How successful are AI-discovered drugs in clinical trials? A first analysis and emerging lessons
Drug Discov Today. 2024 Apr 29:104009. doi: 10.1016/j.drudis.2024.104009. Online ahead of print.ABSTRACTAI techniques are making inroads into the field of drug discovery. As a result, a growing number of drugs and vaccines have been discovered using AI. However, questions remain about the success of these molecules in clinical trials. To address these questions, we conducted a first analysis of the clinical pipelines of AI-native Biotech companies. In Phase I we find AI-discovered molecules have an 80-90% success rate, substantially higher than historic industry averages. This suggests, we argue, that AI is highly capable ...
Source: Drug Discovery Today - May 1, 2024 Category: Drugs & Pharmacology Authors: Madura Kp Jayatunga Margaret Ayers Lotte Bruens Dhruv Jayanth Christoph Meier Source Type: research

How health technology assessment can help to address challenges in drug repurposing: a conceptual framework
Drug Discov Today. 2024 Apr 29:104008. doi: 10.1016/j.drudis.2024.104008. Online ahead of print.ABSTRACTDrug repurposing faces various challenges that can impede its success. We developed a framework outlining key challenges in drug repurposing to explore when and how health technology assessment (HTA) methods can address them. We identified 20 drug-repurposing challenges across the categories of data access, research and development, collaboration, business case, regulatory and legal challenges. Early incorporation of HTA methods, including literature review, empirical research, stakeholder consultation, health economic e...
Source: Drug Discovery Today - May 1, 2024 Category: Drugs & Pharmacology Authors: Teebah Abu-Zahra Sabine E Grimm Mirre Scholte Adam J N Raymakers Aaron S Kesselheim Manuela Joore Source Type: research

How successful are AI-discovered drugs in clinical trials? A first analysis and emerging lessons
Drug Discov Today. 2024 Apr 29:104009. doi: 10.1016/j.drudis.2024.104009. Online ahead of print.ABSTRACTAI techniques are making inroads into the field of drug discovery. As a result, a growing number of drugs and vaccines have been discovered using AI. However, questions remain about the success of these molecules in clinical trials. To address these questions, we conducted a first analysis of the clinical pipelines of AI-native Biotech companies. In Phase I we find AI-discovered molecules have an 80-90% success rate, substantially higher than historic industry averages. This suggests, we argue, that AI is highly capable ...
Source: Drug Discovery Today - May 1, 2024 Category: Drugs & Pharmacology Authors: Madura Kp Jayatunga Margaret Ayers Lotte Bruens Dhruv Jayanth Christoph Meier Source Type: research

How health technology assessment can help to address challenges in drug repurposing: a conceptual framework
Drug Discov Today. 2024 Apr 29:104008. doi: 10.1016/j.drudis.2024.104008. Online ahead of print.ABSTRACTDrug repurposing faces various challenges that can impede its success. We developed a framework outlining key challenges in drug repurposing to explore when and how health technology assessment (HTA) methods can address them. We identified 20 drug-repurposing challenges across the categories of data access, research and development, collaboration, business case, regulatory and legal challenges. Early incorporation of HTA methods, including literature review, empirical research, stakeholder consultation, health economic e...
Source: Drug Discovery Today - May 1, 2024 Category: Drugs & Pharmacology Authors: Teebah Abu-Zahra Sabine E Grimm Mirre Scholte Adam J N Raymakers Aaron S Kesselheim Manuela Joore Source Type: research

AXL receptor as an emerging molecular target in colorectal cancer
Drug Discov Today. 2024 Apr 27:104005. doi: 10.1016/j.drudis.2024.104005. Online ahead of print.ABSTRACTAXL receptor tyrosine kinase (AXL) is a receptor tyrosine kinase whose aberrant expression has recently been associated with colorectal cancer (CRC), contributing to tumor growth, epithelial-mesenchymal transition (EMT), increased invasiveness, metastatic spreading, and the development of drug resistance. In this review we summarize preclinical data, the majority of which are limited to recent years, convincingly linking the AXL receptor to CRC. These findings support the value of targeting AXL with molecules in drug dis...
Source: Drug Discovery Today - April 30, 2024 Category: Drugs & Pharmacology Authors: Lucia De Rosa Rossella Di Stasi Virginia Fusco Luca D D'Andrea Source Type: research

