Fri.May 31, 2024

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Jaguar Health out-licenses plant-based drug for schizophrenia

Drug Discovery World

Jaguar Health’s out-licensing agreement with Magdalena Biosciences to develop novel, natural prescription medicines derived from plants for mental health indications, has been expanded. The agreement now includes the ethnobotanical know-how related to development of a prescription drug compound from a specified medicinal plant for possible schizophrenia and psychoses indications and for development with potential corporate partners.

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On National Cancer Survivors Day, celebrating the power of research

Antidote

This Sunday, June 2, is National Cancer Survivors Day , designed to be a celebration for those who have survived cancer and an inspiration for those recently diagnosed. Since 1991, the national cancer death rate has dropped by 33% , partially due to advancements in treatment, early detection, and reduced smoking rates.

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This week in drug discovery (27-31 May) 

Drug Discovery World

News round-up for 27-31 May by DDW Senior Digital Content Editor Diana Spencer. The selected news highlights this week report breakthrough findings from early phase research and development, mainly preclinical studies and Phase I clinical trials, including a drug that can prevent sepsis deaths, a microbiome based immuno-oncology candidate, and a plant-based therapy for diarrhoea.

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Almost 1 in 3 Americans Know Someone Who's Died From a Drug Overdose

Drugs.com

FRIDAY, May 31, 2024 -- As the opioid addiction crisis continues to lay waste to American life, a new survey finds that nearly a third of U.S. adults now know someone who's died of a drug overdose. Conducted in the spring of 2023, the survey 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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Veridix AI targets biobanks with real-time specimen tracking technology

Drug Discovery World

GlobalTrace, the specimen tracking and chain of custody solution from Veridix AI – the technology arm of the Emmes Group – is now being offered to global customers as a standalone service. The CRO expects new markets to be a key part of its growth strategy, as biobanking and related biospecimen shipping services seek more robust solutions, particularly as a new report highlights the risk factors associated with current inventory management approaches.

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Caffeine Affects Dopamine Function in Parkinson's Patients

Drugs.com

FRIDAY, May 31, 2024 -- Caffeine has been associated with a reduced risk of developing Parkinson’s disease, but a new study says a coffee jolt might not be good for people already diagnosed with the brain disorder. Consuming caffeine appears.

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Amsterdam's 'Psychiatric Ambulance' Could Be Advance For Those in Mental Health Crisis

Drugs.com

FRIDAY, May 31, 2024 -- Ambulances meant for people having a mental health crisis could help folks get the care they need with less confrontation and friction, a new study says. People transported to the hospital by a “psychiatric.

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A greener, more effective way to kill termites

Science Daily: Pharmacology News

Scientists have discovered a highly effective, nontoxic, and less expensive way to lure hungry termites to their doom.

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Mediterranean Diet Cuts Women's Risk of Early Death by 23%

Drugs.com

FRIDAY, May 31, 2024 -- Experts have long extolled the benefits of the Mediterranean diet and a new study adds to that evidence, finding it cuts the odds for an early death in women by 23%. “For women who want to live longer, our study says.

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New tentative approval for Annora Pharma drug brivaracetam

Drug Patent Watch

Brivaracetam is the generic ingredient in two branded drugs marketed by Ucb Inc, Aurobindo Pharma Ltd, Lupin Ltd, Sunshine, and Zydus Pharms and, and is included in seven NDAs.

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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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Could Tough Workouts Trigger a Hot Flash?

Drugs.com

FRIDAY, May 31, 2024 -- While going through menopause, many women who gain weight head to the gym for intense workouts, but new research suggests that too much exercise may help trigger another side effect: hot flashes. In a report published May 29.

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FDA staff outline shortcomings of Lykos data for MDMA therapy

BioPharma Drive: Drug Pricing

Ahead of an advisory panel meeting, agency staff identified several sticking points in the clinical results backing Lykos’ ecstasy-based treatment for PTSD.

