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 ...

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 ...

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, ...

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 ...

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 ...

Intravacc offers state-of-the-art analytical methods for identity, content, purity, structure, formulation, stability, and preclinical assessment Capabilities include ...

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 (FDA) has released a new guidance document pertaining to labeling changes made to pharmaceutical and biological products based on new safety information discovered ...

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 ...