AXL receptor as an emerging molecular target in colorectal cancer
Drug Discov Today. 2024 Apr 27:104005. doi: 10.1016/j.drudis.2024.104005. Online ahead of print.ABSTRACTAXL receptor tyrosine kinase (AXL) is a receptor tyrosine kinase whose aberrant expression has recently been associated with colorectal cancer (CRC), contributing to tumor growth, epithelial-mesenchymal transition (EMT), increased invasiveness, metastatic spreading, and the development of drug resistance. In this review we summarize preclinical data, the majority of which are limited to recent years, convincingly linking the AXL receptor to CRC. These findings support the value of targeting AXL with molecules in drug dis...
Source: Drug Discovery Today - April 30, 2024 Category: Drugs & Pharmacology Authors: Lucia De Rosa Rossella Di Stasi Virginia Fusco Luca D D'Andrea Source Type: research

Development and therapeutic implications of small molecular inhibitors that target calcium ion-related channels in tumor treatment
Drug Discov Today. 2024 Apr 24:103995. doi: 10.1016/j.drudis.2024.103995. Online ahead of print.ABSTRACTCalcium ion dysregulation exerts profound effects on various physiological activities such as tumor proliferation, migration, and drug resistance. Calcium ion-related channels play a regulatory role in maintaining calcium ion homeostasis, with most channels being highly expressed in tumor cells. Additionally, these channels serve as potential drug targets for the development of antitumor medications. In this review, we first discuss the current research status of these pathways, examining how they modulate various tumor ...
Source: Drug Discovery Today - April 26, 2024 Category: Drugs & Pharmacology Authors: Linxi Zhang Changyu Ren Jiao Liu Shuai Huang Chengyong Wu Jifa Zhang Source Type: research

Recent advances in the development of DprE1 inhibitors using AI/CADD approaches
Drug Discov Today. 2024 Apr 25:103987. doi: 10.1016/j.drudis.2024.103987. Online ahead of print.ABSTRACTTuberculosis (TB) is a global lethal disease caused by Mycobacterium tuberculosis (Mtb). The flavoenzyme decaprenylphosphoryl-β-d-ribose 2'-oxidase (DprE1) plays a crucial part in the biosynthesis of lipoarabinomannan and arabinogalactan for the cell wall of Mtb and represents a promising target for anti-TB drug development. Therefore, there is an urgent need to discover DprE1 inhibitors with novel scaffolds, improved bioactivity and high drug-likeness. Recent studies have shown that artificial intelligence/computer-aid...
Source: Drug Discovery Today - April 26, 2024 Category: Drugs & Pharmacology Authors: Kepeng Chen Ruolan Xu Xueping Hu Dan Li Tingjun Hou Yu Kang Source Type: research

A retrospective regulatory analysis of FDA recalls carried out by pharmaceutical companies from 2012 to 2023
This study investigates the types, causes and consequences of recalls, as well as FDA participation and suitable recall strategies. We relied on the FDA website to gather recall data sets from 2012 to 2023, collecting information on the date of issuance, company and type of violation. The most frequent causes for recalls were sterility issues and inadequate compliance with current good manufacturing practices (cGMP). An examination of sterility recalls revealed two primary causes: a lack of assurance in sterility (accounting for 48% of recalls) and instances of non-sterility (making up 45% of recalls). A thorough examinati...
Source: Drug Discovery Today - April 26, 2024 Category: Drugs & Pharmacology Authors: Ravi Patel Aksha Vhora Deepak Jain Rikin Patel Dignesh Khunt Rucha Patel Sathish Dyawanapelly Vijayabhaskarreddy Junnuthula Source Type: research

Development and therapeutic implications of small molecular inhibitors that target calcium ion-related channels in tumor treatment
Drug Discov Today. 2024 Apr 24:103995. doi: 10.1016/j.drudis.2024.103995. Online ahead of print.ABSTRACTCalcium ion dysregulation exerts profound effects on various physiological activities such as tumor proliferation, migration, and drug resistance. Calcium ion-related channels play a regulatory role in maintaining calcium ion homeostasis, with most channels being highly expressed in tumor cells. Additionally, these channels serve as potential drug targets for the development of antitumor medications. In this review, we first discuss the current research status of these pathways, examining how they modulate various tumor ...
Source: Drug Discovery Today - April 26, 2024 Category: Drugs & Pharmacology Authors: Linxi Zhang Changyu Ren Jiao Liu Shuai Huang Chengyong Wu Jifa Zhang Source Type: research

