Don Tracy, Associate Editor

A global survey of scientists and informaticians reveals growing AI investment across the biopharma value chain, but highlights gaps in data integration, standardization, and infrastructure that threaten to stall progress.

Neha Anand, Analyst, Biopharma Intelligence Services, Citeline, explains how the approval of Emrelis is accelerating investor interest, validating biomarker-driven ADCs, and shaping distinct strategic paths for pharma and biotech in the evolving precision oncology landscape.

Neha Anand, Analyst, Biopharma Intelligence Services, Citeline, highlights Emrelis’ potential to broaden its clinical impact by expanding into other solid tumors with high c-MET overexpression, beyond its current focus on non-small cell lung cancer.

Biotech veteran and Stanford physician-scientist brings 30 years of translational research and regulatory experience to strengthen FDA’s drug review and innovation efforts.

Neha Anand, Analyst, Biopharma Intelligence Services, Citeline, explains how the approval of Emrelis marks a pivotal moment for ADC therapies in oncology, reflecting the FDA’s growing confidence in their safety and efficacy and accelerating the shift toward precision medicine in cancer treatment.

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.

The MC4R agonist targets rare genetic and hypothalamic obesity, with potential as a combination or maintenance therapy for general obesity alongside GLP-1 agents.

The submission is supported by four Phase III clinical trials, which showed that icotrokinra demonstrated significant skin clearance in patients with moderate to severe plaque psoriasis.

Neha Anand, Analyst, Biopharma Intelligence Services, Citeline, discusses how Emrelis fits into the current antibody-drug conjugate landscape and what distinguishes its approach in biomarker-driven oncology.

Corina Dutcus, SVP, oncology global clinical development lead at Eisai, discusses the potential of the E7386 and lenvatinib combination to address unmet needs in second-line treatment for endometrial carcinoma patients.

The newly approved prefilled syringe version of Shingrix is expected to simplify administration and supports efforts to increase adult vaccination against shingles (herpes zoster).

Priority review was based on results from the Phase IIb SunRISe-1 trial, which showed that patients treated with TAR-200 for high-risk non-muscle invasive bladder cancer showed a complete response rate of 82.4%.

Research from a recent Cadent study reveals the growing impact of TV and connected TV advertising in raising medication awareness across diverse demographic groups, highlighting shifting dynamics in how patients discover treatment options.

Corina Dutcus, SVP, oncology global clinical development lead, Eisai, explains how E7386 and lenvatinib work together to target advanced endometrial carcinoma through dual mechanisms of action and WNT pathway modulation.

Corina Dutcus, SVP, oncology global clinical development lead, Eisai, highlights how long-term LEAP-002 data provides critical reassurance around Lenvima’s durability and safety in treating unresectable hepatocellular carcinoma.

Preclinical study shows oral PL7737 agonist outperforms tirzepatide alone in rodent models, supporting Palatin’s plans for clinical trials targeting both general and rare forms of obesity.

Corina Dutcus, SVP, oncology global clinical development lead, Eisai, highlights how consistent survival data from the LEAP-002 study reaffirms lenvatinib’s value in first-line treatment of unresectable hepatocellular carcinoma.

Approval of Kerendia was based on results from the Phase III FINEARTS-HF trial, which demonstrated statistically significant and clinically meaningful reductions in cardiovascular events across a broad range of patients with heart failure.

The new drug application is supported by 48-week data from the Phase III MK-8591A-051 and MK-8591A-052 trials, which showed that the doravirine/islatravir combination was non-inferior to both baseline antiretroviral therapy and to bictegravir/emtricitabine/tenofovir alafenamide in treating HIV.

Gala will succeed Bruce Cozadd, effective August 11, 2025.

Approval was based on results from the Phase IIIb TRAILBLAZER-ALZ 6 trial, which showed that Kisunla achieved comparable efficacy in amyloid plaque and P-tau217 reduction while lowering the risk of amyloid-related imaging abnormalities with edema or effusion in patients with early Alzheimer disease.

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.