Mes: octubre 2020

Challau Lets People Around the World ‘Teleport’ to Virtually Visit Places by Beaming Into Remotely Controlled Robots

Travellers can now explore far away destinations in real-time through the eyes of a robot using their smartphone or computer

LONDON, Oct. 23, 2020 /PRNewswire/ — People who have been unable to travel can now, for the first time, visit and explore a variety of destinations with a new platform by Propelmee that lets…

Travellers can now explore far away destinations in real-time through the eyes of a robot using their smartphone or computer

LONDON, Oct. 23, 2020 /PRNewswire/ — People who have been unable to travel can now, for the first time, visit and explore a variety of destinations with a new platform by Propelmee that lets users ‘teleport’ to places thousands of miles away.

UK technology start-up Propelmee today announces the public beta-release of Challau, a first-of-its-kind robot-powered virtual travel platform. Using Challau, travellers can choose from a range of destinations called ‘Portals’ to decide where they want to ‘teleport’ to. Each Portal has a live countdown until it becomes Active, at which point anyone can enter the Portal and virtually arrive at that location. Travellers can then experience the live sights and sounds that a Challau Robot is seeing and hearing at the Portal’s physical location, and then choose to ‘beam into’ a robot.

A digital on-screen joystick lets travellers guide the robot’s movements through their smartphone or computer with a full-screen view from the robot’s main and secondary cameras. People around the robot can also see and hear the beamed in remote travellers, and using the robot’s microphone and speakers, remote travellers can speak to locals should they wish.

Challau also supports physical joysticks and other game controllers that are paired with a browser (e.g. Playstation or Xbox controllers) making the experience like a real-life first-person video game. Challau robots are equipped with built-in safety technology and artificial intelligence to support the virtual travel experience.

«Countries around the world have imposed many travel restrictions and introduced strict quarantining rules. This makes it very difficult for people to travel for leisure or recreation. Tourism is one of the last remaining sectors to go fully digital – there aren’t any good online alternatives for visiting places and that’s what we wanted to solve with Challau», says Zain Khawaja, Founder & CEO of Propelmee.

Challau currently offers virtual travel to 7 destinations in the UK, including iconic tourist attractions such as Trafalgar Square London and historic locations in the city of Oxford. Challau aims to scale up to 21 Portal destinations in the UK and internationally at the start of the New Year.

«Compared to existing online travel options, Challau gives users complete agency to explore as they wish, in real-time. We think that it’s really exciting for people to drive a robot on the other side of the world. It’s the closest thing to actually being there in person», says Khawaja.

The company is extending its technology to support other types of edge devices for unique remote travel experiences in crowded bazaars or busy city centers and is also integrating augmented reality to enrich user experiences. The service is currently free to try at www.challau.com and does not require pre-booking.

Editor’s Notes:

Propelmee owns and operates Challau. Follow @ChallauRobot for more information.

Contact:

Moeen Ashfaq – moeen@propelmee.com

Related Files

Challau tourism robot.png

Related Video

http://www.youtube.com/watch?v=7FRymi23rIA

 

Challau Lets People Around the World ‘Teleport’ to Virtually Visit Places by Beaming Into Remotely Controlled Robots

Travellers can now explore far away destinations in real-time through the eyes of a robot using their smartphone or computer

LONDON, Oct. 23, 2020 /PRNewswire/ — People who have been unable to travel can now, for the first time, visit and explore a variety of destinations with a new platform by Propelmee that lets…

Travellers can now explore far away destinations in real-time through the eyes of a robot using their smartphone or computer

LONDON, Oct. 23, 2020 /PRNewswire/ — People who have been unable to travel can now, for the first time, visit and explore a variety of destinations with a new platform by Propelmee that lets users ‘teleport’ to places thousands of miles away.

UK technology start-up Propelmee today announces the public beta-release of Challau, a first-of-its-kind robot-powered virtual travel platform. Using Challau, travellers can choose from a range of destinations called ‘Portals’ to decide where they want to ‘teleport’ to. Each Portal has a live countdown until it becomes Active, at which point anyone can enter the Portal and virtually arrive at that location. Travellers can then experience the live sights and sounds that a Challau Robot is seeing and hearing at the Portal’s physical location, and then choose to ‘beam into’ a robot.

A digital on-screen joystick lets travellers guide the robot’s movements through their smartphone or computer with a full-screen view from the robot’s main and secondary cameras. People around the robot can also see and hear the beamed in remote travellers, and using the robot’s microphone and speakers, remote travellers can speak to locals should they wish.

Challau also supports physical joysticks and other game controllers that are paired with a browser (e.g. Playstation or Xbox controllers) making the experience like a real-life first-person video game. Challau robots are equipped with built-in safety technology and artificial intelligence to support the virtual travel experience.

«Countries around the world have imposed many travel restrictions and introduced strict quarantining rules. This makes it very difficult for people to travel for leisure or recreation. Tourism is one of the last remaining sectors to go fully digital – there aren’t any good online alternatives for visiting places and that’s what we wanted to solve with Challau», says Zain Khawaja, Founder & CEO of Propelmee.

Challau currently offers virtual travel to 7 destinations in the UK, including iconic tourist attractions such as Trafalgar Square London and historic locations in the city of Oxford. Challau aims to scale up to 21 Portal destinations in the UK and internationally at the start of the New Year.

«Compared to existing online travel options, Challau gives users complete agency to explore as they wish, in real-time. We think that it’s really exciting for people to drive a robot on the other side of the world. It’s the closest thing to actually being there in person», says Khawaja.

The company is extending its technology to support other types of edge devices for unique remote travel experiences in crowded bazaars or busy city centers and is also integrating augmented reality to enrich user experiences. The service is currently free to try at www.challau.com and does not require pre-booking.

Editor’s Notes:

Propelmee owns and operates Challau. Follow @ChallauRobot for more information.

