April, 2024

article thumbnail

Microbiome drug to be tested in IBS clinical trial

Drug Discovery World

EnteroBiotix, a Glasgow, UK based biotechnology company, has dosed the first patient in a clinical trial designed to evaluate EBX-102-02 for the treatment of irritable bowel syndrome (IBS). The Phase II study, named ‘TrIuMPH’ (treating IBS with an intestinal microbiota product for health) will initially enrol 60 patients with IBS and constipation across sites in the UK.

article thumbnail

Will Biopharma Companies Shun Vaccine R&D In A New Pandemic?

Forbes: Drug Truths

Only biopharma could have combated Covid-19; no other industry has the capacity to do so. When the world was in crisis, this industry responded. If need be, it will again, despite the financial consequences.

Vaccine 213
Insiders

Sign Up for our Newsletter

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

article thumbnail

Scientists link certain gut bacteria to lower heart disease risk

Broad Institute

Scientists link certain gut bacteria to lower heart disease risk By Allessandra DiCorato April 2, 2024 Breadcrumb Home Scientists link certain gut bacteria to lower heart disease risk Study finds several species of cholesterol-metabolizing bacteria in people with lower cholesterol levels. By Allessandra DiCorato April 2, 2024 Credit: Ahmed Mohamed Rod-shaped Oscillibacter sp. bacteria take up fluorescently labeled cholesterol (here shown in green).

Disease 145
article thumbnail

Psychiatry drugs finally have pharma’s attention. Can they keep it?

BioPharma Drive: Drug Pricing

Recent biotech company acquisitions have put emerging schizophrenia treatments in focus. But many development hurdles still stand in the way of new medicines for the brain.

Treatment 137
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

Discovery could end global amphibian pandemic

Science Daily: Pharmacology News

A fungus devastating frogs and toads on nearly every continent may have an Achilles heel. Scientists have discovered a virus that infects the fungus, and that could be engineered to save the amphibians.

article thumbnail

Many Cancer Drugs Still Unproven 5 Years After Accelerated Approval

Drugs.com

MONDAY, April 8, 2024 -- New research questions the effectiveness of the U.S. Food and Drug Administration's accelerated drug approval program after finding that many cancer drugs remain unproven five years later.The study, published Sunday in the.

Drugs 116

More Trending

article thumbnail

How long do clinical trials take?

Antidote

Before it is released onto the market, the development of any new drug or medical device must undergo rigorous testing , part of which involves clinical trials. Clinical trials are integral to making sure that any new therapy is both safe and effective for individuals, and volunteers are a vital part of the process.

article thumbnail

Innovative Financing Models for Repurposing Generic Drugs

Drug Patent Watch

A paper presented at the 2nd International Conference on Systems Medicine, AI, and Drug Repurposing proposes a novel approach to overcoming the financial barriers associated with repurposing generic drugs through… Source

article thumbnail

Vertex to buy kidney disease drugmaker Alpine for $4.9B

BioPharma Drive: Drug Pricing

The deal, which company CEO Reshma Kewalramani described as “just the right fit,” is the largest acquistion in Vertex’s 35-year history.

Disease 121
article thumbnail

RNA that doesn't age

Science Daily: Pharmacology News

Certain RNA molecules in the nerve cells in the brain last a life time without being renewed. Neuroscientists have now demonstrated that this. RNAs are generally short-lived molecules that are constantly reconstructed to adjust to environmental conditions. The research group hopes to decipher the complex aging process of the brain and gain a better understanding of related degenerative diseases.

RNA 126
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

Wegovy Helps Those With Both Diabetes, Heart Failure: Study

Drugs.com

TUESDAY, April 9, 2024 -- For people struggling with both diabetes and a common type of heart failure, the weight-loss drug Wegovy may do more for their health than help them shed pounds, new research suggests.In the study, published Saturday in.

Research 111
article thumbnail

Meet the Researcher: Stefano Gullà, Kling Biotherapeutics

Drug Discovery World

DDW’s Megan Thomas speaks to Stefano Gullà, Chief Scientific Officer at Kling Biotherapeutics. MT: Where do you work, and can you tell us what you’re working on at the moment? SG: I am the Chief Scientific Officer at Kling Biotherapeutics. Together with my colleagues, I am tackling what is one of the most pressing problems in biotech, the discovery of targets to serve as the basis for new therapies for cancer and infectious diseases.

