For Publishers
DiscoveryMetadataPeer reviewHostingPublishing
For Researchers
JoinPublishReviewCollect
Register
Blog
About
Search
Advanced search
My ScienceOpen
Search
For Publishers
For Researchers
Blog
About
12
views
40
references
 Top references
cited by
0
    
0 reviews
 Review
0
comments
 Comment
0
recommends
+1 Recommend
1 collections
    0
    shares
      528
      similar
       All similar
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Evaluación positiva de medicamentos: abril, mayo y junio 2020 Translated title: Positive assessment of drugs: April, May and June 2020

      brief-report
      Author(s): , , ,
      Publication date (Print and electronic):
      Journal: Sanidad Militar
      Publisher: Ministerio de Defensa
      Keywords: Alpelisib (Piqray®), Bulevirtida (Hepcludex®), Elexacaftor/Tezacaftor/Ivacaftor (Kaftrio®), Entrectinib (Rozlytrek®), Glasdegib (Daurismo®), Imlifidasa (Idefirix®), Indacaterol/Glicopirronio/Furoato de mometasona (Enerzair Breezhaler® y Zimbus Breezhaler®), Lefamulina (Xenleta®), Luspatercept (Reblozyl®), Remdesivir (Veklury®), Vacuna frente al Ébola (MVA-BNFilo multivalente, recombinante, no-replicativo) (Mvabea®), Vacuna frente al Ébola (Vacuna monovalente recombinante incapaz de replicar con vector ad26 que codifica la longitud completa de glicoproteína (gp) de ébolavirus zaire) (Zabdeno®) , Alpelisib (Piqray®), Bulevirtida (Hepcludex®), Elexacaftor/Tezacaftor/Ivacaftor (Kaftrio®), Entrectinib (Rozlytrek®), Glasdegib (Daurismo®), Imlifidasa (Idefirix®), Indacaterol/Glicopirronio/Furoato de mometasona(Enerzair Breezhaler® y Zimbus Breezhaler®), Lefamulina (Xenleta®), Luspatercept (Reblozyl®), Remdesivir (Veklury®), Vacuna frente al Ébola (MVA-BNFilo multivalente, recombinante, noreplicativo) (Mvabea®), Vacuna frente al Ébola (Vacuna monovalente recombinante incapaz de replicar con vector ad26 que codifica la longitud completa de glicoproteína (gp) de ébolavirus zaire) (Zabdeno®)

      Read this article at

      SciELO
      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          RESUMEN Se reseñan los medicamentos evaluados y con dictamen positivo por comisión de expertos de la Agencia Española de Medicamentos y Productos Sanitarios o de la Agencia Europea del Medicamento hechos públicos en abril, mayo y junio de 2020, y considerados de mayor interés para el profesional sanitario. Se trata de opiniones técnicas positivas que son previas a la autorización y puesta en el mercado del medicamento.

          Translated abstract

          SUMMARY The drugs assessed by the Spanish Agency for Medicines and Health Products or European Medicines Agency made public in April, May and June 2020, and considered of interest to the healthcare professional, are reviewed. These are positive technical reports prior to the authorization and placing on the market of the product.