Contact:

Moeen Ashfaq – moeen@propelmee.com

Related Files

Challau tourism robot.png

Related Video

http://www.youtube.com/watch?v=7FRymi23rIA

 

Cision View original content:http://www.prnewswire.com/news-releases/challau-lets-people-around-the-world-teleport-to-virtually-visit-places-by-beaming-into-remotely-controlled-robots-301158519.html

SOURCE Propelmee

Travel restrictions: Council reviews the list of third countries for which restrictions should be lifted

Travel restrictions: Council reviews the list of third countries for which restrictions should be lifted

Travel restrictions: Council reviews the list of third countries for which restrictions should be lifted

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Travel restrictions: Council reviews the list of third countries for which restrictions should be lifted

Travel restrictions: Council reviews the list of third countries for which restrictions should be lifted

PR Newswire

BRUSSELS, 22 October 2020

BRUSSELS, 22 October 2020 /PRNewswire Policy/ — Following a review under the recommendation on the gradual lifting of the temporary restrictions on non-essential travel into the EU, the Council updated the list of countries for which travel restrictions should be lifted. As stipulated in the Council recommendation, this list will continue to be reviewed regularly and, as the case may be, updated.

Based on the criteria and conditions set out in the recommendation, as from 22 October member states should gradually lift the travel restrictions at the external borders for residents of the following third countries:

Australia

Japan

New Zealand

Rwanda

Singapore

South Korea

Thailand

Uruguay

China, subject to confirmation of reciprocity

Travel restrictions should also be gradually lifted for the special administrative regions of China Hong Kong and Macao, subject to confirmation of reciprocity.

Residents of Andorra, Monaco, San Marino and the Vatican should be considered as EU residents for the purpose of this recommendation.

The criteria to determine the third countries for which the current travel restriction should be lifted cover in particular the epidemiological situation and containment measures, including physical distancing, as well as economic and social considerations. They are applied cumulatively. Reciprocity should also be taken into account regularly and on a case-by-case basis.

Schengen associated countries (Iceland, Lichtenstein, Norway, Switzerland) also take part in this recommendation.

Council Recommendation amending Council Recommendation (EU) 2020/912 on the temporary restriction on non-essential travel into the EU and the possible lifting of such restriction

Background

On 16 March 2020, the Commission adopted a communication recommending a temporary restriction of all non-essential travel from third countries into the EU for one month. EU heads of state or government agreed to implement this restriction on 17 March. The travel restriction was extended for a further month respectively on 8 April 2020 and 8 May 2020.

On 11 June the Commission adopted a communication recommending the further extension of the restriction until 30 June 2020 and setting out an approach for a gradual lifting of the restriction on non-essential travel into the EU as of 1 July 2020.

On 30 June the Council adopted a recommendation on the gradual lifting of the temporary restrictions on non-essential travel into the EU, including an initial list of countries for which member states should start lifting the travel restrictions at the external borders. The list is reviewed every two weeks and, as the case may be, updated.

The Council recommendation is not a legally binding instrument. The authorities of the member states remain responsible for implementing the content of the recommendation. They may, in full transparency, lift only progressively travel restrictions towards countries listed.

A Member State should not decide to lift the travel restrictions for non-listed third countries before this has been decided in a coordinated manner.

Copyright European Union, 1995-2020

SOURCE European Council

BRUSSELS, 22 October 2020 /PRNewswire Policy/ — Following a review under the recommendation on the gradual lifting of the temporary restrictions on non-essential travel into the EU, the Council updated the list of countries for which travel restrictions should be lifted. As stipulated in the Council recommendation, this list will continue to be reviewed regularly and, as the case may be, updated.

Based on the criteria and conditions set out in the recommendation, as from 22 October member states should gradually lift the travel restrictions at the external borders for residents of the following third countries:

Australia

Japan

New Zealand

Rwanda

Singapore

South Korea

Thailand

Uruguay

China, subject to confirmation of reciprocity

Travel restrictions should also be gradually lifted for the special administrative regions of China Hong Kong and Macao, subject to confirmation of reciprocity.

Residents of Andorra, Monaco, San Marino and the Vatican should be considered as EU residents for the purpose of this recommendation.

The criteria to determine the third countries for which the current travel restriction should be lifted cover in particular the epidemiological situation and containment measures, including physical distancing, as well as economic and social considerations. They are applied cumulatively. Reciprocity should also be taken into account regularly and on a case-by-case basis.

Schengen associated countries (Iceland, Lichtenstein, Norway, Switzerland) also take part in this recommendation.

Council Recommendation amending Council Recommendation (EU) 2020/912 on the temporary restriction on non-essential travel into the EU and the possible lifting of such restriction

Background

On 16 March 2020, the Commission adopted a communication recommending a temporary restriction of all non-essential travel from third countries into the EU for one month. EU heads of state or government agreed to implement this restriction on 17 March. The travel restriction was extended for a further month respectively on 8 April 2020 and 8 May 2020.

On 11 June the Commission adopted a communication recommending the further extension of the restriction until 30 June 2020 and setting out an approach for a gradual lifting of the restriction on non-essential travel into the EU as of 1 July 2020.

On 30 June the Council adopted a recommendation on the gradual lifting of the temporary restrictions on non-essential travel into the EU, including an initial list of countries for which member states should start lifting the travel restrictions at the external borders. The list is reviewed every two weeks and, as the case may be, updated.

The Council recommendation is not a legally binding instrument. The authorities of the member states remain responsible for implementing the content of the recommendation. They may, in full transparency, lift only progressively travel restrictions towards countries listed.

A Member State should not decide to lift the travel restrictions for non-listed third countries before this has been decided in a coordinated manner.

Copyright European Union, 1995-2020

SOURCE European Council

Karate Combat to Air on ESPN Deportes in the U.S.

