Phase 3 win for Protagonist Therapeutics with oral plaque psoriasis drug
The promising trial results put icotrokinra on track to fulfill its potential as a best in class oral therapeutic for the chronic skin condition.
Clinical trials & development
US companies enhancing decentralized clinical trials
Traditional clinical trials usually rely on several physical trial sites to recruit and monitor patients.
Medable and Google Cloud partner to deliver digital clinical trials technology
The partners will work together to make Medable’s digital and decentralized clinical trial platform available on Google Cloud Marketplace.
Transparency and remote options key in clinical trial engagement
A recent Lindus Health survey emphasizes the importance of patient-centered designs in clinical trials, particularly highlighting how telehealth options could improve accessibility and convenience for participants.
Abbisko’s pimicotinib hits primary endpoint in phase 3 TGCT trial
Abbisko’s small molecule drug pimicotinib has smashed the primary goal of a phase 3 trial for the treatment of tenosynovial giant cell tumor (TGCT), taking the asset a step further to the market in China and elsewhere.
Senhwa Biosciences starts trial of silmitasertib in children with difficult to treat cancers
The Taiwanese biotech has launched a phase 1/2 trial to test its small molecule cancer therapy in children and young adults with relapsed or treatment resistant tumors.
FDA grants accelerated approval to Novartis’ Scemblix as a first-line leukemia therapy
Scemblix is the first drug to show superiority over all standard of care therapies for a rare type of leukemia.
Novo Nordisk’s semaglutide shows additional cardiovascular benefits in overweight patients
Clinical trial results have revealed that semaglutide treatment significantly reduced hospital admissions in overweight and obese adults with heart disease.
Competitors race to launch GLP-1 drugs amid soaring weight loss demand
Demand for weight loss drugs targeting GLP-1 has exploded in recent years, leading to disruptions in supply chains. Here are the companies racing for approval of their own versions of these highly coveted drugs.
NICE rejects Donanemab for NHS use despite MHRA approval
Donanemab marks a significant advancement in Alzheimer’s treatment, but NHS patients face a setback with NICE's rejection of its cost-effectiveness.
Seaport Therapeutics closes $225 million Series B to develop neuropsychiatric drugs
The Boston-based biotech will use the new fundraise to develop its pipeline of drug candidates for conditions such as major depressive disorder and generalized anxiety disorder.
Sanofi abandons phase 2 trial of Denali’s multiple sclerosis candidate
The big pharma company Sanofi has discontinued a phase 2 trial of U.S. partner Denali Therapeutics’ oditrasertib for the treatment of multiple sclerosis after the drug failed to perform.
Innovent and Ask Pharm join forces to commercialize third-generation lung cancer therapy
The partners are preparing for commercialization of the lung cancer drug limertinib as they await an approval decision from China’s National Drug Administration.
From CDMOs to artificial intelligence - what's the latest in the world of outsourcing?
Outsourcing Pharma sat down ahead of CPHI with Dr Andreas Raabe, CEO of Adragos Pharma, to explore the evolving world of pharmaceutical outsourcing.
How specialized vendors improve patient recruitment success
Patient recruitment is a critical and often challenging aspect of clinical trials, particularly for biopharmaceutical companies seeking to accelerate drug development.
Authenticx CPO Eric Prugh on the impact of AI technology in pharmacovigilance
Artificial intelligence has emerged as a potential solution to inconsistent reporting of adverse events, which to this day remains one of the main challenges in the field of pharmacovigilance.
Pfizer withdraws sickle cell disease drug Oxbryta amid safety concerns
The US big pharma company Pfizer has voluntarily withdrawn the oral sickle cell disease treatment Oxbryta from the market and halted clinical trials of the drug as data indicate a high risk of severe adverse events.
FDA greenlights first treatment for Niemann-Pick disease type C
The small molecule drug arimoclomol (Miplyffa) has got the green light from the U.S. Food and Drug Administration (FDA) for the treatment of the rare disease Niemann-Pick disease type C (NPC), which until now has lacked FDA-approved therapies.
