2022

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Interview with the Jones!Lab on development of novel genome editing tools

Drug Discovery Today

On October 26?27, Vilnius will host the EFIB’2022 event which will bring the European life science sector together. In the field of life sciences, Lithuania is best known for the discovery of gene scissors by Prof. Virginijus Šikšnys. The country now hosts the EMBL Partnership Institute for Genome Editing Technologies at the Vilnius University Life Sciences Center aiming to advance gene editing technologies.

Science 214
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How long do clinical trial phases take?

Antidote

Before a potential new therapy can be administered to patients, it must go through several clinical trial phases designed to test the drug or device for safety and effectiveness. For many new treatments, it will take approximately ten years for the therapy to progress from initial discovery to being approved. Clinical trials alone take six to seven years on average to complete.

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The value of method of use patent claims in protecting your therapeutic assets

Drug Patent Watch

This is a guest post by Ray Miller and Megan E. Bowers, Ph.D. at DLA Piper. Ray may be contacted at raymond.miller@dlapiper.com. When it comes to protecting therapeutic assets, I…. The post The value of method of use patent claims in protecting your therapeutic assets appeared first on DrugPatentWatch - Make Better Decisions.

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What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

FDA Law Blog: Drug Discovery

By Mark A. Tobolowsky & James E. Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Therapies 119
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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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OPDP Issues First Regulatory Action Letter of 2022

Eye on FDA

FDA’s Office of Prescription Drug Promotion (OPDP) issued the first regulatory action letter for 2022. This one has some notable characteristics. As has been frequently noted, enforcement actions by OPDP have diminished considerably over the years. Another characteristic of recent enforcement actions over the past several years is that smaller, less well-known companies have mostly been the recipients of letters from OPDP.

FDA 108

More Trending

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A quiet revolution in the world of proteomics

DrugBaron

Proteomics – examining the panoply of proteins within a complex sample – has been around much longer than the word we use today to describe it. Proteomics the word was coined in around 1997 as a portmanteau coupling the now-ubiquitous “omics” suffix to the word protein. But two decades earlier two-dimensional gel electrophoresis was the cutting-edge technology that first visualised the “complete” catalogue of proteins in a sample, such as a cell lysate or blood sample.

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USA Clinical Trial Market Size and Opportunities

ProRelix Research

Clinical trials form the crux of all regulatory decisions regarding any new health intervention such as drugs and medical devices and thus require to be performed with the utmost care […]. The post USA Clinical Trial Market Size and Opportunities appeared first on ProRelix Research.

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The Inflation Reduction Act: Three Unintended Consequences for Biosimilars, Health Plans, Providers, and Pharmacies (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Drug Channels Outlook 2023. Click here to see the original post and comments from September 2022. During Friday’s webinar, I’ll be sharing my updated thoughts about the IRA’s impact on manufacturers, Part D plans, and patient behavior. By now, you have already read innumerable articles explaining what’s in the new Inflation Reduction Act of 2022 (IRA; P.L. 117-169).

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From U.S. Air Force Captain to CRO Leader: Karl D. Kendall Shares His Story

Conversations in Drug Development Trends

At Worldwide, we are committed to a cause that extends beyond ourselves. Our mission is to work with passion and purpose every day to improve lives. Our study teams are committed to working collaboratively with our sponsors, united in purpose. Worldwide aims to become an employer of choice?for veterans, military members, and?their families, by creating an?

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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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A Comprehensive Guide to Atopic Dermatitis

Olympian Clinical Research

Atopic dermatitis is a form of eczema and is the most common chronic inflammatory skin disease. While this condition is often seen in children, around 16.5 million Americans suffer from this itchy skin condition. Although there is no cure for this condition, with the proper knowledge, treatments, and lifestyle changes, those with eczema may manage their symptoms and lead happy, healthy lives.

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Thirona’s RetCAD™ and iCare are joining forces in Europe to offer an integral solution for eye screening with artificial intelligence.

Drug Discovery Today

Nijmegen, the Netherlands April 27th, 2022 – Thirona, one of the leading companies specializing in artificial intelligence for medical image analysis, has signed a strategic partnership agreement with iCare, for the implementation of Thirona’s RetCAD™ artificial intelligence software into the iCare solutions for eye disease screening, in Europe. The partnership underpins both companies’ technological leadership in this field.

Disease 157
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Medical terms A to Z: Common and confusing terms used in the doctor’s office

Antidote

Generally, a doctor’s visit is intended to provide clarity and insight into a patient’s concerns — but many people are all too familiar with the feeling of walking out of a clinic more confused than when they arrived. In fact, many Americans find themselves searching for health literacy tips after becoming confused by a doctor’s instructions or the directions on a prescription label.

