Fri.May 10, 2024

article thumbnail

Phase II/III study in schizophrenia patients show positive top-line results 

Drug Discovery World

Newron Pharmaceuticals has announced positive top-line results from its potentially pivotal study 008A, evaluating the safety, tolerability and efficacy of evenamide (30 mg bid) in patients with chronic schizophrenia currently being treated with a second-generation antipsychotic including clozapine, but demonstrating an inadequate response to that treatment.

article thumbnail

AI systems are already skilled at deceiving and manipulating humans

Science Daily: Pharmacology News

Many artificial intelligence (AI) systems have already learned how to deceive humans, even systems that have been trained to be helpful and honest. Researchers describe the risks of deception by AI systems and call for governments to develop strong regulations to address this issue as soon as possible.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Funding of $85 million secured for Prader-Willi Syndrome drug

Drug Discovery World

Aardvark Therapeutics has announced an $85 million oversubscribed Series C financing. The funding will be used to complete the clinical trials required for regulatory approval of Aardvark’s lead asset, ARD-101, for the treatment of hyperphagia in patients with Prader-Willi Syndrome (PWS), as well as to demonstrate ARD-101’s complementary mechanism of action to the current GLP-1 therapies in the treatment of obesity, and to advance other Aardvark pipeline programmes.

Drugs 173
article thumbnail

How the brain is flexible enough for a complex world (without being thrown into chaos)

Science Daily: Pharmacology News

Many neurons exhibit 'mixed selectivity,' meaning they can integrate multiple inputs and participate in multiple computations. Mechanisms such as oscillations and neuromodulators recruit their participation and tune them to focus on the relevant information.

109
109
article thumbnail

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.

article thumbnail

This week in drug discovery (6-10 May) 

Drug Discovery World

News round-up for 6-10 May by DDW Multimedia Editor Megan Thomas. A leading news story this week has been the announcement of positive Phase II results of a head and neck cancer trial, but there have been a number of other interesting clinical result announcements. These include the discovery of molecular doorways that could be used to help deliver drugs into the brain to treat neurological disorders, a plant-based medication which may be an effective therapy to help patients stop vaping, immune

Drugs 173
article thumbnail

iTeos shares jump on TIGIT update; Acelyrin swaps CEOs

BioPharma Drive: Drug Pricing

Interim data surpassed expectations, iTeos said. Elsewhere, Acelyrin revealed chief executive officer Shao-Lee Lin is departing and Bluebird bio gave a fuller account of its gene therapy launches.

Therapies 108

More Trending

article thumbnail

FDA delays decision on Moderna RSV vaccine

BioPharma Drive: Drug Pricing

The regulator cited “administrative constraints,” rather than any issue with Moderna’s trial data, for missing a May 12 deadline, the company said.

Vaccine 108
article thumbnail

One in 8 U.S. Adults Have Now Used Blockbuster Meds Like Ozempic

Drugs.com

FRIDAY, May 10, 2024 -- About 1 in 8 U.S. adults (12%) have tried a weight-loss drug like Wegovy, Ozempic, Zepbound or Mounjaro, a new KFF Health Tracking Poll says.About 6% are taking one right now, the poll found.Most patients say they use the.

Drugs 105
article thumbnail

Including Patients with Borderline Personality Disorder in Clinical Trials

Conversations in Drug Development Trends

By: Christine Moore, PhD, Vice President, Neuroscience, Scientific Solutions Patients with borderline personality disorder (BPD) face a heightened risk of substance abuse and suicide, as well as substantial delays in receiving treatment. Despite these risks, there are no medications specifically approved to target the core symptoms of BPD; current treatments are limited to managing underlying affective symptoms.

article thumbnail

Cancer Patients Often Face Medical Debt, Even With Insurance

Drugs.com

FRIDAY, May 10, 2024 -- When cancer strikes, you could easily go into debt, even with health insurance in place, according to a new survey from the American Cancer Society.The survey, based on responses from nearly 1,300 cancer patients and.

105
105
article thumbnail

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.

article thumbnail

CDD Vault Update (May 2024)

Collaborative Drug

Hooray for curve overlays!! We are excited to announce a new round of features associated with our Curve Analytics Module. If you are not yet subscribed to Curve Analytics, please contact your CDD Vault account manager or the CDD Vault Support Team to discuss enabling these features in your Vault.

