Report Type: Industry Trends
Report Category: Research Insights
Report Subcategory: Monoclonal Antibody Conjugated
Date: February 2022
Antibody Drug Conjugates (ADCs): Drugs, Trials, Technology, Companies, News, Deals, Patents, Drug Sales & Forecast, Future Events, DMF, and Manufacturing
Antibody-Drug Conjugates (ADCs):
Antibody-Drug Conjugates (ADCs) are a new class of highly potent biological drugs built by attaching a small molecule anticancer drug or another therapeutic agent to an antibody, with either a permanent or a labile linker. The antibody targets a specific antigen only found on target cells. Once it binds to the cell, it triggers internalization of the antibody, together with the drug. This delivers drugs with a very high specificity to the diseased cells, maximizing their efficacy and minimizing systemic exposure, with the associated risk of side effects.\
Drugs & Companies covered are:
18 approved drugs (life cycle management) and 680+ ADC drugs in pipeline will have benefit on PDUFA fee waiver.
Feb 08, 2022 - Regulatory Update
Clinical Pharmacology Considerations for Antibody-Drug Conjugates; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Clinical Pharmacology Considerations for Antibody-Drug Conjugates,” which provides recommendations for the development of antibody-drug conjugates (ADCs).
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