Applied Clinical Trials Editorial Staff

Aardvark released exploratory data from its stopped Phase 3 HERO trial in Prader-Willi syndrome after FDA lifted the hold, and plans a redesigned Phase 3.

Syneos Health and Optum outline a joint model for trial planning, recruitment and site access, with no financial terms or timelines disclosed.

What sponsors and sites should know about the AstraZeneca-Oracle AI collaboration on trial recruitment, safety monitoring and data governance.

A global phase 3 study found that Moderna’s investigational mRNA-1010 influenza vaccine reduced RT-PCR–confirmed influenza-like illness more effectively than standard-dose vaccines in adults aged 50 years and older.

LUCENT-3 trial open-label extension data show 63.5% of adults with ulcerative colitis administered mirikizumab (Omvoh) who achieved disease clearance at one year maintained composite disease clearance through four years of treatment.

Guselkumab (Tremfya) showed higher 24-week fistula remission than placebo in adults with perianal fistulizing Crohn disease.

Early implementation of real-time clinical trial data sharing aims to reduce delays in safety signal detection and regulatory decision-making, with pilot program development underway.

Elranatamab-bcmm (Elrexfio) improved progression-free survival in a Phase 3 trial of relapsed or refractory multiple myeloma after at least 1 prior therapy.

FDA gives granted accelerated approval to lunsotogene parvec (Otarmeni) for OTOF-related sensorineural hearing loss based on early CHORD trial results in children.

Oral semaglutide lowered HbA1c vs placebo in a phase 3 trial in adolescents with type 2 diabetes, pending full data and review.

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.

Mick Ryan, vice president of IT at ICON plc, discusses the growing use of artificial intelligence in clinical research—from technology and data analysis to patient privacy and ethics.

Q&A with Joachim Lövin explores the challenges and lessons learned in boosting the flexibility of conducting decentralized clinical trials post-COVID.

Efineptakin alfa, the only clinical stage long-acting human interleukin-7, is currently being evaluated in Phase I/II clinical trials in combination with pembrolizumab (Keytruda) for patients with advanced solid tumors, including pancreatic cancer.

The manufacturing process for CAR T-cell therapies is vital in preparing a patient’s cells for a one-time cell therapy infusion that is specifically tailored to meet each patient’s needs.

Darzalex Faspro with bortezomib, lenalidomide, and dexamethasone for induction and consolidation therapy and in combination with maintenance lenalidomide found to improve survival in patients with multiple myeloma who are eligible for autologous stem cell transplant.

The Padcev/Keytruda combination produced statistically significant and clinically meaningful improvements to survival compared to platinum-containing chemotherapy in first-line treatment of adults with previously untreated locally advanced or metastatic urothelial cancer.

Phase II TRANSCEND FL and Phase I TRANSCEND NHL 001 trial data lead to FDA Priority Review designation for Breyanzi to treat relapsed or refractory follicular lymphoma and mantle cell lymphoma.

Intravenous immunoglobulin Gammagard Liquid approved by the FDA to treat neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy.

Monthly, higher doses of novel therapy SRP-5051 (vesleteplirsen) found to produce substantially greater increases in dystrophin and exon skipping compared to the lower weekly dose.

Trial shows Keytruda improved overall survival by 38% compared with placebo in in patients with renal cell carcinoma at intermediate-high or high risk of recurrence after nephrectomy or nephrectomy and resection of metastatic lesions.

The Priority Revew designation was based on findings from the ongoing, global, multicenter, multi-cohort, open-label Phase II DESTINY-PanTumor02 trial of of Enhertu for patients with previously treated HER2-expressing tumors, including biliary tract cancer, bladder cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and other tumor types.

Approval based on findings from the Phase III EoE KIDS trial, in which 66% of patients administered a higher dose of Dupixent based on weight achieved histological disease remission.

Zynrelef was the first dual-acting local anesthetic approved by the FDA with a fixed-dose combination of bupivacaine and meloxicam.

Theratechnologies said it will address the concerns raised in the FDA’s complete response letter and will continue to seek approval for the new formulation of tesamorelin for the treatment of lipodystrophy in patients with HIV.

The FDA made the decision to require boxed warnings on CAR T-cell therapies based on reports of T-cell malignancies in patients administered BCMA- or CD19-directed autologous CAR T-cell immunotherapies.

FDA accepts biologics license application from Autolus Therapeutics for obecabtagene autoleucel to treat adults with relapsed or refractory B-cell acute lymphoblastic leukemia.

Mirati’s oncology portfolio includes promising early phase clinical assets such as a potential first-in-class MTA-cooperative PRMT5 inhibitor and a leading KRAS and KRAS enabling program with a pair of candidates in Phase I development.

Osteoboost was previously granted FDA Breakthrough Device Designation to treat diminished bone health in postmenopausal women with osteopenia.

In clinical trials, Cimerli met FDA standards for biosimilarity to the reference Lucentis, including safety, efficacy, and quality.