Tonix Pharmaceuticals has announced promising phase 3 trial results for TNX-102 SL (sublingual cyclobenzaprine HCl), a treatment targeting fibromyalgia.
Driven by personal loss and inspired by the progress in disease management, Elaine has dedicated more than 20 years to the clinical trial technology industry.
In a blow to millions of Americans battling post-traumatic stress disorder (PTSD), Lykos Therapeutics announced today that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its new drug application (NDA) for midomafetamine...
Phathom Pharmaceuticals, Inc.dedicated to developing and commercializing treatments for gastrointestinal (GI) diseases, announced today that the US Food and Drug Administration (FDA) has approved Voquezna (vonoprazan) 10mg tablets for the relief of heartburn...
Meg Wilkinson, a resilient cancer survivor, recently sat down with OSP editor Liza Laws to discuss her journey from diagnosis to founding the Omentum Project.
OSP recently had the opportunity to sit down with Jim DiCesare, senior director of Americas operations at IQVIA, to discuss their innovative participant payments service.
To guide sponsors, investigators, CROs, and other parties in clinical research, the European Medicines Agency (EMA) has consolidated the contemporary requirements for using computerized systems and electronic data in clinical trials.
Lokavant, a leader in clinical trial intelligence, has just launched Spectrum, a cutting-edge AI software designed to revolutionize clinical trial feasibility and optimization.
Yesterday (June 5) CluePoints, providers of established statistical and AI-driven software solutions, and the Food and Drug Administration (FDA) announced an extension to their long-standing collaboration.
In a collaboration set to alter the landscape of clinical trials, Medable Inc. and Masimo have announced a strategic partnership aimed at revolutionizing evidence generation in medical research.
A ‘transformational’ treatment for people with severe alcohol-associated hepatitis (AH) has today (May 21) been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA).
Kynos Therapeutics Ltd, based in Edinburgh, UK, focuses on developing small molecule kynurenine 3-monooxygenase (KMO) inhibitors for inflammatory disorders.
Qinecsa Solutions (Qinecsa), a lead company in technology-driven end-to-end pharmacovigilance solutions has announced its acquisition of Insife ApS (Insife), a Danish-based firm specializing in innovative pharmacovigilance platforms.
Michael Fronstin, global head of client partnership and commercialization at the company said the combination of Oracle’s life sciences expertise and platform technology help CROs win more business and run trials more efficiently.
In a groundbreaking revelation, a study conducted by RCSI University of Medicine and Health Sciences and Children’s Health Ireland has confirmed the safety and efficacy of a Cystic Fibrosis drug in newborns as young as four weeks old.
Elisa Cascade is the chief product officer at Advarra and is responsible for driving the clinical research company's technology product vision and management. We had a fascinating and inspiring conversation with her - touching on imposter syndrome,...
Pharming Group N.V. has declared the successful enrollment completion in its phase 3 clinical trial of leniolisib, an investigational drug designed for children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome (APDS).
Dr Laura Trotta joined CluePoints in 2015 and moved into her current role as vice president of research in January 2022, where she leads a team of research scientists responsible for developing new statistical and machine learning algorithms to assess...
In an encouraging development, neuromodulation, a form of bioelectric medicine, has emerged as a promising avenue for enhancing health by regulating the nervous system.
On Friday (March 15) leading pharma Auxilius Pharma announced promising results from the first-in-human clinical trial of its originative product-in-development, AUX-001.
In a significant move aimed at supporting patients battling amyotrophic lateral sclerosis (ALS), myTomorrows has announced a strategic partnership with the ALS Association, a leading nonprofit organization dedicated to combating ALS.
In the fast-evolving landscape of clinical trials, technological advancements play a vital role in streamlining processes, enhancing efficiency, and ultimately improving patient outcomes.
ClinOne, a leading provider of clinical trial technology, has unveiled what it calls a major enhancement to its platform, offering customers far more control and flexibility.
The National Institute for Health and Care Excellence (NICE) has issued guidance recommending GSK's Omjjara (momelotinib) as a treatment option for disease-related splenomegaly.
At most major conferences, there is usually a topic or buzzword that everyone talks about - and at this year’s SCOPE held in Orlando this week, it was no different.
An artificial intelligence (AI)-powered tool from UK-based Brainomix was one of only two products to be endorsed by health assessor the National Institute of Health and Care Excellence (NICE).
No new treatments to combat the major public health issue of alcohol use disorder (AUD), have been brought to market for ten years - and with half of heavy drinkers refusing the abstinence route, new drug could be the answer.
GSK plc’s small molecule Omjjara (momelotinib), was granted marketing authorization (MA) yesterday (January 31) by the Medicines and Healthcare products Regulatory Agency (MHRA).
Clinical programmers can now further accelerate clinical study reporting, submission analysis and statistical modeling and more thanks to a new product in EDETEK’s informatics platform, Conform.
Clinical-stage precision oncology company, Repare Therapeutics Inc., has received a $40 million milestone payment from Roche after dosing the first patient in a clinical trial.
Elisa Cascade is chief product officer at Advarra, a business that says it aims to advance the way clinical research is conducted by bringing life sciences companies, CROs, research sites, investigators, and academia together at the intersection of safety,...
Andrew Mills, executive vice president of global commercial Lokavant and says the company can help businesses identify risk trends in trials much earlier than traditional methods.
There is an urgent and unmet need to better understand the features of acute respiratory distress syndrome (ARDS), which is why a clinical research business has been selected to start a phase 2 platform clinical trial to investigate it further.
Decentralized clinical trials (DCTs) are gaining increasing interest as they have the potential to make clinical trial operations quicker, more efficient and more accessible to patients. Check out five DCT organizations that have raised big venture capital...
A lead candidate psychedelic drug developed by the US company MindMed has shown the potential to treat generalized anxiety disorder in a phase 2b trial.
Mission Therapeutics, a clinical-stage biotech developing first-in-class therapeutics targeting mitophagy, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to proceed with a phase 2 trial for its kidney...
Last-line multiple myeloma patients, who have exhausted other treatment options have been responding to oral drug inobrodib in combination with pomalidomide and dexamethasone (pom and dex).
Dr. Michael O’Neal, chief medical officer at Clario, believes that many drugs ultimately fail due to common operational and data challenges that could, and should, be corrected.
We sat down with Cary Claiborne, CEO and president of Adial Pharma, to discuss the challenges of treating alcohol abuse and company's solution – a serotonin-3 receptor antagonist that could affect neurotransmitters like dopamine and modulate the...
A significantly greater improvement in people with depression was achieved after they were given ALT-300, an adjunctive treatment, during a phase 2a study.
Professor Deborah Ashby, interim Dean of the Faculty of Medicine, Imperial College, delivered this year’s Sally Hollis Memorial Lecture. OSP enjoyed a discussion with both her and Professor Jennifer Visser-Rogers, vice-president for statistical research...