          Related collections

          Most cited references40

          • Record: found
          • Abstract: found
          • Article: not found

          Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial

          Yeming Wang, Dingyu Zhang, Guanhua Du … (2021)
          Summary Background No specific antiviral drug has been proven effective for treatment of patients with severe coronavirus disease 2019 (COVID-19). Remdesivir (GS-5734), a nucleoside analogue prodrug, has inhibitory effects on pathogenic animal and human coronaviruses, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in vitro, and inhibits Middle East respiratory syndrome coronavirus, SARS-CoV-1, and SARS-CoV-2 replication in animal models. Methods We did a randomised, double-blind, placebo-controlled, multicentre trial at ten hospitals in Hubei, China. Eligible patients were adults (aged ≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection, with an interval from symptom onset to enrolment of 12 days or less, oxygen saturation of 94% or less on room air or a ratio of arterial oxygen partial pressure to fractional inspired oxygen of 300 mm Hg or less, and radiologically confirmed pneumonia. Patients were randomly assigned in a 2:1 ratio to intravenous remdesivir (200 mg on day 1 followed by 100 mg on days 2–10 in single daily infusions) or the same volume of placebo infusions for 10 days. Patients were permitted concomitant use of lopinavir–ritonavir, interferons, and corticosteroids. The primary endpoint was time to clinical improvement up to day 28, defined as the time (in days) from randomisation to the point of a decline of two levels on a six-point ordinal scale of clinical status (from 1=discharged to 6=death) or discharged alive from hospital, whichever came first. Primary analysis was done in the intention-to-treat (ITT) population and safety analysis was done in all patients who started their assigned treatment. This trial is registered with ClinicalTrials.gov, NCT04257656. Findings Between Feb 6, 2020, and March 12, 2020, 237 patients were enrolled and randomly assigned to a treatment group (158 to remdesivir and 79 to placebo); one patient in the placebo group who withdrew after randomisation was not included in the ITT population. Remdesivir use was not associated with a difference in time to clinical improvement (hazard ratio 1·23 [95% CI 0·87–1·75]). Although not statistically significant, patients receiving remdesivir had a numerically faster time to clinical improvement than those receiving placebo among patients with symptom duration of 10 days or less (hazard ratio 1·52 [0·95–2·43]). Adverse events were reported in 102 (66%) of 155 remdesivir recipients versus 50 (64%) of 78 placebo recipients. Remdesivir was stopped early because of adverse events in 18 (12%) patients versus four (5%) patients who stopped placebo early. Interpretation In this study of adult patients admitted to hospital for severe COVID-19, remdesivir was not associated with statistically significant clinical benefits. However, the numerical reduction in time to clinical improvement in those treated earlier requires confirmation in larger studies. Funding Chinese Academy of Medical Sciences Emergency Project of COVID-19, National Key Research and Development Program of China, the Beijing Science and Technology Project.
          Article 0 comments Cited 1819 times – based on 0 reviews     Review now
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Alpelisib for PIK3CA-Mutated, Hormone Receptor–Positive Advanced Breast Cancer

            Fabrice André, Eva M. Ciruelos, Gábor Rubovszky … (2019)
            PIK3CA mutations occur in approximately 40% of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. The PI3Kα-specific inhibitor alpelisib has shown antitumor activity in early studies.
            Article 0 comments Cited 874 times – based on 0 reviews     Review now
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              Safety and Antitumor Activity of the Multitargeted Pan-TRK, ROS1, and ALK Inhibitor Entrectinib: Combined Results from Two Phase I Trials (ALKA-372-001 and STARTRK-1).

              Alexander Drilon, Salvatore Siena, Sai-Hong Ignatius Ou … (2017)
              Entrectinib, a potent oral inhibitor of the tyrosine kinases TRKA/B/C, ROS1, and ALK, was evaluated in two phase I studies in patients with advanced or metastatic solid tumors, including patients with active central nervous system (CNS) disease. Here, we summarize the overall safety and report the antitumor activity of entrectinib in a cohort of patients with tumors harboring NTRK1/2/3, ROS1, or ALK gene fusions, naïve to prior TKI treatment targeting the specific gene, and who were treated at doses that achieved therapeutic exposures consistent with the recommended phase II dose. Entrectinib was well tolerated, with predominantly Grades 1/2 adverse events that were reversible with dose modification. Responses were observed in non-small cell lung cancer, colorectal cancer, mammary analogue secretory carcinoma, melanoma, and renal cell carcinoma, as early as 4 weeks after starting treatment and lasting as long as >2 years. Notably, a complete CNS response was achieved in a patient with SQSTM1-NTRK1-rearranged lung cancer.Significance: Gene fusions of NTRK1/2/3, ROS1, and ALK (encoding TRKA/B/C, ROS1, and ALK, respectively) lead to constitutive activation of oncogenic pathways. Entrectinib was shown to be well tolerated and active against those gene fusions in solid tumors, including in patients with primary or secondary CNS disease. Cancer Discov; 7(4); 400-9. ©2017 AACR.This article is highlighted in the In This Issue feature, p. 339.
              Article 0 comments Cited 189 times – based on 0 reviews     Review now
                Bookmark
                All references

