LIVIVO - The Search Portal for Life Sciences

zur deutschen Oberfläche wechseln
Advanced search

Search results

Result 1 - 10 of total 16

Search options

  1. Article ; Online: Anticipatory regulation for pandemic responses: are we there yet?

    Oyola-Lozada, Maria Giuliana / Pregelj, Lisette / Jenkins, Anna / Siegel, Evan / Munro, Trent / Hine, Damian

    Trends in biotechnology

    2024  

    Abstract: Can drug and vaccine regulatory agencies leverage their experience during the coronavirus disease 2019 (COVID-19) pandemic to advance from reactive regulation to adaptive regulation and beyond to anticipatory regulation to prevent or curb future ... ...

    Abstract Can drug and vaccine regulatory agencies leverage their experience during the coronavirus disease 2019 (COVID-19) pandemic to advance from reactive regulation to adaptive regulation and beyond to anticipatory regulation to prevent or curb future pandemics?
    Language English
    Publishing date 2024-03-27
    Publishing country England
    Document type Journal Article
    ZDB-ID 47474-5
    ISSN 1879-3096 ; 0167-7799
    ISSN (online) 1879-3096
    ISSN 0167-7799
    DOI 10.1016/j.tibtech.2024.02.016
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 2750: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  2. Article ; Online: Are Manufacturing Patents to Blame for Biosimilar Market Launch Delays?

    Williamson, Rhys / Munro, Trent / Ascher, David / Robertson, Avril / Pregelj, Lisette

    Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

    2023  Volume 27, Issue 3, Page(s) 287–293

    Abstract: Objectives: Biosimilar market launch delays are likely costing healthcare systems billions of dollars and preventing patients accessing affordable biologic therapies sooner. Many claim these delays are mostly caused by originator biologics' large patent ...

    Abstract Objectives: Biosimilar market launch delays are likely costing healthcare systems billions of dollars and preventing patients accessing affordable biologic therapies sooner. Many claim these delays are mostly caused by originator biologics' large patent portfolios asserted during litigation against biosimilar developers, particularly that the manufacturing patents filed after the originator is approved is an important driver of these delays. Our objective was to investigate the accuracy of these claims.
    Methods: We reviewed US Court document submissions for litigation data, including the details of patents asserted against biosimilar owners, and collated biosimilar market launch dates from publicly available databases.
    Results: We find that, although approximately half of all patents asserted in litigation were manufacturing patents, a greater proportion of composition, active pharmaceutical ingredient, and treatment patents are associated with longer market launch delays, whereas a greater proportion of manufacturing patents are associated with shorter market launch delays.
    Conclusions: Our results suggest that manufacturing patents were having less of an impact on market launch delays than other types of patents. Our findings have implications for both biosimilar and originator developers, as well as patent policy and its association with healthcare accessibility.
    MeSH term(s) Humans ; Biosimilar Pharmaceuticals ; Commerce ; Costs and Cost Analysis
    Chemical Substances Biosimilar Pharmaceuticals
    Language English
    Publishing date 2023-12-21
    Publishing country United States
    Document type Review ; Journal Article
    ZDB-ID 1471745-1
    ISSN 1524-4733 ; 1098-3015
    ISSN (online) 1524-4733
    ISSN 1098-3015
    DOI 10.1016/j.jval.2023.12.005
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 5904: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  3. Article ; Online: Delivering impactful solutions for the bioeconomy.

    Hankamer, Ben / Pregelj, Lisette / O'Kane, Shane / Hussey, Karen / Hine, Damian

    Trends in plant science

    2023  Volume 28, Issue 5, Page(s) 583–596

    Abstract: We are increasingly challenged to operate within our planetary boundaries, while delivering on United Nations (UN) Sustainable Development Goal (SDG) 2030 targets, and net-zero emissions by 2050. Failure to solve these challenges risks economic, social, ... ...