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Suicidal Impulses May Peak During Restless Nights

Drugs.com

FRIDAY, May 31, 2024 -- The wee hours of the morning could be the most dangerous for someone on the brink of suicide or homicide, a new study shows. There’s a five-fold greater risk for suicide and an eight-fold greater risk for homicide.

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New tentative approval for MSN 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… Source

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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. Deaths Linked to ATVs Rose by a Third in One Year

Drugs.com

FRIDAY, May 31, 2024 -- In just one year, U.S. deaths linked to the use of all-terrain vehicles (ATVs) jumped by a third, according to the latest report from the Consumer Product Safety Commission. With another summer set to begin and ATVs brought.

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FDA delays decision on Dupixent in COPD; Summit makes a bold claim

BioPharma Drive: Drug Pricing

Regeneron and Sanofi now expect an FDA verdict in September. Elsewhere, Summit claimed victory over Keytruda and Neurocrine’s longtime CEO revealed plans to step down.

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Stress, Discrimination Add to Cancer Burden for LGBTQ+ Americans

Drugs.com

FRIDAY, May 31, 2024 -- While LGBTQ+ people have higher risk factors for cancer, they are apt to face discrimination when in need of high-quality medical care, a new report shows. In particular, LGBTQ+ people have to worry that a health care.

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Discovery of a DCAF11-dependent cyanoacrylamide-containing covalent degrader of BET-proteins

Covalent Modifiers

Gary Tin, Marko Cigler, Matthias Hinterndorfer, Kevin D. Dong, Hana Imrichova, Steven P. Gygi, Georg E. Winter, Bioorganic & Medicinal Chemistry Letters , 2024 [link] Targeted protein degradation is mediated by small molecules that induce or stabilize protein–protein interactions between targets and the ubiquitin–proteasome machinery. Currently, there remains a need to expand the repertoire of viable E3 ligases available for hijacking.

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1 in 8 Older Americans Are Stricken With Traumatic Head Injury

Drugs.com

FRIDAY, May 31, 2024 -- About one in eight U.S. seniors will be treated for a traumatic brain injury, typically during a fall, a new study finds. Medicare data shows that about 13% of seniors suffered a severe concussion during an average follow-up.

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Unpacking FDA’s long-awaited platform technology designation program and guidance

Agency IQ

BY RACHEL COE, MSC Months overdue, the FDA’s Platform Technologies Designation guidance document has just been published by the agency. AgencyIQ breaks down what the designation means for sponsors and its limits for product sponsors. As part of the 2023 Consolidated Appropriations Act (Section 2503), Congress directed FDA to establish a new “Platform Technologies Designation” program.

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Night Owls Could Be Upping Their Mental Health Risks

Drugs.com

FRIDAY, May 31, 2024 -- People who regularly stay up until the wee hours of the morning could be harming their mental health, a new study finds. Regardless of whether people were morning larks or a night owls, they tended to have higher rates of.

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What we expect the EPA to do in June 2024

Agency IQ

BY WALKER LIVINGSTON, ESQ In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. The EPA has delayed the release of several TSCA risk management rules for existing chemicals – these may be released in June.

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 Custom Metadata Types and Custom Settings in Salesforce

Perficient: Drug Development

In Salesforce, data storage and configuration management are crucial for maintaining robust and scalable applications. Two powerful tools that Salesforce developers and administrators frequently use to handle this are Custom Metadata Types and Custom Settings. While both serve unique purposes, they offer distinct benefits and come with their own best practices.

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AdComm votes in favor of new colorectal cancer screening test, but questions about serial testing and labeling remain

Agency IQ

BY LAURA DIANGELO, MPH In May 2024, the FDA’s Molecular and Clinical Genetics Device panel voted 7-2 in favor of the approval of a new blood-based screening test for colorectal cancer, which would be the first blood-based test of this type. Discussions at the panel meeting highlighted questions about the role of screening tests and their place in the clinical workflow, labeling for screening indications, and the challenges of studying “repeat” tests.

