug deal

BioPharma Drive: Drug Pricing

Sosei Heptares could receive more than 700 million euros in a deal to develop medicines aimed at the protein GPR52, an emerging drug target in multiple neurological diseases.

Drugs 113
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Ubiquitous pyrogens and 3D cancer models

Drug Target Review

A collaboration between the University of Twente in the Netherlands and Rousselot has revealed the dynamics between biomaterial purity and the fidelity of 3D cancer models. Their joint study illuminated the profound impact of endotoxins on the accuracy and efficacy of these models, marking a significant breakthrough in cancer research. Through experimentation, contrasting research-grade gelatine, inherently infused with endotoxins, with an ultra-low endotoxin-level gelatine, they revealed that t

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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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AI (Artificial Intelligence) Powered Product People

Perficient: Drug Development

AI (Artificial Intelligence) Powered Product People Have you ever wondered how artificial intelligence can transform not only our lives but also our professions? As someone passionate about technology and digital product development, I have always been intrigued by new tools and how they can improve our lives and careers. In recent times, artificial intelligence (AI) has captured my attention.

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Sun Plus Certain Foods, Meds Can Bring on 'Margarita Rashes'

Drugs.com

MONDAY, March 11, 2024 -- Slicing some fresh limes for that margarita savored in the sun could be a bad combo for some people's skin, dermatologists warn. Folks can break out in what are nicknamed "margarita rashes" if they are skin-sensitive to.

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Roche, following setbacks, turns to its next Alzheimer’s drug

BioPharma Drive: Drug Pricing

Roche said its experimental Alzheimer’s disease drug trontinemab showed it might be able to clear brain plaques faster than other medicines.

Drugs 117
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AI-generated food images look tastier than real ones

Science Daily: Pharmacology News

Researchers have announced an intriguing discovery -- consumers generally prefer AI-generated images of food over real food images, especially when they are unaware of their true nature.

Research 102
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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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Advanced technologies in unlocking the future of drug manufacturing

BioPharma Drive: Drug Pricing

Innovative technologies, such as flow chemistry and biocatalysis, are achieving not only sustainability goals but also unprecedented levels of quality and efficiency.

Drugs 104
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COVID Virus Lingers in Tissues for Over a Year

Drugs.com

MONDAY, March 11, 2024 -- The COVID-19 virus can linger in the blood and tissue of patients for more than a year after they’ve shaken their initial infection, new findings show.

Virus 98
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Optimizing your ELISA Assays | BMG LABTECH

BMG Labtech

Enzyme-Linked Immunosorbent Assays (ELISAs) are an essential technique in today’s laboratory with many applications in the life sciences. They are often the method of choice to detect or measure specific biological molecules (analytes) for diagnostics, drug discovery or fundamental research. In this blog, we look at immunoassays over the years, provide some examples of current and emerging applications, discuss some tips for optimization, and look at some of the benefits of the different ELISA o

Vaccine 98
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How After-School Programs Can Harm Teens' Mental Health

Drugs.com

MONDAY, March 11, 2024 -- Days clogged with numerous after-school activities are detrimental to the mental health of over-scheduled high school students, a new study finds.

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Peering into the tendrils of NGC 604 with NASA's Webb

Science Daily: Pharmacology News

The formation of stars and the chaotic environments they inhabit is one of the most well-studied, but also mystery-shrouded, areas of cosmic investigation. The intricacies of these processes are now being unveiled like never before by NASA's James Webb Space Telescope.

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Novel molecules from generative AI to phase II

SCIENMAG: Medicine & Health

Credit: Insilico Medicine A study published in Nature Biotechnology presents the entire journey of INS018_055, from AI algorithms to Phase II clinical trials for the first time. Raw data from 13 preclinical experiments and 3 clinical trials referenced in this study can be accessed by visiting Insilico’s data room.

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Can using SDoH data help identify patient populations who could benefit from weight loss drugs?

BioPharma Drive: Drug Pricing

SDoH data can help companies understand the footprint of weight loss medications in the market and their impact across populations.