95
article thumbnail

Feds Announce New Measures to Monitor, Prevent Bird Flu

Drugs.com

FRIDAY, May 10, 2024 -- H5N1 avian flu is now infecting U.S. dairy cows and the federal government on Friday announced a myriad of initiatives aimed at preventing the virus' mutation and spread in humans. The illness is typically not fatal in.

Virus 98
article thumbnail

Scientists unlock key to breeding 'carbon gobbling' plants with a major appetite

Science Daily: Pharmacology News

The discovery of how a critical enzyme 'hidden in nature's blueprint' works sheds new light on how cells control key processes in carbon fixation, a process fundamental for life on Earth. The discovery could help engineer climate resilient crops capable of sucking carbon dioxide from the atmosphere more efficiently, helping to produce more food in the process.

article thumbnail

Utah Kids Got E. Coli From Playing Around Lawn Sprinklers

Drugs.com

FRIDAY, May 10, 2024 -- Happily jumping around lawn sprinklers or playing with garden hoses on a hot summer day: An idyllic childhood scene.Not so for a bunch of kids in Utah, who all got serious E. coli illnesses from the contaminated water they.

98
article thumbnail

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

article thumbnail

ONe novae stellar explosion may be source of our phosphorus

Science Daily: Pharmacology News

Astronomers have proposed a new theory to explain the origin of phosphorus, one of the elements important for life on Earth. The theory suggests a type of stellar explosion known as ONe novae as a major source of phosphorus.

87
article thumbnail

Cyberattack Cripples Major U.S. Health Care Network

Drugs.com

FRIDAY, May 10, 2024 -- Ascension, a major U.S. health care system with 140 hospitals in 19 states, announced late Thursday that a cyberattack has caused disruptions at some of its hospitals."Systems that are currently unavailable include our.

article thumbnail

Novavax gets a lifeline with Sanofi vaccine pact

BioPharma Drive: Drug Pricing

Sanofi will ally with the under-pressure biotech, paying $500 million upfront for rights to co-commercialize Novavax’s COVID shot and develop combination influenza vaccines.

Vaccine 72
article thumbnail

His Cancer Journey Shows Health Dangers Firefighters Face

Drugs.com

FRIDAY, May 10, 2024 -- For 14 years, David Perez fought fires in South Florida, thinking he was in peak physical shape. Then a routine physical turned up anomalies in his blood work that turned his life upside down."The labs came back irregular.

98
article thumbnail

What life sciences companies need to know about NIST’s new AI guidance

Agency IQ

BY LAURA DIANGELO, MPH The National Institute of Standards and Technology (NIST) last week released four new documents on artificial intelligence, mostly focusing on generative AI (GAI). The documents seek to both expand NIST’s existing frameworks to directly address the unique aspects of GAI and outline the novel questions still to be addressed in this field.

Science 59
article thumbnail

Career Perspectives: A Conversation with Emily Woolley

Cytel

In this latest edition of our Career Perspectives series, we had the privilege of interviewing Emily Woolley, Senior Director of Biostatistics at Axio, a Cytel company, residing in Oregon, USA. With over a decade of experience in clinical trial statistics and serving as an independent statistician for numerous trials, Emily brings a wealth of expertise and insights.

article thumbnail

How states are looking to control PFAS through different legislative models

Agency IQ

BY WALKER LIVINGSTON, ESQ States across the U.S. have been introducing and enacting legislation to restrict or remediate PFAS at a breakneck pace, with varying approaches and models. This AgencyIQ analysis reviews recently proposed or enacted legislation, with an eye to understanding how these models could be implemented more broadly. Per- and polyfluoroalkyl substances are a large group of synthetic organic chemicals used in many different industrial, commercial, and consumer applications since

59
article thumbnail

Managing Data Challenges in Clinical Studies with a Data Safety Monitoring Board

Quanticate

A Data Safety Monitoring Board (DSMB) plays a critical role in ensuring the safety, credibility, and integrity of ongoing clinical trials. Comprising independent professionals with relevant expertise, the DSMB regularly reviews data accumulated from one or more ongoing clinical trial. The DSMB continuously advises the sponsor on the safety of trial subjects and those yet to be recruited to the trial as well as the validity and scientific merit of the trial.

article thumbnail

FDA holds the line on remanufacturing definitions in newly finalized guidance

Agency IQ

BY LAURA DIANGELO, MPH Almost three years after the initial draft, the FDA has now finalized guidance describing the differences between medical device “servicing” and “remanufacturing” and each activity’s quality system implications. The new guidance maintains the agency’s existing definitions of remanufacturing and servicing, but adds a new section that provide a high level overview of the medical device regulations – primarily for those “less familiar.

