Sat.Mar 11, 2023 - Fri.Mar 17, 2023

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Industry calls on UK Government to support biotech SMEs

Drug Discovery World

Ahead of the UK’s Spring Budget, the UK BioIndustry Association (BIA) is calling on the Treasury to provide additional support through the R&D tax relief scheme to R&D intensive SMEs. These companies are the most at risk from the R&D tax relief rate cut announced at the Autumn Statement, due to their high R&D investment and lack of other revenue sources.

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Formulation, optimization and characterization of raloxifene hydrochloride loaded PLGA nanoparticles by using Taguchi design for breast cancer application

Chemical Biology and Drug Design

Formulation development, optimization and characterization of poly (lactic-co-glycolic acid) nanoparticles loaded with raloxifene by emulsion solvent diffusion evaporation technique to improve oral bioavailability by using Taguchi design. Abstract Multidrug resistance in breast cancer and the associated side-effects of anticancer therapies are significant hurdles in chemotherapy-based treatment.

Treatment 100
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It's Not All Bad News: Data Shows There's a Collaborative Future for 340B

Drug Channels

Today’s guest post comes from Rhiannon Naslund, Chief Marketing Officer at Kalderos. Rhiannon discusses the growing collaboration between manufacturers and covered entities regarding 340B discount claims. She goes on to describe the Kalderos Discount Hub solution that reviews claims that have a high likelihood of being a duplicate discount. To stay up-to-date with the latest drug discount developments, sign up for the Kalderos newsletter.

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What are the stages of idiopathic pulmonary fibrosis?

Antidote

Idiopathic pulmonary fibrosis , or IPF, can be a frightening diagnosis. IPF is a rare, progressive lung disease that develops differently for everyone, and managing its development can be difficult. However, some individuals are able to live with the disease and stay active for many years.

Disease 98
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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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New discovery could help prevent secondary breast cancer

Drug Discovery World

Scientists have discovered why breast cancer cells that have spread to the lungs may ‘wake up’ following years of sleep – forming incurable secondary tumours. Patients with oestrogen receptor positive (ER+) breast cancer – the most common type – have a continued risk of their cancer recurring in another part of their body for many years or even decades after their original diagnosis and treatment.

Research 246
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Evodiamine inhibits malignant progression of ovarian cancer cells by regulating lncRNA?NEAT1/miR?152?3p/CDK19 axis

Chemical Biology and Drug Design

EVO dose-dependently attenuated cell viability, induced G2/M phase arrest, and apoptosis in ovarian cancer cells. EVO regulates ovarian cancer progression through the NEAT1-miR-152-3p-CDK19 axis, which further advances the possibility of EVO as a therapeutic drug for ovarian cancer. Abstract Evodiamine (EVO) has been demonstrated to promote apoptosis of ovarian cancer cells, and upregulate miR-152-3p level in colorectal cancer.

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NOW AVAILABLE: The 2023 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

Drug Channels

I am pleased to announce our new 2023 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers , available for purchase and immediate download. Click here to download a free report overview (including key industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study Analyzes Impact of Inflation Reduction Act on U.S.

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UK Spring Budget a ‘vote of confidence’ in UK life sciences

Drug Discovery World

There was some good news for the UK life sciences sector in the government’s Spring Budget, but did it go far enough? DDW’s Diana Spencer takes a look at the industry’s reaction. There wasn’t much to write home about in the UK government’s Spring Budget, described by Bloomberg UK’s Marcus Ashworth as a “minimalist masterclass”. However, there was some positive news for what the Chancellor Jeremy Hunt referred to as the “largest life sciences sector in Europe”, and some measures that could assist

Science 243
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Small cell vs. non-small cell lung cancer: An overview

Antidote

Lung cancer, the leading cause of cancer deaths in the United States , occurs when cells within the lung begin growing in an uncontrolled way, forming tumors or lesions. It typically begins in the cells lining the bronchi, and can eventually spread throughout the lung and to other parts of the body.

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JOIN HP&M FOR A WEBINAR: “The ‘End’ of the COVID-19 Emergency: The Ryan Haight Act, Telemedicine, and Next Steps?” on Thursday, March 23, 2023 at 12 Noon EST

FDA Law Blog: Biosimilars

The COVID-19 pandemic emergency forced federal regulators to take extraordinary measures to ensure that patients were permitted continued access to important medicines. These government measures included granting temporary exemptions from certain FDA and DEA legal requirements. When the public health emergency ends on May 11, 2023 , so do these exemptions.