NEW YORK, Oct. 22, 2020 /PRNewswire-HISPANIC PR WIRE/ — The second season of Karate Combat, the full-contact karate league, will air on ESPN Deportes starting Thursday, Oct. 22. The 12 week season begins on October 22 at 10 p.m. ET / 7 p.m. PT, with new fight cards weekly. Karate Combat features a diverse roster of male and female athletes from over 32 nations…

NEW YORK, Oct. 22, 2020 /PRNewswire-HISPANIC PR WIRE/ — The second season of Karate Combat, the full-contact karate league, will air on ESPN Deportes starting Thursday, Oct. 22. The 12 week season begins on October 22 at 10 p.m. ET / 7 p.m. PT, with new fight cards weekly. Karate Combat features a diverse roster of male and female athletes from over 32 nations including many of Latin America’s top fighters, who deliver highlight-level knockouts again and again. (Watch the season trailer here.)

Season 2’s bouts take place in four virtual worlds rendered real-time using Epic Games’ Unreal Engine, the video game engine behind Fortnite. Throughout the season, color commentator Bas Rutten, play-by-play commentator Josh Palmer and British-Brazilian presenter Layla Anna-Lee will be joined by a series of guest stars including NFL Super Bowl champion Marshawn Lynch and a surprise guest from the series Game of Thrones.

«We’re proud to present our full contact entertainment in Spanish in the U.S. for the first time with ESPN Deportes,» said Rob Bryan, CEO of Karate Combat. «We’ve brought one of the world’s most practiced sports to pro-level for the first time, and we’re making it incredibly entertaining.»

The season debut on October 22 includes two Latin American champions: Deivis Ferreras from the Dominican Republic vs. Jesus Paucarcaja Lopez of Lima, Peru. In the coming weeks we’ll also see amazing fights from two Ecuadorians, Franklin Mina and Daniel Viveros, and from Venezuela’s Omaira Molina and Mexico’s Fabiola Esquivel González and more. (There are several Brazilian champions fighting too). Each episode gives fans fighter profiles shot in their home countries, bringing their training, as well as their struggles and their passions, to life.

Watch Karate Combat on ESPN Deportes Thursdays at 10 p.m. ET.

Past fights are also available in English at Karate Combat YouTube.

For more information about Karate Combat: press@karate.com

For more information about ESPN Deportes: Santa.Brito@espn.com

About ESPN Deportes:
ESPN Deportes is ESPN’s multimedia, Spanish-language sports brand dedicated to providing the widest variety of sports to the U.S. Hispanic sports fan via television, online and social. The network is devoted to serving the Latino sports fans by offering high-quality, culturally relevant and the most diverse sports programming available on Spanish-language television. For more information visit www.ESPNdeportes.espn.com

About Karate Combat:
About Karate Combat: Karate Combat is a premier Karate brand which operates a professional full contact karate league. The company seeks to evolve the traditional sport of Karate via karate.com, the World’s Gateway to Karate, and branded mobile apps. The firm has headquarters in New York City and Budapest. For more information visit www.karate.com.

Omaira Molina, a top lightweight contender from Venezuela, competes in Karate Combat's second season, airing Thursdays at 10 p.m. ET on ESPN Deportes. Fights take place in a virtual world created by Unreal Engine.

 

Jesus Paucarcaja Lopez of Lima, Peru in the Karate Combat Fighting Pit. The full-contact fights air Thursdays at 10 p.m. ET on ESPN Deportes.

Logo – https://mma.prnewswire.com/media/1318641/ESPN_KARATE_LOGO_Logo.jpg

Photo – https://mma.prnewswire.com/media/1318642/KC_Omaira_Scrap_v2.jpg

Photo – https://mma.prnewswire.com/media/1318643/IMG_2865.jpg

SOURCE Karate Combat

ICYMI: Lydia F. de la Torre in la Opinion: ¿Qué es la Propuesta 24?

SACRAMENTO, California, 22 de octubre de 2020 /PRNewswire-HISPANIC PR WIRE/ —  Hoy, la campaña Sí a la Prop 24 anunció que Lydia de la Torre, abogada especialista en derecho de privacidad, Of Counsel en Squire Patton Boggs y profesora adjunta en la Facultad de Derecho de la Universidad de Santa…

SACRAMENTO, California, 22 de octubre de 2020 /PRNewswire-HISPANIC PR WIRE/ —  Hoy, la campaña Sí a la Prop 24 anunció que Lydia de la Torre, abogada especialista en derecho de privacidad, Of Counsel en Squire Patton Boggs y profesora adjunta en la Facultad de Derecho de la Universidad de Santa Clara, publicó un artículo en La Opinión explicando cómo la Prop 24 permitiría a los californianos recuperarcontrol sobre su información personal. Lydia es una reconocida experta nacional en Derecho de Privacidad y Protección de Datos en California y está disponible para entrevistas en español sobre como la Prop 24 fortalece los derechos de privacidad del consumidor.

De la Torre on Prop 24:

«Las empresas más grandes del mundo recopilan información profundamente personal y privada sobre todos nosotros. La información se comparte y se vende sin muchas restricciones y, con frecuencia, ni siquiera se mantienen a salvo. La Proposición 24 permite a los residentes de California recuperar el control sobre su información personal.»

«En resumen, la proposición 24 pone en sus manos el poder de recuperar el control sobre su información personal y protege especialmente la información sensible y la información de los menores.»

Lea la opinión completa aquí.

Sí a la Privacidad. Sí a la Proposición 24.