Marketing 103
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In our cellular ‘glue,’ scientists find answers about heart attacks, strokes, more

SCIENMAG: Medicine & Health

University of Virginia School of Medicine scientists have found important answers about strokes, heart attacks and cardiovascular diseases by probing the biological glue our bodies create to protect us from those deadly dangers.

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Kids Battling Mental Health Issues Have Tougher Time Recovering From Concussion

Drugs.com

MONDAY, March 11, 2024 -- Kids struggling with mental health problems have a tougher time recovering from a concussion, a new study finds.

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Bad Labs! Bad Labs? Whatcha Gonna Do?

FDA Law Blog: Biosimilars

By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Allyson B. Mullen — On February 20, 2024, FDA issued a letter to the medical device industry ( link ) warning medical device firms of recent FDA concerns related to fraudulent and unreliable laboratory testing data in premarket submissions. Unfortunately, the letter provides little new information to guide industry conduct.

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Real World Data Shows RSV Shot, Beyfortus, Cut Infant Hospitalizations by 90%

Drugs.com

FRIDAY, March 8, 2024 -- Real-world data show that a shot that protects babies against RSV is 90% effective in keeping them out of the hospital. Those numbers outstrip what had been expected of Beyfortus (nirsevimab), which in clinical trials had.

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Every Second Counts

LifeSciVC

By Aoife Brennan, former CEO of Synlogic, as part of the From The Trenches feature of LifeSciVC I have recently completed a turn around the biotech sun: a seven-year assignment at Synlogic that ended this year when an early readout of our Phase 3 program indicated that it was unlikely to meet its primary endpoint. Did I dream of a different outcome for the company – a therapeutic that helped thousands of patients and provided a generous return for investors and employees?

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Medical Costs for Kids' Mental Health Jumped 31% in 5 Years

Drugs.com

MONDAY, March 11, 2024 -- The cost to American families of caring for a child with a mental health condition rose by almost a third between 2017 and 2021, a new report finds, to an average $4,361 per year. Overall, American families spent an.

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Turns out—male roundworms are picky when choosing a mate, new research finds

SCIENMAG: Medicine & Health

A piece of rotting fruit is likely covered in hundreds if not thousands of microscopic roundworms, including C. elegans—a popular experimental model system for studying neurogenetics. With a lifespan of only a few weeks, C. elegans must reproduce quickly and often. The species is made up of hermaphrodites and males.

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New patent for Gilead Sciences drug VOSEVI

Drug Patent Watch

Annual Drug Patent Expirations for VOSEVI Vosevi is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are nineteen… The post New patent for Gilead Sciences drug VOSEVI appeared first on DrugPatentWatch - Make Better Decisions.

Science 59
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Adding Your Style: Custom Icons in Salesforce LWC

Perficient: Drug Development

Aloha trailblazers! Let’s talk about jazzing up your Lightning Web Components (LWC) with a personal touch – custom icons. You know, those tiny visual cues that can make a big difference in how users interact with your app. Salesforce has a solid library of standard icons, but why not sprinkle in some of your own flair? Why Custom Icons? First things first, let’s understand what we’re working with.

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New patent for Pfizer drug DAURISMO

Drug Patent Watch

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

Drugs 59
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Quantitative Strategies for Rare Disease Clinical Trials

Cytel

In 2023, rare diseases accounted for 30% of product pipeline under development, about half of which comprising non-oncology rare diseases. Clinical development in rare diseases has specific challenges. A primary challenge arises from the small populations from which clinical trial participants can be recruited, and from often limited prior knowledge on a disease.

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New patent for Astellas drug XOSPATA

Drug Patent Watch

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

Drugs 59
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Safety Considerations for the Development of ADCs

Fierce BioTech

Safety Considerations for the Development of ADCs dwunderlin Mon, 03/11/2024 - 16:44 Tue, 04/30/2024 - 11:00 Resource Type Webinar Maciej Czerwinski, PhD Duration 60 Minutes Antibody-drug conjugates (ADCs) are a novel modality leveraging monoclonal antibody (mAb)-mediated delivery of a cytotoxic payload molecule to its target. Since the drug conjugated to mAb, typically a highly cytotoxic small molecule, can be released unconjugated in plasma and contribute to drug-drug interaction (DDI) potenti