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E&L Challenges in Biologics, Part Two2 months ago
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European Approval of Donidalorsen Expands RNA-Targeted Prevention Strategies for HAE

Next-Generation Modalities Drive New Antibody Discovery

GSK Acquisition of RAPT Signals Shift Toward Long-Acting Anti-IgE Therapies

State of the Bio/Pharma Workforce: A Comparative Analysis of Employment Trends and Industry Sentiment

Adenovirus Vectors, Cyclodextrins and the Patient Experience: A Deep Dive

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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.

The company composed a letter addressed to global governments to harness competitiveness and innovation to navigate the current global trade economy.

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.

The partnership boosts BOT+BAL immunotherapy, securing US biologics manufacturing and accelerating Phase III mCRC development globally.

A new FDA draft guidance signals broader acceptance of Bayesian methods, shaping clinical trial design, efficiency, and regulatory strategy in drug development.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

Johnson & Johnson reinforces its long-term domestic investment strategy with a new $2 billion biologics facility in Wilson, North Carolina, further elevating the state’s role as a global life sciences hub.

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.

Single-use technologies provide efficiency and flexibility while reducing risk in the manufacture of cell and gene therapies.

Digitalization is expected to reshape bioprocessing, supply chains, and quality systems for biopharma developers amid tariffs, geopolitics, and shifting capital flows, according to BioPlan Associates’ Eric Langer.