La Proposición 24 les da a los consumidores el poder de recuperar el control de nuestra información de manos de miles de corporaciones gigantescas. La Proposición 24 hará lo siguiente:

  • Proteger su información más personal, permitiéndole evitar que las empresas usen o compartan información confidencial sobre su salud, finanzas, raza, etnia y ubicación precisa;
  • Proteger a los jóvenes, TRIPLICANDO LAS MULTAS por violaciones que involucren información sobre niños;
  • Poner nuevos límites a la recopilación y el uso de nuestra información personal por parte de las empresas;
  • Establecer una rama que haga cumplir la ley, la Agencia para Protección de la Privacidad en California, con el objetivo de defender estos derechos y responsabilizar a las empresas, así como extender su aplicación, incluyendo la IMPOSICIÓN DE SANCIONES POR NEGLIGENCIA que resulte en el robo de correos electrónicos y contraseñas de los consumidores;
  • HACER MUCHO MÁS DIFÍCIL DEBILITAR LA PRIVACIDAD en California en el futuro, evitando que intereses especiales y políticos socaven los derechos de privacidad de los californianos, y permitiendo que la Legislatura enmiende la ley para promover el objetivo principal de fortalecer la privacidad del consumidor para protegerlo mejor a usted y a su hijos, como la opción de autorizar el uso de datos, más protecciones para menores especialmente vulnerables y mayor poder para que las personas hagan responsables a los infractores.

www.caprivacy.org 
@caprivacyorg

 

Paid for by Yes on 24, Californians for Consumer Privacy

Committee major funding from Alastair Mactaggart

 

 

FUENTE Californians for Consumer Privacy

La FDA aprueba el primer tratamiento para el COVID-19

In English

SILVER SPRING, Maryland, 22 de octubre de 2020 /PRNewswire-HISPANIC PR WIRE/ — Hoy, la Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) <a target="_blank"…

In English

SILVER SPRING, Maryland, 22 de octubre de 2020 /PRNewswire-HISPANIC PR WIRE/ — Hoy, la Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) aprobó el medicamento antiviral Veklury (remdesivir) para su uso en pacientes adultos y pediátricos de 12 años o mayores y que pesen al menos 40 kilogramos (aproximadamente 88 libras) para el tratamiento del COVID-19 que requiera hospitalización. Veklury sólo debe administrarse en un hospital o en un entorno de atención médica capaz de brindar atención intensiva comparable a la atención hospitalaria para pacientes hospitalizados. Veklury es el primer tratamiento para el COVID-19 en recibir la aprobación de la FDA.

Esta aprobación no incluye a toda la población que se la ha autorizado usar Veklury bajo la Autorización de Uso de Emergencia (EUA) emitida originalmente el 1 de mayo de 2020. Para garantizar el acceso continuo a la población pediátrica previamente cubierta por la autorización EUA, la FDA revisó esta autorización EUA para que Veklury autorice el uso del fármaco para el tratamiento de COVID-19 en casos presuntos o confirmados por un laboratorio en pacientes pediátricos hospitalizados que pesen entre 3.5 kg y menos de 40 kg o en pacientes pediátricos hospitalizados menores de 12 años que pesen al menos 3.5 kg. Los ensayos clínicos que evalúan la seguridad y eficacia de Veklury en esta población de pacientes pediátricos están en curso.

«La FDA se compromete a acelerar el desarrollo y la disponibilidad de tratamientos para el COVID-19 durante esta emergencia de salud pública sin precedentes», dijo el comisionado de la FDA, el doctor Stephen M. Hahn, MD. «La aprobación de hoy está respaldada por datos de múltiples ensayos clínicos que la agencia ha evaluado rigurosamente y representa un logro científico importante durante la pandemia del COVID-19. Como parte del Programa de Aceleración del Tratamiento del Coronavirus de la FDA, la agencia continuará ayudando a llevar nuevos productos médicos a los pacientes lo antes posible, mientras que al mismo tiempo determina si son efectivos y si sus beneficios superan sus riesgos».

Bajo la Ley Federal de Alimentos, Medicamentos y Cosméticos, la aprobación de un nuevo producto farmacéutico requiere evidencia sustancial de efectividad y una demostración de seguridad para los usos previstos del medicamento. Al considerar la aprobación de un medicamento, la FDA realiza una evaluación de riesgo-beneficio basada en rigurosos estándares científicos para garantizar que los beneficios del producto superen sus riesgos para la población destinataria. Esto es diferente del estándar utilizado en la emisión de una autorización EUA.

La aprobación de Veklury fue respaldada por el análisis de datos de la agencia de tres ensayos clínicos controlados aleatorizados que incluyeron pacientes hospitalizados con COVID-19 de leve a grave.

Un ensayo clínico aleatorizado, doble ciego y controlado con placebo (ACTT-1), realizado por el Instituto Nacional de Alergias y Enfermedades Infecciosas, evaluó cuánto tiempo tardaron los sujetos en recuperarse del COVID-19 dentro de los 29 días posteriores al tratamiento. El ensayo examinó a 1,062 sujetos hospitalizados con COVID-19 leve, moderado y grave que recibieron Veklury (n= 541) o placebo (n= 521), más atención estándar. La recuperación se definió como alta hospitalaria o hospitalizado, pero sin requerir oxígeno suplementario y ya no requerir atención médica continua. El tiempo promedio de recuperación del COVID-19 fue de 10 días para el grupo de Veklury en comparación con 15 días para el grupo del placebo, una diferencia estadísticamente significativa. En general, las probabilidades de mejoría clínica en el día 15 también fueron estadísticamente significativamente más altas en el grupo de Veklury en comparación con el grupo de placebo.

Un segundo ensayo clínico aleatorizado, abierto, multicéntrico de sujetos adultos hospitalizados con COVID-19 moderado comparó el tratamiento con Veklury durante cinco días (n= 191) y el tratamiento con Veklury durante 10 días (n= 193) con atención estándar (n= 200). Los investigadores evaluaron el estado clínico de los sujetos en el día 11. En general, las probabilidades de que los síntomas del COVID-19 de un sujeto mejoraran fueron más altas estadísticamente significativas en el grupo de Veklury de cinco días en el día 11, en comparación con aquellos que sólo recibieron atención estándar. Las probabilidades de mejoría en el grupo de tratamiento de 10 días en comparación con los que recibieron solamente atención estándar fueron numéricamente favorables, pero no diferentes estadísticamente significativas.

