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The FDA has cleared subcutaneous mosunetuzumab for adults with relapsed or refractory follicular lymphoma after two or more prior therapies, supported by Phase I/II data showing durable responses and a manageable safety profile with markedly reduced administration time.

Learn how AI-enabled automation can streamline existing operational processes, reduce manual effort, and enhance efficiency while allowing sites to work as they do today.

In today’s ACT Brief, we examine why fragmented data systems continue to slow life sciences research, review how sponsor sourcing decisions may affect site experience and study execution, and report on topline Phase III results for Eli Lilly’s oral GLP-1 therapy orforglipron.

Only with recent advances in cloud computing, data standards, and interoperable platforms has it become feasible to realize the full potential of a digital thread.

Analyze how functional sourcing, application strategy, and consistency across sponsors and CROs directly influence site workflows, execution efficiency, and long-term collaboration.

In today’s ACT Brief, we examine how sponsors are reassessing new engagement technologies to avoid increasing site burden, review new research on integrating unstructured health data to scale eSource-enabled trials, and cover Novo Nordisk’s NDA submission for its fixed-dose amylin–GLP-1 obesity therapy, CagriSema.

New research finds that while eSource adoption is advancing through EHR-to-EDC workflows, scaling its impact will depend on integrating unstructured clinical data using AI, shared standards, and collaborative validation models across sites, sponsors, and vendors.

Explore why new tools should aim to remain burden-neutral before delivering efficiency gains, and how sponsors can introduce systems that benefit sites without disrupting daily trial management.

In today’s ACT Brief, we look at emerging operational changes aimed at reducing site burden, review the FDA approval of GSK’s twice-yearly biologic for severe asthma, and examine a national priority voucher granted for a new multiple myeloma treatment combination.

Examine how evolving sourcing strategies, functional standardization, and system choices can help sponsors support sites more effectively while minimizing operational switching and complexity.

In today’s ACT Brief, we examine new survey data revealing what patients value most in remote clinical trials, break down Sanofi’s latest partnerships aimed at advancing Alzheimer’s and autoimmune therapies, and look at how AI-powered digital pathology is being integrated into oncology research through a new biopharma collaboration.

New survey data show a strong patient preference for fully remote clinical trials, underscoring how convenience, intuitive technology, and FDA-cleared digital tools are reshaping enrollment and retention strategies as decentralized models become a lasting fixture in clinical research.

In today’s ACT Brief, we close out our McKinsey interview series with a look at how AI could transform clinical trials end to end, review new Phase III data supporting Gilead’s investigational HIV regimen, and examine an FDA approval that reshapes first-line treatment for HER2-positive metastatic breast cancer.