Latest News

FDA has approved Komzifti (ziftomenib) as the first once-daily, oral menin inhibitor for adults with relapsed or refractory NPM1-mutated AML, supported by Phase II KOMET-001 data showing meaningful remission rates, durable responses, and a manageable safety profile in a population with limited treatment options.

Leveraging real-world data and AI-driven insights in clinical trial planning can reduce enrollment failures, improve retention, and prevent costly rescue studies by providing a more accurate view of patient populations and site feasibility.

In today’s ACT Brief, we examine declining site satisfaction and strategies to improve sponsor-site collaboration, review a new partnership enabling automated eSource-to-EDC data transfer, and highlight Gilead’s positive Phase III ARTISTRY-1 trial results in virologically suppressed adults with HIV.

The ARTISTRY-1 Phase III trial demonstrated that a single-tablet regimen of bictegravir 75 mg/lenacapavir 50 mg maintains viral suppression and simplifies therapy for people living with HIV, supporting safer, more convenient treatment options.

A new integration between Advarra and IgniteData will enable secure, automated transfer of clinical trial data from EHRs and eSource systems to sponsor EDCs.

Melissa Hutchens, vice president of research & benchmarking at WCG, and Jimmy Garza, senior director of clinical operations at Bayer, discuss findings from the latest WCG CenterWatch Global Site Relationship Survey, revealing a decline in overall site satisfaction. They explore key drivers behind this trend, including technology usability, communication gaps, and limited site input in protocol design, and share actionable approaches to strengthen sponsor-site partnerships and improve study execution.

As biotechs expand their outsourced clinical operations, adopting a CTMS is becoming essential to ensure CRO oversight, regulatory compliance, and real-time visibility across trials and portfolios.

In Vibrance-2, oral alixorexton significantly improved wakefulness and reduced excessive daytime sleepiness with a favorable safety profile, positioning the OX2R agonist for rapid advancement into Phase III trials.

In today’s ACT Brief, we look at how artificial intelligence is reshaping drug development decisions across pharma, discuss evolving sponsor oversight in site selection and protocol design, and review the FDA’s decision to update menopausal hormone therapy labels for clarity and safety.

In 2025, both big pharma and biotech are redefining decision-making as AI, real-world evidence, and flexible deal structures accelerate drug development, flatten organizational silos, and close the innovation gap across the life sciences ecosystem.

In today’s ACT Brief, we look at how adaptive trial models are reshaping precision medicine, new data showing Wegovy’s impact on liver health, and Eli Lilly’s latest collaborations advancing genetic and RNA-based therapies.

Gain insight into why sponsors are taking a larger role in site selection and CRO oversight using robust data to validate feasibility before launch.

Novel trial designs are reshaping clinical development by improving efficiency, reducing redundancies, and accelerating timelines toward a new era of precision medicine.