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Post-Approval Research in Drug Development: Priorities and Practices
A prescriber might ask if a new medication is a good option for use in the patients he or she sees in clinic, with their particular blends of...
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Emergency Approval Mechanisms for Human Vaccines in India
The coronavirus disease 2019 (COVID-19) pandemic highlighted the world’s level of preparedness in managing public health emergencies (PHEs). It...
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Lifileucel: First Approval
Lifileucel (AMTAGVI™), a one-time autologous T cell therapy derived and expanded from tumour-infiltrating lymphocytes (TIL) from a patient’s own...
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NASH: regulatory considerations for clinical drug development and U.S. FDA approval
Nonalcoholic fatty liver disease is a growing public health crisis, with phenotypes from nonalcoholic fatty liver to nonalcoholic steatohepatitis,...
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Viltolarsen: From Preclinical Studies to FDA Approval
Viltolarsen is a phosphorodiamidate morpholino antisense oligonucleotide (PMO) designed to skip exon 53 of the DMD gene for the treatment of Duchenne...
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Zevorcabtagene Autoleucel: First Approval
Zevorcabtagene autoleucel (泽沃基奥仑赛注射液) is a fully humanised B cell maturation antigen (BCMA)-targeting specific chimeric antigen receptor (CAR) T-cell...
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Drug Development for New Psychiatric Drug Therapies
Drug development is an expensive, high risk, and highly regulated process. Only about 6.2% of new molecules tested for mental disorders eventually...
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Omidubicel: First Approval
Omidubicel (omidubicel-onlv; Omisirge ® ) is a nicotinamide-modified stem cell graft derived from cord blood that is being developed by Gamida Cell for...
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Equecabtagene Autoleucel: First Approval
Equecabtagene autoleucel (Fucaso ® ), an autologous anti-B cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR)-T cell therapy that...
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A Milestone in the Treatment of Ataxias: Approval of Omaveloxolone for Friedreich Ataxia
The exciting news about the US FDA approval of omaveloxolone as the first-ever drug to be approved for an inherited ataxia is welcome news for...
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Overview of Biopharmaceutics and Regulatory Concepts Relevant to Drug Product Design
This chapter is new to this edition. Basic pharmacokinetic and biopharmaceutics concepts that are central to drug delivery and drug product design...
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Talicabtagene Autoleucel: First Approval
Talicabtagene autoleucel (NexCAR19™) is a chimeric antigen receptor (CAR) T-cell therapy being developed by the Indian Institute of Technology,...
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Evaluation of Drug Lags in Development Initiation, New Drug Application and Approval Between Japan and the USA and the Impact of Local Versus Multi-regional Clinical Trials
BackgroundDrug time lags occur between the date that new drugs are first approved, often in the USA, and approval is granted in other countries....
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Approval of DFMO for high-risk neuroblastoma patients demonstrates a step of success to target MYC pathway
The “undruggable” MYC oncoproteins are deregulated in 70% human cancers. The approval of DFMO, an irreversible inhibitor of ornithine oxidase (ODC1)...
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Exagamglogene Autotemcel: First Approval
Exagamglogene autotemcel (Casgevy™) is a genetically modified autologous CD34 + cell enriched population. It contains human haematopoietic stem and...
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Trends in the approval of cancer therapies by the FDA in the twenty-first century
The cancer treatment landscape has changed dramatically since the turn of the century, resulting in substantial improvements in outcomes for...
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Quality By Design Approach for Novel Drug Delivery Systems
QbD offers several unique benefits, including deep material and process understanding, flexibility change within the design space without...
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Tabelecleucel: First Approval
Tabelecleucel (Ebvallo TM ) is an allogeneic Epstein–Barr virus (EBV)-specific T-cell immunotherapy that targets and eliminates EBV positive (EBV + )...
