1. Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter achieved high effectiveness with optimistic follow-up results

On March 31, 2025, Johnson & Johnson announced 12-month results from the SmartfIRE study. The findings showed that using the Dual Energy THERMOCOOL SMARTTOUCH™SF Catheter was 86.9% effective when patients were treated with high adherence to the recommended ablation parameters. The Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter is an irrigated, contact-force sensing catheter powered by the TRUPULSE™ Generator, and is fully integrated with the CARTO™ 3 System for advanced electro-anatomical mapping and tag indexing. The primary endpoints were met at 3 months. At 12-month follow-up, 71.5% of patients were free from the recurrence with stringent monitoring. There was also a 40.8% relative reduction in CV-related hospitalizations compared to the baseline and a 60.4% relative reduction in Class I/III antiarrhythmic drug use (AAD) compared to the baseline.

Link: https://www.jnj.com/media-center/press-releases/johnson-johnson-medtech-presents-pivotal-12-month-effectiveness-and-safety-data-from-smartfire-study-at-2025-ehra-congress

2. TREMFYA® reduced symptoms and joint damage in psoriatic arthritis patients in a Phase 3b study

On April 5, 2025, Johnson & Johnson announced the TREMFYA® (guselkumab) Phase 3b APEX study in adults living with active psoriatic arthritis (PsA). The primary endpoint of reducing signs and symptoms and its major secondary endpoint of reducing the progression of structural damage as measured by radiographic progression at 24 weeks were both achieved. TREMFYA® is approved to treat PsA by blocking IL-23 while also binding to CD64, a receptor that produces IL-23.

Link: https://www.jnj.com/media-center/press-releases/tremfya-guselkumab-is-the-first-and-only-il-23-inhibitor-to-significantly-reduce-both-the-signs-and-symptoms-and-the-progression-of-structural-damage-in-adults-living-with-active-psoriatic-arthritis

3. AZD0780 cut LDL-C by over 50% in a Phase IIb trial, with 84% of patients reaching guideline targets

On March 31, 2025, AstraZeneca announced positive results from the PURSUIT Phase IIb trial for AZD0780 which aids in reducing low-density lipoprotein cholesterol (LDL-C). The study demonstrated a significant LDL-C reduction on top of standard-of-care statin therapy, as compared to placebo. High LDL-C is usually a key risk factor for atherosclerotic cardiovascular disease, including stroke and heart attack. AZD0780 is a PCSK9 inhibitor, reducing LDL-C levels by inhibiting the lysosomal trafficking of PCSK9-LDLR complexes and preventing PCSK9-induced LDLR degradation. Therefore, an increasing number of LDL receptors are available to clear LDL cholesterol from the blood. 

At 12 weeks, once-daily AZD0780 led to a 50.7% reduction in LDL-C. Moreover, 84% of trial participants met their American Heart Association/American College of Cardiology guideline-recommended LDL-C target (<70 mg/dL), compared to 13% with the placebo on top of background therapy.

Link: https://www.astrazeneca.com/media-centre/press-releases/2025/azd0780-a-novel-oral-pcsk9-inhibitor-demonstrated-significant-ldl-cholesterol-ldl-c-reduction-in-pursuit-phase-iib-trial.html

4. Termination of Anti-TIGIT antibody trial due to unpromising results

On Apr 03, 2025, BeiGene announced the discontinuation of its clinical development program for ociperlimab (BGB-A1217), an anti-TIGIT antibody, as a potential treatment for lung cancer. The termination was recommended by the Independent Data Monitoring Committee based on the findings from an ongoing Phase 3 AdvanTIG-302 trial. The overall efficacy and safety data assessment suggested that the study was unlikely to meet the primary endpoint of overall survival. Currently, anti-TIGIT therapies have faced setbacks in clinical trials for cancer treatment including Roche's tiragolumab and Merck's vibostolimab.

