Cancers, Vol. 15, Pages 4532: Dosimetry of a Novel 111Indium-Labeled Anti-P-Cadherin Monoclonal Antibody (FF-21101) in Non-Human Primates
lez
Osama Mawlawi
P-cadherin is associated with a wide range of tumor types, making it an attractive therapeutic target. FF-21101 is a human–mouse chimeric monoclonal antibody (mAb) directed against human P-cadherin, which has been radioconjugated with indium-111 (111In) utilizing a DOTA chelator. We investigated the biodistribution of FF-21101(111In) in cynomolgus macaques and extrapolated the results to estimate internal radiation doses of 111In- and yttrium-90 (90Y)-FF-21101 for targeted radioimmunotherapy in humans. Whole-body planar and SPECT imaging were performed at 0, 2, 24, 48, 72, 96, and 120 ...
Source: Cancers - September 13, 2023 Category: Cancer & Oncology Authors: Gregory Ravizzini William Erwin Louis De Palatis Lucia Martiniova Vivek Subbiah Vincenzo Paolillo Jennifer Mitchell Asa P. McCoy Jose Gonzalez Osama Mawlawi Tags: Article Source Type: research
Oncology drug lag in Japan: has it improved over the last decade?
ConclusionsDrug lag has not decreased over the last decade. The percentage of pivotal trials for US approval that included Japan has increased but should be further increased in the future. Japan may require a scheme to encourage smaller non-Japanese companies to include Japan in their global clinical development plan. (Source: International Journal of Clinical Oncology)
Source: International Journal of Clinical Oncology - August 10, 2023 Category: Cancer & Oncology Source Type: research
Immunogenicity risk assessment of synthetic peptide drugs and their impurities
Drug Discov Today. 2023 Jul 17:103714. doi: 10.1016/j.drudis.2023.103714. Online ahead of print.ABSTRACTPeptide drugs play an important part in medicine owing to their many therapeutic applications. Of the 80 peptide drugs approved for use in humans, at least five are now off-patent and are consequently being developed as generic alternatives to the originator products. To accelerate access to generic products, the FDA has proposed new regulatory pathways that do not require direct comparisons of generics to originators in clinical trials. The 'Abbreviated New Drug Application' (ANDA) pathway recommends that sponsors provi...
Source: Drug Discovery Today - July 19, 2023 Category: Drugs & Pharmacology Authors: Anne S De Groot Brian J Roberts Aimee Mattei Sandra Lelias Christine Boyle William D Martin Source Type: research
Immunogenicity risk assessment of synthetic peptide drugs and their impurities
Drug Discov Today. 2023 Jul 17:103714. doi: 10.1016/j.drudis.2023.103714. Online ahead of print.ABSTRACTPeptide drugs play an important part in medicine owing to their many therapeutic applications. Of the 80 peptide drugs approved for use in humans, at least five are now off-patent and are consequently being developed as generic alternatives to the originator products. To accelerate access to generic products, the FDA has proposed new regulatory pathways that do not require direct comparisons of generics to originators in clinical trials. The 'Abbreviated New Drug Application' (ANDA) pathway recommends that sponsors provi...
Source: Drug Discovery Today - July 19, 2023 Category: Drugs & Pharmacology Authors: Anne S De Groot Brian J Roberts Aimee Mattei Sandra Lelias Christine Boyle William D Martin Source Type: research
Immunogenicity risk assessment of synthetic peptide drugs and their impurities
Drug Discov Today. 2023 Jul 17:103714. doi: 10.1016/j.drudis.2023.103714. Online ahead of print.ABSTRACTPeptide drugs play an important part in medicine owing to their many therapeutic applications. Of the 80 peptide drugs approved for use in humans, at least five are now off-patent and are consequently being developed as generic alternatives to the originator products. To accelerate access to generic products, the FDA has proposed new regulatory pathways that do not require direct comparisons of generics to originators in clinical trials. The 'Abbreviated New Drug Application' (ANDA) pathway recommends that sponsors provi...