    Abstract We are increasingly challenged to operate within our planetary boundaries, while delivering on United Nations (UN) Sustainable Development Goal (SDG) 2030 targets, and net-zero emissions by 2050. Failure to solve these challenges risks economic, social, political, climate, food, water, and fuel security. Therefore, new, scalable, and adoptable circular economy solutions are urgently required. The ability of plants to use light, capture CO
    MeSH term(s) Biotechnology ; Plants
    Language English
    Publishing date 2023-03-20
    Publishing country England
    Document type Journal Article ; Review ; Research Support, Non-U.S. Gov't
    ZDB-ID 1305448-x
    ISSN 1878-4372 ; 1360-1385
    ISSN (online) 1878-4372
    ISSN 1360-1385
    DOI 10.1016/j.tplants.2023.02.007
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Bonn / Germany

    Z 2005/719: Show issues

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

    Inter-library loan at ZB MED

    Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

  4. Article ; Online: Assessing the Impact of US Food and Drug Administration Breakthrough Therapy Designation Timing on Trial Characteristics and Development Speed.

    Pregelj, Lisette / Hine, Damian C / Kesselheim, Aaron S / Darrow, Jonathan J

    Clinical pharmacology and therapeutics

    2021  Volume 110, Issue 4, Page(s) 1018–1024

    Abstract: The US Congress created the Breakthrough Therapy designation in 2012 to expedite drug development and review through efficient clinical trial design and intensive interaction with US Food and Drug Administration (FDA) reviewers. Yet, of the 116 pivotal ... ...

    Abstract The US Congress created the Breakthrough Therapy designation in 2012 to expedite drug development and review through efficient clinical trial design and intensive interaction with US Food and Drug Administration (FDA) reviewers. Yet, of the 116 pivotal trials supporting Breakthrough-designated drugs approved 2013-2018, 96 (83%) were already underway or completed when the designation was granted, limiting the potential of the designation to influence trial design. We found no difference between these trials and the 20 (17%) that had not yet begun when the designation was granted (which had greater potential to be impacted by the designation) with respect to phase, size, intervention model (single-arm vs. multi-arm), or use of surrogate end points under the Accelerated Approval (AA) pathway. This finding suggests that, in contrast to previous studies, observed trial characteristics were not likely attributable to the designation, and instead other factors such as disease category (e.g., oncology) may be driving both trial design and Breakthrough designation. The 20 trials in our sample that began after designation was granted were, however, over 8 months shorter than trials of nondesignated drugs. This suggests that designations granted early in clinical development may reduce trial time by influencing aspects of clinical programs other than design characteristics, such as timelines for FDA responses. Alternately, certain drugs may be more likely to both receive an early designation and have a shorter trial duration, for example, because of therapeutic category or large effect size.
    MeSH term(s) Clinical Trials as Topic ; Drug Approval ; Drug Development ; Drug and Narcotic Control ; Humans ; Time Factors ; United States ; United States Food and Drug Administration
    Language English
    Publishing date 2021-07-01
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 123793-7
    ISSN 1532-6535 ; 0009-9236
    ISSN (online) 1532-6535
    ISSN 0009-9236
    DOI 10.1002/cpt.2318
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 20: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  5. Article: Working Hard or Hardly Working? Regulatory Bottlenecks in Developing a COVID-19 Vaccine

    Pregelj, Lisette / Hine, Damian C / Oyola-Lozada, Maria G / Munro, Trent P

    Trends in biotechnology. 2020 Sept., v. 38, no. 9

    2020  

    Abstract: Vaccine solutions rarely reach the public until after an outbreak abates; an Ebola vaccine was approved 5 years after peak outbreak and SARS, MERS, and Zika vaccines are still in clinical development. Despite massive leaps forward in rapid science, other ...

    Abstract Vaccine solutions rarely reach the public until after an outbreak abates; an Ebola vaccine was approved 5 years after peak outbreak and SARS, MERS, and Zika vaccines are still in clinical development. Despite massive leaps forward in rapid science, other regulatory bottlenecks are hamstringing the global effort for pandemic vaccines.
    Keywords COVID-19 infection ; biotechnology ; pandemic ; vaccines
    Language English
    Dates of publication 2020-09
    Size p. 943-947.
    Publishing place Elsevier Ltd
    Document type Article
    Note NAL-AP-2-clean
    ZDB-ID 47474-5
    ISSN 1879-3096 ; 0167-7799
    ISSN (online) 1879-3096
    ISSN 0167-7799
    DOI 10.1016/j.tibtech.2020.06.004
    Database NAL-Catalogue (AGRICOLA)

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 2750: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  6. Article ; Online: Transcription profiling of the isoflavone phenylpropanoid pathway in soybean in response to Bradyrhizobium japonicum inoculation.