Un tercer ensayo clínico independiente, aleatorizado, abierto, multicéntrico de sujetos adultos hospitalizados con COVID-19 grave comparó el tratamiento con Veklury durante cinco días (n= 200) y el tratamiento con Veklury durante 10 días (n= 197). Los investigadores evaluaron el estado clínico de los sujetos en el día 14. En general, las probabilidades de que los síntomas del COVID-19 de un sujeto mejoraran fueron similares para los del grupo de Veklury de cinco días que para los del grupo de Veklury de 10 días, y no hubo diferencias estadísticamente significativas en las tasas de recuperación o tasas de mortalidad entre los dos grupos.

Información importante sobre el uso de Veklury para tratar el COVID-19 para su uso aprobado está disponible en la información de prescripción del medicamento que incluye instrucciones de dosificación, posibles efectos secundarios e interacciones con otros medicamentosas. Los posibles efectos secundarios incluyen: niveles elevados de enzimas hepáticas, que pueden ser un signo de daño hepático; y reacciones alérgicas, que pueden incluir cambios en la presión arterial y frecuencia cardíaca, nivel bajo de oxígeno en la sangre, fiebre, dificultad para respirar, sibilancias, hinchazón (por ejemplo, labios, alrededor de los ojos, debajo de la piel), erupción cutánea, náuseas, sudoración o escalofríos. Información de seguridad similar sobre el uso de Veklury para tratar el COVID-19 en ciertos pacientes pediátricos hospitalizados bajo la autorización EUA está disponible en las hojas informativas para los proveedores de atención médica y para los pacientes y cuidadores.

La FDA otorgó a esta solicitud las designaciones Fast Track (Vía Rápida) y Priority Review (Revisión Prioritaria). La Agencia también otorgó a esta solicitud un Vale de Revisión Prioritaria de Contramedidas Médicas de Amenazas Importantes, que brinda incentivos adicionales para ciertos productos médicos destinados a tratar o prevenir daños por amenazas químicas, biológicas, radiológicas y nucleares específicas.

La FDA otorgó la aprobación y volvió a emitir una autorización EUA revisada a Gilead Sciences Inc.

Más información

La FDA, una dependencia del Departamento de Salud y Servicios Sociales de los Estados Unidos, protege la salud pública asegurando la protección, eficacia y seguridad de los medicamentos tanto veterinarios como para los seres humanos, las vacunas y otros productos biológicos destinados al uso en seres humanos, así como de los dispositivos médicos. La dependencia también es responsable de la protección y seguridad de nuestro suministro nacional de alimentos, los cosméticos, los suplementos dietéticos, los productos que emiten radiación electrónica, así como de la regulación de los productos de tabaco.

 

FUENTE Food & Drug Administration (FDA) (HHS)

La FDA aprueba el primer tratamiento para el COVID-19

In English

SILVER SPRING, Maryland, 22 de octubre de 2020 /PRNewswire-HISPANIC PR WIRE/ — Hoy, la Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) <a target="_blank"…

In English

SILVER SPRING, Maryland, 22 de octubre de 2020 /PRNewswire-HISPANIC PR WIRE/ — Hoy, la Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) aprobó el medicamento antiviral Veklury (remdesivir) para su uso en pacientes adultos y pediátricos de 12 años o mayores y que pesen al menos 40 kilogramos (aproximadamente 88 libras) para el tratamiento del COVID-19 que requiera hospitalización. Veklury sólo debe administrarse en un hospital o en un entorno de atención médica capaz de brindar atención intensiva comparable a la atención hospitalaria para pacientes hospitalizados. Veklury es el primer tratamiento para el COVID-19 en recibir la aprobación de la FDA.

Esta aprobación no incluye a toda la población que se la ha autorizado usar Veklury bajo la Autorización de Uso de Emergencia (EUA) emitida originalmente el 1 de mayo de 2020. Para garantizar el acceso continuo a la población pediátrica previamente cubierta por la autorización EUA, la FDA revisó esta autorización EUA para que Veklury autorice el uso del fármaco para el tratamiento de COVID-19 en casos presuntos o confirmados por un laboratorio en pacientes pediátricos hospitalizados que pesen entre 3.5 kg y menos de 40 kg o en pacientes pediátricos hospitalizados menores de 12 años que pesen al menos 3.5 kg. Los ensayos clínicos que evalúan la seguridad y eficacia de Veklury en esta población de pacientes pediátricos están en curso.

«La FDA se compromete a acelerar el desarrollo y la disponibilidad de tratamientos para el COVID-19 durante esta emergencia de salud pública sin precedentes», dijo el comisionado de la FDA, el doctor Stephen M. Hahn, MD. «La aprobación de hoy está respaldada por datos de múltiples ensayos clínicos que la agencia ha evaluado rigurosamente y representa un logro científico importante durante la pandemia del COVID-19. Como parte del Programa de Aceleración del Tratamiento del Coronavirus de la FDA, la agencia continuará ayudando a llevar nuevos productos médicos a los pacientes lo antes posible, mientras que al mismo tiempo determina si son efectivos y si sus beneficios superan sus riesgos».

Bajo la Ley Federal de Alimentos, Medicamentos y Cosméticos, la aprobación de un nuevo producto farmacéutico requiere evidencia sustancial de efectividad y una demostración de seguridad para los usos previstos del medicamento. Al considerar la aprobación de un medicamento, la FDA realiza una evaluación de riesgo-beneficio basada en rigurosos estándares científicos para garantizar que los beneficios del producto superen sus riesgos para la población destinataria. Esto es diferente del estándar utilizado en la emisión de una autorización EUA.

La aprobación de Veklury fue respaldada por el análisis de datos de la agencia de tres ensayos clínicos controlados aleatorizados que incluyeron pacientes hospitalizados con COVID-19 de leve a grave.