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Salesforce Field Encryption to Secure Data

Perficient: Drug Development

In today’s data-driven world, protecting sensitive information is more crucial than ever. Salesforce Field Encryption provides organizations with a powerful tool to ensure their most critical data remains secure, even in the face of potential security breaches. In this comprehensive guide, we’ll walk you through the fundamentals of Salesforce Field Encryption, offering insights into its functionalities and best practices for seamless implementation.

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What we expect European regulators to do in June 2024

Agency IQ

BY SEBASTIAN GODOY, MPH , KIRSTEN MESSMER, PHD, RAC , COREY JASEPH, MS, RAC , KARI OAKES , CHELSEY MCINTYRE, PHARMD In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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New patent for Maia Pharms drug ANGIOMAX RTU

Drug Patent Watch

Annual Drug Patent Expirations for ANGIOMAX+RTU Angiomax Rtu is a drug marketed by Maia Pharms Inc and is included in one NDA. It is available from three suppliers.

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What we expect EU chemical regulators to do in June 2024

Agency IQ

BY SCOTT STEPHENS, MPA Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. This recurring feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more.

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Inclusive Pattern Generation Protocols to Decode Thiol-Mediated Uptake

Covalent Modifiers

Saidbakhrom Saidjalolov, Filipe Coelho, Vincent Mercier, Dimitri Moreau, and Stefan Matile ACS Central Science 2024 10 (5), 1033-1043 DOI: 10.1021/acscentsci.3c01601 Thiol-mediated uptake (TMU) is an intriguing enigma in current chemistry and biology. While the appearance of cell-penetrating activity upon attachment of cascade exchangers (CAXs) has been observed by many and is increasingly being used in practice, the molecular basis of TMU is essentially unknown.

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GxP AI - How Quality Systems Can Responsibly Control AI to Enhance Productivity and Streamline Operations

Fierce BioTech

GxP AI - How Quality Systems Can Responsibly Control AI to Enhance Productivity and Streamline Operations swheeler Fri, 05/31/2024 - 15:04 Wed, 07/10/2024 - 11:00 Resource Type Webinar Bryan Ennis Jamie Hijimans Michelle Vuolo Duration 60 minutes As AI capabilities push into GxP regulated business functions, how can Quality and IT teams partner to ensure they are properly controlled?

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After Dobbs, a Rise in Out-of-State Patients for Abortion in Washington State

Drugs.com

FRIDAY, May 31, 2024 -- Following the fall of Roe v. Wade in the summer of 2022, there's been a surge in women from as far away as Texas and Florida traveling to Washington state to have a legal abortion, new data shows. The study focused on the.

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Shifting Strategies: Tackling Patient Support Program Reverification

Drug Channels

Today’s guest post comes from Jan Nielsen, Patient Solutions Division President at AssistRx. Jan discusses the challenges facing life sciences organizations’ patient support program reverification processes. Jan then highlights how the right vendor can help overcome these challenges for both pharmacy and medical benefit products. She offers real-world examples how of AssistRx implements these solutions for clients.

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Embrace Strategic Thinking: 3 Smart Ways to Escape Admin Chaos and Innovate Boldly

Perficient: Drug Development

Do you e ver wish you had more time to focus on strategic thinking , to wrap your arms around a long-term vision, instead of spending your days drowning in admin istrative tasks ? D igging deep into your idea factory takes time and energy, and a never-ending cycle of burn reports, meetings, a nd timecard approvals can drain both – pushing innovation to the back burner.

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Generative AI: The new era of life sciences innovation

Fierce BioTech

Generative AI: The new era of life sciences innovation In this executive brief , discover how generative AI can accelerate drug discovery, streamline manufacturing oversight, enhance patient engagement, leverage models like Amazon Bedrock, secure data, and scale AI workloads. dfarris Fri, 05/31/2024 - 11:03 In this executive brief, discover how generative AI can accelerate drug discovery, streamline manufacturing oversight, enhance patient engagement, leverage models like Amazon Bedrock, secure

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