Emily Schoenthaler

The half-life-extended antibody failed its primary endpoints in two Phase 2 SKYWAY sub-studies, so Spyre is dropping it in rheumatic diseases and moving it into a combination trial in hidradenitis suppurativa.

Boehringer Ingelheim will pay Sino Biopharmaceutical $358 million upfront and near-term for options on six biologic oncology programs, deepening a partnership that began in 2024.

A former CIA officer, Pacific Research Institute economists, and industry groups say Treasury's proposed COINS Act biotechnology restrictions are too broad, while the National Security Commission on Emerging Biotechnology backs the move. Comments are due December 7, 2026.

Today’s BioPharm Brief covers FDA’s final potency assurance guidance for cell and gene therapies, Lonza’s deal to acquire Merck KGaA’s US CDMO business, and Phase 2a data for Tiziana’s intranasal anti-CD3 antibody foralumab in progressive multiple sclerosis.

At AAPS PharmSci 360 2026, University of Iowa PhD candidate Siddhanth Hejmady explains how adding a payload or radiolabel to trastuzumab changes its behavior in bulk solution and at interfaces, and why developability teams should pair DLS with QCM-D.

In the Phase 2a INFORM-MS trial, Tiziana’s nasal foralumab reduced microglial activation on PET imaging at 50 µg in non-active secondary progressive MS, while the 100-µg dose showed no significant effect.

The deal adds five US sites and about 1,100 employees, more than doubling Lonza’s US network and filling a gap in US bioconjugation capacity the company flagged weeks earlier.

AAPS PharmSci 360 2026 in New Orleans centered on auditable AI, modeling-guided formulation, oral peptide delivery, high-concentration antibody suspensions, and the push toward $10-per-gram monoclonal antibodies.

The deal gives Fresenius options on biosimilars spanning monoclonal and bispecific antibodies, ADCs, and fusion proteins, starting with polatuzumab vedotin and teprotumumab, and could expand its portfolio from 29 to 66 molecules.

FDA set a May 1, 2027 target date for AMT-130, a one-time gene therapy that silences the huntingtin gene, and plans an advisory committee meeting.

FDA approves Sun Pharma’s Ilumya for active psoriatic arthritis, BioMarin licenses a subcutaneous Fabry enzyme replacement therapy from GC Biopharma and Hanmi, and Lonza expands bioconjugation capacity in Visp to meet rising ADC demand.

In an interview for BioPharm International’s AAPS PharmSci 360 2026 coverage, Nanoform’s Chris Worrall shares 18-month stability data for a 440 mg/mL trastuzumab suspension and explains how ultra-high-concentration formulations could shorten administration and support at-home injection.

Industry experts discuss how reshoring, fill/finish capacity, and cold chain technology are shaping a more resilient biopharma supply chain.

The first-in-class molecule, licensed to Dianthus as DNTH212 outside Greater China, is designed to block type 1 interferon production and BAFF/APRIL-driven B-cell activity with a single drug.

The IL-23p19 inhibitor tildrakizumab becomes the third drug in its class approved for psoriatic arthritis, and the only one given exclusively by a healthcare provider.

In the final part of a three-part interview, Anurag Rathore, PhD, professor of chemical engineering at IIT Delhi, explains how his team has cut monoclonal antibody costs toward $10 per gram and why process intensification will spread one unit operation at a time.

As part of BioPharm International’s AAPS PharmSci 360 2026 coverage, Nanoform’s Chris Worrall explains why stability and viscosity have kept antibody formulations below 200 mg/mL, and how a low-temperature particle engineering process and non-aqueous suspensions could support ultra-high concentrations.

Updated phase 2 IOV-LUN-202 data show Iovance’s TIL cell therapy lifileucel produced a 24.6% response rate in previously treated non-squamous metastatic NSCLC, rising to 52.0% in KRAS and HER2 wild-type patients, as the company launches a biomarker-enriched registrational cohort.

In the 80-week phase 3 TRANSCEND-T2D-2 trial in adults with type 2 diabetes, Eli Lilly’s GIP/GLP-1/glucagon triple agonist retatrutide lowered A1C by 2.2% and body weight by up to 20.9%, compared with 1.8% and 9.4% with Ozempic 2 mg.

Genmab’s petosemtamab plus pembrolizumab cuts the risk of death by 50% in phase 3 head and neck cancer, AbbVie submits a BLA for etentamig in relapsed or refractory multiple myeloma, and Benitec reports interim data for BB-301 gene therapy in OPMD-related dysphagia.

The EGFR×LGR5 bispecific antibody met both primary endpoints, overall survival and objective response rate, at the first interim analysis of LiGeR-HN1 in first-line PD-L1-positive recurrent or metastatic head and neck cancer.

Long-term phase 2 data presented at ESMO 2026 show 3SBio’s tivunatamig plus chemotherapy extended progression-free survival vs tislelizumab plus chemotherapy in squamous and non-squamous NSCLC.

Anurag Rathore, PhD, professor of chemical engineering at IIT Delhi, explains how his team cuts monoclonal antibody costs without cutting purification steps, and why the $10-per-gram target could make antibodies viable for infectious disease and global access.

At AAPS PharmSci 360, Thermo Fisher Scientific scientists described how predictive modeling guides technology selection for poorly soluble drugs, and outlined plans to bring solvent-free KinetiSol technology to commercial scale in 2027.

BMS and SystImmune’s bispecific ADC iza-bren nearly doubles progression-free survival in EGFR-mutated lung cancer, GSK and Hansoh’s B7-H3 ADC Ris-Rez extends progression-free survival in relapsed osteosarcoma, and Immatics’ TCR bispecific IMA402 posts a 32% response rate in PRAME-high tumors.

Phase 1b data at ESMO 2026 show the TCR-based T-cell engager produced durable responses in PRAME-high melanoma, with 91% of patients alive at one year in the recommended dose range.

In two small phase 1b trials, the half-life-extended bispecific antibody improved skin disease and reduced airway inflammation. Aclaris will move next into a Phase 2b trial in eosinophilic esophagitis.

Merck and Kelun’s sac-TMT extends overall survival in pretreated endometrial cancer, Bristol Myers Squibb reports interim data and a patient death in its phase 1 CAR-T trial in multiple sclerosis, and BioNTech and DualityBio’s HER2 ADC meets its phase 3 goal but with limited expected benefit.

Full Phase 3 TroFuse-005 data presented at ESMO 2026 show the TROP2-directed ADC sacituzumab tirumotecan cut the risk of death by 32% vs chemotherapy, and an FDA decision is expected by June 2027.

BioNTech and DualityBio's HER2-directed ADC modestly improved progression-free survival over chemotherapy in DYNASTY-Breast02, but higher interstitial lung disease rates and an established competitor limit its potential in this setting.