From a potential first at home treatment for thyroid eye disease to progress in lymphoma and a first in class antibody entering the clinic for kidney fibrosis, today's BioPharm Brief highlights three developments advancing biologic drug development.
The European Investment Bank-backed investment establishes a new single-use GMP facility with which Icosagen can support complex protein therapeutics from early discovery through phase 1/2 clinical manufacturing.
The FDA has accepted Sarepta's supplemental New Drug Applications seeking to convert casimersen (Amondys 45) and golodirsen (Vyondys 53) from accelerated to traditional approval in Duchenne muscular dystrophy, with a PDUFA target action date of February 28, 2027, backed by ESSENCE confirmatory trial data and years of real-world evidence.
The FDA has granted priority review to Genentech's sBLA for Enspryng (satralizumab), an IL-6 receptor-targeting monoclonal antibody, as a potential first at-home subcutaneous treatment for thyroid eye disease, based on Phase III SatraGO data showing significant proptosis reduction, with an FDA decision expected by October 15, 2026.
ADC Therapeutics has completed enrollment of 100 patients in the Phase 1b LOTIS-7 trial evaluating loncastuximab tesirine-lpyl plus the bispecific antibody glofitamab in relapsed/refractory diffuse large B-cell lymphoma, with full data expected in Q4 2026 following earlier results showing an 89.8% overall response rate.
From his presentation at BIO 2026, Infinimune CEO Dr Wyatt McDonnell makes the case for how human-derived antibodies and human-trained AI models eliminate species translation failure and compress time to IND.
Eisai highlights next-generation Alzheimer's research, Talawar Therapeutics secures $285 million to advance a first-in-class bispecific antibody, and the FDA approves a new biologic for thyroid eye disease.
52-abstract package includes first reported real-world at-home subcutaneous administration data and phase 2 combination findings with anti-tau antibody.
Dr Wyatt McDonnell, Infinimune CEO, details how FDA's non-animal model guidances are reshaping non-clinical safety strategies for mAb developers in his talk at BIO 2026.
New York-based biotech enters Nasdaq through JATT II merger, betting IL-13 × IL-18 dual blockade can break the efficacy ceiling in I&I
Lumvoa gains FDA approval for thyroid eye disease, adding an IGF-1R antagonist supported by phase 3 active and chronic TED trials.
At BIO 2026, Baker McKenzie's Oren Livne explains how MFN pricing, tariffs, and geopolitical risk are driving demand for flexible deal structures in biopharma licensing.
Industry experts from Sanofi, GxP Frame, and Open Biopharma outline how AI is transforming drug discovery, manufacturing, and workforce strategy through biopharma partnerships in the latest episode of Drug Digest.
Crystalys Therapeutics CEO Dr James Mackay explains at BIO 2026 that gout remains an underserved therapeutic are and represents a compelling drug development target due to its unmet need and simple biology.
At BIO International Convention 2026, Sabeen Mekan, MD, of Zymeworks discussed how novel payloads, pathway-targeted ADCs, and multispecific antibody technologies are helping shape the next generation of antibody-drug conjugates for cancer treatment.
Jeff Talbot of Roseman University of Health Sciences discusses how Las Vegas is positioning itself as a growing life sciences hub by offering cost-effective laboratory space, access to capital, and a flexible environment for biotech startups and emerging companies.
MilliporeSigma's Sebastian Arana identifies process characterization gaps, tech transfer complexity, and analytical lag as top CGT manufacturing scale-up barriers at BIO 2026.
At BIO International Convention 2026, Mohit Trikha, PhD, CEO of Kiva Bioscience, discussed why emerging human-based preclinical models may have their greatest impact in predicting drug toxicity and tolerability rather than replacing animal testing outright.
Speaking from the show floor at BIO 2026, Dr Anil Kane, Thermo Fisher Scientific's global head of technical and scientific affairs, details how AI partnerships are accelerating drug development decisions across the CDMO continuum.
The FDA's approval of sacituzumab govitecan-hziy for first-line metastatic triple-negative breast cancer validates the Trop-2/SN-38 hydrolyzable linker platform across four positive Phase 3 trials, with implications for ADC development strategy, pharmacogenomic labeling, and biomarker-stratified regulatory programs.
As the biologic pipeline diversifies across ADCs, bispecific antibodies, and fusion proteins, formulation science has become the critical discipline bridging molecular complexity and patient-ready therapy.
At BIO 2026, Dr Howard Berman, ReAlta Life Sciences’ CEO, explains how an astrovirus-derived anti-inflammatory peptide targets multiple pathways that drive neonatal hypoxic-ischemic encephalopathy (HIE).
AI models can deliver transformative insights into drug manufacturing, but only when fed complete, traceable, and representative datasets.
At BIO International Convention 2026, Sabeen Mekan, MD, Vice President of Clinical Development at Zymeworks and panelist for The Next Generation of ADCs: Building Kinder, Gentler Cancer Therapeutics, discusses why safety is becoming an increasingly important differentiator in antibody-drug conjugate development and how biomarker-driven patient selection may help guide future treatment decisions.
MilliporeSigma Global Head of Process Solutions Sebastián Arana outlines why manufacturing flexibility, not just capacity, is now the strategic priority for biomanufacturers at BIO 2026.
This episode explores a first-in-class antibody entering the clinic for kidney fibrosis, the world's first approved bispecific ADC, and a major acquisition that strengthens AbbVie's immunology pipeline.
At the BIO International Convention 2026, oncology drug development expert Mohit Trikha, PhD, CEO, Kivu Bioscience, discusses the promise and limitations of organoids and other human-based preclinical models, emphasizing the need for stronger validation, cross-functional collaboration, and early regulatory engagement to improve clinical trial success rates.
Dr Wyatt McDonnell, Infinimune CEO and co-founder, posits that translatable, decision-linked single-cell data, and not data volume, are what drive effective therapeutic antibody development in this second segment of an interview at BIO 2026.
Mediar Therapeutics has dosed the first participants in a Phase 1 trial evaluating MTX-439, a first-in-class monoclonal antibody targeting SMOC2 for fibrosis associated with chronic kidney disease. The study marks the company's third anti-fibrotic program to enter clinical development and highlights growing interest in fibrosis-directed biologics.
China's National Medical Products Administration has approved izalontamab brengitecan (iza-bren) for recurrent or metastatic nasopharyngeal carcinoma, making it the first bispecific antibody-drug conjugate to receive regulatory approval anywhere in the world.
