R&D/Clinical Trials

In the Phase III ICONIC-LEAD trial, 75% of adolescents with moderate-to-severe plaque psoriasis treated with icotrokinra achieved completely clear skin by week 24.

Enrollment for the Phase II trial follows FDA clearance of SPG302 Investigational New Drug application for schizophrenia.

Results from the Phase III ZENITH trial show that Winrevair lowered the risk of all-cause death, lung transplantation, and pulmonary arterial hypertension-related hospitalization by 76%.

BIIB080 marks the first antisense oligonucleotide targeting tau to enter clinical development for the treatment of Alzheimer disease.

In the SOUL trial, Rybelsus produced a 14% risk reduction of major adverse cardiovascular events in patients with type 2 diabetes and cardiovascular disease and/or chronic kidney disease.

The trial size adjustment, along with protocol modifications and the addition of higher-enrollment sites, is expected to facilitate completion of the NEPHRO CRRT study of Niyad in patients undergoing renal replacement therapy by the end of 2025.

Results from the COCOON study showed that Rybrevant plus Lacluze reduced grade 2 or higher dermatologic events by 50% compared to standard care in patients with epidermal growth factor receptor-mutated non-small cell lung cancer.

Results from multiple clinical trials showed that Tagrisso demonstrated survival benefits in EGFR-mutated non-small cell lung cancer, both as monotherapy and in combination therapies.

Research also showed that the test has a very low false positive rate.

The investment, which is a 25% increase from previous years, will support three new advanced manufacturing facilities, expansions at existing sites, and R&D efforts.

Results from the STEER and STRENGTH studies showed that OAV101 IT led to a 2.39-point improvement in motor function in patients with spinal muscular atrophy.

In the Phase III STOP-HS1 and STOP-HS2 trials, results show that patients treated with povorcitinib for hidradenitis suppurativa experienced a ≥50% reduction in the total abscess and inflammatory nodule count.

Company executives provide updates on cancer treatment pelareorep and other elements of the company’s pipeline.

In the Phase III CALYPSO trial, eneboparatide demonstrated statistical significance in achieving albumin-adjusted serum calcium normalization while eliminating the need for active vitamin D and oral calcium therapy in chronic hypoparathyroidism.

Data from the Phase III MINT trial found that Uplizna demonstrated a greater reduction in Myasthenia Gravis Activities of Daily Living score compared to placebo at week 26.

New real-world and implementation study data highlight the efficacy of ViiV’s long-acting injectables for HIV prevention and treatment, with Apretude showing zero HIV acquisitions and Cabenuva maintaining high viral suppression rates.

Immunotherapy pioneer Mark Frohlich, MD, CEO of Indapta Therapeutics, discusses the promise of harnessing natural killer cells to reshape treatment for cancer and autoimmune disease.

Topline results from the Phase III VERITAC-2 trial found that vepdegestrant provided a statistically significant and clinically meaningful improvement in progression-free survival in patients with ER+/HER2- advanced or metastatic breast cancer.

Results from multiple Phase III trials of Icotrokinra in moderate-to-severe plaque psoriasis and a Phase IIb trial in ulcerative colitis successfully met all primary endpoints.

What biopharma companies need to know about this evolving regulatory pathway.

Artiva Biotherapeutics' CEO Fred Aslan, MD, discusses the concept of an immune reset and what the company is tracking in trials to assess its potential.

Jonathon Whitton, AuD, PhD, VP, auditory global program head, Regeneron, discusses how key regulatory designations, such as the FDA's Regenerative Medicine Advanced Therapy designation, facilitate accelerated development and commercialization of DB-OTO through increased collaboration with regulators.

Artiva Biotherapeutics' CEO Fred Aslan, MD, discusses two ongoing trials for autoimmunity indications in the US and how AlloNK differs from traditional B-cell depletion strategies.

Five-year data from Phase III trials demonstrated that 67.7% of patients moderate-to-severe plaque psoriasis treated with UCB’s Bimzelx achieved complete skin clearance.

Clinical trial results found that a majority of patients with atopic dermatitis who were treated with Ebgylss achieved complete or near complete skin clearance at three years on a single monthly maintenance dose.

Jonathon Whitton, AuD, PhD, VP, auditory global program head, Regeneron, discusses the promising results of DB-OTO in the CHORD trial for children with otoferlin-related hearing loss.

The recent shift in Health Economics and Outcomes Research functions across major pharmaceutical companies highlights a lack of understanding of its value.

Dr. Hernan Bazan, CEO of South Rampart Pharma, discusses his company’s current pipeline.

Aliya Omer, VP, US franchise head, breast cancer, AstraZeneca, discusses how results of the trial compare with other treatments for gBRCAm HER2-negative high-risk early breast cancer.

Under terms of the deal, Gubra will receive an initial $350 million payment and could earn up to $1.875 billion more in development and sales milestones for the potential weight loss drug.