Mon.Jul 15, 2024

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New DDW Highlights podcast: 15 July 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. Clinical trial news has caught our attention this week. Despite the revelation from Phesi that a third of clinical trials fail at Phase II, DDW has reported positive human trial updates on therapeutics for myasthenia gravis, non-small cell lung cancer, Marburg virus, and Parkinson’s dis

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Revolution Medicines firms up Phase 3 trial plans with latest cancer drug data

BioPharma Drive: Drug Pricing

Updated results show the biotech's RAS inhibitor shrank pancreatic tumors in 20% to 25% of study participants, but with high rates of side effects like rash and nausea.

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DDW Highlights: 15 July 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. Clinical trial news has caught our attention this week. Despite the revelation from Phesi that a third of clinical trials fail at Phase II, DDW has reported positive human trial updates on therapeutics for myasthenia gravis, non-small cell lung cancer, Marburg virus, and Parkinson’s dis

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Lexeo gene therapy shows signs of heart benefit in small study

BioPharma Drive: Drug Pricing

The company claims the results support exploring the possibility of an accelerated approval, citing flexibility by FDA officials in reviewing rare disease gene therapies.

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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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77% of researchers not using alternatives to animal testing

Drug Discovery World

New survey findings have revealed that 77% of R&D professionals are not using in vitro cell-based alternatives to animal testing, and only 23% describe themselves as ‘very familiar’ with any kind of animal model alternative. More than 350 survey respondents participated in the survey by The Pistoia Alliance, including representatives from pharma companies, regulators, and CROs.

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Through the Looking Glass? Loper Bright Will Force FDA to Change Its Approach to Litigation and Advocacy

FDA Law Blog: Biosimilars

By John W.M. Claud & JP Ellison — The Supreme Court’s recent decision in Loper Bright v. Raimondo has done away with Chevron deference to federal agencies’ interpretation of ambiguous statutes, including the FDA. The decision commands that federal judges must make their own decisions in suits against FDA, considering—but not deferring to—the Agency’s interpretation of ambiguous statutory provisions.

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Some Youths Still Taking Opioids Months After Surgery

Drugs.com

MONDAY, July 15, 2024 -- Many tweens and teens are filling prescriptions for opioids far in advance of surgeries unlikely to be associated with severe pain afterward, a new study says.Worse, a significant minority continue to fill those opioid.

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AACR: A focal point of the cancer research community

Drug Discovery World

From 5-10 April 2024 in San Diego, the cancer research community gathered for the annual meeting of the American Association for Cancer Research (AACR). DDW’s Megan Thomas spoke with biotech and pharma leaders to understand more about the cancer research landscape. An event of this size provides a wide-angle lens through which innovators can not only present their own work but learn about the work being carried out by their peers.

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Too Little, Too Much: Poor Sleep Linked to Vessel Damage in Those With Diabetes

Drugs.com

MONDAY, July 15, 2024 -- Diabetics who sleep too little or too much are more likely to suffer damage to their small blood vessels, a condition that can cause organ damage throughout their bodies.Short sleep duration is tied to a 2.6 times increased.

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Cross-industry consortium to improve AAV formulation

Drug Discovery World

The Cell and Gene Therapy Catapult (CGT Catapult) has established a cross-industry consortium to improve the understanding and process optimisation of adeno-associated virus (AAV) formulation. AAV-based gene therapies are being developed to treat a broad range of inherited and chronic diseases and several of these therapies have already been approved for clinical use.

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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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Most Americans Think Incontinence, Pelvic Pain after Childbirth is Normal -- It's Not

Drugs.com

MONDAY, July 15, 2024 -- Roughly a month after having her second child, Nicole Gerardi-Lukens suddenly felt pressure in her pelvis that was so intense it sent her to the hospital.When doctors told her bladder had prolapsed — meaning that it had s.

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Successful off-label use of CAR-T therapy in a child with lupus

Drug Discovery World

In June 2023, a patient at Universitätsklinikum Erlangen in Germany became the first child with lupus to receive CAR-T therapy. The treatment was the last resort to slow down systemic lupus erythematosus (SLE), which is a serious autoimmune disease that was attacking the patient’s body and seriously affected her ability to lead a normal life. The treatment team in Erlangen has now published the results of this successful treatment in the medical journal The Lancet.

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Some Diabetes Drugs May Lower Dementia Risk

Drugs.com

MONDAY, July 15, 2024 -- Some diabetes drugs appear to lower the risk that people with type 2 diabetes will develop dementia or Alzheimer’s disease, a new evidence review says.The risk of dementia and Alzheimer’s is significantly lower in patients t.

