Fri.Mar 08, 2024

article thumbnail

FDA advisory committee meeting delays approval of donanemab

Drug Discovery World

The US Food and Drug Administration (FDA) has revealed plans to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) to discuss the Phase III TRAILBLAZER-ALZ 2 trial. The trial evaluated the efficacy and safety of Eli Lilly’s donanemab in early symptomatic Alzheimer’s disease. The FDA has said it hopes to further understand topics related to evaluating the safety and efficacy of donanemab, including the safety results in donanemab-treated patients

FDA 130
article thumbnail

Amylyx ALS drug fails crucial study, putting company’s future in doubt

BioPharma Drive: Drug Pricing

The results have led Amylyx to pause promotion of Relyvrio and potentially pull it from the market in the coming weeks, a major blow to the company and ALS patients.

Marketing 137
Insiders

Sign Up for our Newsletter

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

article thumbnail

This week in drug discovery (4-8 March) 

Drug Discovery World

News round-up for 4-8 March by DDW Digital Content Editor Diana Spencer. It was antibodies hitting the headlines this week, with the discovery of antibodies with potential against a new influenza target, the launch of a Phase I trial to investigate a novel type of bispecific antibody, and the announcement that the FDA will delay approval of donanemab to hold a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee.

article thumbnail

Study reveals genetic clusters that may explain differences in type 2 diabetes risk

Broad Institute

Study reveals genetic clusters that may explain differences in type 2 diabetes risk By Corie Lok March 8, 2024 Breadcrumb Home Study reveals genetic clusters that may explain differences in type 2 diabetes risk The clusters point to a range of biological processes that likely contribute to the development of type 2 diabetes. By Brandon Chase, Massachusetts General Hospital Communications March 8, 2024 Related content Largest and most diverse genome-wide association study of type 2 diabetes revea

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

Humanised bispecific antibody for asthma enters Phase I trial

Drug Discovery World

Biopharmaceutical company Innovent Biologics has launched the first-in-human (FIH) Phase I clinical trial of IBI3002, a novel bispecific antibody targeting Interleukin 4 receptor α (IL-4Rα) and thymic stromal lymphopoietin (TSLP). The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IBI3002 in healthy participants and participants with mild to moderate asthma.

Trials 130
article thumbnail

Brucine alleviates fibroblast?like synoviocytes dysfunction and inflammation by regulating YY1 during rheumatoid arthritis

Chemical Biology and Drug Design

Brucine suppressed the proliferation, migration, invasion, inflammation, and macrophage M1 polarization, as well as induced apoptosis in RA-FLSs by decreasing YY1 via circ_0139658/miR-653-5p axis. Abstract Brucine is a weak alkaline indole alkaloid with wide pharmacological activities and has been identified to protect against rheumatoid arthritis (RA) process.

More Trending

article thumbnail

Saikosaponin D mitigate pilocarpine?induced astrocyte injury by regulating the NLRP3/caspase?1 signaling pathway

Chemical Biology and Drug Design

Saikosaponin D (SSD) was used to treat pilocarpine (PP)-induced primary astrocyte injury model in rats. SSD was proved to enhance cell viability, inhibit inflammatory and oxidative stress responses, and improve mitochondrial dysfunction, thus playing a neuroprotective role in the PP-induced primary astrocyte injury model. Abstract Studies have shown that saikosaponin D (SSD) has favorable neurotherapeutic effects.

article thumbnail

FDA delays decision on Lilly’s closely watched Alzheimer’s drug

BioPharma Drive: Drug Pricing

The agency expects to convene a group of outside experts to more closely scrutinize the safety and efficacy of the medicine, donanemab, pushing back the timing of its potential approval.

FDA 122
article thumbnail

Lack of focus doesn't equal lack of intelligence -- it's proof of an intricate brain

Science Daily: Pharmacology News

Imagine a busy restaurant: dishes clattering, music playing, people talking loudly over one another. It's a wonder that anyone in that kind of environment can focus enough to have a conversation. A new study provides some of the most detailed insights yet into the brain mechanisms that help people pay attention amid such distraction, as well as what's happening when they can't focus.

120
120
article thumbnail

FDA Approves Wegovy to Help Prevent Heart Attack, Stroke

Drugs.com

FRIDAY, March 8, 2024 -- Wegovy (semaglutide), the weight-loss version of blockbuster diabetes drug Ozempic, was approved on Friday by the U.S. Food and Drug Administration to help prevent heart attack, stroke and heart death.“Wegovy is now the.