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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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Critical Steps Your Workplace Can Take Today to Prevent Suicide

NIOSH Science Blog: Drugs

Employers can play a vital role in suicide prevention. Historically, suicide, mental health, and well-being have been underrepresented in workplace health and safety efforts, but this is changing. In some European countries, there are workplace standards for workplace psychosocial hazards that put workers at risk for suicide. Additionally, in France, employers have been made accountable for toxic workplaces and management practices that contributed to worker suicides.[1] Some of the latest workp

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Artificial sweetener dampened T cell response in mice

Drug Discovery World

Scientists at the Francis Crick Institute have found that high consumption of a common artificial sweetener, sucralose, lowers activation of T cells in mice. If found to have similar effects in humans, one day it could be used therapeutically to help dampen T cell responses. For example, in patients with autoimmune diseases who suffer from uncontrolled T cell activation.

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Informa Connect’s Medicaid & Government Pricing Congress

Drug Channels

Informa Connect’s Medicaid & Government Pricing Congress May 16-18, 2023 in Washington, DC www.informaconnect.com/medicaid2023 Drug Channels readers save 10% with code 23DRCH10 * Join the life science industry on May 16-18, 2023 in Washington, DC at the Medicaid & Government Pricing Congress to conquer complex Medicaid regulatory guidelines and evolve strategies to contract, report and comply with federal and state healthcare programs.

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FDA to Require Breast Density Notification Amongst Other Updates to Mammography Regulations

FDA Law Blog: Biosimilars

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this month, FDA published a final rule to update the mammography regulations, issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). The MQSA was passed to ensure, among other things, that nationwide, patients have access to quality mammography services.

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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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New patent expiration for Endo Ventures drug SUMAVEL DOSEPRO

Drug Patent Watch

Annual Drug Patent Expirations for SUMAVEL+DOSEPRO Sumavel Dosepro is a drug marketed by Endo Ventures Ltd and is included in one NDA. There are nine patents protecting this drug. SUMAVEL… The post New patent expiration for Endo Ventures drug SUMAVEL DOSEPRO appeared first on DrugPatentWatch - Make Better Decisions.

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This week in drug discovery (13-17 March)

Drug Discovery World

News round-up for 13-17 March by DDW Digital Content Editor Diana Spencer. In the news this week we have covered a number of early-stage studies that could lead to potentially huge breakthroughs in the treatment of metastatic breast cancer, Long Covid, bacterial diseases, bone cancer, and autoimmune conditions. The top stories: mRNA vaccine 100% effective against deadly bacteria For the first time, researchers have developed an mRNA vaccine that is 100% effective against a type of bact

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Optimizing Small Clinical Trials with Simulation-Guided Design: A Case Study

Cytel

Smaller clinical trials can be optimized in significant ways using simulation-guided design. A small biotech studying chronic pain had a one-year trial it planned to implement, but wondered if it could be shortened. Let’s take a closer look at how Cytel helped this sponsor reduce their trial time without sacrificing power.

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Predictive Oncology partners with the world’s largest funder of cancer research to launch PEDAL™

Predictive Oncology

Cancer Research Horizons to incorporate PEDAL into future drug discovery processes to enable drug development on a global scale 11 marketed drugs 2nd largest oncology out-licensor globally 150+ active licenses 160+ new drugs into early-phase clinical trials $647 million revenue from royalties & IP $2.8 billion raised by their spinout and startup portfolio Read more about the collaboration here.

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New patent for Celator Pharms drug VYXEOS

Drug Patent Watch

Annual Drug Patent Expirations for VYXEOS Vyxeos is a drug marketed by Celator Pharms and is included in one NDA. It is available from one supplier. There are nine patents… The post New patent for Celator Pharms drug VYXEOS appeared first on DrugPatentWatch - Make Better Decisions.

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Scottish regulator approves first chronic hepatitis delta virus drug

Drug Discovery World

The Scottish Medicines Consortium (SMC) has become the first UK health authority to permit routine NHS use of Gilead Sciences’ Hepcludex (bulevirtide) for the treatment of chronic hepatitis delta virus (HDV) infection. The drug has been accepted for the treatment of chronic HDV infection in adult patients with evidence of significant fibrosis, whose disease has responded inadequately to interferon-based therapy or who are ineligible to receive interferon-based therapy due to intolerance or contr

Virus 130
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Reversible Dual-Covalent Molecular Locking of the 14-3-3/ERR? Protein–Protein Interaction as a Molecular Glue Drug Discovery Approach

Covalent Modifiers

Bente A. Somsen, Rick J.C. Schellekens, Carlo J.A. Verhoef, Michelle R. Arkin, Christian Ottmann, Peter J. Cossar, and Luc Brunsveld Journal of the American Chemical Society 2023 DOI: 10.1021/jacs.2c12781 Molecules that stabilize protein–protein interactions (PPIs) are invaluable as tool compounds for biophysics and (structural) biology, and as starting points for molecular glue drug discovery.