    Pregelj, Lisette / McLanders, Joanne R / Gresshoff, Peter M / Schenk, Peer M

    Functional plant biology : FPB

    2020  Volume 38, Issue 1, Page(s) 13–24

    Abstract: Isoflavones are legume-specific secondary metabolites that function as defence compounds, signal molecules and regulators of gene expression during both pathogen attack and beneficial plant-microbe interactions. They are synthesised by a branch of the ... ...

    Abstract Isoflavones are legume-specific secondary metabolites that function as defence compounds, signal molecules and regulators of gene expression during both pathogen attack and beneficial plant-microbe interactions. They are synthesised by a branch of the core phenylpropanoid pathway, using several isoenzymes within each enzymatic step. Gene-specific quantitative real-time reverse transcriptase PCR (qRT-PCR) was used to quantify expression of isoflavone synthesis genes in soybean (Glycine max L). Genes encoding chalcone synthase 7 (CHS7), chalcone synthase 8 (CHS8) and isoflavone synthase 1 (IFS1) displayed high basal expression levels in roots compared with hypocotyls, suggesting they could be the gene family members encoding the isoenzyme that contributes the most to the principal substrate flux towards specific isoflavone synthesis in roots. The genes encoding phenylalanine ammonia lyase 1 (PAL1) and IFS1 showed induction in root tissue after inoculation with Bradyrhizobium japonicum (Kirchner) Jordan, suggesting a control point. The absence of a functional nodulation regulator, GmNARK (G. max nodulation autoregulation receptor kinase), in the soybean mutant nts1007 resulted in significantly increased basal expression of PAL1 compared with levels induced by B. japonicum, suggesting that GmNARK is a negative regulator for isoflavone phenylpropanoid pathway genes during nodulation and that distinct genes, as opposed to the complete pathway, are coordinately regulated by the nodulation status of the mutant.
    Language English
    Publishing date 2020-06-02
    Publishing country Australia
    Document type Journal Article
    ZDB-ID 2071582-1
    ISSN 1445-4416 ; 1445-4408
    ISSN (online) 1445-4416
    ISSN 1445-4408
    DOI 10.1071/FP10093
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Bonn / Germany

    Z 4753: Show issues

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

    Inter-library loan at ZB MED

    Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

  7. Article ; Online: Working Hard or Hardly Working? Regulatory Bottlenecks in Developing a COVID-19 Vaccine.

    Pregelj, Lisette / Hine, Damian C / Oyola-Lozada, Maria G / Munro, Trent P

    Trends in biotechnology

    2020  Volume 38, Issue 9, Page(s) 943–947

    Abstract: Vaccine solutions rarely reach the public until after an outbreak abates; an Ebola vaccine was approved 5 years after peak outbreak and SARS, MERS, and Zika vaccines are still in clinical development. Despite massive leaps forward in rapid science, other ...

