News

Boehringer Ingelheim has started a phase 2 trial of BI 3034701, an investigational triple GLP-1/GIP/NPY2 receptor agonist for obesity and overweight.

Deck Bio’s Dr Johanna K. Kaufmann spoke at BIO 2026 about how the company’s multi-peptide major histocompatibility complex T cell engager strategy aims to expand patient eligibility and overcome solid tumor heterogeneity and antigen escape resistance.

Oncolytics Biotech CEO Jared Kelly warns that investor demand for near-term tumor response data is blocking funding for trials with proven overall survival benefits.

Updated clinical findings for brenetafusp highlight how T-cell receptor bispecific therapies may overcome key mechanisms of checkpoint inhibitor resistance while expanding immunotherapy to a broader range of solid tumors.

FDA has granted priority review to obinutuzumab (Gazyva) for primary membranous nephropathy after phase 3 MAJESTY trial results showed superior remission versus tacrolimus.

Allogene Therapeutics has published complete phase 1 data in the Journal of Clinical Oncology for ALLO-316, a CD70-targeted allogeneic CAR T therapy, showing a 31% confirmed response rate and durable remissions in patients with high CD70-expressing metastatic renal cell carcinoma.

ImmunoBrain has published phase 1b data in Nature Medicine and presented late-breaking results at AAIC 2026 for IBC-Ab002, an investigational anti-PD-L1 monoclonal antibody that met its primary safety endpoint and showed encouraging trends in biomarkers of neuronal and synaptic damage in patients with early Alzheimer's disease.

As part of our continuing coverage from the BIO International Convention 2026, Pharmaceutical Executive spoke with Martha Fowler, founder of Steer Bio, about the company's regenerative medicine platform, its lead program for cancer-related lymphedema, and how non-dilutive funding is supporting its path toward first-in-human studies.

Today's BioPharm Brief explores three developments in Alzheimer's disease and autoimmune research, including promising preclinical gene therapy data, a new FDA-approved at-home treatment option, and a licensing deal for a novel CD40L-targeting antibody.

The FDA has approved lecanemab-irmb (Leqembi Iqlik) a once-weekly subcutaneous autoinjector formulation, as an initiation dose for early Alzheimer's disease, making it the first anti-amyloid antibody offering at-home dosing across the entire treatment course, from initiation through maintenance.

Innovent Biologics and Spero Therapeutics have signed a $1.1 billion licensing deal for IBI355, a phase 2-ready Fc-silent anti-CD40L antibody planned for testing in IgG4-related disease and Sjögren's disease.

Today's BioPharm Brief highlights three regulatory and clinical milestones, including an FDA RMAT designation for a regenerative therapy in osteoarthritis, promising rectal cancer data from GSK's AZUR-1 study, and a new perioperative treatment option for muscle-invasive bladder cancer.

Speaking at BIO 2026, Novartis Contract Manufacturing's Carrie Bracco explains how capacity pressures and biotech flexibility needs are reshaping CMO partnerships.

The biopharmaceutical landscape grows increasingly complex, and competition for experienced engineering talent has intensified accordingly. For professionals with advanced expertise, evaluating potential employers involves assessing innovation capabilities, organizational culture, career trajectory opportunities, and tangible contributions to healthcare advancement.

In biopharmaceutical environments, specialized liquid formulation ingredient sourcing choices shape development timelines, production continuity, regulatory readiness and commercial performance.

The FDA has approved Padcev, a Nectin-4-directed antibody-drug conjugate, plus Keytruda as neoadjuvant and adjuvant treatment for muscle-invasive bladder cancer regardless of cisplatin eligibility, based on Phase III EV-304 data showing a 47% reduction in recurrence risk.

The FDA has granted Regenerative Medicine Advanced Therapy designation to Allocetra, Enlivex's macrophage-reprogramming cell therapy, for age-related symptomatic knee osteoarthritis in patients 64 and older, based on Phase I/IIa data showing durable pain and function improvements.

GSK reports that dostarlimab (Jemperli) monotherapy achieved sustained clinical complete responses in the phase 2 AZUR-1 trial for dMMR/MSI-H locally advanced rectal cancer, with data to be submitted for regulatory review.

Opamtistomig, a PD-L1/4-1BB bispecific antibody from Nanjing Leads Biolabs, has been granted priority review by China's NMPA for advanced extrapulmonary neuroendocrine carcinoma, a rare and aggressive cancer with no globally approved therapy.

The FDA has approved subcutaneous Sarclisa Escena, administered via on-body injector, across all existing multiple myeloma indications for the IV formulation, making isatuximab the first anticancer monoclonal antibody available through both wearable injector and manual subcutaneous administration in the US.

Teva Pharmaceuticals has entered a global licensing agreement with Polpharma Biologics for exclusive commercialization rights to a proposed biosimilar of Ocrevus (ocrelizumab), the CD20-targeted monoclonal antibody used to treat relapsing and primary progressive multiple sclerosis.

Today's BioPharm Brief explores three very different paths toward innovation, from AI-guided precision medicine and a first-in-class autoimmune cell therapy to a late-stage clinical setback in transthyretin amyloid cardiomyopathy.

CARDIO-TTRansform, the largest Phase III trial conducted to date in transthyretin-mediated amyloid cardiomyopathy, did not meet its primary composite endpoint for Wainua (eplontersen), though a monotherapy subgroup showed a nominally significant reduction in cardiovascular events.

Chemomab Therapeutics and Scipher Medicine will merge to advance nebokitug, a first-in-class anti-CCL24 monoclonal antibody, into a precision medicine Phase 2 trial in rheumatoid arthritis guided by Scipher's PrismRA test and AI Network Medicine platform.

Abu Dhabi is expanding its role in global biopharmaceutical manufacturing through strategic investments, advanced infrastructure, and international partnerships designed to accelerate biologics production, innovation, and supply chain resilience.

As part of BioPharm International's continuing coverage from the BIO International Convention 2026, Sara Jane Demy, CEO of Demy-Colton, discusses how artificial intelligence, global collaboration, and renewed investment could help improve drug development success rates and accelerate innovation.

As part of BioPharm International's continuing coverage from the BIO International Convention 2026, Sara Jane Demy discusses signs of renewed investment activity and why inclusive scientific leadership remains essential to advancing drug development.

Today's BioPharm Brief highlights advances in neurology, hematology, and nephrology, featuring new Alzheimer's disease biomarker data, an expanded pediatric approval for von Willebrand disease prophylaxis, and the first dual BAFF and APRIL inhibitor approved for IgA nephropathy.