The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorizations for Pombliti + Opfolda, a two-component therapy to treat Pompe disease.
Integrated drug formulation and clinical trials company, BDD Pharma, will be expanding its phase appropriate development, manufacturing, and clinical testing services after a £2 million ($1.3 million) investment.
Rohit Nambisam is CEO of Lokavant, OSP caught up with him at DIA Global in Boston earlier this summer to find out more about him and the work he is passionate about.
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....
The first patient has been dosed with an orally available small molecule cancer immunotherapy drug, Sosei Group Corporation and Cancer Research UK have announced.
Healthcare technology company Koneska is extending its contribution to critical neuroscience research by collaborating with an academic partnership program.
A partnership between technology company Fluree and Vitality TechNet is a ‘groundbreaking effort’ to shorten timelines within the drug discovery process.
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.
Nathan Johnson has 20 years’ experience in clinical research as an innovator and programmer with expertise in statistical analysis and reporting, SAS programming, standards development, and data management.
OSP was fortunate enough to have an interesting discussion with Stephen Corson, who is a statistics manager at Phastar, a specialist biometrics CRO headquartered in the UK.
The first oral pill in the United States specifically for postpartum depression, a serious mental illness, has been approved by the US Food and Drug Administration (FDA).
At-risk families of patients diagnosed with motor neurone disease (MND), better known in the US as amyotrophic lateral sclerosis (ALS) will now have access to genetic sequencing thanks to a financial award from Innovate UK.
Dr. Susan Wood is CEO and president of VIDA Diagnostics. She has over 25 years of experience championing clinical intelligence solutions into routine clinical use.
PureTech Health plc has been awarded $11.4 million (£8.9 million) from the US Department of Defense (DoD) to advance its therapeutic candidate for the potential treatment of neurological and neuropsychiatric disorders.
A company that ‘translates science into survival’ by developing new therapies has completed its acquisition of a technology company leading in artificial intelligence (AI) and machine learning (ML).
The National Health Service (NHS) research ethics committee has approved a non-cancer chronic pain clinical trial being rolled out by private health clinic LVL Health.
The US Food and Drug Administration (FDA) has today (July 31) given clearance via its 510(k) process to one of the artificial intelligence solutions cleared for colonoscopy.
Columbia University is running three separate efforts to improve diversity within clinical trials, and it released data showing that early improvements could be seen.
The EMA organized a task force made up of various stakeholders to gather insights on potential EU-level actions to improve the set up of clinical trials during public health emergencies.
An experimental antidepressant developed by Neumora Therapeutics has shown promising results in a phase 2 trial, leading the company to plan its pathway to phase 3 testing.
The U.S. startup Surge Therapeutics has raised $32 million in a Series B round to bankroll the development of a hydrogel-based immunotherapy delivered during cancer surgery.
Liz Beatty is co-founder and chief strategy officer at Inato, a clinical trials platform which flips the traditional model and allows community sites to participate in the trials that are best aligned with their interests and that of their patients.
Roche has entered a licensing and collaboration deal with the U.S. company KSQ Therapeutics to co-develop KSQ’s lead cancer drug, which is designed to sabotage the DNA repair mechanisms of cancer cells.
Cumulus Neuroscience, a global digital health company focused on advancing neuroscience clinical trials and patient care, presented interim data from their first-in-class CNS-102 feasibility study at the European Network to Cure ALS Annual Meeting (ENCALS)...
2San, a supplier of self-diagnostic tests, has partnered with Proov to distribute their proprietary at-home fertility tests in select Hy-Vee stores across eight states in the Midwest.
Acasti Pharma, a late-stage biopharma company with drug candidates addressing rare and orphan diseases, has selected WuXi Clinical Development to conduct its STRIVE-ON phase 3 safety trial for GTX-104, a novel injectable nimodipine formulation for intravenous...
Ora, a clinical research organization (CRO) for ophthalmology pharmaceutical and device development, has partnered the North West London Clinical Trials Alliance, to improve the quality and access to clinical research in the region.
The Israeli company Galmed Pharmaceuticals is deploying artificial intelligence (AI) tools developed by the U.S. company OnKai to help carry out clinical trials of a rare disease treatment in communities that have low access to healthcare.
Jason Dong, co-CEO-founder of Mural Health, wants to make sure patients taking part in trials are not out of pocket. He joined OSP while at DIA Global to discuss how his business came about and why it is so important.
Updated guidelines for risk-based quality management (RBQM) are much more than just for monitoring purposes and can show quality by design concepts, save immeasurable time on manpower and shows there has been a complete mindset shift within the last 15...
OSP spoke to senior director of clinical trials, Erin Leckrone, and Kathleen Kane, senior manager of clinical operations at Be The Match Biotherapies, to discuss how creating a well-designed and reviewed protocol is critical to a study's overall...
Anorexia nervosa is a notoriously difficult illness to treat. It has the highest mortality rate of any psychiatric disorder, yet there is currently no FDA approved therapy for the condition.
The first and only approved anti-amyloid Alzheimer's Disease (AD) treatment shown to reduce the rate of disease progression and slow cognitive impairment has been granted approval by the FDA.
With the FDA issuing guidance on more diversity within clinical trials, it is a subject many companies are being encouraged to focus on, each with their own approach.
Drugs like Annovis Bio’s buntanetap and prasinezumab have the potential to “revolutionize the treatment of Parkinson’s Disease” says analytics company, GlobalData, an analytics company, but it is a complex road ahead.
New guidelines have been issued by the FDA called Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials. Curavit was ahead of the game with its plans, find out how.
Kicking off a series of DIA Global interviews in Boston, OSP had the pleasure of speaking to Cal Collins, co-founder and CEO of OpenClinica - a company that wants to empower data managers, clinical researchers, and study participants.
The world’s first anti-fibrotic small molecule inhibitor, discovered and designed by generative artificial intelligence (AI) has completed the first patient dose in a phase 2 clinical trial.
