Don Tracy, Associate Editor

The full approval of Spikevax covers children aged six months through 11 years who are at increased risk for severe COVID-19, transitioning the vaccine from emergency use to full licensure.

Approval was based on results from the DOORwaY90 trial, which demonstrated a 98.5% overall response rate and 100% local tumor control in patients treated with the SIR-Spheres Y-90 resin microspheres for unresectable hepatocellular carcinoma.

The supplemental New Drug Application is supported by Phase III data, which showed Caplyta significantly prolonged time to relapse compared to placebo and reduced the risk of relapse by 63% in patients with schizophrenia.

Ekterly becomes the first FDA-approved oral on-demand treatment for hereditary angioedema in patients aged 12 years and older.

Biljana Naumovic, US President, oncology, solid tumor, Johnson & Johnson Innovative Medicine, outlines how the company is working to ease care transitions, support community oncologists, and reduce overwhelm in cancer treatment delivery.

Biljana Naumovic, US President, oncology, solid tumor, Johnson & Johnson Innovative Medicine, shares how the company is supporting cancer care teams through timely education, community-based trials, and tools to manage complex treatment transitions.

The Phase II THULITE trial will analyze the safety and efficacy of BI 1815368, an investigational oral therapy designed to reduce fluid leakage in the retina and ease the treatment burden for patients with diabetic macular edema.

Accelerated approval was based on results from the Phase I/II LINKER-MM1 trial, which showed a 70% objective response rate in patients with relapsed or refractory multiple myeloma treated with Lynozyfic.

Results from the Phase III ZENITH trial show that patients treated with Winrevair (sotatercept-csrk) for pulmonary arterial hypertension experienced a 76% reduction in the composite risk of death, lung transplant, and ≥24-hour hospitalization.

The new platform integrates PCR-based diagnostic data with statistical modeling and AI to provide real-time visibility into infectious disease trends at local and global levels.

Updated label allows Neuraceq to be used in selecting patients for amyloid-targeting therapies and includes the use of quantitative PET imaging metrics to support diagnosis and monitor disease progression in Alzheimer’s care.

Biljana Naumovic, US President, oncology, solid tumor, Johnson & Johnson Innovative Medicine, discusses the importance of collaboration across the healthcare community to develop inclusive and effective AI solutions that enhance decision-making and patient outcomes in oncology.

Results from the Phase III VEGA-3 trial show that a significantly higher number of patients with presbyopia who received MR-141 achieved a ≥3-line gain in binocular near visual acuity without compromising distance vision compared to placebo.

The transaction, finalized following regulatory clearance, includes two FDA-approved rare tumor therapies: Ogsiveo for desmoid tumors and Gomekli for symptomatic plexiform neurofibromas.

Results from the Phase III Vivacity-MG3 trial show that Imaavy provides more consistent disease control than other approved FcRn blockers in adults with generalized myasthenia gravis.

Biljana Naumovic, US President, oncology, solid tumor, Johnson & Johnson Innovative Medicine discusses key takeaways from the Oncology Care Index and how they are shaping the company’s approach to clinical research, community partnerships, and continuity of care.

The supplemental premarket approval application is supported by Phase III data, which showed significant improvements in neck appearance in patients treated with Skinvive.

Gamifant marks the first-ever FDA-approved treatment for both adult and pediatric patients with hemophagocytic lymphohistiocytosis macrophage activation syndrome in the context of known or suspected Still's disease.

Under terms of the deal, AbbVie will acquire Capstan’s lead asset, CPTX2309—an in vivo anti-CD19 CAR T-cell therapy in Phase I development for B cell-mediated autoimmune diseases.

A monthly roundup of business and people news in the pharmaceutical industry.

The recommendation for Enflonsia is indicated for respiratory syncytial virus prevention in infants under eight months of age, expanding protection options ahead of the 2025–2026 season.

Pedro Valencia, VP, asset strategy, leadership, oncology, AbbVie, outlines how the company is accelerating development across lung, gastrointestinal, and ovarian cancers following ASCO 2025, with a focus on advancing antibody drug conjugates and expanding late-stage studies.

Label changes remove Risk Evaluation and Mitigation Strategy programs and eases monitoring requirements, supporting broader access to Bristol Myers Squibb’s CAR T-cell therapies Breyanzi and Abecma for patients with large B cell lymphoma and multiple myeloma.

Biljana Naumovic, US President, oncology, solid tumor, Johnson & Johnson Innovative Medicine explains how insights from the Oncology Care Index are helping address oncologists’ challenges with keeping up amid a surge in cancer treatment breakthroughs.

Results from the Phase IIIb FRONTIER5 trial demonstrated that Mim8 prophylaxis was well-tolerated when administered without a washout period or loading dose in patients with hemophilia A.

Pedro Valencia, VP, asset strategy leadership, oncology, AbbVie, explains how the company partners with patient advocacy groups to identify unmet needs and prioritize patient-centered benefits in the development of innovative cancer therapies.

Results from the Phase III BASIS trial show that once-weekly subcutaneous Hympavzi reduced annualized bleeding rates by 93% compared to on-demand treatment with bypassing agents in patients with hemophilia A or B.

The label update for Amyvid adds guidance for assessing amyloid plaque levels and may help inform diagnostic and treatment decisions in patients being evaluated for Alzheimer disease.

Pedro Valencia, VP, asset strategy leadership, oncology, AbbVie, discusses how early data from ABBV-706 shows up to 50% response rates in rare neuroendocrine tumors, offering a potential advance over traditional chemotherapy.

Under the renewed deal, Bayer and Tsinghua University will work to enhance the drug discovery and development process across key therapeutic areas, with Bayer continuing to provide funding and scientific support.