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

Researchers develop artificial building blocks of life

Science Daily: Pharmacology News

For the first time, scientists have developed artificial nucleotides, the building blocks of DNA, with several additional properties in the laboratory.

DNA 127
article thumbnail

A close research partnership with African scientists helps solve the mystery of malaria-like illnesses

Broad Institute

A close research partnership with African scientists helps solve the mystery of malaria-like illnesses By Claire Hendershot March 8, 2024 Breadcrumb Home A close research partnership with African scientists helps solve the mystery of malaria-like illnesses Two scientists discuss how they used genetic sequencing to identify causes of malaria-mimicking infections in Senegal.

Research 111
article thumbnail

Good news for coral reef restoration efforts: Study finds 'full recovery' of reef growth within four years

Science Daily: Pharmacology News

While the majority of the world's reefs are now under threat or even damaged potentially beyond repair, a new study offers some encouraging news: efforts to restore coral reefs not only increase coral cover, but they can also bring back important ecosystem functions, and surprisingly fast.

114
114
article thumbnail

U.S. School Shootings Have Risen 12-fold Since 1970

Drugs.com

FRIDAY, March 8, 2024 -- During the past half-century, the United States’ annual number of school shootings has increased more than twelvefold, a new study finds.What’s more, children are now four times more likely to be a school shooting.

111
111
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

How to Use the Personalization Connector for Salesforce Sales and Service Clouds

Perficient: Drug Development

Have you ever wondered what happens if you connected Personalization with Sales and Service Clouds? The Personalization connector for Sales and Service Clouds exposes user data and server-side campaigns in Salesforce CRM for your contacts and leads. The Key for Success To use Personalization for Sales and Service Clouds, you’ll need to have: User identity systems fully working.

Packaging 110
article thumbnail

Machine Learning in Drug Discovery

Broad Institute

Machine Learning in Drug Discovery By Rose Circeo March 8, 2024 Breadcrumb Home Machine Learning in Drug Discovery Symposium Machine Learning in Drug Discovery The next Machine Learning in Drug Discovery Symposium will take place in Fall 2024. Check back soon for dates and registration. The symposium will highlight recent progress in the application of machine learning techniques to drug discovery and bring together researchers in the field that can benefit from networking.

article thumbnail

Ambien, Lunesta, Sonata: What Are the 'Z Meds' for Sleep?

Drugs.com

FRIDAY, March 8, 2024 -- Ambien, Lunesta, Sonata: Millions of bleary-eyed Americans turn to this class of so-called "Z-drugs" to get restful sleep.But how do these drugs work, and do they come with risks? Experts at the U.S. Food and Drug.

Drugs 105
article thumbnail

Copay Comes Full Circle: An Industry Ready for Disruption

Drug Channels

Today’s guest post comes from Logan Melchione, VP of Patient Affordability at Paysign. Logan discusses the evolution of patient support programs. She then outlines how these programs must evolve to stay relevant and valuable. To request an analysis of your copay savings program and learn more about Paysign’s patient affordability solutions, contact affordability@paysign.com or visit paysign.com/rx.

Drugs 97
article thumbnail

FDA Delays Decision on New Alzheimer's Drug, Donanemab

Drugs.com

FRIDAY, March 8, 2024 -- Instead of approving the new Alzheimer's drug donanemab this month, as was expected, the U.S. Food and Drug Administration will now require the experimental medication be scrutinized more closely by an expert panel, the.

FDA 105
article thumbnail

New study reveals molecular fingerprint of biological aging

SCIENMAG: Medicine & Health

University of Pittsburgh researchers have uncovered blood-based markers linked with healthy and rapid aging, allowing them to predict a person’s biological age — how fast a person’s cells and organs age regardless of their birthdate.

article thumbnail

Many Older Americans Pop Daily Aspirin, Even Though It's No Longer Recommended: Poll

Drugs.com

FRIDAY, March 8, 2024 -- Lots of seniors are regularly taking low-dose aspirin in hopes of preventing heart attacks and strokes, even though updated guidelines often advise against it.About one in four older adults take aspirin at least three times.

