Drug Discovery World

SEPTEMBER 14, 2022

Nicola Richmond, VP of AI, BenevolentAI, will be speaking at the Tech Theatre, ELRIG Drug Discovery 2022, sponsored by DDW. Nicola Richmond is a mathematician with over 20 years’ experience of developing digital solutions to problems in drug discovery and development. She will be presenting a talk on ‘The lab of the future is now: Using AI or automation for the drug discovery process’ The Tech Theatre will feature a series of seminars focused on automation and technology for dr

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Drug Channels

SEPTEMBER 16, 2022

Today’s guest post comes from Edward Hensley, Chief Commercial Officer at AssistRx. Edward compares the pros and cons of electronic benefit verification using artificial intelligence, direct connectivity, or data connectivity. He also describes the circumstances where each solution provides the greatest value. To learn more, download AssistRx’s free eBook: Specialty Drug Patient Support Programs: 2022 Progress Report.

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Antidote

SEPTEMBER 12, 2022

There are many factors one should consider before deciding to enroll in a clinical trial. Though every clinical trial is designed to help researchers advance their knowledge about a specific condition, the details regarding a study’s duration, risks, benefits, and required time commitment can vary. When determining how to participate in clinical trials, these elements are all good things to discuss with the research team to determine if a study is a good fit.

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Drug Discovery Today

SEPTEMBER 16, 2022

Why opening up communication channels can stop the spread of misinformation

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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

Drug Discovery World

SEPTEMBER 16, 2022

News round-up for 12-16 September by DDW Digital Content Editor Diana Spencer. A slightly quieter week for news in light of national events in the UK, but the vital work of the international drug discovery community goes on and new discoveries are being made all the time. . The last seven days have seen important breakthroughs in the treatment of dermatitis in younger children, metastatic colorectal cancer and desmoid tumours, while drugs for Alzheimer’s disease and psoriasis have overcome regu

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Drug Channels

SEPTEMBER 13, 2022

By now, you have already read innumerable articles explaining what’s in the new Inflation Reduction Act of 2022 (IRA; P.L. 117-169). Today, I want to highlight three significant—and presumably unintended—drug channel consequences from the hastily-passed IRA legislation. These include disruption to the now-booming biosimilar market, the prospects of physician/hospital vertical integration that will raise commercial healthcare costs and expand 340B, and the need for complex new processes to admini

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Antidote

SEPTEMBER 15, 2022

Successful clinical trial patient recruitment is a multi-step process that is worth taking the time to thoroughly understand. Clinical trial recruitment companies often make mention of thorough research, rigorous testing, and continuous optimization — but what does that mean in practical terms?

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Drug Discovery World

SEPTEMBER 16, 2022

A female-led start-up developing a live biotherapeutic product to address infant gut needs, has raised £1.3M ($1.5M) in equity and grant funding. . BoobyBiome, founded by scientists Dr Lydia Mapstone, Dr Sioned Jones and Tara O’Driscoll, aims to develop a novel product for babies who do not have access to the microbiome in breast milk. . Working with Associate Professor Dr Mona Bajaj-Elliot at the Institute of Child Health in Great Ormond Street Hospital, they have uncovered a community of bac

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Drug Channels

SEPTEMBER 14, 2022

I invite you to join me for three new video webinars during 2023. These live, interactive events will be broadcast via Zoom from the Drug Channels Video studio in beautiful downtown Philadelphia. During these events, I'll address the latest issues confronting the U.S. drug channel. Topics will be determined based on what’s happening—trends, policy changes, company announcements, and more.

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Crown Bioscience

SEPTEMBER 15, 2022

Using whole genome sequencing to better understand PDX genomic profiles is a highly comprehensive method for analyzing whole genomes. By incorporating WGS into preclinical tumor studies, the genomic and pathogenic features of cancers can be better understood, and translational biomarkers can be identified more efficiently.

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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.

Clinical Trials

Drug Patent Watch

SEPTEMBER 15, 2022

Annual Drug Patent Expirations for EPRONTIA Eprontia is a drug marketed by Azurity and is included in one NDA. It is available from one supplier. The generic ingredient in EPRONTIA…. The post New patent for Azurity drug EPRONTIA appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Discovery World

SEPTEMBER 16, 2022

Domainex has revealed human ex vivo data indicating that DMXD-011 could be effective in treating interferonopathies such as lupus, Sjögren’s syndrome, and scleroderma. The drug candidate is an inhibitor of protein kinases TBK1 and IKK-epsilon, which previous studies suggest should be highly-effective in the treatment of inflammatory diseases. The efficacy of DMXD-011 has already been shown in animal models of lupus and rheumatoid arthritis, without any evidence of side effects or toxicity.

