Sat.Aug 03, 2024 - Fri.Aug 09, 2024

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First engineered cell therapy for a solid tumour gets US approval

Drug Discovery World

Adaptimmune Therapeutics’ Tecelra (afamitresgene autoleucel) has become the first engineered cell therapy for a solid tumour cancer approved in the US. It is also the first new therapy option in more than a decade for synovial sarcoma, which is a rare, soft tissue cancer that most commonly impacts young adults. Peter Marks, Director of the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER), said the approval of the “state-of-the-art immunotherapy technology”

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Greenland fossil discovery reveals increased risk of sea-level catastrophe

Science Daily: Pharmacology News

Seeds, twigs, and insect parts found under two miles of ice confirm Greenland's ice sheet melted in the recent past, the first direct evidence that the center -- not just the edges -- of the two-mile-deep ice melted away in the recent geological past. The new research indicates that the giant ice sheet is more fragile than scientists had realized until the last few years -- and reveals increased risk of sea-level catastrophe in a warmer future.

Research 145
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In tone-setting verdict, FDA rejects MDMA as a therapy aid for PTSD

BioPharma Drive: Drug Pricing

The decision to turn down an application from Lykos Therapeutics comes at a pivotal time for psychedelics research, which, after decades of dismissal, has recently gained momentum.

Therapies 128
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Exploring the potential of ADCs beyond oncology

Drug Target Review

What are the main therapeutic areas beyond oncology where ADCs show potential? A number of areas represent significant opportunities for Antibody Drug Conjugates (ADCs) beyond oncology, leveraging their ability to deliver therapeutic agents specifically to diseased cells or tissues while minimising off-target effects. The development of ADCs in these areas is ongoing, with several preclinical and clinical studies exploring their potential.

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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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15% of Parkinson’s cases linked to genetic factors, study says 

Drug Discovery World

Centogene has announced data from its Rostock International Parkinson’s Disease (ROPAD) Study revealing the genetic factors and prevalence of Parkinson’s disease (PD). The findings from the study indicate that approximately 15% of PD-related cases are tied to genetic variants, with the majority being linked to LRRK2 and GBA1. The data was published in Brain in a paper titled, ‘ Relevance of genetic testing in the gene-targeted trial era: the Rostock Parkinson’s disease study’

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Record-breaking recovery of rocks that originated in Earth's mantle could reveal secrets of planet's history

Science Daily: Pharmacology News

Scientists have recovered the first long section of rocks that originated in the Earth's mantle, the layer below the crust and the planet's largest component. The rocks will help unravel the mantle's role in the origins of life on Earth, the volcanic activity generated when it melts, and how it drives the global cycles of important elements such as carbon and hydrogen.

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More Evidence That an Artificial Sweetener Poses Heart Risk

Drugs.com

THURSDAY, Aug. 8, 2024 -- There's more evidence to suggest that the common artificial sweetener erythritol might pose dangers to consumers' hearts.The new study, involving 20 healthy adult volunteers, found that at doses commonly found in an.

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New understanding of bacteria mutation rates could help combat AMR

Drug Discovery World

Scientists have discovered a way to control mutation rates in bacteria, introducing the possibility of new strategies to combat antimicrobial resistance (AMR). The researchers used high-performance computing to simulate more than 8,000 years of bacterial evolution, allowing scientists to predict mechanisms that control mutation rates. They then made more than 15,000 cultures of E. coli in lab conditions to test their predictions.

DNA 162
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Bacteria encode hidden genes outside their genome--do we?

Science Daily: Pharmacology News

A 'loopy' discovery in bacteria is raising fundamental questions about the makeup of our own genome -- and revealing a potential wellspring of material for new genetic therapies.

Therapies 142
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With pharma in ‘catbird seat,’ biotechs get less upfront in drug partnerships

BioPharma Drive: Drug Pricing

Recent data from J.P. Morgan indicates early-stage startups are getting smaller upfront payments in alliances than a few years ago, a trend industry insiders attribute to weaker leverage in deal talks.

Drugs 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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Childhood Vaccines Have Saved 1 Million U.S. Lives Since 1994, CDC Says

Drugs.com

FRIDAY, Aug. 9, 2024 -- In findings that offer compelling evidence of the power of childhood vaccines, a new government report shows the routine shots have prevented hundreds of millions of illnesses, tens of millions of hospitalizations and more.