105
105
article thumbnail

Balancing training data and human knowledge makes AI act more like a scientist

Science Daily: Pharmacology News

When you teach a child how to solve puzzles, you can either let them figure it out through trial and error, or you can guide them with some basic rules and tips. Similarly, incorporating rules and tips into AI training -- such as the laws of physics --could make them more efficient and more reflective of the real world. However, helping the AI assess the value of different rules can be a tricky task.

Trials 85
article thumbnail

Tremor Could Point to Higher Odds for Dementia

Drugs.com

FRIDAY, March 8, 2024 -- Dementia could three times more common among people suffering from essential tremor, a movement disorder that causes involuntary shaking, a new study suggests.“Not only do tremors affect a person’s ability to complete.

98
article thumbnail

FDA clears use of Novo’s obesity drug to protect heart health

BioPharma Drive: Drug Pricing

The approval makes Novo’s Wegovy the first weight-loss drug with such a claim on its prescribing information, which could have important implications for use and insurance coverage.

FDA 73
article thumbnail

Senate Passes Bill to Compensate More Americans Exposed to Radiation

Drugs.com

FRIDAY, March 8, 2024 -- More Americans exposed to radiation caused by the government would be compensated under a bill that passed the U.S. Senate Thursday.The bipartisan legislation, which would cost an estimated $50 billion, would expand the.

article thumbnail

Novel PET tracer maps fructose metabolism to identify cardiac and neural disorders

SCIENMAG: Medicine & Health

Reston, VA—A new PET radiotracer can differentiate diseased tissues from healthy tissues based on fructose metabolism, according to new research published in the March issue of The Journal of Nuclear Medicine. Fructose metabolism—or fructolysis—is indicative of a variety of diseases, and by noninvasively mapping fructolysis physicians can more accurately detect diseases and treat them earlier.

Disease 73
article thumbnail

Could 'Lazy Eye' in Childhood Raise Risks for Adult Disease?

Drugs.com

FRIDAY, March 8, 2024 -- Children with “lazy eye” are more likely to become adults facing an array of serious health problems, a new study warns.Kids diagnosed with amblyopia are more likely to develop high blood pressure, obesity and diabetes.

Disease 96
article thumbnail

Why Cigna is capping cost increases for pricey obesity drugs

BioPharma Drive: Drug Pricing

The the first of its kind move comes as pharmacy benefit managers continue to try to prove their value to clients, and shows how major players are working to meet demand for the fast-selling medicines.

article thumbnail

It's That Time Again: Tips on Adjusting to the Start of Daylight Saving Time

Drugs.com

FRIDAY, March 8, 2024 -- When the clocks spring forward or fall back, many folks will find themselves struggling to adjust. The transition to Daylight Saving Time can be tough on people, both mentally and physically. Research has found that people.

article thumbnail

New patent for Glaxosmithkline drug ARNUITY ELLIPTA

Drug Patent Watch

Annual Drug Patent Expirations for ARNUITY+ELLIPTA Arnuity Ellipta is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. There are six patents… The post New patent for Glaxosmithkline drug ARNUITY ELLIPTA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
article thumbnail

You Can Safely Avoid Addictive Long-Acting Opioids After Knee Replacement

Drugs.com

FRIDAY, March 8, 2024 -- It's well known that long-acting opioid meds raise the odds for addiction in users -- including folks dealing with pain after an orthopedic surgery.Now, new research suggests that patients fare just as well if doctors.

Doctors 59
article thumbnail

Celebrating Women in Digital at Adobe Summit 2024

Perficient: Drug Development

March is not just about the arrival of spring. It’s a celebration of women’s achievements, history, and ongoing societal impact. As we continue to recognize women this month, we’re excited to take the celebration to Adobe Summit 2024! Join us on Tuesday, March 6 for our Women in Digital Breakfast at the Grand Lux Cafe in The Palazzo.

article thumbnail

Early Treatment Can Push HIV Into Remission in Kids: Study

Drugs.com

FRIDAY, March 8, 2024 -- Ever since one child, dubbed the 'Mississippi baby,' went into drug-free remission of HIV in 2013, experts have wondered if giving treatment within hours of birth might do the same for others.The results of a new trial.

article thumbnail

Next Generation Awards

Broad Institute

Next Generation Awards By Maria Nemchuk March 8, 2024 Breadcrumb Home Next Generation Awards The Next Generation Awards at the Broad Institute recognize early-career scientists (no more than 15 years after their postdoctoral position or medical residency), a group that is sometimes overlooked for funding. On average, biomedical researchers do not receive their first major grant until the age of 43.