Podcasts about bamlanivimab

The place of monoclonal antibodies in COVID-19 is changing. In this episode, learn about their role in prophylaxis of patients who are at high risk of complications from acquiring COVID-19 or treatment of high-risk patients who have a mild to moderate COVID-19 infection. Listen as Gregory Huhn, MD, MPHTM, discusses when and how to use monoclonal antibodies including:BebtelovimabCilgavimab/tixagevimabSotrovimabPresenter:Gregory Huhn, MD, MPHTMAssociate ProfessorDepartment of Infectious DiseasesRush University Medical CenterSenior Director of HIV ServicesDepartment of Infectious DiseasesCook County HealthChicago, IllinoisReview the downloadable slidesets at: https://bit.ly/3xOfu1ALink to full program: https://bit.ly/3EBdf38

The SARS-CoV-2 omicron variant has affected which of our COVID-19 treatment strategies are currently effective, with some expected to maintain their efficacy and some expected to lose their efficacy. In this episode, Arthur Kim, MD, discusses the effects of the SARS-CoV-2 omicron variant on many of the COVID-19 approved, authorized, and investigational treatment options, including:Direct-acting, small-molecule antiviral agents such as   molnupiravir, nirmatrelvir + ritonavir, and remdesivirMonoclonal antibody treatments such as bamlanivimab + etesevimab, casirivimab + imdevimab, cilgavimab + tixagevimab, regdanvimab, and sotrovimabPresenter:Arthur Kim, MDAssociate ProfessorDepartment of MedicineHarvard Medical SchoolDirector, Viral Hepatitis ClinicDivision of Infectious DiseasesMassachusetts General HospitalBoston, MassachusettsReview the downloadable slidesets at:https://bit.ly/3FXc90whttps://bit.ly/32tp2BTLink to full program: https://bit.ly/3Ix8uZg

During this episode, Lynora Saxinger, MD, FRCPC, CTropMed, updates listeners on the latest Emergency Use Authorizations and guideline recommendations for optimal clinical management of COVID-19. Gain practical insights on patient identification, risk stratification, and treatment.Key points include:Treatment of COVID-19 can be broken into antiviral and immune-modulating therapiesEach agent should be used at the correct disease stage to maximize benefitAntiviral medications and mAbs show the greatest promise early during COVID-19, before the host immune response is mountedPassive immunization with mAbs can prevent infection and severe disease—and mortality—if given early to hospitalized personsOperational challenges to using these medications exist, but given the epidemic of unvaccinated persons, these treatments become increasingly relevant to reduce burden on healthcare systemsPresenter:Lynora Saxinger, MD, FRCPC, CTropMedCochair, Scientific Advisory Group  Alberta COVID-19 Emergency Coordination Centre  Associate ProfessorDivision of Infectious DiseasesDepartment of Medicine  University of AlbertaEdmonton, Alberta, CanadaContent based on an online CME program supported by an educational grant from Gilead Sciences, Inc.Follow along with the slides at:https://bit.ly/3BxQKtD Link to full program:https://bit.ly/3BwzdlC

Bamlanivimab was the first neutralising monoclonal antibody to receive emergency use authorisation from the FDA as a treatment for mild to moderate COVID-19 on 9 November 2020, 94 days after the monoclonal antibody discovery workflow began for the molecule. This achievement, says Eli Lilly, represents the shortest timeline from discovery to public usage for a monoclonal antibody to date. In February 2021, bamlanivimab administered with etesevimab received emergency use authorisation for treatment of recently diagnosed, mild to moderate COVID-19 in patients who are high risk for progression to severe COVID-19. Jones and Bedinger talk us through the Bamlanivimab story – and how one technology enabled this therapeutic to reach clinic in eight months during the pandemic. Tune in to find out how Eli Lilly strategised and built multiple collaborations enabling this Covid-19 therapeutic to reach patients in just over eight months, plus details of Carterra's involvement in the process.