Link: https://ir.beigene.com/news/beigene-provides-update-on-the-ociperlimab-bgb-a1217-clinical-development-program/4f7a71c1-cb84-4fa6-b562-65c239f04bc6/

5. Updates on EU approval

Company

Drug

Target

Indication

Supported data

Pfizer

RSV Vaccine ABRYSVO®

Expanded approval in prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age

Phase 3 MONeT clinical trial;

RSV A and RSV B NTs 1 month after RSVpreF vaccination in adults 18-59 years of age at high risk were non-inferior to adults ≥ 60 years of age 

AstraZeneca and Daiichi Sankyo

Enhertu (trastuzumab deruxtecan) 

HER2-directed ADC

Adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment

DESTINY-Breast06 Phase III trial;

Enhertu showed a 38% reduction in the risk of disease progression or death versus chemotherapy in patients with chemotherapy-naïve HR-positive, HER2-low metastatic breast cancer with a median progression-free survival (PFS) of 13.2 months versus 8.1 months.

AstraZeneca

Imfinzi (durvalumab) in combination with chemotherapy 

Anti-PD-L1

Adults with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence and no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. In this regimen, patients are treated with Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery.

AEGEAN trial;

A statistically significant and clinically meaningful 32% reduction in the risk of recurrence, progression events or death versus neoadjuvant chemotherapy alone in patients treated with the Imfinzi-based perioperative regimen;

Link: 

https://www.pfizer.com/news/press-release/press-release-detail/european-commission-approves-pfizers-rsv-vaccine-abrysvor

https://www.astrazeneca.com/media-centre/press-releases/2025/enhertu-approved-in-eu-in-post-et-breast-cancer.html

https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-approved-in-eu-for-aegean.html

6. Updates on the U.S. FDA decisions

Company

Regulatory decisions

Drug

Target

Indication

Supported data

Novartis

Accelerated approval

Vanrafia® (atrasentan)

Endothelin A (ETA) receptor antagonist

Reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression

Phase III ALIGN study;

Patients receiving Vanrafia in combination with a RAS inhibitor achieved clinically meaningful and statistically significant proteinuria reduction of 36.1% compared to placebo

Astra Zeneca

Approval

Imfinzi (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapy after radical cystectomy

Anti-PD-L1

Adult patients with muscle-invasive bladder cancer

NIAGARA Phase III trial;

Imfinzi-based perioperative regimen demonstrated a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus the comparator arm;

Estimated 67.8% of patients treated with the regimen were event free at two years compared to 59.8% in the comparator arm.

Amgen

Approval

UPLIZNA

Anti-CD19

Adult patients with Immunoglobulin G4-related disease

MITIGATE trial;

This trial demonstrated the potential of UPLIZNA to decrease disease activity by reducing 87% in the risk of IgG4-RD flare compared to placebo during the 52-week placebo-controlled period

Biogen

Fast Track designation

BIIB080

Antisense oligonucleotide (ASO) therapy targeting tau

Alzheimer’s disease

Phase 1b CELIA study;

Dose-dependent reductions in soluble tau protein in cerebrospinal fluid (CSF), decreases in aggregated tau pathology in the brain as measured by positron emission tomography (PET), and favorable trends in exploratory clinical outcomes

Sanofi

Orphan drug designation

Rilzabrutinib

Bruton’s tyrosine kinase (BTK) inhibitor

Warm autoimmune hemolytic anemia (wAIHA) and IgG4-related disease (IgG4-RD)

/


Link:

https://www.novartis.com/news/media-releases/novartis-receives-fda-accelerated-approval-vanrafia-atrasentan-first-and-only-selective-endothelin-receptor-antagonist-proteinuria-reduction-primary-iga-nephropathy-igan

https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-approved-in-the-us-for-bladder-cancer.html

https://www.amgen.com/newsroom/press-releases/2025/04/uplizna-inebilizumabcdon-is-now-the-first-and-only-fdaapproved-treatment-for-igg4related-disease

https://investors.biogen.com/news-releases/news-release-details/biogens-investigational-tau-targeting-therapy-biib080-receives

https://www.sanofi.com/en/media-room/press-releases/2025/2025-04-03-05-00-00-3054815