Vaccine 111
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Antibody-drug conjugate for solid tumours enters Phase I trials

Drug Discovery World

The first patient has been dosed in a Phase I clinical trial of AGX101, a novel TM4SF1-directed antibody-drug conjugate being developed for the treatment of solid cancers. Developer Angiex is focused on nuclear-delivered antibody-drug conjugates (ND-ADCs), which release therapeutic payloads directly into the nucleus or cytosol, where the site of payload action is located.

Trials 147
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Smallest arm bone in human fossil record sheds light on the dawn of Homo floresiensis

Science Daily: Pharmacology News

A new study reports the discovery of extremely rare early human fossils from the Indonesian island of Flores, including an astonishingly small adult limb bone. Dated to about 700,000 years old, the new findings shed light on the evolution of Homo floresiensis, the so-called 'Hobbits' of Flores whose remains were uncovered in 2003 at Liang Bua cave in the island's west.

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Biotech Red Queen launches with $55M to build versatile antivirals

BioPharma Drive: Drug Pricing

The funding from Apple Tree Partners will help the startup advance an antiviral drug pipeline that includes a COVID treatment nearing mid-stage testing.

Treatment 133
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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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Many Doctors Underestimate the Pain of IUD Insertion for Women. The CDC Wants to Change That

Drugs.com

THURSDAY, Aug. 8, 2024 -- Plenty of women know that having an IUD inserted in their uterus can be an excruciating experience, but new government guidance issued Thursday may soon make the experience less painful for many.For the first time, updated.

Doctors 111
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FDA urged to approve MDMA-assisted therapy for PTSD

Drug Discovery World

Two veteran advocacy organisations, Reason for Hope and the Veteran Mental Health Leadership Coalition, have issued a joint statement urging the US Food and Drug Administration (FDA) to approve MDMA-assisted therapy for post-traumatic stress disorder (PTSD). Last month, an FDA Advisory Committee recommended against approval, with only two out of 11 committee members voting that the evidence was sufficient to show efficacy; and one out of 11 voting that the benefits of MDMA alongside FDA’s propos

FDA 147
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Scientists lay out revolutionary method to warm Mars

Science Daily: Pharmacology News

Ever since we learned that the surface of planet Mars is cold and dead, people have wondered if there is a way to make it friendlier to life. The newly proposed method is over 5,000 times more efficient than previous schemes to globally warm Mars, representing a significant leap forward in our ability to modify the Martian environment.

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Lilly boosts outlook on rising Zepbound revenue

BioPharma Drive: Drug Pricing

Sales of the in-demand obesity drug crested $1 billion in the second quarter as improved Lilly production helped the company fulfill wholesaler backorders.

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Heavy Marijuana Use More Than Triples Odds for Head & Neck Cancers

Drugs.com

THURSDAY, Aug. 8, 2024 -- People who use marijuana at high levels are putting themselves at more than three times the risk for head and neck cancers, new research warns.The study is perhaps the most rigorous ever conducted on the issue, tracking.

Research 111
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GSK’s autoimmune efforts

Drug Discovery World

DDW Editor Reece Armstrong speaks to Roger Levy , Global Medical Expert Immunology & Specialty Medicine at GSK about the company’s work into treating systemic sclerosis-associated interstitial lung disease and its recent BLISSc-ILD study evaluating its belimumab treatment. RA: Can you give us an overview of the BLISSc-ILD study? RL: The BLISSc-ILD study is a randomised, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of belimumab in 300 adults

Disease 147
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3D-printed blood vessels bring artificial organs closer to reality

Science Daily: Pharmacology News

Lab-grown organs are a long-time 'holy grail' of organ engineering that has yet to be achieved, but new research has brought that goal a big step closer to reality using a new 3D-printing method called co-SWIFT. co-SWIFT prints branching networks of double-layered vessels that are infused with smooth muscle cells and endothelial cells into living human cardiac tissue, and can even replicate patient-specific vascular structures,indicating that it could one day be used for personalized medicine.

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Zepbound shortages ease, but Lilly cautions pharmacy availability may remain ‘choppy’

BioPharma Drive: Drug Pricing

After months of supply strains, Lilly has begun to catch up with demand. Consumers may still need to wait for their prescriptions to be filled, however.