In this podcast episode, Sharon R. Lewin, AO, FRACP, PhD, FAHMS, and Arthur Kim, MD, discuss data on the potential use of monoclonal antibodies (mAb) for the prevention and treatment of COVID-19, including:Rationale for use of mAbPotential for resistance to mAbSingle vs combination therapy with mAbChallenges in implementation of mAb as treatment or preventionBamlanivimabSotrovimabCasirivimab plus imdevimabLink to full program, including downloadable slidesets:  https://bit.ly/3zVTwYWPresenters: Sharon R. Lewin, AO, FRACP, PhD, FAHMSDirector, The Peter Doherty Institute for Infection and ImmunityProfessor of Infectious DiseasesFaculty Medicine Dentistry and Health SciencesUniversity of Melbourne and Royal Melbourne HospitalConsultant Infectious Diseases PhysicianDepartment of Infectious DiseasesRoyal Melbourne Hospital and Alfred HospitalMelbourne, AustraliaArthur Kim, MDAssociate ProfessorDepartment of MedicineHarvard Medical SchoolDirector, Viral Hepatitis ClinicDivision of Infectious DiseasesMassachusetts General HospitalBoston, MassachusettsSharon R. Lewin, AO, FRACP, PhD, FAHMS, has disclosed that she has received consulting fees from AbbVie, Gilead Sciences, and ViiV Healthcare; funds for research support from Leidos; and other financial or material support from Gilead Sciences, Merck, and ViiV Healthcare.Arthur Kim, MD, has disclosed that he has served on the drug and safety monitoring board for Kintor.

In COVID-19 clinical update #71, Daniel Griffin reviews updated school and child care guidance from CDC, transmission in schools, accuracy of lateral flow assays, update to J&J/Janssen vaccine EUA to include GBS, interim immunogenicity of Ad.26.CoV2.s, effectiveness of mRNA vaccines to prevent hospitalization, Bamlanivimab plus Etesevimab for mild or moderate disease, and a meta-analysis of ivermectin results. Hosts: Daniel Griffin and Vincent Racaniello Subscribe (free): iTunes, Google Podcasts, RSS, email Become a patron of TWiV! Links for this episode School and child care guidance (CDC) Transmission in schools (CDC) Accuracy of lateral flow diagnostics (Lancet) GBS with Ad.26.CoV2.s vaccine (FDA) Ad.26.CoV2.s interim immunogenicity (NEJM) mRNA vaccine effectiveness to prevent hospitalization (medRxiv) Bamlanivimab plus Etesevimab (NEJM) Meta-analysis of ivermectin studies (Clin Inf Dis) Letters read on TWiV 780 Timestamps by Jolene. Thanks! Intro music is by Ronald Jenkees Send your questions for Dr. Griffin to daniel@microbe.tv

In COVID-19 clinical update #71, Daniel Griffin reviews updated school and child care guidance from CDC, transmission in schools, accuracy of lateral flow assays, update to J&J/Janssen vaccine EUA to include GBS, interim immunogenicity of Ad.26.CoV2.s, effectiveness of mRNA vaccines to prevent hospitalization, Bamlanivimab plus Etesevimab for mild or moderate disease, and a meta-analysis of ivermectin results. Hosts: Daniel Griffin and Vincent Racaniello Subscribe (free): iTunes, Google Podcasts, RSS, email Become a patron of TWiV! Links for this episode School and child care guidance (CDC) Transmission in schools (CDC) Accuracy of lateral flow diagnostics (Lancet) GBS with Ad.26.CoV2.s vaccine (FDA) Ad.26.CoV2.s interim immunogenicity (NEJM) mRNA vaccine effectiveness to prevent hospitalization (medRxiv) Bamlanivimab plus Etesevimab (NEJM) Meta-analysis of ivermectin studies (Clin Inf Dis) Letters read on TWiV 780 Timestamps by Jolene. Thanks! Intro music is by Ronald Jenkees Send your questions for Dr. Griffin to daniel@microbe.tv