Research 147
article thumbnail

Investigating antipsychotics in a Parkinson’s disease psychosis model

Drug Target Review

What are the key findings of the preclinical study regarding the neurophysiological brain state in a Parkinson’s disease psychosis (PDP) model? The animal model is based on creating a dopamine-deficient state, by a specific lesion of dopaminergic cells, and then exposing it to repeated substitution therapy with L-DOPA. This creates a condition which mimics the state in advanced PD in humans.

Disease 105
article thumbnail

The FDA’s New Draft Guidance on DMCs: What to Know

Cytel

Data monitoring committees (DMCs) review ongoing clinical trial data to make recommendations regarding trial conduct based on risk-benefit. DMCs are an essential component to ensuring the integrity and safety of clinical trials. New draft guidance published by the U.S. FDA on the use of DMCs in clinical trials provides six major updates to the FDA’s expectations regarding DMC structure and practice.

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

5 FDA decisions to watch in the second quarter

BioPharma Drive: Drug Pricing

The FDA could soon expand use of two multiple myeloma cell therapies as well as a top-selling medicine from Sanofi and Regeneron, while Pfizer’s years of gene therapy work might finally pay dividends.

FDA 121
article thumbnail

After being insulted, writing down your feelings on paper then getting rid of it reduces anger

Science Daily: Pharmacology News

Researchers have discovered a simple, but effective, strategy to help people reduce their feelings of anger. Disposing of a piece of paper containing your written thoughts on the cause of your anger can effectively neutralize it. This process is like a Japanese tradition called hakidashisara, in which people write their negative thoughts on a plate then destroy it.

Science 118
article thumbnail

Chlamydia Vaccine Shows Promise in Early Trial

Drugs.com

FRIDAY, April 12, 2024 -- A chlamydia vaccine has triggered immune responses in an early trial, raising hopes that one day it might help curb the spread of the sexually transmitted infection (STI).There is currently no vaccine for chlamydia, which.

Vaccine 103
article thumbnail

Where is the opportunity in the therapeutic antibody market?

Drug Discovery World

In this free webinar, you will hear from Dr Jill O’Donnell-Tormey, CEO and Director of Scientific Affairs at Cancer Research Institute; Dr Roger Levy, Senior Global Medical Director, GSK Specialty Medicine; Dr Sheila Keating, VP of Immunology at Gigagen; as well as event sponsors Dr Milind Nigam, Leader – Scientific Solutions Consulting at Benchling, and Dr Paola Genevini, Technical Sales Specialist at Bio-Rad.

Marketing 147
article thumbnail

How to move from diversity to inclusion in medical research

Antidote

Increasing racial diversity in clinical research is a common topic in the industry, and for good reason. The purpose of a clinical trial is to ensure that any new medications are safe and effective for the patient population, so it is of the utmost importance that studies have participant pools that reflect the diversity of real-world individuals.

article thumbnail

Women in Stem with Dr Christine Schuberth-Wagner

Drug Target Review

Can you tell us about your journey in the field of STEM and the challenges you encountered along the way? Everything started in school with an experiment on isolating DNA from bananas. Making a little tangle of DNA visible to the eye and understanding that this is the basis of complex organisms, which might be altered in disease, was the defining moment for my future path in life sciences.

Science 103
article thumbnail

Novartis pauses some trials of cancer drug Kisqali to fix manufacturing

BioPharma Drive: Drug Pricing

The company said the pause is necessary to meet regulatory limits on nitrosamine, but added it will not affect commercial supply nor regulatory review of the drug in early breast cancer.

Trials 112
article thumbnail

Chatbot outperformed physicians in clinical reasoning in head-to-head study

Science Daily: Pharmacology News

ChatGPT-4, an artificial intelligence program designed to understand and generate human-like text, outperformed internal medicine residents and attending physicians at two academic medical centers at processing medical data and demonstrating clinical reasoning.

article thumbnail

Therapeutic Vaccine Prevents Pancreatic Cancer's Recurrence in 3-Year Trial

Drugs.com

MONDAY, April 8, 2024 -- A pancreatic cancer vaccine has continued to protect a small group of patients from their cancer coming back, three years after receiving the jab, a new study says.Eight patients have not had their pancreatic cancer recur.

