Sat.Mar 18, 2023 - Fri.Mar 24, 2023

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Research reveals the unique biological features of roginolisib 

Drug Discovery World

iOnctura, a clinical stage biotechnology company developing cancer therapies, has published non-clinical research on roginolisib in the AACR journal Cancer Research Communications. Roginolisib is a first-in-class, non-ATP-competitive, allosteric modulator of PI3Kd which prevents tumour proliferation and breaks immune tolerance in patients with solid and haematological tumours.

Research 246
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Therapeutic efficacy of caffeic acid phenethyl ester in cancer therapy: An updated review

Chemical Biology and Drug Design

Caffeic acid phenethyl ester (CAPE) demonstrating its anticancer potential through specifically targets genes involved in cell death, cell cycle regulation, angiogenesis, and metastasis in various types of cancers. Abstract Nowadays, there is a lot of public and scientific interest in using phytochemicals to treat human ailments. Existing cancer medicines still run across obstacles, despite significant advancements in the field.

Therapies 100
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An overview of key hemophilia facts

Antidote

The rare, inherited blood disorder hemophilia is estimated to impact approximately 20,000 individuals in the United States , and over 400,000 worldwide. Currently, there is no cure for hemophilia — but through ongoing research, medical experts are continually learning more about the disease.

Disease 98
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Drug Channels News Roundup, March 2023: My $0.02 on Insulin Price Cuts, AbbVie vs. AFPs, Optum Expands, ASAP340B, and Hooray for Pharmacists

Drug Channels

Spring is here in sunny downtown Philadelphia, worldwide headquarters of Drug Channels. The vernal equinox has brought us an unexpected bounty of noteworthy news: Thoughts on the recent insulin price cuts by Lilly, Novo, and Sanofi AbbVie gets tougher on alternative funding programs Optum quietly adds a new drug channel role A novel partnership emerges to modernize the 340B program Plus, a celebration of pharmacists’ activities during the COVID-19 pandemic.

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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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Positive Phase III results for prostate cancer drug

Drug Discovery World

Pfizer and Astellas have announcesd positive top-line results from the Phase III EMBARK trial evaluating XTANDI (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR). Patients enrolled in the trial were randomised to one of three study arms: XTANDI plus leuprolide, placebo plus leuprolide, or XTANDI monotherapy.

Trials 240
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Perspectives on cutting?edge nanoparticulate drug delivery technologies based on lipids and their applications

Chemical Biology and Drug Design

Lipidic Nanoparticle drug and technology. Lipidic carriers like Liposomes, Niosomes, Solid-Lipid Nanoparticles, Micelles etc. Abstract Numerous nanotech arenas in therapeutic biology have recently provided a scientific platform to manufacture a considerable swath of unique chemical entities focusing on drugs. Recently, nanoparticulate drug delivery systems have emerged to deliver a specific drug to a specified site.

Drugs 100

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Winning the Race for Patient Access: Identifying Copay Accumulator Impact

Drug Channels

Today’s guest post comes from Logan Melchione, Senior Director of Account Management at Paysign. Logan discusses the financial impacts of copay accumulators on manufacturers and patients. She describes how to reduce the strain on manufacturers' programs while also increasing patient access. Click here to learn about the Paysign Solution. Email affordability@paysign.com to set up a meeting with Paysign at Asembia’s Specialty Pharmacy Summit, April 30-May 4.

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Biggest overhaul of UK clinical trial regulation for 20 years

Drug Discovery World

A series of new measures will be introduced by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to make it faster and easier to gain approval and run clinical trials in the UK. These changes represent the biggest overhaul in UK clinical trials regulation in over 20 years and are designed to make the UK one of the best countries in the world to conduct clinical research.

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New patent for Paratek Pharms drug NUZYRA

Drug Patent Watch

Annual Drug Patent Expirations for NUZYRA Nuzyra is a drug marketed by Paratek Pharms Inc and is included in two NDAs. It is available from one supplier. There are ten… The post New patent for Paratek Pharms drug NUZYRA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 95
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Winter Weekend Read Roundup

Cytel

Last week, we featured our final Winter Weekend Read, the last in a series designed to showcase our complimentary publications on a variety of topics on clinical trial design and data science, all authored by Cytel’s experts.

