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Libro La Economía funcionará cuando TÚ la entiendas de Gregorio Hernández Jiménez (invertirenbolsa.info)

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    Consulta aquí qué empresas tienen los inversores en sus carteras en las estadísticas de Invertirenbolsa.info



    Candidatos a vacuna de Pfizer y BioNTech logran estatus de "vía rápida" de FDA


    h
    ​​​//lta.reuters.com/articulo/salud-vacunas-coronavirus-idLTAKCN24E1EB-OUSLT

  • #2
    BioNTech dice que su vacuna para el covid-19 estará lista para fin de año, pero la inmunidad global podría tomar una década


    https://cnnespanol.cnn.com/2020/07/1...ar-una-decada/

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    • #3
      Fortísima, +9%

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      • #4
        LA VACUNA COVID DE PFIZER-BIONTECH PODRÍA ESTAR LISTA EN NOVIEMBRE

        By Urbano Cala / septiembre 1, 2020
        https://www.lagradona.com/la-vacuna-...-en-noviembre/

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        • #5
          Pfizer y BionTech preparadas para el sorpaso: planean aprobar su vacuna en noviembre


          https://www.merca2.es/vacuna-pfizer-...eneca-janssen/

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          • #6
            Alcista de libro, buscando los 85 dólares, rebota en la base del canal

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            • #7

              La vacuna del coronavirus de Pfizer y BionTech entra en fase de aprobación en Europa
              • Las compañías tienen un preacuerdo para distribuir 200 millones de dosis
              1. Javier Ruiz-Tagle

              6/10/2020 - 18:29


              La Agencia Europea del Medicamento ha comenzado el proceso de evaluación y posterior aprobación de la vacuna contra el coronavirus que desarrollan las farmacéuticas Pfizer y Bionteh. El organismo ha otorgado al antígeno un procedimiento acelerado para su estudio, por lo que los tiempos se acortarán para su llegada al mercado. Se trata de la segunda vacuna que entra en la fase de aprobación, tras hacerlos la de AstraZeneca hace unos días.



              La Agencia se apoyará para su análisis en los datos cosechados en las primeras fases de ensayos clínicos, donde la vacuna mostró su capacidad para generar inmunidad. Las estimaciones que maneja la multinacional americana es que podrían tener una primera autorización de emergencia pandémica en el plazo aproximado de un mes. La Agencia irá analizando también datos en tiempo real a medida que se vayan concluyendo los diversos estudios puestos en marcha por las farmacéuticas.

              Pfizer y BioNTech firmaron a principios de septiembre con la UE un acuerdo mediante el cuál se reservaban unos 200 millones de dosis de su vacuna, con una opción de 100 millones de dosis posteriores. Los envíos comenzarían a partir de finales de 2020, si concluyen con éxito los ensayos clínicos y obtienen la autorización regulatoria. Sin embargo, aún falta por concretar la compra, como sí se ha hecho con Sanofi/GSK o, antes, con AstraZeneca.

              La propuesta de acuerdo de suministro con la Comisión Europea supondría para Pfizer y BioNTech el mayor pedido inicial de dosis de vacunas hasta la fecha. Las dosis de la vacuna para Europa se producirían en las fábricas de BioNTech en Alemania, y en la de Pfizer en Bélgica. Si se recibe la aprobación regulatoria para el candidato, la Comisión Europea lideraría el proceso de asignación de las dosis de la vacuna entre los 27 Estados miembros de la UE.
              forum0

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              • #8
                Pfizer and BioNTech Coronavirus Vaccine Accepted for Rolling Review in Canada


                https://www.fool.com/investing/2020/...ne-accepted-f/

                Comentario


                • #9
                  Pfizer y BioNTech compiten para satisfacer las necesidades globales de una vacuna contra el Covid-19
                  https://www.latercera.com/pulso-trad...GJ23EAVFCJT3I/

                  Comentario


                  • #10
                    Libros de Gregorio Hernández Jiménez (invertirenbolsa.info)
                    Pfizer and BioNTech Announce New England Journal of Medicine Publication of Phase 1 Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19
                    PDF VersionNEW YORK and MAINZ, GERMANY, October 14, 2020Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that preliminary, peer-reviewed data from the Phase 1 portion of their ongoing U.S. study of BNT162b2 were published online in the New England Journal of Medicine (NEJM). BNT162b2, which has advanced into a global Phase 3 study, is part of the companies’ mRNA-based vaccine development program against COVID-19. The publication describes key safety and immunogenicity data from the Phase 1 portion of the U.S. trial for the BNT162b2 and BNT162b1 vaccine candidates. Among the Phase 1 study participants aged 18 to 55 years, the 50% neutralizing geometric mean titers (GMTs) for the two vaccine candidates at the 30-μg dose level on day 28 or day 35 ranged from 1.7 to 4.6 times the GMT of a panel of SARS-CoV-2 human convalescent sera (HCS). In addition, 50% neutralizing GMTs among participants 65 to 85 years of age ranged from 1.1 to 2.2 times the GMT of the HCS panel, demonstrating strong immunogenicity in younger and older adults. Further, across all populations, BNT162b2 administration was well tolerated with mild to moderate fever in fewer than 20% of the participants. Data were initially made available to the public on August 20, 2020 via the online preprint server, medRxiv. For additional details, please read the previously issued press release.

                    As previously announced, BNT162b2 was selected as the vaccine candidate to advance into a global Phase 2/3 study based on the totality of available data from preclinical and clinical studies. As of today, the trial has enrolled over 37,000 participants. For further information about this trial, visit www.ClinicalTrials.gov using the number NCT04368728.

                    About Pfizer: Breakthroughs That Change Patients’ Lives

                    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

                    Pfizer Disclosure Notice

                    The information contained in this release is as of October 14, 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

                    This release contains forward-looking information about Pfizer’s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine, the BNT162 mRNA vaccine program, and modRNA candidates BNT162b2 and BNT162b1 (including qualitative assessments of available data, potential benefits, and expectations for clinical trials), that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary data, including the possibility of unfavorable new preclinical or clinical trial data and further analyses of existing preclinical or clinical trial data that may be inconsistent with the data used for selection of the BNT162b2 vaccine candidate and dose level for the Phase 2/3 study; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications; whether regulatory authorities will be satisfied with the design of and results from these and future preclinical and clinical studies; whether and when any biologics license and/or emergency use authorization applications may be filed in any jurisdictions for BNT162b2 or any other potential vaccine candidates; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine candidate’s benefits outweigh its known risks and determination of the vaccine candidate’s efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; manufacturing capabilities or capacity, including whether the estimated numbers of doses can be manufactured within the projected time periods indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; and competitive developments.

                    A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

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