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NIH Director's Blog: Drug Discovery

SEPTEMBER 13, 2022

Each year, more than 2.8 million people in the United States develop bacterial infections that don’t respond to treatment and sometimes turn life-threatening [1]. Their infections are antibiotic-resistant, meaning the bacteria have changed in ways that allow them to withstand our current widely used arsenal of antibiotics. It’s a serious and growing health-care problem here and around the world.

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LifeSciVC

SEPTEMBER 15, 2022

By Joshua Brumm, CEO of Dyne Therapeutics, as part of the From The Trenches feature of LifeSciVC By all accounts, 2022 did not start according to plan for the biotech industry. The U.S. economy and growth stocks struggled with the broader biotech index down by more than 45 percent through the first half of the year. Throughout my career in biotech, I have learned that this industry is filled with twists and turns and, at times, setbacks.

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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 Patent Watch

SEPTEMBER 14, 2022

Annual Drug Patent Expirations for VENCLEXTA Venclexta is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. There are eight patents…. The post New patent for Abbvie Inc drug VENCLEXTA appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Discovery World

SEPTEMBER 16, 2022

A new In Vitro Pharmacology Working Group to accelerate regulatory submissions has been created by the Pistoia Alliance, a global advocate for greater collaboration in life sciences R&D. The group will include liaisons from the US Food and Drug Administration’s Center for Drug Evaluation and Research, as well as representatives from biopharmaceutical companies, contract research organisations (CROs), technology suppliers and regulatory agencies. .

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Pharma Manufacturing

SEPTEMBER 12, 2022

Research into nanomaterials has opened the door to new therapeutic strategies

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Drug & Device Law

SEPTEMBER 15, 2022

A little over a year ago, we discussed one of the best decisions we had ever read on why comparative risk claims – premised on a manufacturer’s alleged failure to warn that a competing product was supposedly “safer” – are both statistically invalid and practically impossible. That decision, Nelson v. C.R. Bard, Inc. , 553 F. Supp.3d 343 (S.D. Miss. 2021), explained at length both how product “comparisons,” if based on the FDA’s voluntary “MAUDE” adverse event reporting system are inherently sus

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Drug Patent Watch

SEPTEMBER 13, 2022

Annual Drug Patent Expirations for CIPRODEX Ciprodex is a drug marketed by Novartis and is included in one NDA. It is available from three suppliers. There are four patents protecting…. The post New patent expiration for Novartis drug CIPRODEX appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Discovery World

SEPTEMBER 16, 2022

A biologic therapy for very young children with moderate to severe eczema (or atopic dermatitis) has been shown to be safe and effective in an international trial. Sponsored by Regeneron and Sanofi, the study of dupilumab in poorly controlled eczema is the first large-scale randomised double-blind trial of a monoclonal antibody for any skin disease in patients aged six months to six years.

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Pharma Manufacturing

SEPTEMBER 14, 2022

Hint: It’s not by raising prices

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Drug & Device Law

SEPTEMBER 14, 2022

From the defense perspective, the worst thing about a mass tort is that it is so … massive. The more the merrier? No way. The presence of multiple plaintiffs signals to the jury that something must be wrong with the product. Don’t believe us? We think there is research to support our dislike of consolidation but, even beyond that, our eyes and ears don’t lie.

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Drug Patent Watch

SEPTEMBER 13, 2022

Annual Drug Patent Expirations for MAVENCLAD Mavenclad is a drug marketed by Emd Serono Inc and is included in one NDA. It is available from one supplier. There are four…. The post New patent for Emd Serono drug MAVENCLAD appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Discovery World

SEPTEMBER 15, 2022

A new partnership will bring together Microsoft’s computational services, cloud and artificial intelligence (AI) and Novo Nordisk’s drug discovery, development and data science capabilities. Through the agreement, Microsoft will provide AI technology, foundational science models and expertise and work alongside Novo Nordisk’s data scientists and domain experts to accelerate the company’s R&D.