Primer nivel de gravedad: Pacientes con COVID-19 leve a moderado que no están hospitalizados. · Bamlanivimab 700 mg intravenosa dosis única. Más etesevimab 1.400 mg intravenosa dosis única 1.400 mg (AIIa). · Casirivimab 1200 mg intravenosa dosis única. Más imdevimab 1200 mg intravenosa dosis única (AIIa). Segundo nivel de gravedad: 1-No usar dexametasona u otros corticosteroides (AIIa). 2-No hay datos suficientes para recomendar a favor o en contra del uso rutinario de remdesivir en estos pacientes. Tercer nivel de gravedad: 1-Remdesivir dosis 200 mg Intravenosa una dosis, luego 100 mg IV una vez día por 4 días. Se puede extender hasta 10 días si lo requiere. (p. Ej., Para pacientes que requieren un mínimo de oxígeno suplementario) (BIIa). 2-Dexametasona dosis 6 mg Intravenosa una vez día por 10 días. Mas remdesivir a la dosis comentada. (p. Ej., Para pacientes que requieren cantidades crecientes de oxígeno) (BIII). 3-Dexametasona (p. Ej., Cuando la terapia combinada con remdesivir no se puede usar o no está disponible) (BI). Cuarto nivel de gravedad: 1-Dexametasona sola, a la misma dosis ya comentada (AI). 2-Una combinación de dexametasona más remdesivir, a las mismas dosis ya comentadas. (BIII). 3-Agregue tocilizumab a una dosis única intravenosa de 8 g/ Kg de peso corporal a una de las dos opciones anteriores (BIIa). Para los pacientes que fueron hospitalizados recientemente y que tienen necesidades de oxígeno en rápido aumento e inflamación sistémica. Quinto nivel de gravedad: 1- El uso de dexametasona en pacientes hospitalizados con COVID-19 que requieran ventilación mecánica invasiva o ECMO (AI). Si dexametasona no está disponible, como alternativa pueden ser utilizados corticosteroides tales como prednisona, metilprednisolona, o hidrocortisona a dosis equivalentes a la dexametasona. (BIII). 2-El tocilizumab debe administrarse solo en combinación con dexametasona (u otro corticosteroide en una dosis equivalente), en pacientes dentro de las 24 horas posteriores al ingreso en la unidad de cuidados intensivos. REFERENCIA https://files.covid19treatmentguidelines.nih.gov/guidelines/section/section_100.pdf https://www.covid19treatmentguidelines.nih.gov/management/therapeutic-management/ ADAPTACION PARA AUDIO-OYENTES: Medicina en una página. ==================================================== PODCAST CORONAVIRUS. COVID-19 Este es un podcast en el que desde el ojo de la ciencia. Aprenderemos del coronavirus y de la enfermedad covid-19. Recuerden al enemigo es mejor conocerlo. Para acabarlo. Esta es una producción de: Medicina en una página. medicinaenunapagina@gmail.com Dirección y Conducción: John Jarbis García Tamayo. Médico y cirujano, Epidemiólogo y Pedagogo Universitario. Portada: Gracias a Sam Balye por compartir su trabajo (foto-portada) en https://unsplash.com/. Música: https://www.youtube.com/audiolibrary/music?nv=1

Hasta el día de hoy para el tratamiento específico de pacientes con COVID-19, con acción directa contra el virus SARS CoV-2. Estamos usando medicamentos antivirales, anticuerpos monoclonales e inhibidores de proteínas. En este episodio describiremos 2 tipos autorizados por la administración de Drogas y Alimentos de los EE. UU. (FDA). Por un lado, los que son aprobados y por otro lado los que son solo autorizados para uso de emergencia. Además, cuales son para pacientes hospitalizados y los que son para los pacientes no hospitalizados. Tratamientos aprobados y autorizados por las FDA. Primero: El primer tratamiento aprobado para para el tratamiento de pacientes con COVID-19, hospitalizados con síntomas de moderados a graves. Medicamento antiviral remdesivir (Veklury). Segundo: Tratamientos autorizados para uso de emergencia para el COVID-19 por la FDA. Para pacientes hospitalizados: 1- Plasma covalente COVID-19. 2- Baricitinib, en combinación con Remdesivir. Para pacientes NO hospitalizados: 1- Los anticuerpos monoclonales: Casirivimab e Imdevimab. 2- Los anticuerpos monoclonales: Bamlanivimab y Etesevimab. REFERENCIA https://www.fda.gov/news-events/press-announcements/la-fda-aprueba-el-primer-tratamiento-para-el-covid-19 https://www.fda.gov/news-events/press-announcements/la-fda-emite-una-autorizacion-de-uso-de-emergencia-para-el-plasma-convaleciente-como-un-tratamiento https://www.fda.gov/news-events/press-announcements/actualizacion-sobre-el-coronavirus-covid-19-la-fda-autoriza-una-combinacion-de-medicamentos-para-el https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19-0

Editor's Summary by Gregory Curfman, MD, Deputy Editor of JAMA, the Journal of the American Medical Association, for the July 6, 2021 issue.

