Therapeutic Areas

A planned analysis of the KEYNOTE-942/mRNA-4157-P201 clinical trial found that at a median follow-up of approximately three years, adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Keytruda continued to show a clinically meaningful improvement in recurrence-free survival in patients with resected high-risk melanoma.

PrEPVacc halts study of experimental HIV vaccine regimens and a new form of oral pre-exposure prophylaxis.

DREAMM-7 was a Phase 3, multicenter, open-label, randomized trial analyzing the efficacy and safety of Blenrep plus bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma previously administered at least one prior line of treatment.

Education and equitable access are key to unlocking its full potential in the present and future.

Rexulti was found to be a well-tolerated treatment for the debilitating symptoms of agitation associated with dementia due to Alzheimer’s disease.

Studies with Zenith-CKD showed significant albuminuria reduction.

BI 690517 is a novel, potent, highly selective aldosterone synthase inhibitor that reduces the progression of kidney damage and lowers the risk of cardiovascular events in patients with chronic kidney disease.

The approval of pembrolizumab (Keytruda; Merck) combined with gemcitabine and cisplatin for the treatment locally advanced unresectable or metastatic biliary tract cancer is the sixth sixth indication for the anti-PD-1 therapy for gastrointestinal cancers.

Bingham discusses the logistical challenges associated with coordinating patient involvement in rare disease clinical trials.

Exploring the implications of FDA’s renewed focus and commitment to expand the use of accelerated approval for gene therapy products.

New protocols, remote patient monitoring, and improved standards of care among ways industry can take next steps in CAR T-cell research.

Webinar Date/Time: Wed, Sep 20, 2023 10:00 AM EDT

Clinical trials in this area reflect new science, and corresponding challenges in their execution.

Webinar Date/Time: Thursday, September 7th, 2023 at 10am EDT | 7am PDT | 3pm BST | 4pm CEST

In this Q&A, David Esposito, CEO of ONL Therapeutics provides a glimpse into the company's mission, challenges, and strategies associated with clinical trials.

In support of the recent ARPA-H NITRO OA Cure Moonshot, the online resources identifies major OA treatment trials and allows patients to sign up.

In this Q&A, Craig Serra, head of commercial solutions and partnerships within the clinical research business unit at Flatiron Health (affiliate of the Roche Group), shares his perspective on clinical research, the role of data, and Flatiron Health’s efforts to that end.

In an interview with Applied Clinical Trials' sister publication, Pharmaceutical Executive, Elizabeth (Beth) Garner, chief scientific officer for Ferring Pharmaceuticals, discusses what it was like transitioning from working as a gynecologic oncologist and seeing patients to working in pharma, specifically clinical trials.

Jeff Liter, CEO of Luminary Therapeutics discusses the company's unique approach in the fast-evolving landscape of cancer treatment.

First guidance in this area from the Agency addresses the unique challenges when designing clinical studies for these drugs

Nathalie Dubois-Stringfellow, Sangamo’s chief development officer discusses the company's diverse clinical programs, strategic collaborations, including a partnership with Pfizer, and the crucial role of patient safety.

Recent study results highlight need for new metrics in ECOG scoring to mitigate variability.

In this Q&A, John Kastelein, MD, founder and chief scientific officer, NewAmsterdam Pharma, discusses the challenges and opportunities within the cardiovascular field, exploring the current landscape for lipid-lowering therapies and the unique potential advantages of CETP inhibitors.

Examining the two areas of weakness cited in FDA draft guidance.

Stakeholders must alter their mindsets when it comes to early-phase design and interpreting regulatory guidance for CGT trials.

Increased data output from the use of devices can accelerate trials for this therapeutic area in need of new therapies.

Webinar Date/Time: Thursday, May 25th, 2023 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

January 2023 guidance from FDA on dosages in oncology provides further context on expectations with Project Optimus.

Tiffany Chow, MD, a specialist in behavioral neurology and senior medical director at Alector, discusses the unique challenges of designing clinical trials for frontotemporal dementia.

Leal Health Poster Highlights Negative Impact of Patient ECOG Scores on Clinical Trial Enrollment Eligibility at 2023 ASCO GU Cancers Symposium.