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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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Informa Connect’s Annual Life Sciences Commercial Contracts & Chargebacks Congress

Drug Channels

Informa Connect’s Annual Life Sciences Commercial Contracts & Chargebacks Congress May 16-17, 2023 The Omni Shoreham Hotel | Washington, DC Hybrid Event informaconnect.com/contracts-chargebacks Exclusive Offer for Drug Channels Readers: Register Now to SAVE 10% * using promo code 23DC10 Informa Connect’s 19th Annual Commercial Contracts & Chargebacks Congress , taking place May 16-17 in Washington, DC, offers crucial updates on policy changes and contracting best practices to increase ef

Science 75
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This week in drug discovery (20-24 March)

Drug Discovery World

News round-up for 20-24 March by DDW Digital Content Editor Diana Spencer. This week we have seen a number of developments in the treatment of solid tumours hitting the headlines. Pennsylvania researchers may have found a way to boost CAR-T therapy in these tumours, previously only successful in blood cancers, which could have huge implications for cancer treatment.

Drugs 130
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New patent expiration for Otsuka drug ABILIFY

Drug Patent Watch

Annual Drug Patent Expirations for ABILIFY Abilify is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in six NDAs. It is available from one supplier.… The post New patent expiration for Otsuka drug ABILIFY appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Q1 2023 Newsletter – Recombinant metabolising enzymes

Metabolite Tales Blog

Hypha’s Q1 2023 newsletter – Recombinant metabolising enzymes In our Q1 2023 newsletter we focus on Hypha’s recombinant enzymes, in particular new innovations to our PolyCYPs platform. Sign up at the bottom of the page in the link here to receive our quarterly newsletter by email. Read newsletter Biotransformation of pirfenidone to an oxidised metabolite which matches the CYP1A2 product.

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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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3 Common Questions Related to Clinical Trial Performance Data

H1 Blog

Over the past decade, the cost and time impact to bring drugs to market have been increasing. With the recent trends in healthcare (more diversity and inclusion for both patients as well as physicians) and the economy (recession and hyperinflation), this is not a trend we expect will decrease any time soon. One of the few elements industry players can control is better use of the data elements captured and available to them.

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Low endotoxin biomaterials could help to reduce animal testing

Drug Discovery World

A new study has found that highly purified gelatin biomaterials could enhance the reliability and reproducibility of 3AD in vitro models, creating new possibilities for replacing preclinical animal trials. The joint study by the University of Twente, The Netherlands, and Rousselot Biomedical investigated for the first time the impact of endotoxins on 3D breast tumour-immune cancer models.

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New patent expiration for Pfizer drug XELJANZ XR

Drug Patent Watch

Annual Drug Patent Expirations for XELJANZ+XR Xeljanz Xr is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. There are five patents… The post New patent expiration for Pfizer drug XELJANZ XR appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Molecules that Matter – Rezafungin

Metabolite Tales Blog

Molecules that Matter – Rezafungin Rezafungin is an echinocandin with a chemical modification that confers high stability, a longer half-life, and allows for a once-a-week dosing regimen. In March 2023, Cidara, one of our past clients received the fantastic news that rezafungin was approved to treat a group of severe fungal infections commonly faced by hospitalised patients.

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Maximizing the Impact of Commercial Learning and Development Training by Utilizing the Kirkpatrick Model

ACTO

Commercial Learning and Development (CL&D) teams at Life Science companies can drive better business outcomes by utilizing the Kirkpatrick Model, which is the gold standard for assessing program performance. This model measures training effectiveness on four levels: Reaction, Learning, Behavior, and Results. By capturing and standardizing data and creating a continuous learning environment, organizations can gain valuable insights into the impact of their training initiatives.

Science 52
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Global cancer research: Where are the breakthroughs?

Drug Discovery World

This latest ebook sponsored by Sino Biological features insight on how the global drug discovery and development sector is making breakthroughs in cancer research. Download this exclusive eBook to learn more about: The global developments tackling the burden of cancer Advances and challenges in cancer drug discovery The ‘dark matter’ behind cancer The drug that may be a non-toxic way to treat breast cancer The post Global cancer research: Where are the breakthroughs?

Research 130
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New patent expiration for Pf Prism drug XELJANZ

Drug Patent Watch

Annual Drug Patent Expirations for XELJANZ Xeljanz is a drug marketed by Pfizer and Pf Prism Cv and is included in three NDAs. It is available from two suppliers. There… The post New patent expiration for Pf Prism drug XELJANZ appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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What You Need to Know About ICH Q14 and ICH Q2(R2), Part 2

The Premier Consulting Blog

For researchers who are developing or working with analytical procedures, the new ICH Q14 Analytical Procedure Development and revised ICH Q2(R2) Validation of Analytical Procedures drafts represent foundational guidance documents. Together, they describe suggested development and validation activities for the lifecycle of an analytical procedure used to assess the quality of drug substances and drug products.

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Brain Tumor Awareness Month: Can proton beam therapy improve the long-term quality of life of patients with oligodendroglioma brain tumors?

On Medicine

What matters most to patients? A previous study involving brain tumor patients identified that when anti-tumor treatment is understood to be ‘the only option’, the risk and impact of side effects may not be adequately explained to and understood by patients. It was also noted that there is a strong desire for more information to be provided regarding support services.

