Development

AI-driven protein design, continuous-learning R&D platforms, mechanistic PK/PD modeling, and automated analytical workflows are now foundational tools reshaping how biopharmaceuticals are discovered, characterized, and delivered.

A Journal of Pancreatology review underscores renewed interest in TIGIT, but clinical evidence remains mixed across solid tumors.

The FDA has approved Lupin’s Ranluspec, an interchangeable biosimilar to Lucentis, for wet AMD, diabetic eye disease, and other retinal conditions.

Agilent’s Dr. Ganesh Bala explains how MAM-based LC–MS peptide mapping has become a foundational analytical tool for ADC and bioconjugate CQA monitoring in this Q&A piece.

Teva launches Ahzantive, an EMA-approved aflibercept biosimilar, in select European markets for wet AMD and other retinal diseases.

CytomX and Regeneron aim to deepen their joint effort to develop protease-activated bispecific immunotherapies designed to improve tumor selectivity and widen the therapeutic window in solid tumors.

The FDA has granted Breakthrough Therapy Designation to Biogen's investigational antisense oligonucleotide salanersen for spinal muscular atrophy, supported by Phase 1b data showing motor function improvements and reduced neurodegeneration in children previously treated with gene therapy.

IDefine and UT Southwestern will assess a preclinical EHMT1 gene replacement strategy for Kleefstra syndrome.

Lilly adds Ascidian’s RNA exon-editing platform for rare inherited kidney disease targets in a deal with no disclosed clinical data.

Interim phase 1b/2 data from Tenaya Therapeutics’ MyPEAK-1 study showed TN-201 gene therapy was generally well-tolerated and associated with improvements in cardiac remodeling, symptom burden, and functional measures in patients with MYBPC3-associated hypertrophic cardiomyopathy.¹

Eli Lilly has entered a licensing agreement with Hanmi Pharmaceutical for sonefpeglutide, a long-acting GLP-2 receptor agonist in Phase 2 development for short bowel syndrome. The deal includes $75 million upfront and up to $1.2 billion in milestone payments, plus royalties.

FDA draft guidance outlines how prior scientific knowledge may support gene therapy development for rare and life-threatening diseases.

Flexible laboratory and good manufacturing practice-ready infrastructure in Basel is designed to support biopharma startups, manufacturing scale-up, and innovation growth, says SENN Development CEO Dr. Johannes Eisenhut.

From multifunctional antibodies and T-cell engagers to in vivo cell therapies and hepatitis B functional cures, the most important large-molecule therapies of 2026 reveal the technological trends driving the next generation of biologic medicines.

Dual primary endpoints were met in both PANKU-Breast02 and PANKU-Esophagus01 phase 3 trials based on interim analyses, while priority review is underway for the esophageal cancer indication in China, Bristol Myers Squibb and Biokin stated.

Webinar Date/Time: Tue, Jun 23, 2026 11:00 AM EDT

Biopharma in 2026 advances decentralized manufacturing, AAV automation, QC modernization, and APAC clinical trial strategy.

BioNTech and Bristol Myers Squibb report confirmed ORRs exceeding 60% at the lower dose in both non-squamous and squamous first-line NSCLC; three global Phase 3 trials are now enrolling.

New clinical and translational data presented at ASCO 2026 and published in Nature Medicine demonstrate encouraging anti-tumor activity and manageable safety for Immatics’ IMA401 TCR bispecific in patients with MAGE-A4-positive solid tumors.

Webinar Date/Time: Wed, Jun 24, 2026 11:00 AM EDT

New five-year data from the Phase 3 tebentafusp (brand name Kimmtrak) trial are continuing to generate attention across oncology, particularly in metastatic uveal melanoma, a rare and historically difficult-to-treat cancer with limited treatment options and poor long-term survival outcomes. The study, presented during the 2026 annual meeting of the American Association for Cancer Research, represents the longest prospective Phase 3 randomized trial to report five-year overall survival data in metastatic uveal melanoma and the longest follow-up study for any T-cell engager in a solid tumor.

Five-year follow-up data from the Phase 3 Kimmtrak trial are providing new evidence that precision immunotherapy approaches can deliver durable benefits in metastatic uveal melanoma, a disease long considered resistant to immune-based treatments.

Fosun Pharma has dosed the first participant in a mainland China trial of FXB0871, as a parallel phase 1 study continues in the United States and Canada under Teva's TEV-56278 designation

Phase 3 B-Well trial results published in The New England Journal of Medicine showed that GSK's investigational antisense oligonucleotide bepirovirsen achieved functional cure rates of up to 26% in chronic hepatitis B, significantly exceeding outcomes typically seen with current standard-of-care therapies.

Pfizer and Innovent Biologics have entered a global oncology collaboration worth up to $10.5 billion to develop 12 early-stage cancer programs, underscoring growing interest among multinational pharmaceutical companies in China's biotechnology innovation ecosystem.