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Easy Dynamic Property Permissions for the Optimizely CMS

Perficient: Drug Development

I recently worked with a client who wanted to restrict access to specific properties of the content types. We set up some Editor Descriptor attributes, and applied a decorator to the properties in the model classes, which worked well. Then they wanted changes. The problem is that figuring out who has access requires looking at the code. Any updates require code changes, which becomes a big deal when the properties are already in Production.

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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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Could OTC Nasal Sprays Ease Colds & Flu and Cut Antibiotic Use?

Drugs.com

MONDAY, July 15, 2024 -- Over-the-counter nasal sprays could be a potent weapon against a major public health threat -- antibiotic resistance, researchers report.Their analysis, which looked at data from nearly 14,000 adults, found that common.

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Legacy SureChEMBL retirement

The ChEMBL-og

Dear SureChEMBL users, About six months ago, we introduced the new version of SureChEMBL. It brought significant improvements in terms of performance and stability, and it also allows us to implement new functionalities. After the survey at the beginning of the year, we prioritised what should be delivered first. You should see the materialisation of our work in the coming months.

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AI Better at Predicting Progression to Alzheimer's Than Standard Care

Drugs.com

MONDAY, July 15, 2024 -- An AI program has proven better than doctors at sifting through the telltale signs that indicate who with early dementia will progress to Alzheimer’s disease, a new study says.AI predicted in 4 cases out of 5 when early d.

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Mastering Salesforce OmniScript: A Comprehensive Guide to Streamlined Workflows

Perficient: Drug Development

Introduction to Salesforce OmniScript Salesforce OmniScript is a powerful tool within the Salesforce ecosystem designed to streamline and enhance the user experience through guided, interactive workflows. It is part of the Salesforce OmniStudio suite, which also includes tools like FlexCards and Integration Procedures. OmniScript allows organizations to create seamless, step-by-step processes for their users, ensuring data accuracy and process compliance.

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Late Cancer Diagnosis Biggest Health Concern for Most, Poll Shows

Drugs.com

MONDAY, July 15, 2024 — When it comes to health worries, cancer leads the way, a new poll shows. The University of Cambridge poll included 2,000 adults who said their biggest concern is getting diagnosed with cancer when it's too late to treat it. S.

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The Complexity Advantage: Why Advanced Delivery Methods Deter Generic Competition

Drug Patent Watch

The Strategic Advantage of Complex Drug Delivery Systems In the highly competitive pharmaceutical landscape, adopting complex drug delivery systems can […] Source

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New Drug Tames Stress Incontinence in Clinical Trial

Drugs.com

MONDAY, July 15, 2024 -- An experimental drug appears to help women deal with stress incontinence, clinical trial data show.The drug, for now dubbed TAS-303, reduced the frequency of leaks related to stress incontinence by about 58%, compared with.

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Rx for Change: How Nonprofit Pharma is Reshaping the Industry

Drug Patent Watch

An HHS report titled “The Potential Role of The Nonprofit Pharmaceutical Industry in Addressing Shortages and Increasing Access to Essential […] Source

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Thinking of a Switch Away from Meat? Your Genes May Be Key

Drugs.com

MONDAY, July 15, 2024 -- Pondering a move to a vegetarian or vegan diet? Your heart might be in it, but your genes might not, a new study says.Genetics are an important part of whether a person responds well or poorly to a vegetarian diet.

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Providing Clarity Regarding the Regulation of Respirators Used in Health Care Settings

NIOSH Science Blog: Drugs

A Discussion Paper, Streamlining Regulatory Oversight of Respirators Used in Health Care Settings will Improve Worker Protection, was recently published in the National Academy of Medicine’s NAM Perspectives journal by respiratory experts outside of the federal government. This paper highlights continued confusion amongst interested parties including health care organizations and manufacturers seeking approval regarding federal regulations and guidance on the use of air-purifying respirators (AP

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Five Cases of Bird Flu Reported in Colorado Poultry Workers

Drugs.com

MONDAY, July 15, 2024 -- Five poultry workers in Colorado have been diagnosed with bird flu, state health officials reported Sunday."In coordination with the Colorado Department of Agriculture, the State Emergency Operations Center and Centers for.

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Global Childhood Vaccination Rates Still Haven't Recovered from Pandemic Declines

Drugs.com

MONDAY, July 15, 2024 -- More than four years after the pandemic began, childhood vaccination rates worldwide have yet to recover, a new report shows.The latest data, issued Monday by the World Health Organization and the United Nations.

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