Opinions expressed by Digital Journal contributors are their own. Bringing a new biologic drug from concept to clinic is a complex journey fraught with technical and regulatory hurdles. For ...
The predominance of manufacturing process patents asserted in litigation by originator biologics companies against would-be biosimilar entrants has resulted in a number of Congressional and ...
OKLAHOMA CITY--(BUSINESS WIRE)--Cytovance Biologics, a U.S.-based Contract Development and Manufacturing Organization (CDMO), announced the launch of its in-house formulation development services, ...
HCW Biologics Inc. and WY Biotech Co., Ltd. have finalized a licensing agreement for the development and commercialization of HCW11-006, a novel immunotherapy targeting age-related diseases and cancer ...
The drug discovery services market is projected to advance from US$ 21.5 billion in 2026 to US$ 67.3 billion by 2035, compounding at a CAGR of 13.5 per cent over the forecast period. The market had ...
Documentary standards such as monographs, general chapters, and reference standards are essential for efficiently meeting regulatory requirements and ensuring the intended efficacy and safety of drugs ...
A new laser technique decodes molecular vibrations to predict whether a drug will be effective, potentially cutting years ...
White paper outlines how BioDlink’s predictive digital platform reduces freeze-drying cycle development from over 60 days to under 30, enhancing scale-up precision for complex biologics A case study ...
Glycosylation is a critical quality attribute of therapeutic proteins, yet current analytical methods often fail to meet rapid, high-throughput demands. Here, we adopted an optimized glycosylation ...
This Brush Up is sponsored by MilliporeSigma. Learn more about therapeutic synthesis pathways. Drug development is a process that spans many years, from the initial phase of identifying potential drug ...
The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...
The U.S. Food and Drug Administration (FDA) announced on Wednesday (October 29) a plan to streamline the approval process for biosimilars, which are generic versions of complex biological drugs. These ...
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