Fri.Sep 27, 2024

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Insomnia treatment approved in Japan

Drug Discovery World

Nxera Pharma Japan has received approval from the Ministry of Health, Labour and Welfare of Japan (MHLW) of its New Drug Application (NDA) for ACT-541468 (daridorexant or Quviviq) in 25 and 50mg doses for the treatment of adult patients with insomnia. The approval of Quviviq, a novel dual orexin receptor antagonist, is based on robust clinical efficacy and safety data including from a dedicated Japanese Phase III trial.

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FDA, after delay, clears Regeneron and Sanofi drug for COPD

BioPharma Drive: Drug Pricing

Dupixent is the first biologic medicine approved in the U.S. for the lung condition, though competitors from GSK, AstraZeneca and Roche could follow.

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FDA approves Sarclisa combination for multiple myeloma

Drug Discovery World

The US Food and Drug Administration (FDA) has approved Sanofi’s anti-CD38 monoclonal antibody isatuximab-irfc (Sarclisa) for newly diagnosed multiple myeloma. It is approved in combination with bortezomib, lenalidomide, and dexamethasone for adults with who are not eligible for autologous stem cell transplant (ASCT). The efficacy of the treatment was evaluated in the IMROZ trial in patients with newly diagnosed multiple myeloma who were not eligible for ASCT.

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Treatment Could Be New Option for People Battling Ulcerative Colitis

Drugs.com

FRIDAY, Sept. 27, 2024 -- An experimental monoclonal antibody treatment appears to ease the digestive disorder ulcerative colitis in patients who've failed other medications, a new trial shows.The treatment, tulisokibart, spurred remission of.

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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 approach to schizophrenia treatment secures US approval

Drug Discovery World

The US Food and Drug Administration (FDA) has approved Cobenfy (xanomeline and trospium chloride) capsules for the treatment of schizophrenia in adults. It is the first antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors, which has long been the standard of care. “Schizophrenia is a leading cause of disability worldwide.

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FDA Approves, Cobenfy, a New Kind of Drug for Schizophrenia

Drugs.com

FRIDAY, Sept. 27, 2024 -- The first new type of medication in decades to help fight against schizophrenia was approved on Thursday by the U.S. Food and Drug Administration. Cobenfy (xanomeline/trospium chloride) could bring patients what they've.

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Upping Dose of Anti-Opioid Drug Might Work Better to Curb Addiction

Drugs.com

FRIDAY, September 27, 2024 -- Patients with opioid use disorder who receive higher doses of a drug to treat their addiction are more likely to have positive results, a new study finds. Daily doses of the drug buprenorphine is a standard treatment.

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Three new life science start-ups join Discovery Park

Drug Discovery World

A group of former Pfizer employees have created their own businesses based at and supported by Discovery Park, a life sciences community in Kent, UK. The new businesses are all contract research organisations (CROs), namely Biowaived, Matheus Engineering and Particology. Their launch has been supported by Pfizer’s Pharmaceutical Sciences Small Molecule (PSSM) division, with contracts for work to build their initial viability and momentum.

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FDA Approves New Kind of Drug for Schizophrenia

Drugs.com

FRIDAY, Sept. 27, 2024 -- The first new type of medication in decades to help fight against schizophrenia was approved on Thursday by the U.S. Food and Drug Administration.Cobenfy (xanomeline/trospium chloride) could bring patients what they've.

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Babies born after fertility treatment have higher risk of heart defects, study suggests

Science Daily: Pharmacology News

The risk of being born with a major heart defect is 36% higher in babies who were conceived after assisted reproductive technology, such as in vitro fertilization (IVF), according to results of a very large study.

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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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Grandma, the Family Dog: Unexpected Sources of Opioid Tragedies for Young Kids

Drugs.com

FRIDAY, Sept. 27, 2024 -- Grandma's pill organizer. Fido's pain medication. A tossed-away tissue.All are potential sources of opioid poisoning for young children, researchers at the New Jersey Poison Control Center report.Their five-year look at.

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How are pronouns processed in the memory-region of our brain?