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DrugPatentWatch Week in Review

Drug Patent Watch

FEATURED ARTICLE Branded Generics Promise Profits for Drugmakers, Peace of Mind for Patients Developing nations offer welcoming and growing markets as Abbott focuses exclusively on reformulating and marketing off-patent medications…. The post DrugPatentWatch Week in Review appeared first on DrugPatentWatch - Make Better Decisions.

Marketing 120
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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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Co-crystallization in drug development ~ Exploring the benefits of co-crystals ~

Drug Discovery Today

Over the last decade, co-crystallization has become an attractive alternative to improve the physiochemical properties of drugs without affecting their pharmacology. As a result of the pharmaceutical benefits co-crystals exhibit, industrial interest is on the rise. Here Dr. Thomas Kendall, application specialist at crystallization and solid-state specialist Technobis Crystallization Systems, gives a perspective on the benefits of co-crystals and explains how they can be screened.

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Publication in Nature Chemistry Demonstrates the Benefits of Native Mass Spectrometry in the Interrogation of Target Ecosystems and Drug Discovery

Drug Discovery Today

Joint publication in Nature Chemistry between OMass Therapeutics’ scientists and co-founder Professor Dame Carol Robinson’s team at Oxford University. Data demonstrates the ability of native mass spectrometry (MS) to interrogate the pharmacology of the beta-1 adrenergic receptor (ß1AR), a G protein-coupled receptor (GPCR).

Drugs 133
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CDCDB: A large and continuously updated drug combination database

Drug Patent Watch

This article was originally published by Guy Shtar, Louise Azulay, Omer Nizri, Lior Rokach & Bracha Shapira in Scientific Data volume 9, Article number: 263 under a Creative Commons Attribution…. The post CDCDB: A large and continuously updated drug combination database appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 119
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2 Strategies to Grow Your Excipient Business by Tracking Drug Patents

Drug Patent Watch

Drugs contain ingredients with therapeutic activity, so-called “active ingredients” as well as inactive ingredients. These inactive ingredients, called excipients, are included in oral products for various reasons, such as to…. The post 2 Strategies to Grow Your Excipient Business by Tracking Drug Patents appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 115
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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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Aptamer Group opens new state-of-the-art laboratories

Drug Discovery Today

The new facilities will support the increased demand for Optimer technology.

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IBM and Algorithmiq join forces to pave the way toward useful quantum advantage for quantum chemistry

Drug Discovery Today

Collaboration with innovative Finnish software company to explore how to reduce the time and cost of drug discovery and development using quantum computers

Drugs 113
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Discovery Park celebrates 10 years and plans to double jobs over the next decade

Drug Discovery Today

The team behind the success of one the country’s largest science and innovation park has announced its plans to grow and double the number of people employed on site as it celebrates a decade of delivering jobs and investment in the South East.

Science 113
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Nerve cell discovery may lead to better treatment for diseases of the nervous system

Drug Discovery Today

A discovery that may improve treatment options for patients with neurodegenerative diseases has been made by scientists at King’s College London and the University of Bath.

Treatment 113
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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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North West chemical manufacturer secures £2.2m to supercharge growth

Drug Discovery Today

Chemical manufacturer LCC has raised £2.2m of investment from a panel of regional investors, to expand its team and continue its global operation from the UK.

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Enhanced pacemaker developer Ceryx Medical wins prestigious Institute of Physics award

Drug Discovery Today

University of Bath spin-out hailed for revolutionary development to provide world’s first curative therapy for heart failure

Therapies 113
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Patient-specific cancer tumours replicated in 3D bioprinting advance

Drug Discovery Today

Bowel cancer patients could in future benefit from a new 3D bioprinting technology which would use their own cells to replicate the complex cellular environment of solid tumours in 3D models. The University of Bristol-led advance, published in Biofabrication, would allow clinicians to treat the models, known as spheroids, with chemotherapy drugs and radiation to help them understand an individual patient’s resistance to therapies.

Therapies 113
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Sphere Fluidics opens new laboratory facilities at Granta Park in Cambridgeshire, UK

Drug Discovery Today

Investment in purpose-built facilities supports ongoing recruitment and growth in new product development activities First phase of new facility doubles overall space capacity, with view to expand further as later stages of building complete

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Lithuania to host one of the most important biotechnology events in Europe: EFIB’22

Drug Discovery Today

On the 26th-27th of October, Vilnius is hosting the European Forum for Industrial Biotechnology & the Bioeconomy 2022 (EFIB'22). The forum will bring together business leaders, entrepreneurs, scientists, and investors as one of Europe's most meaningful events for biotechnology. We caught up with the Executive Director of the Lithuanian Biotechnology Association, Agne Vaitkeviciene, who told us about the importance of the forum and the potential of the Lithuanian life sciences sector.

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