                Author and article information

                Journal
                Journal ID (publisher-id): sm
                Title: Sanidad Militar
                Abbreviated Title: Sanid. Mil.
                Publisher: Ministerio de Defensa (Madrid, Madrid, Spain )
                ISSN (Print): 1887-8571
                Publication date (Print and electronic): September 2020
                Volume: 76
                Issue: 3
                Pages: 177-182
                Affiliations
                [1] orgnameServicio de Farmacología Clínica
                [3] Madrid orgnameHospital Central de la Defensa Gómez Ulla orgdiv1Servicio de Farmacia Hospitalaria España
                [2] orgnameServicio de Farmacología Clínica
                Article
                Publisher ID: S1887-85712020000300177 Publisher ID: S1887-8571(20)07600300177
                DOI: 10.4321/s1887-85712020000300007
                SO-VID: 05efc91d-2b62-4cbc-9f44-ae360c3baa25
                License:

                http://creativecommons.org/licenses/by/4.0/

                History
                Date accepted : 22 October 2020
                Date received : 16 October 2020
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 40, Pages: 6
                Product

                SciELO Spain

                Categories
                Subject: Notas Técnicas

                Keywords: Alpelisib (Piqray®),Luspatercept (Reblozyl®),Bulevirtida (Hepcludex®),Elexacaftor/Tezacaftor/Ivacaftor (Kaftrio®),Glasdegib (Daurismo®),Lefamulina (Xenleta®),Indacaterol/Glicopirronio/Furoato de mometasona(Enerzair Breezhaler® y Zimbus Breezhaler®),Imlifidasa (Idefirix®),Entrectinib (Rozlytrek®),Indacaterol/Glicopirronio/Furoato de mometasona (Enerzair Breezhaler® y Zimbus Breezhaler®),Remdesivir (Veklury®),Vacuna frente al Ébola (MVA-BNFilo multivalente, recombinante, no-replicativo) (Mvabea®),Vacuna frente al Ébola (Vacuna monovalente recombinante incapaz de replicar con vector ad26 que codifica la longitud completa de glicoproteína (gp) de ébolavirus zaire) (Zabdeno®),Vacuna frente al Ébola (MVA-BNFilo multivalente, recombinante, noreplicativo) (Mvabea®)
                Data availability:
                Keywords: Alpelisib (Piqray®), Luspatercept (Reblozyl®), Bulevirtida (Hepcludex®), Elexacaftor/Tezacaftor/Ivacaftor (Kaftrio®), Glasdegib (Daurismo®), Lefamulina (Xenleta®), Indacaterol/Glicopirronio/Furoato de mometasona(Enerzair Breezhaler® y Zimbus Breezhaler®), Imlifidasa (Idefirix®), Entrectinib (Rozlytrek®), Indacaterol/Glicopirronio/Furoato de mometasona (Enerzair Breezhaler® y Zimbus Breezhaler®), Remdesivir (Veklury®), Vacuna frente al Ébola (MVA-BNFilo multivalente, recombinante, no-replicativo) (Mvabea®), Vacuna frente al Ébola (Vacuna monovalente recombinante incapaz de replicar con vector ad26 que codifica la longitud completa de glicoproteína (gp) de ébolavirus zaire) (Zabdeno®), Vacuna frente al Ébola (MVA-BNFilo multivalente, recombinante, noreplicativo) (Mvabea®)

                Comments

                Comment on this article