Science Daily: Pharmacology News

A new study shows how individual brain cells in the hippocampus respond to pronouns. 'This may help us unravel how we remember what we read.

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U.S. Preterm Births Are on the Rise

Drugs.com

FRIDAY, Sept. 27, 2024 -- Over the past decade, rates of preterm birth in the United States jumped more than 10%, a new study of more than 5 million births shows.The rise dovetailed with an increase in some factors that make an early delivery more.

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Return of the elephants seals: From a few to thousands

Science Daily: Pharmacology News

A new international study has revealed the genetic impact of hunting in northern elephant seals. The research shows that this species narrowly escaped extinction by hunting, resulting in lasting genetic effects in the present population.

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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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U.S. E-Bike and Scooter Injuries are Soaring

Drugs.com

FRIDAY, September 27, 2024 — Folks who depend on e-bikes and powered scooters to get around know they might get hurt, but they might be surprised by just how likely that really is.Rates of injury on the trendy transportation devices skyrocketed b.

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Orbitronics: New material property advances energy-efficient tech

Science Daily: Pharmacology News

Orbital angular momentum monopoles have been the subject of great theoretical interest as they offer major practical advantages for the emerging field of orbitronics, a potential energy-efficient alternative to traditional electronics. Now, through a combination of robust theory and experiments, their existence has been demonstrated.

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At Two Dallas Hospitals, Kids' ER Visits for Heat Illness Nearly Tripled Over Last Decade

Drugs.com

FRIDAY, September 27, 2024 -- In a sign that climate change may be fueling heat illnesses in kids, a new study reveals that such visits to two Texas children's emergency rooms spiked 170% between 2012 and 2023.Study leader Dr. Taylor Merritt, a.

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J&J builds case for Talvey; FDA panel questions PD-1 drugs for certain cancers

BioPharma Drive: Drug Pricing

New data show Talvey’s potential in multiple myeloma drug combinations. Elsewhere, AbbVie got more positive Parkinson’s drug data and Biogen ended a Sage collaboration.

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Deep underground flooding beneath arima hot springs: A potential trigger for the 1995 Kobe (Hyogo-Ken Nanbu) earthquake

Science Daily: Pharmacology News

Researchers showed that the 1995 Kobe (Hyogo-ken Nanbu) earthquake, which struck southern Hyogo Prefecture, may have been triggered by deep underground flooding beneath Arima Hot Springs. By analyzing the stable isotope ratios of hydrogen and oxygen as well as chloride ions in Arima hot spring water over several decades, the researchers have uncovered a likely connection between the earthquake and water originating from the subducting Philippine Sea Plate.

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Cover Image

Chemical Biology and Drug Design

Cover Image © molekuul_be/Shutterstock.

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A new birthplace for asteroid Ryugu

Science Daily: Pharmacology News

Asteroid Ryugu possibly did not travel as far from its place of origin to its current near-Earth orbit as previously assumed. New research suggests that Ryugu was formed near Jupiter. Earlier studies had pointed to an origin beyond the orbit of Saturn.

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How Employers Can Advance the 2024 National Strategy for Suicide Prevention

NIOSH Science Blog: Drugs

Suicide is a serious public health threat. In 2022 in the United States, nearly 50,000 adults died by suicide, 13.2 million adults seriously considered suicide, 3.8 million planned a suicide attempt, and 1.6 million attempted suicide.[1] In that same year, 267 adults died by suicide while at work in the United States.[2] That is one person dying in the workplace by suicide every workday in a year.

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Discovery of 3,775-year-old preserved log supports 'wood vaulting' as a climate solution

Science Daily: Pharmacology News

A new study suggests that an ordinary old log could help refine strategies to tackle climate change. A team of researchers analyzed a 3,775-year-old log and the soil it was excavated from. Their analysis revealed that the log had lost less than 5% carbon dioxide from its original state.

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Could Fertility Treatments Raise Heart Defect Risks in Babies?