Source: Drug Discovery Today - July 19, 2023 Category: Drugs & Pharmacology Authors: Anne S De Groot Brian J Roberts Aimee Mattei Sandra Lelias Christine Boyle William D Martin Source Type: research
Immunogenicity risk assessment of synthetic peptide drugs and their impurities
Drug Discov Today. 2023 Jul 17:103714. doi: 10.1016/j.drudis.2023.103714. Online ahead of print.ABSTRACTPeptide drugs play an important part in medicine owing to their many therapeutic applications. Of the 80 peptide drugs approved for use in humans, at least five are now off-patent and are consequently being developed as generic alternatives to the originator products. To accelerate access to generic products, the FDA has proposed new regulatory pathways that do not require direct comparisons of generics to originators in clinical trials. The 'Abbreviated New Drug Application' (ANDA) pathway recommends that sponsors provi...
Source: Drug Discovery Today - July 19, 2023 Category: Drugs & Pharmacology Authors: Anne S De Groot Brian J Roberts Aimee Mattei Sandra Lelias Christine Boyle William D Martin Source Type: research
Avasopasem for the treatment of radiotherapy-induced severe oral mucositis
Expert Opin Investig Drugs. 2023 Jun 26. doi: 10.1080/13543784.2023.2230117. Online ahead of print.ABSTRACTINTRODUCTION: Oral mucositis (OM) remains a significant, highly symptomatic, disruptive side effect of radiation and concomitant chemoradiation therapy used for the treatment of squamous cell cancers of the head and neck. Despite its clinical and economic burden, implementation of an effective intervention has been elusive.AREAS COVERED: Increased understanding of the complexity of the biological basis for its pathogenesis has yielded potential druggable targets of such as the mitigation of superoxide formation and ox...
Source: Expert Opinion on Investigational Drugs - June 26, 2023 Category: Drugs & Pharmacology Authors: Stephen T Sonis Carryn M Anderson Source Type: research
Development of a 2D-QSAR Model for Tissue-to-Plasma Partition Coefficient Value with High Accuracy Using Machine Learning Method, Minimum Required Experimental Values, and Physicochemical Descriptors
ConclusionWe could develop a 2D-QSAR model forKp value with the highest accuracy using a few in vitro experimental data and physicochemical descriptors. (Source: European Journal of Drug Metabolism and Pharmacokinetics)
Source: European Journal of Drug Metabolism and Pharmacokinetics - June 2, 2023 Category: Drugs & Pharmacology Source Type: research
Current status and hotspots evolution in myeloproliferative neoplasm: a bibliometric analysis from 2001 to 2022
CONCLUSIONS: The research is in a stage of rapid development. The collaboration between different institutions or countries (regions) still has room to grow. The hotspot analysis shows that the research of MPN mainly focuses on gene mutation, thrombosis, new drug applications, disease progression, etc.PMID:37259732 | DOI:10.26355/eurrev_202305_32457 (Source: European Review for Medical and Pharmacological Sciences)
Source: European Review for Medical and Pharmacological Sciences - June 1, 2023 Category: Drugs & Pharmacology Authors: M-L Chen H-C Zhang E-P Yang Source Type: research
Current status and hotspots evolution in myeloproliferative neoplasm: a bibliometric analysis from 2001 to 2022
CONCLUSIONS: The research is in a stage of rapid development. The collaboration between different institutions or countries (regions) still has room to grow. The hotspot analysis shows that the research of MPN mainly focuses on gene mutation, thrombosis, new drug applications, disease progression, etc.PMID:37259732 | DOI:10.26355/eurrev_202305_32457 (Source: Pharmacological Reviews)
Source: Pharmacological Reviews - June 1, 2023 Category: Drugs & Pharmacology Authors: M-L Chen H-C Zhang E-P Yang Source Type: research
Current status and hotspots evolution in myeloproliferative neoplasm: a bibliometric analysis from 2001 to 2022
CONCLUSIONS: The research is in a stage of rapid development. The collaboration between different institutions or countries (regions) still has room to grow. The hotspot analysis shows that the research of MPN mainly focuses on gene mutation, thrombosis, new drug applications, disease progression, etc.PMID:37259732 | DOI:10.26355/eurrev_202305_32457 (Source: European Review for Medical and Pharmacological Sciences)
Source: European Review for Medical and Pharmacological Sciences - June 1, 2023 Category: Drugs & Pharmacology Authors: M-L Chen H-C Zhang E-P Yang Source Type: research
