ADVERTISEMENT

Oncology

Equillium Seeks Accelerated Approval For GVHD Drug Despite Primary Endpoint Miss

The biotech is banking on itolizumab’s longer-term efficacy as well as unmet need in frontline acute graft-versus-host disease as it prepares to meet with the FDA.

Rybrevant/Lazcluze Survival Win Could Overcome Tagrisso’s Convenience Advantage

J&J is confident that its bispecific antibody/kinase inhibitor combo’s overall survival win over AstraZeneca’s single-agent pill will shift the standard of care.

PharmaMar’s Aplidin Back On EMA’s Agenda After Conflict Of Interest Controversy

The European Medicines Agency is re-evaluating the marketing application for Aplidin. The initial application was rejected in 2018, but that rejection was revoked last year following a court case for another company’s drug that clarified impartiality requirements for experts consulted by the EMA.

Taiho Expands Cancer Pipeline With ADCs In $400m Araris Buy

Taiho’s acquisition of Swiss next-generation antibody-drug conjugate developer Araris is one of about 10 ADC deals so far in 2025. The companies previously partnered in 2023.

BPGbio: Fusing Patient-Driven Innovation With Causal AI

Biotech BPGbio applies causal AI to generate insights from samples from what the CEO says is one of the world's largest biobanks. With several promising late-stage programs, its platform seems to be yielding fruit.

Orano Med And Molecular Partners Transform Thorium Into Cancer Therapy

Swiss firm Molecular Partners and French national offshoot Orano Med have partnered to develop a potent new class of radiopharmaceuticals.

Breyanzi Becomes Fourth CAR T-Cell Therapy Reimbursed In England

A lower asking price from BMS and more insight into the benefits Breyanzi offers have convinced the health technology assessment institute, NICE, to reverse its rejection of the one-off treatment for large B-cell lymphoma.

Arcus’s Casdatifan Differentiates, But Data Overshadowed By Gilead Opting Out

With new Phase I/Ib results in kidney cancer, the HIF-2a inhibitor outshines Merck’s Welireg, but longtime Arcus partner Gilead decided not to exercise its option for casdatifan.

Genmab Has First Wholly Owned Antibodies In Phase III, Hunts For More

CMO Tahamtan Ahmadi explained Genmab hopes to do a deal in 2025 like its ProfoundBio acquisition in 2024 as the company seeks to develop more antibodies entirely on its own.

Depemokimab & Tzield Among 10 New EU Filings

GSK’s depemokimab, if approved, could become the first ultra-long-acting drug for treating asthma and chronic rhinosinusitis with nasal polyps. Meanwhile, Sanofi’s teplizumab, which the US approved as the first disease-modifying therapy for type 1 diabetes in 2022, has now been filed for review by the European Medicines Agency.