Drugs.com

FRIDAY, September 27, 2024 -- Babies conceived through assisted reproductive technology are more likely to be born with a major heart defect, new research shows.That risk was 36% higher in babies conceived through techniques such as in vitro.

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Large variation in how girls grow after their first period

Science Daily: Pharmacology News

There is unexpectedly large variation in height growth in girls after their first period. Every second girl grows either more or less in length than the 6-8 centimeters that is considered standard.

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CDD Vault Update (September 2024 #4) - Release Notes

Collaborative Drug

Inventory Index Updates: Search, sort, and filter by Synonym, FW, and Exact Mass. Add metadata columns to the index table using the pencil icon in the right corner. Inventory Alerts: Users can set email alerts based on their inventory sample current amount. Set a threshold and the alert email will list all samples below that threshold at the frequency specified.

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Asteroid Ceres is a former ocean world that slowly formed into a giant, murky icy orb

Science Daily: Pharmacology News

A crater-rich dwarf planet named Ceres located in the main asteroid belt between the orbits of Mars and Jupiter was long thought to be composed of a materials mixture not dominated by water ice. Researchers at Purdue used data from NASA's Dawn mission to show that Ceres' crust could be over 90 percent ice.

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Inside The Altascientist Issue 41: Immunomodulation Assessments for Clinical Trials–Sophisticated Bioanalytical Approaches to Support Complex Modalities

Alta Sciences

Inside The Altascientist Issue 41: Immunomodulation Assessments for Clinical Trials–Sophisticated Bioanalytical Approaches to Support Complex Modalities pmjackson Fri, 09/27/2024 - 20:21 Immunomodulatory drugs are at the forefront for the treatment of various types of cancer, infectious diseases, and numerous autoimmune diseases, including rheumatoid arthritis, type I diabetes, lupus, and multiple sclerosis.

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Ancient sunken seafloor reveals earth's deep secrets

Science Daily: Pharmacology News

Geologists discover a mysterious subduction zone deep beneath the Pacific Ocean, reshaping our understanding of Earth's interior.

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Promoting Inclusivity and Equality for Auditory Disabilities in Healthcare-Universal Design Approach

Perficient: Drug Development

In today’s rapidly evolving world, the importance of inclusivity and equality cannot be overstated, especially in healthcare. One area that often goes overlooked is the need for accommodating auditory disabilities. By integrating principles of universal design, we can create healthcare environments that are accessible and equitable for everyone, regardless of their hearing abilities.

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The Benefits of Real-Time ePRO/eCOA in Clinical Trials: Stay Ahead with Instant Insights

Crucial Data Solutions

Clinical trial delays cost everyone. They cost sponsors in the traditional, dollars-and-cents way. However, they also cost patients and their. The post The Benefits of Real-Time ePRO/eCOA in Clinical Trials: Stay Ahead with Instant Insights appeared first on Crucial Data Solutions.

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Agentic AI: The New Frontier in GenAI

Perficient: Drug Development

In the rapidly evolving landscape of digital transformation, businesses are constantly seeking innovative ways to enhance their operations and gain a competitive edge. While Generative AI (GenAI) has been the hot topic since OpenAI introduced ChatGPT to the public in November 2022, a new evolution of the technology is emerging that promises to revolutionize how businesses operate: Agentic AI.

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Communicating the Value of Biopharma Assets to Potential Investors

Fierce BioTech

Communicating the Value of Biopharma Assets to Potential Investors How can an emerging company attract the right partner for a therapeutic asset (& optimize its value in a transaction)? This paper offers some insights. jpiatt Fri, 09/27/2024 - 09:55 How can an emerging company attract the right partner for a therapeutic asset (& optimize its value in a transaction)?

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Insights into Therapeutic Areas in Clinical Research

Quanticate

Advancements in preclinical and clinical research are driving major changes across various therapeutic areas, steering the industry into a new phase of medical innovation. Each scientific field whether it be oncology , dermatology , rare disease , or others, presents unique challenges and opportunities that are crucial to improving patient outcomes, as well as guiding the efforts of researchers, physicians, and pharmaceutical companies in advancing healthcare solutions globally.