FDA 59
article thumbnail

Maze lands new partner for Pompe drug, after Sanofi pact came apart

BioPharma Drive: Drug Pricing

An alliance with Shionogi involves similar terms as a deal Sanofi canceled in response to an unusual challenge from the Federal Trade Commission.

Drugs 65
article thumbnail

European Ombudsman suggests Commission needs more robust evidence when reclassifying medical devices

Agency IQ

BY COREY JASEPH, MS, RAC The European Ombudsman recently updated its investigation into the complaint that the Commission reclassified brain stimulation devices without a thorough look at the scientific evidence. But the advice went beyond the specific instance of the reclassification regulation to suggest that the regulator needs to ensure its feedback mechanisms are robust and thorough.

article thumbnail

Acceptance Criteria – Part 2 of User Story

Perficient: Drug Development

This blog is the second post in a series about leveraging user stories to improve product outcomes. In this post, we will explore how acceptance criteria can be used to define the scope and requirements of user stories. What are Acceptance Criteria? Acceptance criteria, or AC, are the minimum level of expectations that need to be met to mark a user story as complete.

article thumbnail

France reintroduces pesticide plan, this time with EU indicator

Agency IQ

BY RAYAN BHARGAVA, MSC Though delayed due to farmer protests, the latest version of France’s longstanding pesticide reduction plan has been published. This last iteration replaces France’s own indicator of the amount and intensity of pesticide use with a metric adopted by the EU that attempts to refine human health risk assessment, but employs a controversial weighting scheme.

59
article thumbnail

Advancing Equity: Education Accessibility in the Universal Design Series -2

Perficient: Drug Development

Welcome to the second installment of our Universal Design Series, where we continue our exploration of the critical intersection of Equity for Learning in Education Accessibility. In this edition, we’ll delve into the principles, strategies, and significance of advancing equity through Universal Design in creating accessible and inclusive learning environments.

article thumbnail

Telehealth Tougher When English Isn't First Language

Drugs.com

FRIDAY, May 10, 2024 -- Telehealth is revolutionizing health care in America by making it easier than ever to reach a doctor – but not everyone is benefitting, a new study reports.People with limited English skills are more likely to have worse.

Doctors 52
article thumbnail

How to use AI in clinical trial marketing

Antidote

Artificial intelligence, most commonly known as AI, has become a buzzword across many industries. While it is most commonly used in relation to art generators or web searches, AI has many practical applications beyond these uses — especially within the clinical trial marketing space. The global market size of AI-based clinical trial marketing is expected to reach nearly 8 billion by 2031 , mainly due to the extensive advancements in the medical field.

article thumbnail

Oral Rinse Might Alert Doctors to Stomach Cancers

Drugs.com

FRIDAY, May 10, 2024 -- A quick swish at the doctor’s office could someday provide early detection of stomach cancer, the fourth-leading cause of cancer deaths worldwide, a new study reports.Researcher found distinct differences in bacteria.

Doctors 52
article thumbnail

FDA Publishes Guidance for CAR T Products

thought leadership

In January 2024, the FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products issued a guidance document- Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products. This long-awaited guidance provides guardrails which allow CAR T product developers and manufacturers to focus efforts for consistent expectations rather than relying on perspective review of prior approvals.

article thumbnail

The Pros & Cons of Robotic Knee Replacement Surgery

Drugs.com

FRIDAY, May 10, 2024 -- Robot-assisted total knee replacements tend to have better outcomes on average, a new study reports.Unfortunately, there’s a downside – having a surgical robot assist a human surgeon can make the procedure much more.

52
article thumbnail

New patent for Janssen Biotech drug BALVERSA

Drug Patent Watch

Annual Drug Patent Expirations for BALVERSA Balversa is a drug marketed by Janssen Biotech and is included in one NDA. It is available from one supplier.

Drugs 52