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New global cancer research DDW eBook

Drug Discovery World

This latest ebook sponsored by Sino Biological features insight on how the global drug discovery and development sector is making breakthroughs in cancer research. Download this exclusive eBook to learn more about: The global developments tackling the burden of cancer Advances and challenges in cancer drug discovery The ‘dark matter’ behind cancer The drug that may be a non-toxic way to treat breast cancer Download now.

Research 130
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New patent for Baxter Hlthcare drug NOURESS

Drug Patent Watch

Annual Drug Patent Expirations for NOURESS Nouress is a drug marketed by Baxter Hlthcare Corp and is included in one NDA. It is available from one supplier. There are twelve… The post New patent for Baxter Hlthcare drug NOURESS appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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BARDA Program Proposal Production and Contract Management 

DS in Pharmatics

The Biomedical Advanced Research and Development Authority (BARDA) is) probably best known for its role in Operation Warp Speed and subsequent efforts to accelerate the manufacturing of COVID-19 vaccines. BARDA, formed in 2006, anticipated threats such as the COVID-19 pandemic.

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The road to commercialization: how our platform drives revenue

Cyclica

So how does Cyclica make money (or revenue)? This fundamental question is central to any business model or corporate strategy. In the case of a traditional pharmaceutical company selling approved medicines, it’s a fairly straightforward answer - they generate cash through the manufacturing, marketing, and ultimately the sale of medicines to patients (albeit through a circuitous supply chain).

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Developing next generation pan-SARS-CoV-2 vaccines 

Drug Discovery World

SpyBiotech, a UK-based biotechnology company with a novel vaccine platform technology that can target infectious diseases, cancer, and chronic diseases, has received a grant of $4,094,561 from the Bill & Melinda Gates Foundation to further develop its novel SpyVector platform. This project will harness SpyBio’s ‘plug and display’ technology to design a broadly cross-protective coronavirus vaccine.

Vaccine 130
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New patent for Altathera Pharms drug SOTALOL HYDROCHLORIDE

Drug Patent Watch

Annual Drug Patent Expirations for SOTALOL+HYDROCHLORIDE Sotalol Hydrochloride is a drug marketed by Altathera Pharms Llc, Apotex, Aurobindo Pharma Usa, Beximco Pharms Usa, Epic Pharma Inc, Impax Pharms, Mylan, Oxford… The post New patent for Altathera Pharms drug SOTALOL HYDROCHLORIDE appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Provenance Metadata — towards reproducible research

The Open Targets Blog

My name is Manuel Bernal Llinares, I'm the back end lead at Open Targets, where I mentor, supervise and work hand in hand with enthusiastic software engineers to bring our flagship target discovery platform to the life sciences community. In this blog post I introduce to you our next stop in the technical roadmap, which is a step forward on improving our data pipelines and also our FAIRness scoring, a new feature that addresses provenance metadata, reliability and reproducibility in our dat

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Retrospective Claims Data Analysis Unlocks Discovery in Multiple Sclerosis Research

Cytel

One of the lesser-known complications associated with Multiple Sclerosis is a higher risk of serious infections (SIs). Cytel’s RWE experts conducted a retrospective analysis of claims data to determine the incidence of SIs among people with various types of MS.

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Researchers discover treatment for rare muscle disease

Drug Discovery World

Israeli researchers have developed a drug that is effective in treating a rare genetic muscle disease. The research team from Ben-Gurion University of the Negev and Soroka Medical Center discovered the severe hereditary muscle disease that develops around the age of 40 years, progressing to complete immobility of the limbs and the chest muscles. The team demonstrated that the disease is caused by a mutation in the gene encoding HMG CoA reductase, inhibiting the enzyme’s activity.

Disease 130
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New patent expiration for Glaxo Grp drug BREO ELLIPTA

Drug Patent Watch

Annual Drug Patent Expirations for BREO+ELLIPTA Breo Ellipta is a drug marketed by Glaxo Grp Ltd and is included in one NDA. It is available from two suppliers. There are… The post New patent expiration for Glaxo Grp drug BREO ELLIPTA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Proactive interviews Predictive Oncology about partnering with Cancer Research Horizons to leverage AI for new cancer drugs

Predictive Oncology

Dominic Pollard of Cancer Research Horizons and Dr. Pamela Bush of Predictive Oncology discuss the potential impact of their collaboration and how it can advance cancer drug development. This alliance between the world’s largest private funder of cancer research, with 11 marketed drugs and 150 active licenses, and the incorporation of our AI-driven, machine-learning PEDAL platform with access to an extensive biobank of tumor-specific samples, represents a promising win for patients, not just in