Un ensayo clínico aleatorizado, doble ciego y controlado con placebo (ACTT-1), realizado por el Instituto Nacional de Alergias y Enfermedades Infecciosas, evaluó cuánto tiempo tardaron los sujetos en recuperarse del COVID-19 dentro de los 29 días posteriores al tratamiento. El ensayo examinó a 1,062 sujetos hospitalizados con COVID-19 leve, moderado y grave que recibieron Veklury (n= 541) o placebo (n= 521), más atención estándar. La recuperación se definió como alta hospitalaria o hospitalizado, pero sin requerir oxígeno suplementario y ya no requerir atención médica continua. El tiempo promedio de recuperación del COVID-19 fue de 10 días para el grupo de Veklury en comparación con 15 días para el grupo del placebo, una diferencia estadísticamente significativa. En general, las probabilidades de mejoría clínica en el día 15 también fueron estadísticamente significativamente más altas en el grupo de Veklury en comparación con el grupo de placebo.

Un segundo ensayo clínico aleatorizado, abierto, multicéntrico de sujetos adultos hospitalizados con COVID-19 moderado comparó el tratamiento con Veklury durante cinco días (n= 191) y el tratamiento con Veklury durante 10 días (n= 193) con atención estándar (n= 200). Los investigadores evaluaron el estado clínico de los sujetos en el día 11. En general, las probabilidades de que los síntomas del COVID-19 de un sujeto mejoraran fueron más altas estadísticamente significativas en el grupo de Veklury de cinco días en el día 11, en comparación con aquellos que sólo recibieron atención estándar. Las probabilidades de mejoría en el grupo de tratamiento de 10 días en comparación con los que recibieron solamente atención estándar fueron numéricamente favorables, pero no diferentes estadísticamente significativas.

Un tercer ensayo clínico independiente, aleatorizado, abierto, multicéntrico de sujetos adultos hospitalizados con COVID-19 grave comparó el tratamiento con Veklury durante cinco días (n= 200) y el tratamiento con Veklury durante 10 días (n= 197). Los investigadores evaluaron el estado clínico de los sujetos en el día 14. En general, las probabilidades de que los síntomas del COVID-19 de un sujeto mejoraran fueron similares para los del grupo de Veklury de cinco días que para los del grupo de Veklury de 10 días, y no hubo diferencias estadísticamente significativas en las tasas de recuperación o tasas de mortalidad entre los dos grupos.

Información importante sobre el uso de Veklury para tratar el COVID-19 para su uso aprobado está disponible en la información de prescripción del medicamento que incluye instrucciones de dosificación, posibles efectos secundarios e interacciones con otros medicamentosas. Los posibles efectos secundarios incluyen: niveles elevados de enzimas hepáticas, que pueden ser un signo de daño hepático; y reacciones alérgicas, que pueden incluir cambios en la presión arterial y frecuencia cardíaca, nivel bajo de oxígeno en la sangre, fiebre, dificultad para respirar, sibilancias, hinchazón (por ejemplo, labios, alrededor de los ojos, debajo de la piel), erupción cutánea, náuseas, sudoración o escalofríos. Información de seguridad similar sobre el uso de Veklury para tratar el COVID-19 en ciertos pacientes pediátricos hospitalizados bajo la autorización EUA está disponible en las hojas informativas para los proveedores de atención médica y para los pacientes y cuidadores.

La FDA otorgó a esta solicitud las designaciones Fast Track (Vía Rápida) y Priority Review (Revisión Prioritaria). La Agencia también otorgó a esta solicitud un Vale de Revisión Prioritaria de Contramedidas Médicas de Amenazas Importantes, que brinda incentivos adicionales para ciertos productos médicos destinados a tratar o prevenir daños por amenazas químicas, biológicas, radiológicas y nucleares específicas.

La FDA otorgó la aprobación y volvió a emitir una autorización EUA revisada a Gilead Sciences Inc.

Más información

La FDA, una dependencia del Departamento de Salud y Servicios Sociales de los Estados Unidos, protege la salud pública asegurando la protección, eficacia y seguridad de los medicamentos tanto veterinarios como para los seres humanos, las vacunas y otros productos biológicos destinados al uso en seres humanos, así como de los dispositivos médicos. La dependencia también es responsable de la protección y seguridad de nuestro suministro nacional de alimentos, los cosméticos, los suplementos dietéticos, los productos que emiten radiación electrónica, así como de la regulación de los productos de tabaco.

 

FUENTE Food & Drug Administration (FDA) (HHS)

ONTo What Matters Most encourages safe travels, reinforces airport’s commitment to passengers, community

ONTARIO, Calif., Oct. 22, 2020 /PRNewswire/ — At Ontario International Airport (ONT), what matters most are the customers and communities it serves, the safe travels it helps to make possible, and the connections and opportunities it creates for one of the most robust population and economic centers in the United States.

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ONTARIO, Calif., Oct. 22, 2020 /PRNewswire/ — At Ontario International Airport (ONT), what matters most are the customers and communities it serves, the safe travels it helps to make possible, and the connections and opportunities it creates for one of the most robust population and economic centers in the United States.

Even amid the disruptions of a global pandemic, ONT’s commitment to the vital role it plays has been unbending, and is at the heart of a new recovery initiative for one of America’s most successful aviation gateways.

ONTo What Matters Most emphasizes Ontario’s core values and embraces the challenges and opportunities of our new reality – one that puts a higher premium than ever on health and safety. The campaign embraces the airport’s popular «ONT» brand.

«For months now, everything we do – the way we socialize, shop, work, travel and so much more – has been impacted by the COVID-19 pandemic. What Matters Most captures that desire we all have to move forward, and to do so safely and responsibly,» said Alan D. Wapner, President of the Ontario International Airport Authority (OIAA) Board of Commissioners.