    Abstract Vaccine solutions rarely reach the public until after an outbreak abates; an Ebola vaccine was approved 5 years after peak outbreak and SARS, MERS, and Zika vaccines are still in clinical development. Despite massive leaps forward in rapid science, other regulatory bottlenecks are hamstringing the global effort for pandemic vaccines.
    MeSH term(s) Betacoronavirus/drug effects ; Betacoronavirus/immunology ; Betacoronavirus/pathogenicity ; COVID-19 ; COVID-19 Vaccines ; Coronavirus Infections/epidemiology ; Coronavirus Infections/immunology ; Coronavirus Infections/prevention & control ; Coronavirus Infections/virology ; Drug Approval/organization & administration ; Ebola Vaccines/administration & dosage ; Ebola Vaccines/biosynthesis ; Ebolavirus/drug effects ; Ebolavirus/immunology ; Ebolavirus/pathogenicity ; Europe/epidemiology ; Global Health/trends ; Government Regulation ; Hemorrhagic Fever, Ebola/epidemiology ; Hemorrhagic Fever, Ebola/immunology ; Hemorrhagic Fever, Ebola/prevention & control ; Hemorrhagic Fever, Ebola/virology ; Humans ; Influenza A Virus, H1N1 Subtype/genetics ; Influenza A Virus, H1N1 Subtype/immunology ; Influenza Vaccines/administration & dosage ; Influenza Vaccines/biosynthesis ; Influenza, Human/epidemiology ; Influenza, Human/immunology ; Influenza, Human/prevention & control ; Influenza, Human/virology ; Middle East Respiratory Syndrome Coronavirus/drug effects ; Middle East Respiratory Syndrome Coronavirus/immunology ; Middle East Respiratory Syndrome Coronavirus/pathogenicity ; Pandemics/prevention & control ; Pneumonia, Viral/epidemiology ; Pneumonia, Viral/immunology ; Pneumonia, Viral/prevention & control ; Pneumonia, Viral/virology ; SARS Virus/drug effects ; SARS Virus/immunology ; SARS Virus/pathogenicity ; SARS-CoV-2 ; Severe Acute Respiratory Syndrome/epidemiology ; Severe Acute Respiratory Syndrome/immunology ; Severe Acute Respiratory Syndrome/prevention & control ; Severe Acute Respiratory Syndrome/virology ; United States/epidemiology ; Viral Vaccines/administration & dosage ; Viral Vaccines/biosynthesis ; Zika Virus/drug effects ; Zika Virus/immunology ; Zika Virus/pathogenicity ; Zika Virus Infection/epidemiology ; Zika Virus Infection/immunology ; Zika Virus Infection/prevention & control ; Zika Virus Infection/virology
    Chemical Substances COVID-19 Vaccines ; Ebola Vaccines ; Influenza Vaccines ; Viral Vaccines
    Keywords covid19
    Language English
    Publishing date 2020-06-13
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 47474-5
    ISSN 1879-3096 ; 0167-7799
    ISSN (online) 1879-3096
    ISSN 0167-7799
    DOI 10.1016/j.tibtech.2020.06.004
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 2750: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  8. Article ; Online: Changes in clinical trial length.

    Pregelj, Lisette / Verreynne, Martie-Louise / Hine, Damian

    Nature reviews. Drug discovery

    2015  Volume 14, Issue 5, Page(s) 307–308

    MeSH term(s) Clinical Trials as Topic/methods ; Drug Design ; Humans ; Regression Analysis ; Research Design ; Time Factors
    Language English
    Publishing date 2015-05
    Publishing country England
    Document type Journal Article
    ZDB-ID 2062954-0
    ISSN 1474-1784 ; 1474-1776
    ISSN (online) 1474-1784
    ISSN 1474-1776
    DOI 10.1038/nrd4611
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 5564: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 334: Show issues
    Zs.MG 63: Show issues

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  9. Article ; Online: Working Hard or Hardly Working? Regulatory Bottlenecks in Developing a COVID-19 Vaccine

    Pregelj, Lisette / Hine, Damian C. / Oyola-Lozada, Maria G. / Munro, Trent P.

    Trends in Biotechnology

    2020  Volume 38, Issue 9, Page(s) 943–947

    Keywords Biotechnology ; Bioengineering ; covid19
    Language English
    Publisher Elsevier BV
    Publishing country us
    Document type Article ; Online
    ZDB-ID 47474-5
    ISSN 1879-3096 ; 0167-7799
    ISSN (online) 1879-3096
    ISSN 0167-7799
    DOI 10.1016/j.tibtech.2020.06.004
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

    Full text online

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 2750: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  10. Article: Working Hard or Hardly Working? Regulatory Bottlenecks in Developing a COVID-19 Vaccine

    Pregelj, Lisette / Hine, Damian C / Oyola-Lozada, Maria G / Munro, Trent P

    Trends Biotechnol

    Abstract: Vaccine solutions rarely reach the public until after an outbreak abates; an Ebola vaccine was approved 5 years after peak outbreak and SARS, MERS, and Zika vaccines are still in clinical development. Despite massive leaps forward in rapid science, other ...

    Abstract Vaccine solutions rarely reach the public until after an outbreak abates; an Ebola vaccine was approved 5 years after peak outbreak and SARS, MERS, and Zika vaccines are still in clinical development. Despite massive leaps forward in rapid science, other regulatory bottlenecks are hamstringing the global effort for pandemic vaccines.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #597298
    Database COVID19

    Kategorien

    Inter-library loan at ZB MED

    Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

To top