Biohaven’s real-world trial shows positive results for spinocerebellar ataxia drug
The US biotech’s neurological drug candidate showed a reduction in disease progression of at least 50% and the company will now file with the FDA.
Insilico Medicine claims phase 2 win for AI-designed drug
The Hong Kong headquartered company says its idiopathic pulmonary fibrosis drug performed well in a phase 2a trial and met its primary endpoint.
NuraBio closes $140m fundraising to develop neuroprotective drugs
The series A financing will enable Nura Bio to advance its lead drug candidate into the next stage of clinical trials, shortly after successfully completing a first phase 1 clinical trial.
Women in science - Alison O'Neill at YPrime on thinking out loud and collaborating
Alison has more than 35 years of broad experience delivering clinical trials to sponsors with a patient centric mindset.
Boehringer Ingelheim score with phase 3 idiopathic pulmonary fibrosis win
The German big pharma will submit a new drug application to the US FDA after success at phase 3 for nerandomilast.
F2G raises $100 million to combat innovation 'paucity' in antifungals
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 expands site and patient platform with ClinOne acquisition
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.
How modern trial designs propel cancer therapies to the market - interview
Clinical trials are becoming increasingly complex as emerging technologies such as immunotherapy enter the mainstream.
CluePoints sponsors RBQMLive 2024, focusing on risk-based quality management
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.
Pharma companies must prioritize patient reach, report says
Pharmaceutical companies are under increasing pressure to ensure that essential healthcare products are accessible to all, regardless of socioeconomic status or location.
AI-driven insights: SOMS boosts clinical trial success
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 partner to enhance patient data engagement
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 and Memorial Hermann boost cancer care engagement
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.
New collaboration aims to streamline clinical trial access for patients
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 begins phase 3 trial of fezolinetant for VMS in breast cancer
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.
EC Approves Balversa for patients with metastatic urothelial carcinoma
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's Livdelzi granted accelerated FDA approval for primary biliary cholangitis
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's explosive 185% revenue growth: A game-changer in rare disease treatment
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's trial results showing promise in fibromyalgia treatment
Tonix Pharmaceuticals has announced promising phase 3 trial results for TNX-102 SL (sublingual cyclobenzaprine HCl), a treatment targeting fibromyalgia.
Revolutionizing partner evaluations in pharma outsourcing: expert insights
In the rapidly evolving pharmaceutical industry, the process of evaluating outsourcing partners is critical to ensuring quality, efficiency, and innovation.
How personal loss and hope drove Elaine Maynard’s work in clinical trials and patient-centric technologies
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.
Lykos’ heartache over FDA setback as new trial for groundbreaking PTSD treatment ordered
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...
DIA 2024
Using technology to transform clinical trials: An interview with PhaseV CEO Raviv Pryluk
In a rapidly evolving landscape where speed and precision are critical, the integration of advanced technologies in clinical trials is essential.
FDA to decide on Lykos' MDMA therapy for PTSD, offering hope for millions
The FDA is expected to make a pivotal decision on Sunday (August 11) regarding the approval of Lykos Therapeutics’ MDMA-assisted therapy for PTSD.
Red Queen Therapeutics debuts to tackle viral infections with $55M funding
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).
Exploring sleep apnea solutions: Skye and Beacon's innovative obesity trial collaboration
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).
Ann Graham from her shocking cancer diagnosis to supporting youngsters battling the disease
Ann Graham changed the direction of her career after being treated for osteocarcoma - a type of cancer that usually affects children and young people.
How ICH E6(R3) is set to upgrade clinical trials: Insights from industry experts
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...
Revolutionary Alzheimer's drug donanemab approved – what does this mean for the future of care?
The approval of donanemab marks a significant breakthrough in Alzheimer's treatment, promising transformative changes in patient care and research.
Suzanne LeBlang - passionate about patient care and the Focused Ultrasound Foundation
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.
AI, patient engagement, and interoperability: Innovations shaping clinical trials
As clinical trials continue to evolve, next-generation mobile technologies and applications are at the forefront of transforming the research landscape.