Jun 22, 2026, 07:54 by

Seasoned Biopharmaceutical Leader and Board Director Steps Up to Lead the Company’s Next Phase of Growth in Customized Interleukin Therapies

Jun 22, 2026, 07:54 by

New ultra-high-throughput kit enables discovery teams to generate transcriptome-wide compound-response data directly from 1536-well plates

Jun 22, 2026, 07:54 by

Cancer Research UK’s Centre for Drug Development is using TrialAssure LINK AI to support medical writing in CRUK-sponsored studies

Jun 22, 2026, 07:54 by

UniQure plans to submit its Huntington’s disease gene therapy, AMT-130, for FDA approval after reaching agreement with the agency on using three years of clinical data. The therapy demonstrated a 75% slowdown in disease progression among patients receiving the higher dose. The development marks a major shift in the FDA’s stance following recent leadership changes and is being viewed as a positive signal for the broader cell and gene therapy sector. Following the announcement, UniQure shares surged nearly 80%, reflecting renewed investor confidence in the program and its regulatory pathway.

Jun 22, 2026, 07:54 by

Spot Biosystems has emerged from stealth with $40 million in funding and a breakthrough non-viral gene therapy platform for Duchenne muscular dystrophy (DMD). The company demonstrated the world's first successful delivery of full-length dystrophin to human skeletal muscle using engineered extracellular vesicles (EVs). Early clinical data showed dystrophin increases of over 1,000% and 2,000% in two pediatric DMD patients, along with improved muscle function. The technology aims to overcome the limitations of traditional viral gene therapies by enabling repeat dosing and larger genetic payload delivery.

Jun 18, 2026, 08:53 by

Biogen has agreed to acquire RayThera in a deal worth up to $1 billion, significantly expanding its immunology pipeline and strengthening its presence in immune-mediated disease research. The acquisition brings multiple anti-inflammatory drug candidates to Biogen, including a lead therapy expected to enter Phase 1 clinical trials in Q3 2026. Once the transaction closes, Biogen will oversee the development, manufacturing, and global commercialization of these assets. The deal reflects Biogen’s long-term strategy to accelerate innovation and advance new treatment options in immunology.

Jun 18, 2026, 08:53 by

Paradigm Clinical Research has opened a new psychedelic research suite at its Redding, California site, adding a purpose-built space to support psychiatric clinical trials investigating psychedelic-assisted therapies. The facility will support studies in major depressive disorder, treatment-resistant depression, PTSD, substance use disorders, and anorexia nervosa, overseen by board-certified psychiatric staff. The Redding location is notable for its access angle: Shasta County has a veteran population nearly double the state average, and recent regional health assessments have flagged behavioral health and substance use treatment as priority gaps. The company frames the expansion as part of a broader push to bring specialized psychiatric trial access to rural and underserved areas rather than concentrating it in major metro centers.

Jun 18, 2026, 01:01 by User Not Found

Clinical Research News | For years, TMF leaders advocated for active TMF, a model where the TMF is a "place to go to do your work" instead of a passive archive. The shift to active TMF made significant progress for life sciences, moving toward applications that deliver real-time trial execution and TMF management. With the introduction of agentic AI in clinical trials, TMF management is now evolving from active to autonomous.

Jun 17, 2026, 06:00 by

J Pharma Co., Ltd., a clinical-stage biotechnology company focused on novel therapies targeting amino acid transporters, and Uniphar, a leading international healthcare services company, today jointly announced progress in the development of JPH203 (nanvuranlat), a novel LAT1 inhibitor for the treatment of second-line biliary tract cancer. Following alignment with the U.S. Food and Drug Administration (FDA), the program has advanced into Phase 3 clinical development and initial patients are now enrolled in the global study.

Jun 17, 2026, 06:00 by

Jun 17, 2026, 01:01 by User Not Found

Clinical Research News | At last month's Bio-IT World Conference & Expo, Douaa Mugahid, PhD, Data Officer at the Hi-IMPAcTB Consortium at the Harvard School of Public Health moderated a panel of academics, investors, and consultants to take on the future of public data and software infrastructure. It is time to safeguard publicly funded data infrastructure, which underpins virtually all of modern biomedical research.

Jun 16, 2026, 08:27 by

Jun 16, 2026, 08:27 by

Novo Nordisk's Wegovy® pill has become the first daily GLP-1 weight-loss tablet approved in the UK, offering adults with obesity and overweight a convenient alternative to weekly injections. The approval was based on the Phase 3 OASIS 4 trial, where patients achieved up to 16.6% average weight loss over 64 weeks. As obesity affects around 15 million people in the UK, the launch of this oral semaglutide treatment is expected to expand access to effective obesity care and strengthen the growing role of GLP-1 drugs in long-term weight management.

Jun 16, 2026, 01:00 by User Not Found

Clinical Research News | For the roughly 1.3 to 2 million women who visit their doctor each year with abnormal postmenopausal bleeding, the diagnostic journey has long been an uncomfortable one. The standard workup typically involves an endometrial biopsy—an invasive, often painful procedure that, despite its widespread use, fails to yield a conclusive diagnosis in more than 30% of cases. Two veteran diagnostics executives think there's a better way, and they're betting nearly $45 million in venture funding on it.

Jun 15, 2026, 08:31 by

Roche has received FDA approval for the VENTANA PTEN (SP218) RxDx Assay, the first companion diagnostic test designed to identify PTEN protein loss in patients with prostate adenocarcinoma. The breakthrough test helps clinicians determine which patients may benefit from AstraZeneca’s targeted therapy TRUQAP (capivasertib), advancing personalized cancer treatment. Supported by results from the CAPItello-281 clinical trial, the approval marks a significant step in precision oncology, offering new hope for patients with aggressive PTEN-deficient metastatic prostate cancer while reinforcing Roche’s leadership in companion diagnostics and personalized healthcare solutions.

Jun 12, 2026, 07:18 by

CEPI has committed $60 million to accelerate Ebola Bundibugyo vaccine development with Moderna and the University of Oxford amid an ongoing outbreak in the Democratic Republic of Congo. The funding will support preclinical and early clinical development, along with manufacturing readiness for potential large-scale trials. Health agencies report 282 confirmed cases and 42 deaths, highlighting urgent containment needs. The initiative strengthens global vaccine R&D efforts focused on faster outbreak response and infectious disease preparedness.

Jun 12, 2026, 07:18 by

WCG announced the appointment of Anthony Doyle as chief financial officer, effective June 15, 2026. Anthony brings more than two decades of financial leadership experience across healthcare, clinical research, and both public and private equity-backed organizations.

Jun 11, 2026, 01:01 by User Not Found

Clinical Research News | A novel urine-based liquid biopsy developed at Stanford University is showing remarkable accuracy in predicting bladder cancer recurrence and may soon reshape how clinical trials enroll and treat patients. The test, developed by urologic oncologist Joseph Liao, M.D., and colleagues, filters out age-related background mutations in urine to produce a cleaner, more reliable signal for detecting residual cancer after surgery and immunotherapy.

Jun 10, 2026, 07:07 by

Jun 10, 2026, 07:07 by

Greg Licholai, MD, Chief Medical Officer at Syneos Health, joins Board of Directors of Paradigm Clinical Research, a clinical research site organization