Pharmacy 120
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Cost Keeps Many Who Need Them From Getting New Weight-Loss Meds

Drugs.com

WEDNESDAY, Aug. 7, 2024 (HealthDay news) -- Medicare and Medicaid patients are less likely to get cutting-edge weight-loss drugs than people with private insurance are, a new study finds.Medicaid accounted for less than 10% of semaglutide (Ozempic.

Drugs 111
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FDA approves oral therapy for Grade 2 IDH-mutant glioma

Drug Discovery World

The US Food and Drug Administration (FDA) has approved Voranigo, an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, indicated for the treatment of patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma. It is approved in patients with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection.

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Cracking the code of life: new AI model learns DNA's hidden language

Science Daily: Pharmacology News

With GROVER, a new large language model trained on human DNA, researchers could now attempt to decode the complex information hidden in our genome. GROVER treats human DNA as a text, learning its rules and context to draw functional information about the DNA sequences.

DNA 132
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Novo shares tumble on lower-than-expected obesity drug sales

BioPharma Drive: Drug Pricing

Quarterly revenue from Ozempic and Wegovy missed Wall Street estimates by about 9%, concerning some analysts and causing a stock sell-off costing the Danish drugmaker tens of billions in market value.

Marketing 110
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Certain Pollens Worse for Triggering Asthma Attacks

Drugs.com

FRIDAY, Aug. 9, 2024 -- Pollen is a known trigger for seasonal allergies and asthma, but new research suggests that certain plant species release pollen that are especially tough on asthmatics.Species-specific pollen alerts could help keep people.

Research 115
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Phase I IgG1 antibody treatment could halt fibrosis

Drug Discovery World

The first cohort of participants has been dosed in a Phase I trial MTX-474, a human IgG1 antibody designed to neutralise EphrinB2 signalling to treat fibrosis. The study, taking place in Australia, is designed to assess the safety, tolerability, pharmacokinetics, and target engagement of MTX-474 in healthy participants. Ephrin ligands and Eph receptors mediate biological processes involved in tissue fibrosis including cell migration, myofibroblast activation, and tissue remodelling.

Treatment 147
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Scientists and climate change: Extreme concern and high level of engagement

Science Daily: Pharmacology News

Scientists from across academic disciplines are extremely concerned about climate change. Many of them have already changed their own lifestyles or engaged in advocacy and protest, with even more being willing to do so in future. This is evident from a large-scale survey of scientists from all over the world.

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Unlocking the Power of Azure Integration Services for the Financial Services Industry

Perficient: Drug Development

In today’s rapidly evolving digital landscape, financial services organizations are increasingly relying on cutting-edge technologies to stay competitive and deliver exceptional services to their clients. Microsoft’s Azure Integration Services , a suite of tools designed to seamlessly connect applications, data, and processes, is emerging as a game-changer for the financial services industry.

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Botanicals Like Turmeric, Green Tea Are Harming Americans' Livers

Drugs.com

MONDAY, Aug. 5, 2024 -- Botanicals like turmeric, green tea and black cohosh may seem benign, but their overuse is being increasingly linked to liver injury. New research suggests that 7% of U.S. adults are using at least one of the six leading.

Research 111
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Innovate UK grant supports development of oligonucleotides

Drug Discovery World

CatSci and Reach Industries have won an Innovate UK grant to accelerate the development of oligonucleotide therapeutics. The grant will fund a collaboration that combines scientific expertise with machine vision tools with an aim to streamline the synthesis, purification and analysis of RNA medicines. Based on the Lumi Visual Intelligence platform developed by Reach Industries, CatSci and Reach plan to build a set of tools that combine local area monitoring with multiple global 3D mapping Lumi c

RNA 147
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Processing traumatic memories during sleep leads to changes in the brain associated with improvement in PTSD symptoms

Science Daily: Pharmacology News

Currently, the first-choice treatment for PTSD is exposure-based psychotherapy, where therapists help rewire the emotions associated with the traumatic memory in the patient's brain, shifting from fear and arousal to a more neutral response. However, up to 50% of patients fail to respond well to this treatment. In a new study scientists showed for the first time that reactivating therapeutically-altered memories during sleep leads to more brain activity related to memory processing, which is ass

Treatment 127
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Amgen talks obesity drug ‘differentiation’; Servier brain cancer drug approved by FDA

BioPharma Drive: Drug Pricing

Executives at Amgen had few updates on their drug MariTide, but defended what they see as the once-monthly shot’s competitive profile.

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