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Drug Discovery World

SEPTEMBER 15, 2022

The Scottish Medicines Consortium (SMC) has ruled Idefirix (imlifidase) clinically and cost-effective in highly sensitised adult patients prior to kidney transplant from a deceased donor. . The recommendation, which follows a positive ruling by the National Institute of Health and Care Excellence (NICE), marks an important milestone as highly sensitised patients are currently highly unlikely to receive a compatible kidney transplant.

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Drug Discovery World

SEPTEMBER 15, 2022

This is the latest episode of the free DDW podcast, “Revealing the magic of cell therapy”. It covers two narrated articles written for Volume 22, Issue 4 – Fall 2021 of DDW. They are called “ The magic of cell therapy ” and “ Cellular assays to bridge the gap in immunogenicity prediction ”. In the first article, Marjie Hadad talks to cell therapy expert and Kadimastem CEO Asaf Shiloni about the potential of cell therapy.

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Drug Discovery World

SEPTEMBER 15, 2022

A new combination therapy could represent a significant advancement in the treatment of metastatic colorectal cancer. Findings from the SUNLIGHT trial have revealed that the combination of trifluridine/tipiracil plus bevacizumab showed a statistically significant improvement in overall survival compared to trifluridine/tipiracil alone. The Phase III clinical trial studied participants with refractory metastatic colorectal cancer (mCRC) following two chemotherapy regimens.

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Drug Discovery World

SEPTEMBER 15, 2022

This is the latest episode of the free DDW podcast, “Revealing the magic of cell therapy”. It covers two narrated articles written for Volume 22, Issue 4 – Fall 2021 of DDW. They are called “ The magic of cell therapy ” and “ Cellular assays to bridge the gap in immunogenicity prediction ”. In the first article, Marjie Hadad talks to cell therapy expert and Kadimastem CEO Asaf Shiloni about the potential of cell therapy.

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Drug Discovery World

SEPTEMBER 15, 2022

BioIVT has acquired XenoTech, a p rovider of products and services for preclinical testing that specialises in ADME, DMPK and DDI testing of potential drug candidates. . Through the acquisition, BioIVT aims to expand the portfolio of research models and services that are available to its clients to support their R&D function. . “XenoTech has a well-established and excellent reputation for producing microsomes, subcellular fractions, and for designing and implementing ADME-Tox studies on a

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Drug Discovery World

SEPTEMBER 15, 2022

Fragment-based drug discovery (FBDD) is a method used for finding hit compounds as one strategy of hit identification (hit ID) in the drug discovery process. . This free event, Introduction into Fragment Based Drug Discovery, will be hosted by DDW and supported by WuXiAppTec. . The event will take place on Thursday, October 13 at 3PM BST, 4PM CET, 10AM EST, 7AM PDT. .

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Drug Discovery World

SEPTEMBER 14, 2022

Download this App Note from Analytik Jena to learn about: Detection of lipid changes in microglia cells in generating therapeutic approach towards neuroinflammation diseases. Application of label-free matrix-assisted laser desorption/ionisation (MALDI) MS cell fingerprinting workflows or cellular assays capable of characterising drug off-target responses with high throughput sample preparation done by Cybio FeliX.

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Drug Discovery World

SEPTEMBER 14, 2022

This whitepaper, brought to you by The Jackson Library, will teach: The benefits of the JAX NSG TM -MHC I/II KO mouse platform humanised with pre-characterised PBMCs. How this platform can support a wide range of immunological studies, especially those containing T cells responses. The versatility of this platform to various research disciplines. The post The latest MHC class I & II deficient in vivo platform humanised with PBMCs appeared first on Drug Discovery World (DDW).

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Drug Discovery World

SEPTEMBER 14, 2022

Download the new App Note from Analytik Jena to find out more about: The detection of lipid changes in microglia cells in generating therapeutic approach towards neuroinflammation diseases. The application of label-free matrix-assisted laser desorption/ionisation (MALDI) MS cell fingerprinting workflows or cellular assays capable of characterising drug off-target responses with high throughput sample preparation done by Cybio FeliX.

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Drug Discovery World

SEPTEMBER 14, 2022

Mouse models with human immune cell engraftment provide platforms to evaluate compounds to treat a variety of human diseases. Humanised PBMC (hu-PBMC) mice feature quick engraftment of adult peripheral blood mononuclear cells and enable short-term studies requiring mature human T cells. Hu-PBMC mice are used as in vivo models to study and evaluate compounds for T cell immune modulation, infectious diseases and graft rejection research.

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