News

The Phase III INDEPENDENCE trial (NCT04717414) failed to meet its primary endpoint of achieving transfusion independence in patients with myelofibrosis-associated anemia treated with Reblozyl (luspatercept-aamt).

Despite the setback with the Oncologic Drugs Advisory Committee vote, GSK emphasizes the unmet need in multiple myeloma and highlights global momentum behind Blenrep combination approvals.

New data from the VOLITION study reveal that 89% of treatment-naïve individuals with HIV chose to switch to long-acting cabotegravir and rilpivirine after achieving viral suppression with oral DTG/3TC, with real-world evidence further supporting its effectiveness across diverse populations.

In this video interview, Ramita Tandon, chief biopharma officer at Walgreens, outlines her five-year vision for community-based research, calling for deeper industry alignment, infrastructure expansion, and patient-first design principles.

Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how real-world data is helping researchers navigate gastrointestinal side effects, dose flexibility, and long-term tolerability in off-label GLP-1 use.

Results from the Phase III PURPOSE 1 (NCT04994509) and PURPOSE 2 (NCT04925752) trials highlight Yeztugo’s (lenacapavir) safety and efficacy in pregnant women, young adults, and others historically excluded from HIV prevention studies.

In the Phase III CARES trials, anselamimab did not meet the primary endpoint for advanced-stage AL amyloidosis, but a prespecified subgroup analysis revealed meaningful improvements in survival and cardiovascular outcomes.

Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how therapeutic alignment and cross-functional collaboration enable the company to support GLP-1 trials across multiple disease areas.

In this video interview, Ramita Tandon, chief biopharma officer at Walgreens, offers practical insights for sponsors and CROs exploring partnerships with retail research sites, emphasizing collaboration, innovation, and shared accountability.

Results from a Phase Ib trial (NCT03666000) show that azer-cel demonstrated a 75% overall response rate and a 55% complete response in patients with relapsed/refractory diffuse large b-cell lymphoma.

In this video interview, Ramita Tandon, chief biopharma officer at Walgreens, shares how the company is driving more inclusive enrollment by engaging diverse communities, developing culturally competent materials, and meeting patients where they are.

Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how a focused GLP-1 task force and deep market insights are helping sponsors stand out in an increasingly competitive obesity drug landscape

New Phase II data presented at ENDO 2025 highlight avexitide’s potential to significantly reduce severe hypoglycemic events in patients with post-bariatric hypoglycemia, with Phase III results expected in 2026.

A new global report finds that clinical research teams are making progress but still lack the skills and tools needed to keep pace with growing trial complexity and emerging technologies.

Results from a retrospective study found that Amtagvi (lifileucel) achieved a 48.8% objective response rate in patients with advanced melanoma who had previously received immune checkpoint inhibitors.

In this video interview, Ramita Tandon, chief biopharma officer at Walgreens, discusses the operational investments required to activate pharmacies as clinical trial sites, including staff training, regulatory coordination, and patient-facing technology.

In the new EXPrESSIVE clinical trial program, Merck will evaluate MK-8527, a once-monthly, oral PrEP therapy, in populations at high risk of HIV-1 infection, including adolescent girls and women in sub-Saharan Africa.

Results from the Phase III CAHtalyst show that patients treated with Crenessity for classic congenital adrenal hyperplasia achieved and maintained lower, more physiologic glucocorticoid doses while keeping key adrenal biomarkers at or below baseline levels.

In the BaxHTN Phase III study, AstraZeneca’s baxdrostat demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure in patients with uncontrolled or treatment-resistant hypertension.

In this video interview, Ramita Tandon, chief biopharma officer at Walgreens, reflects on the company’s three-year evolution as a clinical trials partner, highlighting its pharmacy-led model and community-driven approach to trial access and participation.

Why a fundamental reimagining of how clinical studies operate is still necessary to achieve a true paradigm shift—and shed the cycle of reliance on incremental gains.

Why a fundamental reimagining of how clinical studies operate is still necessary to achieve a true paradigm shift—and shed the cycle of reliance on incremental gains.

By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often delay drug approvals, including safety concerns, trial design flaws, and manufacturing gaps.

The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.

In this video interview, Heather Horville, solutions consultant at Greenphire, emphasizes the growing need for clinical operations to embed patient-centric services—from consent through final visit—to improve retention and overall trial success.

In the P304 Phase III study, Moderna’s mRNA-1010 demonstrated a 26.6% relative efficacy over a standard-dose flu vaccine in adults aged 50+, showing consistent protection across strains and age groups.

Results from the Phase III EMBARK trial show that in combination with leuprolide, Xtandi (enzalutamide) demonstrated a statistically significant and clinically meaningful overall survival benefit in men with non-metastatic hormone-sensitive prostate cancer and high-risk biochemical recurrence.

Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.