Before COVID, ONT was America’s fastest-growing airport two years running, welcoming more than 5.5 million passengers in 2019. While all airports experienced a decline in passenger volumes once the pandemic hit, ONT’s recovery rate is the third highest in the U.S. and No. 1 in California. The number of passengers flying into or out of ONT has increased every month since May, and several carriers have initiated or announced new service offering. Delta Air Lines began twice-daily, nonstop service to Seattle-Tacoma International Airport this month, Southwest plans to initiate new, nonstop service to Houston in November and international carrier Volaris is planning new service to Mexico City, also in November.

«We’re excited about the future, and are determined to create the safest, most welcoming travel experience we possibly can,» said OIAA CEO Mark Thorpe. «Everything we do is with our customers in mind. ONTo What Matters Most not only reinforces that commitment, but expresses our gratitude to a community and a region that have been so supportive of us over the years.»

The campaign will include multimedia advertising, signage and messaging around ONT’s enhanced safety protocols, as well as its location, amenities, convenience and accessibility.

«Whether it’s a business traveler, a leisure traveler, a college student returning for the holidays or someone wanting to visit a family member across the country, we want to assure our customers that what matters most to them is our priority as well,» said Ronald O. Loveridge, Vice President of the OIAA Board of Commissioners.

For more on ONTo What Matters Most, click here.

About Ontario International Airport

Ontario International Airport (ONT) is the fastest growing airport in the United States, according to Global Traveler, a leading publication for frequent fliers. Located in the Inland Empire, ONT is approximately 35 miles east of downtown Los Angeles in the center of Southern California. It is a full-service airport which, before the coronavirus pandemic, offered nonstop commercial jet service to 26 major airports in the U.S., Mexico and Taiwan. More information is available at www.flyOntario.com. Follow @flyONT on Facebook, Twitter, andInstagram   

About the Ontario International Airport Authority (OIAA)

The OIAA was formed in August 2012 by a Joint Powers Agreement between the City of Ontario and the County of San Bernardino to provide overall direction for the management, operations, development and marketing of ONT for the benefit of the Southern California economy and the residents of the airport’s four-county catchment area. OIAA Commissioners are Ontario City Council Member Alan D. Wapner (President), Retired Riverside Mayor Ronald O. Loveridge (Vice President), Ontario City Council Member Jim W. Bowman (Secretary), San Bernardino County Supervisor Curt Hagman (Commissioner) and retired business executive Julia Gouw (Commissioner).

OIAA Media Contact:
Steve Lambert, (909) 841-7527 slambert@flyontario.com

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SOURCE Ontario International Airport

Toyota of Lancaster offers popular hybrid models to Los Angeles County

LANCASTER, Calif., Oct. 22, 2020 /PRNewswire-PRWeb/ — In Los Angeles County, hybrid vehicles are a popular option and Toyota has long offered hybrid models. Serving Los Angeles County, Toyota of Lancaster is host to several hybrid options from Toyota including many 2021 models.

The Prius was the first hybrid offered by Toyota, and those interested in the original Toyota hybrid can get the latest 2021 model at Toyota of <span…

LANCASTER, Calif., Oct. 22, 2020 /PRNewswire-PRWeb/ — In Los Angeles County, hybrid vehicles are a popular option and Toyota has long offered hybrid models. Serving Los Angeles County, Toyota of Lancaster is host to several hybrid options from Toyota including many 2021 models.

The Prius was the first hybrid offered by Toyota, and those interested in the original Toyota hybrid can get the latest 2021 model at Toyota of Lancaster in two varieties. There’s the traditional Prius and the plug-in hybrid Prius Prime. With the Prius Prime, drivers can charge up at home and drive for up to 25 miles on just electricity alone. Once the batteries run down, the Prius Prime will switch back to traditional hybrid operation seamlessly.

Toyota of Lancaster has 2021 hybrid versions of the Corolla, Camry, Avalon and Highlander already available and in stock. Joining the list is the all-new 2021 Venza which, like the Prius Prime, is a plug-in hybrid.

Toyota of Lancaster almost has all the Toyota Hybrid models that are expected to be offered for the 2021 model year. However, 2021 RAV4 Hybrid models have left the inventory quickly and the dealership is still anticipating arrivals of 2021 RAV4 Prime models which are plug-in hybrid versions of the RAV4.

Toyota of Lancaster has already put together several research pages for the 2021 Toyota hybrid options currently available at the dealership. Interested shoppers in the Los Angeles area can browse through these research pages on http://www.toyotaoflancaster.com. Also on the dealership’s website, car shoppers can explore all the new Toyota models currently in inventory.
In addition to the dealership’s website, Toyota of Lancaster provides plenty of ways for interested parties to contact a salesperson. To talk to a salesperson directly, car shoppers can reach out via phone at 661-948-0731. Toyota of Lancaster is located at 43301 12th St. W, Lancaster, California 93534.

 

SOURCE Toyota of Lancaster

The Cromwell to Reopen Oct. 29 as the First Adults-Only Resort on the Las Vegas Strip

LAS VEGAS, Oct. 22, 2020 /PRNewswire/ — Caesars Entertainment, Inc. (NASDAQ: CZR) («Caesars» or «the Company») today announced plans to resume operations at The Cromwell on Thursday, Oct. 29 at 10 a.m. Pacific Time as the first adults-only resort on the Las Vegas Strip. The boutique hotel and gaming floor will be open seven days a week for guests 21 and over. Guests of all ages will be welcome at GIADA, the award-winning restaurant of…

LAS VEGAS, Oct. 22, 2020 /PRNewswire/ — Caesars Entertainment, Inc. (NASDAQ: CZR) («Caesars» or «the Company») today announced plans to resume operations at The Cromwell on Thursday, Oct. 29 at 10 a.m. Pacific Time as the first adults-only resort on the Las Vegas Strip. The boutique hotel and gaming floor will be open seven days a week for guests 21 and over. Guests of all ages will be welcome at GIADA, the award-winning restaurant of notable chef Giada De Laurentiis.

