Calliditas Therapeutics AB announced today (November 24) that its partner Everest Medicines has revealed that China's National Medical Products Administration (NMPA) has approved Nefecon.
CluePoints, a company providing risk-based study execution (RBx) and risk-based quality management (RBQM) software for clinical trials has won the best Contract Research Organization (CRO) in the specialist providers category at Citeline’s 2023 SCRIP...
OSP was delighted to speak to Galina Nesterova, executive medical director at the Rare Disease & Pediatrics Center of Excellence, and Susan McCune, vice president of pediatrics and clinical pharmacology both within medical science and strategy at...
Owlstone Medical's exegenous volatile organic compound (EVOC) breath test can reveal signs of liver cirrhosis and portal hypertension, a study has found.
Excessive costs cost and time to market in clinical trials could soon be eliminated thanks to the addition of a patient access store (PAS) to Phesi's trial accelerator platform.
myTrialsConnect, a research community powered by artificial intelligence (AI) has been launched following a partnership between Elligo Health Research and Avallano.
Executive director of Medical Research Network's (MRN's) digital health, Edward Triebell, joined OSP for a Q&A where he shared some interesting shifts and statistics about digital trends in clinical research.
From Disney to the drug world, Liss Easy has had a fascinating journey to where she is now in her role as vice president and general manager of clinical operations at IQVIA.
Clinical stage pharma company PharmaKure believe their combined drug targeting amyloid deposits associated with Alzheimer’s Disease can bring quality of life to patients.
The treatment of rare brain disease, progressive supranuclear palsy (PSP), that has no disease modifying therapies, has been given a glimmer of hope by Amylyx Pharmaceuticals.
Feedback has been submitted to the US Food and Drug Administration (FDA) with guidelines intended for sponsors of clinical trials related to psychedelic compounds.
Saama, a provider of artificial intelligence (AI) based solutions, announced today (October 17) that it has formed a multi-year agreement with biopharma giant, AstraZeneca.
In our first podcast interview of 2023, BioPharma Reporter spoke with Dr Sarah Bateup, therapy lead at Clerkenwell Health, about the potential of psychedelic medicine and her work within the psychedelic therapy training space.
Technology company, Medable Inc., offering services for modern clincal trials has joined forces with Pluto Health, a smart care coordination services company offering a health coordination platform.
A new generative artificial intelligence (AI) tool has been launched by H1, a global healthcare data company and will have a 'profound impact on clinical trial diversity'.
Calliditas Therapeutics AB announced on Friday (October 5) that the European Medicines Agency (EMA) has issued a positive opinion on the company’s drug, setanaxib in Alport Syndrome (AS).
At DPharm 2023, there was a huge meeting of minds to discuss the latest innovations in clinical trials. Outsourcing Pharma was delighted to have an in-depth discussion with IQVIA’s Elan Josielewski, senior principal and head of operations, patient centered...
A study to evaluate the effect of seladelparm, a small molecule treatment by CymaBay Therapeutics, Inc. on patients with cirrhosis was announced this month (September 21).
Mural Health Technologies, Inc. has raised $8 million in seed funding for the growth of its Mural link platform it says is aimed at ‘modernizing the clinical trial experience for both patients and caregivers’.
Built upon seven years of real-world patient journey data, Belong.Life has recently announced the launch of its software as a service (SaaS)-based conversational artificial intelligence (AI) cancer clinical trial matching platform.
An oral treatment, developed by the U.S. company Crinetics Pharmaceuticals, Inc., has shown promise as an alternative to injected therapies for tackling the rare disease acromegaly in a phase 3 trial.
OSP spoke to Vesta Marciulioniene, director global regulatory clinical services at ICON Biotech, a contract research organisation who shares insights on the new EMA guideline for computerised systems and electronic data in clinical trials and what new...
CymaBay announced recently the initiation of its 52-week, placebo-controlled, randomized, phase 3 study — 'Intended to Determine the Effects of seladelpar on normalization of Alkaline phosphatase (ALP) Levels in subjects with Primary Biliary Cholangitis...
More people are talking about mental illness than ever before. However, despite increased awareness, it remains one of the most neglected areas of public health globally, with research and quality of care lagging behind physical health conditions.
With more than 63 biopharma companies attending and 15 event partners sharing solutions, the 7th Annual IPF Summit being held in Boston next month (September 2023) is not to be missed.
QuantHealth announced it has raised a $15 million series A funding round today (August 22) for its clinical simulator that can predict how a patient will respond to treatment in a clinical trial.
The US Food and Drug Administration (FDA) has given orphan drug designation (ODD) to Redx’s Zelasudil for the potential treatment of idiopathic pulmonary fibrosis (IPF).
The first patient has been dosed with an orally available small molecule cancer immunotherapy drug, Sosei Group Corporation and Cancer Research UK have announced.
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 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.
Greenphire, provider of clinical trial financial solutions, has released its global 2023 State of Clinical Trial Patient Convenience Market Trends survey.
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.
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.
The U.S. startup Readout AI has closed a pre-seed financing round to fuel the development of an artificial intelligence (AI)-based tool to speed up data analysis in clinical trials.
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.