Recent advances in the development of DprE1 inhibitors using AI/CADD approaches
Drug Discov Today. 2024 Apr 24:103987. doi: 10.1016/j.drudis.2024.103987. Online ahead of print.ABSTRACTTuberculosis (TB) is a global lethal disease caused by Mycobacterium tuberculosis (Mtb). The flavoenzyme decaprenylphosphoryl-β-d-ribose 2'-oxidase (DprE1) plays a crucial part in the biosynthesis of lipoarabinomannan and arabinogalactan for the cell wall of Mtb and represents a promising target for anti-TB drug development. Therefore, there is an urgent need to discover DprE1 inhibitors with novel scaffolds, improved bioactivity and high drug-likeness. Recent studies have shown that artificial intelligence/computer-aid...
Source: Drug Discovery Today - April 26, 2024 Category: Drugs & Pharmacology Authors: Kepeng Chen Ruolan Xu Xueping Hu Dan Li Tingjun Hou Yu Kang Source Type: research

A retrospective regulatory analysis of FDA recalls carried out by pharmaceutical companies from 2012 to 2023
This study investigates the types, causes and consequences of recalls, as well as FDA participation and suitable recall strategies. We relied on the FDA website to gather recall data sets from 2012 to 2023, collecting information on the date of issuance, company and type of violation. The most frequent causes for recalls were sterility issues and inadequate compliance with current good manufacturing practices (cGMP). An examination of sterility recalls revealed two primary causes: a lack of assurance in sterility (accounting for 48% of recalls) and instances of non-sterility (making up 45% of recalls). A thorough examinati...
Source: Drug Discovery Today - April 26, 2024 Category: Drugs & Pharmacology Authors: Ravi Patel Aksha Vhora Deepak Jain Rikin Patel Dignesh Khunt Rucha Patel Sathish Dyawanapelly Vijayabhaskarreddy Junnuthula Source Type: research

Development and therapeutic implications of small molecular inhibitors that target calcium ion-related channels in tumor treatment
Drug Discov Today. 2024 Apr 24:103995. doi: 10.1016/j.drudis.2024.103995. Online ahead of print.ABSTRACTCalcium ion dysregulation exerts profound effects on various physiological activities such as tumor proliferation, migration, and drug resistance. Calcium ion-related channels play a regulatory role in maintaining calcium ion homeostasis, with most channels being highly expressed in tumor cells. Additionally, these channels serve as potential drug targets for the development of antitumor medications. In this review, we first discuss the current research status of these pathways, examining how they modulate various tumor ...
Source: Drug Discovery Today - April 26, 2024 Category: Drugs & Pharmacology Authors: Linxi Zhang Changyu Ren Jiao Liu Shuai Huang Chengyong Wu Jifa Zhang Source Type: research

Recent advances in the development of DprE1 inhibitors using AI/CADD approaches
Drug Discov Today. 2024 Apr 24:103987. doi: 10.1016/j.drudis.2024.103987. Online ahead of print.ABSTRACTTuberculosis (TB) is a global lethal disease caused by Mycobacterium tuberculosis (Mtb). The flavoenzyme decaprenylphosphoryl-β-d-ribose 2'-oxidase (DprE1) plays a crucial part in the biosynthesis of lipoarabinomannan and arabinogalactan for the cell wall of Mtb and represents a promising target for anti-TB drug development. Therefore, there is an urgent need to discover DprE1 inhibitors with novel scaffolds, improved bioactivity and high drug-likeness. Recent studies have shown that artificial intelligence/computer-aid...
Source: Drug Discovery Today - April 26, 2024 Category: Drugs & Pharmacology Authors: Kepeng Chen Ruolan Xu Xueping Hu Dan Li Tingjun Hou Yu Kang Source Type: research

A retrospective regulatory analysis of FDA recalls carried out by pharmaceutical companies from 2012 to 2023
This study investigates the types, causes and consequences of recalls, as well as FDA participation and suitable recall strategies. We relied on the FDA website to gather recall data sets from 2012 to 2023, collecting information on the date of issuance, company and type of violation. The most frequent causes for recalls were sterility issues and inadequate compliance with current good manufacturing practices (cGMP). An examination of sterility recalls revealed two primary causes: a lack of assurance in sterility (accounting for 48% of recalls) and instances of non-sterility (making up 45% of recalls). A thorough examinati...
Source: Drug Discovery Today - April 26, 2024 Category: Drugs & Pharmacology Authors: Ravi Patel Aksha Vhora Deepak Jain Rikin Patel Dignesh Khunt Rucha Patel Sathish Dyawanapelly Vijayabhaskarreddy Junnuthula Source Type: research