**For high-res photos of The Cromwell, click here**

This announcement follows the successful reopening of Caesars Palace Las Vegas, Flamingo Las Vegas, Harrah’s Las Vegas, Paris Las Vegas, Bally’s Las Vegas, The LINQ Hotel + Experience, Planet Hollywood Resort & Casino, as well as The LINQ Promenade, High Roller Observation Wheel, FLY LINQ and Eiffel Tower Viewing Deck.

«The first standalone boutique hotel on the Strip, The Cromwell brings an exclusive, elevated lifestyle experience to the destination, focusing on hospitality, amenities and personalized service,» said Senior Vice President and The Cromwell General Manager Ken Janssen. «In line with the boutique hotel experience, we are pleased to announce that we will reopen on Oct. 29 as the first adults-only property on Las Vegas Boulevard, with a continued emphasis on our enhanced health and safety protocols.»

The following amenities will open at The Cromwell:

Restaurants

  • GIADA – will be open to guests of all ages
  • eatwell – will be open for fast-casual service, as well as mobile ordering

Bars and Lounges

  • Bound Cocktail Lounge
  • Interlude Casino Lounge
  • Drai’s Lounge – located at Drai’s After Hours

Gaming

  • William Hill Sports Book
  • Player-friendly gaming offerings like:
    • Single «0» Roulette 
    • EZ Baccarat 
    • 3-2 Shoe and Double-Deck Blackjack
    • 100X Odds on Craps
  • The Abbey, the high-limit slot area

Fitness Center

  • Fitness Center

Retail

  • Curios

Located on the bustling corner of Las Vegas Boulevard and Flamingo Road – directly across from Caesars Palace – The Cromwell keeps it intimate with 188 rooms including 19 suites and has received the Forbes Travel Guide Recommended Award for several consecutive years. The standalone boutique hotel also features a 40,000-square-foot casino with gaming offerings from single «0» roulette to EZ Baccarat to 100X odds on Craps to 3-2 shoe and double-deck blackjack, making playing at The Cromwell one of the best odds to win big in Vegas. Additional amenities include Bound – the elevated lobby bar, Interlude Casino Lounge, award-winning GIADA – the first-ever restaurant by celebrity chef and television personality Giada De Laurentiis, the fast-casual eatwell, and Drai’s After Hours – located at its original home beneath the boutique hotel.

Additionally, The Cromwell will debut the newly branded William Hill Sports Book on reopening day, with new customer offerings that include self-service sports betting kiosks and an expanded betting menu featuring LIVE InPlay Wagering.

Guests can save up to 30 percent on their next stay at The Cromwell with Caesars’ Halloween Sale from Oct. 26 through Nov. 2, as well as the Fall Savings Sale from Nov. 2-23, for select travel dates through September 2021. These hotel offers are based on availability and cannot be combined with any other offer. Offer codes: SEMI20 and FALL20.

As the Company previously announced, self-parking will remain free for Nevada residents with valid identification, registered hotel guests, and Caesars Rewards loyalty members rated Platinum and above. Beginning on Friday, Oct. 30, all other guests will be charged to self-park at Caesars’ Las Vegas resorts, including The Cromwell. The Cromwell valet will remain closed at this time. Caesars Entertainment will donate all parking fee profits collected to several charitable organizations who support Caesars team members and local communities in need, through the end of the first quarter in 2021.

The resumption of business at The Cromwell follows the reopening of Caesars regional casinos and hotels across the country, in addition to the Las Vegas properties mentioned above. Caesars will open its remaining Las Vegas properties in line with customer demand, regulatory requirements and any additional health and safety considerations.

The Cromwell has implemented Caesars’ new health and safety protocols, which enhance its existing plans and practices in these areas. All Caesars properties are focused on the well-being of team members, guests and the community, and continue to work to create an environment with high standards of sanitization and physical distancing practices. Among the enhanced health and safety protocols include more frequent cleaning and sanitization. Caesars has also implemented a health screening program for all employees. Team members and guests are required to wear masks, which the Company makes available, at all Caesars properties.

For more information on the Company’s health and safety protocols, visit: www.Caesars.com/health. 

About Caesars Entertainment, Inc. 
Caesars Entertainment, Inc. (NASDAQ: CZR) is the largest casino-entertainment company in the U.S. and one of the world’s most diversified casino-entertainment providers. Since its beginning in Reno, Nevada, in 1937, Caesars Entertainment has grown through development of new resorts, expansions and acquisitions. Caesars Entertainment’s resorts operate primarily under the Caesars®, Harrah’s®, Horseshoe® and Eldorado® brand names. Caesars Entertainment offers diversified amenities and one-of-a-kind destinations, with a focus on building loyalty and value with its guests through a unique combination of impeccable service, operational excellence and technology leadership. Caesars Entertainment is committed to its employees, suppliers, communities and the environment through its PEOPLE PLANET PLAY framework. For more information, please visit www.caesars.com/corporate.

Forward-Looking Statements
This press release includes «forward-looking statements» intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. You can identify these statements by the fact that they do not relate strictly to historical or current facts and by the use of words such as «plan,» «will,» «continue,» or the negative or other variations thereof or comparable terminology. These forward-looking statements are based on current expectations and projections about future events. You are cautioned that forward-looking statements are not guarantees of future performance or results and involve risks and uncertainties that cannot be predicted or quantified and, consequently, the actual performance and results of the Company may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to: future actions, new projects, strategies, future performance, the outcomes of contingencies, future financial results of the Company, and uncertainties related to COVID-19 and the impact of the Company’s responses to it; and other factors described from time to time in our reports filed with the Securities and Exchange Commission. You are cautioned to not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

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SOURCE Caesars Entertainment, Inc.