Hasta el día de hoy para el tratamiento específico de pacientes con COVID-19, con acción directa contra el virus SARS CoV-2. Estamos usando medicamentos antivirales, anticuerpos monoclonales e inhibidores de proteínas. En este episodio describiremos 2 tipos autorizados por la administración de Drogas y Alimentos de los EE. UU. (FDA). Por un lado, los que son aprobados y por otro lado los que son solo autorizados para uso de emergencia. Además, cuales son para pacientes hospitalizados y los que son para los pacientes no hospitalizados. Tratamientos aprobados y autorizados por las FDA. Primero: El primer tratamiento aprobado para para el tratamiento de pacientes con COVID-19, hospitalizados con síntomas de moderados a graves. Medicamento antiviral remdesivir (Veklury). Segundo: Tratamientos autorizados para uso de emergencia para el COVID-19 por la FDA. Para pacientes hospitalizados: 1- Plasma covalente COVID-19. 2- Baricitinib, en combinación con Remdesivir. Para pacientes NO hospitalizados: 1- Los anticuerpos monoclonales: Casirivimab e Imdevimab. 2- Los anticuerpos monoclonales: Bamlanivimab y Etesevimab. REFERENCIA https://www.fda.gov/news-events/press-announcements/la-fda-aprueba-el-primer-tratamiento-para-el-covid-19 https://www.fda.gov/news-events/press-announcements/la-fda-emite-una-autorizacion-de-uso-de-emergencia-para-el-plasma-convaleciente-como-un-tratamiento https://www.fda.gov/news-events/press-announcements/actualizacion-sobre-el-coronavirus-covid-19-la-fda-autoriza-una-combinacion-de-medicamentos-para-el https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19-0

Daniel Griffin discusses a front-line health care worker survey, pre-exposure seropositivity and subsequent infection in healthy young adults, fitted filtration efficiency of double masking, BinaxNow rapid in-home antigen test, postvaccination infections in a nursing facility, safety of mRNA vaccine in pregnant women, case control study of Bamlanivimab, no evidence for brain infection in patients with neurolgical symptoms, and mortality among US patients hospitalized with COVID-19. Hosts: Daniel Griffin and Vincent Racaniello Subscribe (free): iTunes, Google Podcasts, RSS, email Become a patron of TWiV! Links for this episode Healthcare worker survey (KFF) Seropositivity and infection risk in young adults (Lancet) Efficiency of double masking (JAMA) BinaxNow antigen test (Abbott) mRNA vaccine safety in pregnant persons (NEJM) Bamlanivimab case control study (CID) COVID-19 neuropathology (Brain) Mortality among hospitalized COVID-19 patients (JAMA) Letters read on TWiV 747 Timestamps by Jolene. Thanks! Intro music is by Ronald Jenkees Send your questions for Dr. Griffin to daniel@microbe.tv

Daniel Griffin discusses a front-line health care worker survey, pre-exposure seropositivity and subsequent infection in healthy young adults, fitted filtration efficiency of double masking, BinaxNow rapid in-home antigen test, postvaccination infections in a nursing facility, safety of mRNA vaccine in pregnant women, case control study of Bamlanivimab, no evidence for brain infection in patients with neurolgical symptoms, and mortality among US patients hospitalized with COVID-19. Hosts: Daniel Griffin and Vincent Racaniello Subscribe (free): iTunes, Google Podcasts, RSS, email Become a patron of TWiV! Links for this episode Healthcare worker survey (KFF) Seropositivity and infection risk in young adults (Lancet) Efficiency of double masking (JAMA) BinaxNow antigen test (Abbott) mRNA vaccine safety in pregnant persons (NEJM) Bamlanivimab case control study (CID) COVID-19 neuropathology (Brain) Mortality among hospitalized COVID-19 patients (JAMA) Letters read on TWiV 747 Timestamps by Jolene. Thanks! Intro music is by Ronald Jenkees Send your questions for Dr. Griffin to daniel@microbe.tv

The FDA revoke Emergency Use Authorization for bamlanivimab; Issues identified at a Janssen manufacturing facility; Merck halts trials for investigational COVID-19 therapy; A new contraceptive is approved; And Ragwitek has approval expanded.

