News

Halozyme and Incyte will advance subcutaneous INCA033989 for mutCALR-positive MPNs, with the aim of improving treatment delivery while supporting targeted clinical development.

Prevention, precision, and progress take center stage as researchers report advances in pancreatic cancer prevention, uncover new insights into colorectal cancer immunotherapy, and introduce the first rapid-onset botulinum toxin approved in Europe.

The EC has approved AbbVie's Boey (trenibotulinumtoxinE), the first serotype E neurotoxin for glabellar lines, with faster onset than current options.

A preclinical study links a DR5-Lig3 feedback loop to immune recognition and checkpoint inhibitor response in dMMR colorectal cancer.

A phase 1 trial of mKRAS-VAX, an off-the-shelf synthetic peptide vaccine targeting mutant KRAS, safely stimulated durable, tumor-specific T-cell responses in 90% of high-risk individuals, with none of the 20 participants developing pancreatic cancer after a median follow-up of 16.5 months.

Keytruda improved progression-free survival versus chemotherapy in first-line dMMR advanced or recurrent endometrial cancer.

Nirrin Technologies founder and CEO Bryan Hassell discusses how simplifying protein quantitation could improve method transferability, support automation, and reduce bottlenecks across biologics development and manufacturing.

Umoja Biopharma has received FDA clearance of its IND application for UB-VV400, a CD22-directed in vivo CAR T-cell therapy candidate built on the company's VivoVec lentiviral platform, positioning it as the industry's first known in vivo CAR T program targeting CD22 for relapsed or refractory B-cell malignancies.

At BIO 2026, Thermo Fisher Scientific's Paul Jorjorian highlighted late-stage raw material switches as being among the most disruptive and underestimated risks in biopharma development.

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.

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.

Voyager Therapeutics presented six-month GLP toxicology data showing its tau-silencing AAV gene therapy VY1706 was well tolerated and reduced tau protein by up to 75% in key brain regions of non-human primates, with a clinical trial in Alzheimer's disease expected to begin in the second half of 2026.

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.