Vaccine 111
article thumbnail

This week in drug discovery (8-12 April) 

Drug Discovery World

News round-up for 8-12 April by DDW Digital Content Editor Diana Spencer. The cancer research news has been coming thick and fast from the American Association of Cancer Research (AACR) Annual Meeting in San Diego this week, so our Friday round-up focuses on drug discovery in oncology. The top stories: Genetically engineered dendritic cells enhance lung cancer therapy A study by researchers at the UCLA Health Jonsson Comprehensive Cancer Center in the US suggests that injecting engineered dendri

article thumbnail

Optimizely Search & Navigation: Boosting in Unified Search

Perficient: Drug Development

In the Optimizely Search & Navigation admin view, administrators can set a certain weight of different properties (title, content, summary, or document content). When an user searches for a keyword that matches to a property’s value, the higher weight of that property will make the matching pages to be more likely to appear at the top of the search result.

103
103
article thumbnail

FDA Tells Congress What It Wants, What it Really Really Wants (it really really really wants a zigazig-ah)

FDA Law Blog: Biosimilars

By Sara W. Koblitz — Every year, federal agencies submit a budget request to Congress to fund various agency initiatives, and every year FDA includes a list of legislative proposals that it would like to see come out of Congress. This year is no different , and in fact some of the requests on this year’s list are repeat offenders from last year’s. And though FDA may not have gotten everything that it wanted last year, reviewing and reflecting on these lists of legislative proposals provides im

FDA 101
article thumbnail

Bristol Myers CAR-T therapy approved by FDA for earlier myeloma use

BioPharma Drive: Drug Pricing

The FDA’s clearance comes three weeks after a panel of advisers endorsed expanded use of Abecma despite safety concerns raised by the agency.

FDA 121
article thumbnail

Stellar collisions produce strange, zombie-like survivors

Science Daily: Pharmacology News

Densely packed, fast-moving stars at the Milky Way's center can collide with each other. New research uses simulations to explore the outcomes of these collisions. Some collisions are more like 'violent high fives' while others are full-on mergers.

Research 121
article thumbnail

Household Radon Can Lead to Lung Cancer -- Has Your Home Been Tested?

Drugs.com

THURSDAY, April 11, 2024 -- Kentucky resident Chasity Harney embraced a thoroughly healthy lifestyle -- eating right, exercising and never touching tobacco.So, her 2018 diagnosis of advanced lung cancer, which came at the age of 40, was a complete.

103
103
article thumbnail

First tumour agnostic HER2 directed ADC gets US approval

Drug Discovery World

Daiichi Sankyo and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumours. Enhertu has been granted accelerated approval to treat patients who have received prior systemic treatment and have no satisfactory alternative treatment options.

article thumbnail

Azure SQL Server Performance Check Automation

Perficient: Drug Development

On Operational projects that involves heavy data processing on a daily basis, there’s a need to monitor the DB performance. Over a period of time, the workload grows causing potential issues. While there are best practices to handle the processing by adopting DBA strategies (indexing, partitioning, collecting STATS, reorganizing tables/indexes, purging data, allocating bandwidth separately for ETL/DWH users, Peak time optimization, effective DEV query Re-writes etc.,), it is necessary to be awar

93
article thumbnail

New patent expiration for Salix Pharms drug RELISTOR

Drug Patent Watch

Annual Drug Patent Expirations for RELISTOR Relistor is a drug marketed by Salix Pharms and Salix and is included in two NDAs. It is available from one supplier.

Drugs 91
article thumbnail

Diagonal starts up with $128M to make better ‘activator’ antibody drugs

BioPharma Drive: Drug Pricing

The startup claims to have a more efficient way to develop biologic drugs that treat disease by turning on cellular pathways, rather than blocking them.

Drugs 116
article thumbnail

Engineers design soft and flexible 'skeletons' for muscle-powered robots

Science Daily: Pharmacology News

Engineers designed modular, spring-like devices to maximize the work of live muscle fibers so they can be harnessed to power biohybrid robots.