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Why clinical trial matching software should put patients first

Antidote

Before any new medication, therapy, or treatment is put onto the market, it must first be approved by the Food and Drug Administration. Part of this approval process is thorough testing through clinical trials to ensure that any therapy is safe and effective before it is released to the general public.

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New patent for Vertex Pharms drug SYMDEKO (COPACKAGED)

Drug Patent Watch

Annual Drug Patent Expirations for SYMDEKO+%28COPACKAGED%29 Symdeko (copackaged) is a drug marketed by Vertex Pharms Inc and is included in one NDA. It is available from one supplier. There are… The post New patent for Vertex Pharms drug SYMDEKO (COPACKAGED) appeared first on DrugPatentWatch - Make Better Decisions.

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Malfunctioning monocytes could be drug target in Long Covid

Drug Discovery World

Researchers have shown for the first time that malfunctioning behaviour of a type of immune cell is linked to specific symptoms of Long Covid. Normally functioning monocytes, made in the bone marrow, would travel through the blood to the lungs where they surround and kill the virus and boost the immune response. However, scientists and clinicians discovered that in Long Covid, abnormal migration of these cells corresponds to the most commonly reported symptom, shortness of breath.

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Are You Doing Proteomics Correctly for Xenografts?

Crown Bioscience

Proteomic profiling is an important aspect of cancer research and drug development. It provides protein abundance information that complements genomics data from next-generation sequencing (NGS).

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We’re in this together: Achieve your goals faster with DrugBank on your side

DrugBank

The moment you decide which DrugBank license or products best suit your needs isn’t the final step in our relationship, it is just the beginning. And from our perspective, it’s also the most exciting part because we get to dig into your goals and connect you with a whole team of support professionals who can help you get where you need to be.

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New patent for Axsome Malta drug SUNOSI

Drug Patent Watch

Annual Drug Patent Expirations for SUNOSI Sunosi is a drug marketed by Axsome Malta and is included in one NDA. It is available from two suppliers. There are ten patents… The post New patent for Axsome Malta drug SUNOSI appeared first on DrugPatentWatch - Make Better Decisions.

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GARDP and the University of Liverpool join forces against AMR

Drug Discovery World

The Global Antibiotic Research and Development Partnership (GARDP) and the University of Liverpool have confirmed an agreement to collaborate on new projects to address antimicrobial resistance (AMR) for the benefit of public health. Since 2018, GARDP and the University of Liverpool have been working together to advance new treatment options for new-borns with sepsis.

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Natural Product-likeness in ChEMBL

The ChEMBL-og

Recently, we included a Natural Product-likeness score for chemical compounds stored in ChEMBL. We made use of an algorithm published by Peter Ertl, Silvio Roggo and Ansgar Schuffenhauer in 2008. Whereas the original version of this algorithm used a commercial data set of Natural Product molecules for training the algorithm (the CRC Dictionary of Natural Products) and an in-house library of synthetic molecules as a negative set, we used Greg Landrum's RDKit implementation which is based on ~50,0

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Industry Voices: Yannis Jemiai on Simulation-Guided Design and the Changing Landscape of Clinical Trial Strategy

Cytel

Many industries have long since adopted the practice of modeling and simulating experimental scenarios. And despite initial hesitancy in the clinical trials space, simulation-guided design has revolutionized, and will continue to transform, the landscape of clinical trial development. We are already seeing incredible gains in productivity, efficiency, and in our ability to ask and answer increasingly more complex and novel questions.

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New patent expiration for Takeda Pharms drug GATTEX KIT

Drug Patent Watch

Annual Drug Patent Expirations for GATTEX+KIT Gattex Kit is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. There are… The post New patent expiration for Takeda Pharms drug GATTEX KIT appeared first on DrugPatentWatch - Make Better Decisions.

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Potential treatment for patients with acute myeloid leukaemia 

Drug Discovery World

Ellipses Pharma, a global drug development company focused on accelerating the development of cancer medicines and treatments through an innovative drug development model, has been granted Orphan Drug Designation (ODD) by the FDA for EP0042, a dual FLT-3 and Aurora kinase inhibitor, for the treatment of acute myeloid leukaemia (AML). In February 2023, the FDA approved EP0042’s Investigational New Drug Application, which allowed for the opening of additional trial sites in the US for this comp

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What You Need to Know About ICH Q14 and ICH Q2(R2), Part 1

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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UKQSAR Spring 2023 Meeting Announcement

The ChEMBL-og

The next UKQSAR meeting will be held at the European Bioinformatic Institute (EBI) on 20th April. This is where the ChEMBL team is also located! It would be great to welcome you for the occasion and have a chat if you have any questions on our services! See below for the official announcement. The meeting is free but you have to register. -- **REGISTRATION TO ATTEND IN PERSON IS NOW CLOSED** Join the waiting list to be notified if a place becomes available, or register virtually to join the meet