One year after a rejection by the US Food and Drug Administration (FDA), the UK firm F2G has raised $100 million to push its candidate olorofim to the market for the treatment of rare fungal infections in 2026.
uMotif, a fast-growing company in the clinical research technology sector, has taken a significant step in expanding its platform with the acquisition of ClinOne, a provider of site platform solutions.
Phastar have implemented an RBQM app within their Clinical Intelligence Data Visualisation Platform, enabling a comprehensive overview of the entire trial across all sites which can be shown in various visualisation graphs, tailored by client.
CluePoints, the leading provider of risk-based quality management (RBQM) and data quality oversight software, has announced the full agenda and speaker line-up for the highly anticipated RBQMLive 2024.
Slope, a global provider of biospecimen lifecycle software, data, and services for clinical trials, has announced the launch of a new suite of premium services designed to optimize biospecimen operations and data management.
Pharmaceutical companies are under increasing pressure to ensure that essential healthcare products are accessible to all, regardless of socioeconomic status or location.
In an in-depth conversation, OSP senior editor, Liza Laws, interviews Adrian Kizewski, associate director at IQVIA, to uncover the transformative impact of the Sub-population Optimization & Modeling Solution (SOMS) on clinical trials.
Seqster and PatientsLikeMe have announced a strategic partnership to integrate real-time electronic health record (EHR) data with patient engagement tools, aiming to significantly improve clinical research and patient outcomes.
Reimagine Care, the leading provider of on-demand cancer care, and Memorial Hermann Health System, one of Texas's largest not-for-profit health systems, have announced an ambitious multi-year expansion of their pioneering partnership.
Global health technology company myTomorrows announced a new partnership on Tuesday (Aug 27) with Pancreatic Cancer Europe (PCE), a multi-stakeholder platform dedicated to improving care for pancreatic cancer patients.
Astellas Pharma Inc. has announced the initiation of its phase 3 pivotal study, Highlight 1, for fezolinetant, an investigational nonhormonal oral treatment for vasomotor symptoms (VMS) in women with breast cancer receiving adjuvant endocrine therapy.
Janssen-Cilag International NV, a Johnson & Johnson company, announced that the European Commission (EC) has approved Balversa (erdafitinib) as a once-daily oral monotherapy for adult patients with unresectable or metastatic urothelial carcinoma (mUC)...
Gilead Sciences, Inc. has announced that the US Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC), a rare and chronic autoimmune disease affecting the bile...
Ayvakit, a groundbreaking therapy developed by Blueprint Medicines, has witnessed a remarkable 185% year-over-year revenue growth in the second quarter of this year (2024).
Tonix Pharmaceuticals has announced promising phase 3 trial results for TNX-102 SL (sublingual cyclobenzaprine HCl), a treatment targeting fibromyalgia.
In the rapidly evolving pharmaceutical industry, the process of evaluating outsourcing partners is critical to ensuring quality, efficiency, and innovation.
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...
Red Queen Therapeutics, a new clinical-stage biotechnology company, has launched with a mission to develop antiviral treatments for serious viral diseases, including coronaviruses, influenza, and respiratory syncytial virus (RSV).
In this Q&A, we delve into the collaboration between Skye Bioscience and Beacon Biosignals to enhance the evaluation of nimacimab, a promising treatment for obesity and its comorbid conditions, including obstructive sleep apnea (OSA).
The recent draft guidance released by the US Food and Drug Administration (FDA) in collaboration with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) marks a significant update in Good Clinical...
When she was young, Suzanne used to love hearing her father, a cardiologist, talking to his colleagues on the phone about patients and the care they needed.
As clinical trials continue to evolve, next-generation mobile technologies and applications are at the forefront of transforming the research landscape.
As a strategic brand consultant at ramarketing, Laura combines her extensive background in clinical research with strategic leadership and creative expression.
dsm-firmenich has announced the launch of CBtru – an advanced formulated cannabidiol (CBD) drug product intermediate designed for oral solid delivery formats.
In a rapidly evolving pharmaceutical industry, Yseop stands out by leveraging artificial intelligence to streamline drug discovery and clinical trial processes.
Clinical trials are the backbone of medical advancements, yet the process of managing and utilizing clinical data has long been plagued by inefficiencies and manual labor.
During a panel discussion held at DIA Global in San Diego this week, which was moderated by Peter Wahl, vice president and global head of scientific affairs at CorEvitas, industry experts delved into the integration of real-world data (RWD) and advanced...
Liza Laws speaks with Nikesh Shah, VP, global head of drug safety and pharmacovigilance (PV), and Dr Siva Kumar Buddha, director of pharmacovigilance and head of signal and risk management at Indegene.
As DIA's 60th anniversary at the annual event in San Diego approaches, OSP is excited to bring you insights from Advarra, a leader in advancing clinical research.
Get ready for a big reveal at the DIA conference in San Diego as GiftHealth introduces its latest AI-enabled features designed to revolutionize patient care.
Shionogi is stepping up its game in the fight against infectious diseases by opening its first discovery lab in the US, in sunny San Diego, California.
In celebration of Clinical Trials Day last month, OSP sat down with Diane Lacroix, vice president of clinical data management at eClinical Solutions, to delve into the latest advancements and future directions in clinical trials.
In an intriguing interview with Cybin’s CEO, Doug Drysdale, OSP senior editor, Liza Laws found out how second-generation psychedelics could be the biggest breakthrough in psychiatry in 40 years.
