Development

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.

Regulatory review of Eisai’s subcutaneous lecanemab highlights how delivery innovation may expand access and scalability for disease-modifying Alzheimer’s therapies.

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.

The European Commission’s approval of GSK’s Arexvy for adults 18 years and older expands the respiratory syncytial virus vaccine market and signals broader adoption of adult immunization strategies.

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

Biopharma manufacturing faces a global workforce crisis, driving adoption of continuous upstream automation to protect and scale capacity, says Eric Langer of BioPlan Associates, in the continuation of his industry outlook.

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.

In 2026, AI and automation are anticipated to solve talent gaps and economic shifts to drive resilient drug discovery and manufacturing.

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.

As biologic modalities grow more complex and timelines compress, integrated, end-to-end CDMO partnerships are emerging as a strategic differentiator to enable biopharma companies to reduce risk, accelerate development, and maintain quality and regulatory continuity across the full product lifecycle.

A new FDA draft guidance signals broader acceptance of Bayesian methods, shaping clinical trial design, efficiency, and regulatory strategy in drug development.

Ben Edwards of Avance Clinical explains how generative AI and adaptive trials speed early-stage drug development by improving data access and capital efficiency.

As the J.P. Morgan Healthcare Conference gets underway, Lonza’s Michael De Marco weighs in on regional manufacturing shifts as biotech pipelines mature, signaling new therapy launches within 12–18 months.

In part two of an interview, Daniel Delubac, iOrganBio CEO, explains how digitized, in-vitro human biology models aim to improve preclinical drug testing.

AI-driven human cell models aim to replace animal testing and deliver more accurate, data-driven insights, says iOrganBio CEO Daniel Delubac ahead of the J.P. Morgan Healthcare Conference.

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.

The CDC has narrowed pediatric vaccine guidance, resetting evidence expectations and signaling potential shifts in vaccine uptake and market demand.

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