BioBusiness

A new Cellares–Stanford collaboration aims to demonstrate how automated platforms could standardize gene-edited stem cell manufacturing and accelerate clinical translation.

FDA’s acceptance of Affinia Therapeutics’ IND positions the company to test lower-dose, heart-targeted AAV gene therapy for BAG3 cardiomyopathy.

The SK bioscience–Gates MRI agreement highlights how scalable mAbs could broaden infant RSV prevention beyond high-income markets.

The VESPER-3 trial results show that extended-interval GLP-1 dosing may expand obesity care by balancing sustained weight loss with reduced injection burden.

AdvanCell and 48Hour Discovery align peptide discovery with a Lead-212 infrastructure to build a durable targeted alpha therapy pipeline aimed at oncology markets.

This new licensing deal with SanegeneBio signals growing confidence in RNAi technologies.

Such targeted private investments underscore the growing importance of early manufacturing scale-up in de-risking immunomodulatory biologics for neurodegenerative diseases.

The company’s major long-term capital commitment highlights how global drugmakers are anchoring future innovation, advanced modalities, and supply resilience within China’s life sciences ecosystem.

Cellares’ $257M Series D signals growing industry urgency to industrialize cell therapy manufacturing through automation and scalable production models.

This fast track designation signals growing regulatory momentum for trispecific antibodies as the myeloma field pushes beyond single-target immunotherapies.

Integrated biotech–CDMO partnerships are becoming critical as fusion protein complexity pushes developers to align discovery and manufacturing earlier.

Green chemistry is emerging as a strategic lever for biopharma manufacturing, enabling safer processes, efficiency gains, and long-term competitiveness.

Mendra’s launch highlights the growing use of AI to improve patient identification, clinical execution, and commercialization in rare disease programs.

EU regulators clear Otsuka’s antisense injectable to prevent hereditary angioedema attacks, reinforcing momentum for RNA-based rare disease medicines.

Next-gen antibody R&D is shifting to multifunctional modalities driven by manufacturing scale and regulatory acceleration.

GSK’s purchase of RAPT underscores growing biopharma focus on durable biologics designed to reduce dosing burden in food allergy and immunology care.

The approval of aflibercept for visual impairment from macular edema following retinal vein occlusion is based on clinical data that suggests higher-dose anti-VEGF therapy can preserve vision while extending dosing intervals.

A new FDA draft guidance signals broader acceptance of Bayesian methods, shaping clinical trial design, efficiency, and regulatory strategy in drug development.

EU approval of a prefilled Shingrix syringe streamlines vaccine delivery, while Phase III data position bepirovirsen as a potential functional cure for hepatitis B.

In a new team-up, MD Anderson and SOPHiA GENETICS will apply advanced analytics to cancer testing to improve complex data interpretation for clinical use.

China’s authorization of GSK’s Nucala (mepolizumab) for treating COPD signals regulatory momentum for precision respiratory medicines in the country.

The company’s Phase III setrusumab trials in osteogenesis imperfecta missed fracture endpoints but showed strong bone density gains.

Key 2025 FDA draft and final guidances emphasize the modernization of biotech regulations, acceleration of rare-disease therapies, and streamlining of biosimilar pathways.

Samsung Biologics’ Maryland acquisition signals a major push into US biologics manufacturing, reshaping the company’s capacity strategy and supply chain resilience.

This past year in biologics was marked by clinical trends, manufacturing scalability, and regulatory acceleration for antibody therapeutics.