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).
Uncensored and brutally honest accounts from participants, caregivers and health professionals providing insights into clinical trial experiences are being shared by The Portrait Project.
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.
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 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.
Phesi, a global provider of patient-centric data analytics, has released the results of its mid-year global analysis of all clinical trials conducted in 2023 to date.
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.
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)...
Lisa Moneymaker is full of energy, enthusiasm, and wisdom. She is well-known on the pharma circuit and it’s easy to see why. She has been chief technology officer and chief product officer at Saama since October last year and feels passionately about...
A licensing agreement between Evotec SE and Bristol Myers Squibb Company (BMS) that will ‘bolster a pipeline of programmes targeting several neurodegenerative conditions’ was announced today (July 11).
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.
Clerkenwell Health, a specialist clinical research organisation (CRO) focused on supporting clients with the design and delivery of psychedelic-assisted therapy trials, is sponsoring the upcoming Psych Symposium 2023 on Thursday 6 July in London.
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.
The escalation of a drug targeting tumors, by releasing active chemotherapy into the disease tissue, has had ‘remarkable’ results and also shown a reduction in side-effects.
CStone Pharmaceuticals' shares have risen after academic journal Nature Cancer published the clinical study results of its lung-cancer treatment sugemalimab.
With the clinical trial landscape continuing to evolve and adapt, OSP took the opportunity to speak to CluePoints, a software company that provides sponsors and CROs a better way of detect and manage risks that may impact the outcome of clinical trials.
Mural Health is on a mission to make it as easy as possible for people to take part in clinical trials, the company will be heading to DIA Global in Boston where they hope to glean a meaningful understanding of the current landscape and hot topics.
The message mdgroup, an organization devoted to creating 'remarkable patient experiences through solutions for clinical trial recruitment, engagement, retention, and outcomes', is that its focus is on people not technology.
CluePoints is continuing to invest in artificial intelligence (AI) and machine learning (ML) they say they want to help clients 'extract every drop of potential from the RBQM-driven interrogation of their own datasets'. It says it recognizes...
A cannabinoid receptor, that has shown potential as an effective treatment for chemotherapy induced peripheral neuropathy (CIPN) has been given approval for a phase 1 clinical trial by the Medicines and Healthcare Products Regulatory Agency (MRHA) and...
With generative AI continuing to create a buzz, OSP took the opportunity to speak to Indegene, a digital-first, life sciences commercialization company that helps biopharmaceutical, emerging biotech and medical device companies develop products. Talking...
Duchenne Muscular Dystrophy (DMD) is a genetic disorder that primarily affects males, caused by a mutation in the gene that encodes for a protein called dystrophin. This protein is crucial for the normal functioning of muscles, and its absence leads to...
Jim Murphy is Greenphire's CEO and leads the company's strategy and he says he is committed to fostering a culture of growth, innovation, excellence and employee satisfaction. Under his leadership, the company has expanded exponentially - in...
Pennsylvania-based Levolta Pharmaceuticals has entered into an exclusive licensing and distribution agreement with Saudi Arabia company, Tabuk Pharmaceutical Manufacturing Company to start commercializing a therapy for osteoarthritis (OA).
A study looking at the feasibility of using repeated sampling of validated digital measures at home, in patients with early-stage Alzheimer’s Disease (AD), has completed enrollment for a multi-site study.
H1, a US data healthcare data technology company has been selected by non-profit funder of Parkinson’s Disease (PD) research, The Michael J Fox Foundation (MJFF), for its Trial Landscape solution.
Vicore Pharma’s drug candidate, C21 formulation, currently in a phase 2a trial aimed at people with idiopathic pulmonary fibrosis (IPF), has been patented.
Small molecule drug, Tagrisso (Osimertinib) taken alongside chemotherapy has showed a strong improvement in progression-free survival for patients with EGFR (epidermal growth factor receptor)-mutated advanced lung cancer, a phase 3 study has revealed.
With an increase in clinical studies demanding an increase in CRAs, we spoke to Sara Brannon, director of quality and training development, at ICON, to find out their approach to recruiting and how the industry is suffering due to a global shortage because...
A company focusing on developing fibrin-targeted therapies to treat inflammatory neurodegenerative and retinal diseases announced the initiation of dosing for its lead asset THN391Monday (May 15) .
Exscientia plc has announced a sixth molecule has been created through its generative artificial intelligence (AI) platform to enter clinical stage. It is the third clinical molecule from a collaboration with Sunitomo Pharma to enter phase 1 trials.
Scorpion Therapeutics, a clinical-stage oncology company, has announced that the first patient has been dosed in a phase 1/2 clinical trial of STX-478, its treatment for breast cancer and other solid tumors.
Symptom improvements have been hailed as ‘very compelling’ after results from a phase 1 study into a combination of drugs to treat myelofibrosis prove positive.
TWO US clinical investigator sites have been opened for a phase 1 clinical trial for patients with soft tissue sarcoma and the first patient has been dosed.
An agreement has been reached to promote Cingulate Inc’s ‘first true entire active day medication’ designed to treat attention deficit hyperactivity disorder (ADHD).
Finding a treatment for a skin disease that significantly diminishes the quality of life for those living with it has moved forward to the next phase of trials.