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...
OSP had a discussion with Tracy Curley, CEO of iSpecimen, and Eric Langlois, chief revenue officer of iSpecimen and Michael Howell,founder of Mountaineer Biosciences, Inc. to discuss a number of issues those working in precision medicine still face.
Astellas Pharma Inc. and Pfizer Inc. today announced that the companies received approval from the US Food and Drug Administration (FDA) for a supplemental New Drug Application for small-molecule drug Xtandi (enzalutamide).
The first and only enzyme replacement therapy for the treatment of a very rare and complex blood disorder has been approved by the US Food and Drug Administration.
The Pistoia Alliance is a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D. It has just announced its four new strategic priorities made up of global pharma and tech representatives to deliver new project...
A small molecule, oral targeted therapy for adults with metastatic colorectal cancer (CRC) has been approved by the US Food and Drug Administration (FDA).
A partnership between clinical research technology company uMotif and cognitive science company, Cogstate Limited, will see the companies continue existing work that includes a major phase 2 clinical trial of a psychedelic therapeutic.
The US Food and Drug Administration (FDA) has approved a potassium-competitive acid blocker (PCAB) as a new treatment for the healing of all grades of erosive esophagitis.
Advanced tech company, PhaseV, has raised $15 million in funding that it says it will use to ‘push the boundaries of machine learning for clinical trial optimization’.
Clerkenwell Health is partnering with Transcend Therapeutics to trial the use of methylone in patients with severe post-traumatic stress disorder (PTSD).
The unique glutamatergic mechanism of action in Newron Pharmaceuticals’ investigational new drug can potentially produce a long-lasting antipsychotic response in patients with TRS, and the benefits will accrue over time.
A 15-year partnership between Medidata, a Dassault Systèmes company, and the National Cancer Institute (NCI) has been extended by five years. The NCI is part of the National Institutes of Health.
Chinese biopharmaceutical company, Hutchmed Limited, has announced today (Friday September 29) that it has taken a step towards bringing a colon and rectum cancer drug to a third market.
The French-U.S. company Novadiscovery has hailed a “watershed moment for clinical trial design” as its trial simulation tool successfully predicted the outcome of a phase 3 oncology trial run by AstraZeneca.
HumanFirst, a cloud-based software company accelerating patient-centered drug development through AI, has announced the launch of its precision measures platform.
A kidney disease drug with a ‘durable and clinically meaningful impact on kidney function’ has been granted priority review by the US Food and Drug Administration (FDA).
OSP discussed going beyond industry sponsors and how to support both patients and centers through clincal trial design with Erin Leckrone, senior director, clinical trials and Kathleen Kane, senior manager, clinical operations, at Be The Match BioTherapies....
Calliditas Therapeutics AB’s phase 3 study looking at a cure for a kidney disease called IgA nephropathy (IgAN) has met its primary endpoint and the full data has been published in The Lancet.
Patients suffering from catheter-related bloodstream infections could be treated with Citius Pharmaceuticals antibiotic lock solution after it achieved 92 milestone events in its phase 3 trial.
Chronic hives could be treated effectively, conveniently, and rapidly after positive results from a clinical trial by Novartis produced positive top line results.
The first patient has been enrolled in a phase 3 clinical trial of leniolsib a treatment for a rare inherited condition affecting how the immune system works.