News

In this video interview, Michael Miller, chief operating officer at Quanterix, discusses how biopharma companies—especially smaller biotechs—can leverage platform trials and biomarker-driven accelerated approvals to remain efficient and competitive amid shifting public-private funding dynamics.

Results from the long-term extension of the Phase III TRAILBLAZER-ALZ 2 trial (NCT04437511) showed sustained benefits with early Kisunla treatment, including reduced risk of disease progression and high rates of amyloid clearance in early Alzheimer disease.

In the ongoing Phase II CRDF-004 trial, onvansertib plus standard-of-care showed a 49% confirmed ORR and early PFS benefit in first-line RAS-mutated metastatic colorectal cancer, with a favorable safety profile and dose-dependent efficacy across endpoints.

In this pilot episode of the Applied Clinical Trials Brief, we examine the renewed push for placebo-controlled vaccine trials in the US, why experts warn it violates core ethical standards, and how these proposals could jeopardize both participant safety and future innovation.

In this video interview, Michael Miller, chief operating officer at Quanterix, outlines key technical and regulatory considerations for clinical operations professionals integrating biomarkers into studies, stressing the importance of clarity on biomarker purpose and working with qualified assay partners.

VYNE Therapeutics will terminate its Phase IIb trial of topical Repibresib gel in nonsegmental vitiligo after failing to meet F-VASI50 and F-VASI75 endpoints at week 24, despite nominally significant improvements in other secondary and exploratory measures.

Results from the Phase III Clarity AD open-label extension trial (NCT03887455) suggest weekly subcutaneous maintenance dosing with Leqembi may offer a more convenient and well-tolerated alternative for patients continuing long-term treatment.

In Study 2 of the Phase III UP-AA trial, upadacitinib 15 mg and 30 mg met primary and secondary endpoints for scalp hair regrowth in patients with severe alopecia areata.

In this video interview, Michael Miller, chief operating officer at Quanterix, highlights neurology and oncology as two therapeutic areas experiencing major advances from biomarker integration, from blood-based diagnostics in Alzheimer’s to multiomic strategies in cancer research.

Results from the Phase III BRUIN CLL-314 trial (NCT05254743) showed that Jaypirca (pirtobrutinib) achieved superiority in overall response rates compared to Imbruvica (ibrutinib) in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

The submission is supported by Phase IIIb APEX trial results showing Tremfya reduced symptoms and inhibited structural progression in biologic-naïve patients with active psoriatic arthritis.

In this video interview, Michael Miller, chief operating officer at Quanterix, discusses how the use of biomarkers is expanding beyond exploratory endpoints to inform efficacy and patient selection, driving improved outcomes and greater efficiency in clinical research.

Sun Pharma’s INSPIRE-1 and INSPIRE-2 studies met their primary endpoint at Week 24, with Ilumya 100 mg demonstrating superior efficacy over placebo in treating active psoriatic arthritis.

Results from the Phase III VIKTORIA-1 trial (NCT05501886) demonstrated that gedatolisib administered with fulvestrant, with or without Ibrance (palbociclib), showed statistically significant and clinically meaningful improvements in progression-free survival in patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer.

New statistical frameworks such as net treatment benefit offer a multidimensional approach to evaluating efficacy, safety, and patient-centered outcomes in oncology trials.

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, advises clinical research organizations to assess their portfolios, diversify funding sources, and strengthen industry-academic partnerships to maintain compliance and continuity amid shifting federal priorities.

Results from the Phase III PREVAIL trial (NCT05556096) of gefurulimab demonstrated a statistically significant and clinically meaningful improvement in Myasthenia Gravis Activities of Daily Living at 26 weeks compared to placebo.

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, advises clinical research teams to closely scrutinize federal fund certifications and document good-faith compliance efforts, even when policies stem from nonbinding executive orders.

Results from the Phase III ABTECT-1 (NCT05507203) and ABTECT-2 (NCT05507216) trials showed that Abivax’s obefazimod demonstrated significant clinical remission in patients with ulcerative colitis.

Astegolimab met its primary endpoint in the Phase IIb ALIENTO trial with a 15.4% reduction in annualized exacerbation rate at 52 weeks, while the Phase III ARNASA study showed a 14.5% reduction and did not meet the primary endpoint.

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, explains how clinical research teams can accurately report on diversity-related grant work while minimizing exposure to False Claims Act scrutiny, by focusing on precise language and framing.

Despite ambitions to streamline regulatory review, FDA’s Elsa platform has been prone to hallucinations, prompting internal scrutiny and questions about AI reliability and governance.

A new myTomorrows survey of physicians in the United States highlights the need for smarter, AI-driven tools to overcome inefficiencies in clinical trial access and improve patient care timelines.

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, outlines how even unenforced executive orders can influence federal funding decisions, prompting sponsors and sites to alter public trial messaging to avoid informal scrutiny.

New long-term data from the Phase III FLAURA2 trial confirm that Tagrisso combined with chemotherapy delivers a significant overall survival benefit over monotherapy in patients with advanced EGFR-mutated non-small cell lung cancer.

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, explains how recent executive orders are creating uncertainty around compliance for clinical research teams receiving federal funding, and why staying alert to agency interpretation is key.

The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (NCT03767348) trial in advanced melanoma was not an adequate, well-controlled study and that its heterogeneous patient population limited interpretability, preventing approval in its current form.