Mon.Jul 15, 2024

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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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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.

Trials 127
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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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Leveraging binding pose metadynamics to optimise target fishing predictions for three diverse ligands and their true targets

Chemical Biology and Drug Design

The ability of binding pose metadynamics to improve the rankings of true targets predicted via pharmacophore mapping was investigated using three diverse ligands and their six true targets. Binding pose metadynamics improved the predicted rankings for four out of the six true targets, while also providing the highest-ranked predictions. Abstract Computational target fishing plays an important role in target identification, particularly in drug discovery campaigns utilizing phenotypic screening.

Drugs 100
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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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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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New geological datings place the first European hominids in the south of the Iberian Peninsula 1.3 million years ago

Science Daily: Pharmacology News

One of the most important controversies about human evolution and expansion is when and by what route the first hominids arrived in Europe from the African continent. Now, geological dating techniques at the Orce sites (Baza basin, Granada, Spain) place the human remains found in this area as the oldest in Europe, at approximately 1.3 million years old.

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Widespread practice among athletes harms both performance and health

Science Daily: Pharmacology News

Drastically cutting back on caloric intake to lose weight ahead of competition is commonplace among athletes. However, this type of 'dieting' doesn't just diminish performances, it can also compromise their immune systems.

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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.

Research 130
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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.

Research 111
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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.

Therapies 130
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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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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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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.

Therapies 130
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What is the medical definition of obesity?

Antidote

Obesity, a condition that impacts 2 out of 5 adults in the United States , has become a significant health concern, both due to the impacts it has on individuals with the condition and the effect it can have on the overall medical system. It is estimated that obesity is responsible for nearly $1.73 billion in excess treatment costs annually, compounded by the fact that individuals with obesity are far more likely to have other conditions such as hypertension, diabetes, and osteoarthritis.

Treatment 111
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New research demonstrates potential for increasing effectiveness of popular diabetes, weight-loss drugs

Science Daily: Pharmacology News

A network of proteins found in the central nervous system could be harnessed to increase the effectiveness and reduce the side effects of popular diabetes and weight-loss drugs, according to new research.

Research 110
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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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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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Scorching storms on distant worlds revealed

Science Daily: Pharmacology News

An international study reveals the extreme atmospheric conditions on the celestial objects, which are swathed in swirling clouds of hot sand amid temperatures of 950C. Using NASA's powerful James Webb Space Telescope (JWST), researchers set out to capture the weather on a pair of brown dwarfs -- cosmic bodies that are bigger than planets but smaller than stars.

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Shannen Doherty Dies of Breast Cancer at 53

Drugs.com

MONDAY, July 15, 2024 -- Actress Shannen Doherty, best known for her roles in 1990s television hits such as “Beverly Hills, 90210” and “Charmed," has died at 53 after a long struggle with breast cancer.In a statement, Doherty's publicist, Leslie Slo.

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Cosmic wrestling match

Science Daily: Pharmacology News

Our universe is around 13.8 billion years old. Over the vastness of this time, the tiniest of initial asymmetries have grown into the large-scale structures we can see through our telescopes in the night sky: galaxies like our own Milky Way, clusters of galaxies, and even larger aggregations of matter or filaments of gas and dust. How quickly this growth takes place depends, at least in today's universe, on a sort of wrestling match between natural forces: Can dark matter, which holds everything

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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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JWST unveils stunning ejecta and CO structures in Cassiopeia A's young supernova

Science Daily: Pharmacology News

Researchers announced the latest findings from the James Webb Space Telescope (JWST) of the supernova remnant, Cassiopeia A (Cas A). These observations of the youngest known core collapse supernova in the Milky Way provide insights into the conditions that lead to the formation and destruction of molecules and dust within supernova ejecta. The study's findings change our understanding of dust formation in the early universe in the galaxies detected by JWST 300 million years after the Big Bang.

Research 101
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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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NASA's Webb investigates eternal sunrises, sunsets on distant world

Science Daily: Pharmacology News

Researchers using NASA's James Webb Space Telescope have finally confirmed what models have previously predicted: An exoplanet has differences between its eternal morning and eternal evening atmosphere. WASP-39 b, a giant planet with a diameter 1.3 times greater than Jupiter, but similar mass to Saturn that orbits a star about 700 light-years away from Earth, is tidally locked to its parent star.

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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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Early life antibiotic increases risk of asthma: providing clues to a potential prevention adult asthma

Science Daily: Pharmacology News

Early exposure to antibiotics can trigger long term susceptibility to asthma, according to new research. Importantly the research team isolated a molecule produced by gut bacteria that in the future could potentially be trialed as a simple treatment, in the form of a dietary supplement, for children at risk of asthma to prevent them developing the disease.

Trials 81
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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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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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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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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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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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Nitrosamines in Focus: Regulatory Requirements and Best Practices

Fierce BioTech

Nitrosamines in Focus: Regulatory Requirements and Best Practices dwunderlin Mon, 07/15/2024 - 11:10 Thu, 09/12/2024 - 10:00 Resource Type Webinar Chris Williams Chad Bastian Duration 60 Minutes Nitrosamines, potent carcinogens, have prompted stringent regulations for their detection and control in various products. Regulatory bodies demand robust analytical methods and timely risk assessments.

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New tentative approval for Alembic drug dabigatran etexilate mesylate

Drug Patent Watch

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five NDAs.

Drugs 52
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Genome-Wide RNA-seq and Array-Based NanoString Transcriptomic Technologies: Which to Use and When?

Crown Bioscience

The rapid increase of precision oncology approaches in recent years has been fueled in part by technological innovations and an increased interest in personalized therapies. Precision medicine approaches rely on biomarkers to define optimal treatment strategies and also play important roles in the diagnosis of disease, treatment efficacy assessment, and/or disease progression.

RNA 52
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New patent expiration for Hatchtech drug XEGLYZE

Drug Patent Watch

Annual Drug Patent Expirations for XEGLYZE Xeglyze is a drug marketed by Hatchtech and is included in one NDA. It is available from one supplier. There are five patents protecting this drug.

Drugs 52
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Choosing the Right RNA Analysis Methods: Genome-wide RNA-Seq vs. Nanostring nCounter vs. Targeted RNA-Seq Panels

Crown Bioscience

In the world of RNA analysis, researchers have an array of technologies at their disposal. Each method comes with its unique strengths, making the choice dependent on specific research needs and constraints. In this post, we'll delve into three popular RNA analysis methods— transcriptome-wide RNA-Seq, Nanostring nCounter, and targeted RNA-Seq panels—comparing their features and discussing when to use each.

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