Brian Crombie has a provocative interview with Dr. Carl Hansen, CEO of AbCellera Biologics, a British Columbia-based company that has developed a neutralizing monoclonal antibody treatment, bamlanivimab for the treatment of Covid 19, yet it sits in storage in Canada. AbCellera CEO and co-founder Carl Hansen calls Canada's reluctance to deploy the company's COVID-19 treatment “absolutely appalling and inexcusable.” In the U.S., bamlanivimab has been used to treat hundreds of thousands of COVID patients; Biden White House said monoclonal antibody treatments save one life for every 52 doses administered. Canada has also authorized the treatment. But while the federal government has purchased thousands of doses, provincial governments have balked at making them available to doctors, citing the logistical challenges of administering the treatment and a lack of evidence that it works.

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This week it's all COVID related news; There's new CDC guidance for those who are vaccinated; A first over the counter test that doesn't require a prescription; Nasopharyngeal povidone iodine and the combo of Bamlanivimab-Etesevimab is assessed; And there's reports of vaccine local reactions.

Guest: Ravindra Ganesh, M.B.B.S., M.D. and Raymund R. Razonable, M.D.  Host: Amit K. Ghosh, M.D. (@AmitGhosh006)  In this episode, Ravindra Ganesh, M.B.B.S., M.D. and Raymund R. Razonable, M.D. join Amit K. Ghosh, M.D. to review the use of monoclonal antibody as a new antiviral agent in the treatment of COVID-19 infection.  Who is most likely to benefit from monoclonal antibody infusions? Drs. Ganesh and Razonable, discuss recent studies on monoclonal antibody infusions in patients with mild to moderate COVID-19 infections. Also discussed are the logistical challenges faced and the innovative solutions that were implemented while administering this therapy, particularly navigating the acceptance of treatment, its real and perceived side effects, and lack of awareness due to inequity and poverty. Research on the development of subcutaneous or intramuscular administration for prophylaxis against COVID-19 in patients at high risk for complications or at high risk for being exposed to SARS-CoV-2 is also discussed in this episode.  Additional resources:  AskMayoExpert COVID-19 Navigator: https://askmayoexpert.mayoclinic.org/navigator/COVID-19  Weinreich DM, Sivapalasingam S, Norton T, et al. REGN-COV2, a neutralizing antibody cocktail, in outpatients with Covid-19. N Engl J Med 2021;384:238-251.  Chen P, Nirula A, Heller B, et al. SARS-CoV-2 neutralizing antibody LY-CoV555 in outpatients with Covid-19. N Engl J Med 2021;384:229-237.  Gottlieb RL, Nirula A, Chen P, et al. Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial.JAMA. Published online January 21, 2021. doi:10.1001/jama.2021.0202  An EUA for Bamlanivimab—A Monoclonal Antibody for COVID-19. JAMA. Published online December 11, 2020. doi:10.1001/jama.2020.24415  Monoclonal Antibodies: Update on this COVID-19 Experimental Therapy  https://discoverysedge.mayo.edu/2021/02/17/monoclonal-antibodies-update-on-this-covid-19-experimental-therapy/  Connect with the Mayo Clinic's School of Continuous Professional Development online at https://ce.mayo.edu/ or on Twitter @MayoMedEd. 

ONS member Donna Bydlon, BSN, RN, OCN®, network director of infusion services at St. Luke's University Hospital and Health Network in Bethlehem, PA, and member of the Greater Lehigh Valley ONS Chapter, joins Stephanie Jardine, BSN, RN, oncology clinical specialist at ONS, to discuss monoclonal antibodies to treat cancer and COVID-19 and considerations for nurses. Editor's note: After we released this episode, the U.S. Food and Drug Administration (FDA) revoked its emergency use authorization (EUA) for bamlanivimab as a single agent for COVID-19. FDA issued a new EUA permitting bamlanivimab plus etesevimab for COVID-19. The information in this episode still applies to the new EUA. Music Credit: "Fireflies and Stardust" by Kevin MacLeod Licensed under Creative Commons by Attribution 3.0 Earn 0.5 contact hours of nursing continuing professional development (NCPD) by listening to the full recording and completing an evaluation at myoutcomes.ons.org by February 26, 2023. The planners and faculty for this episode have no conflicts to disclose, and the episode has no commercial support. ONS is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center's Commission on Accreditation. Episode Notes Check out these resources from today's episode: Complete this evaluation for free NCPD. ONS Voice article: COVID-19 Drug Reference Sheet: Bamlanivimab and Etesevimab Oncology Nursing Forum article: Administration of Subcutaneous Monoclonal Antibodies in Patients With Cancer ONS/ASCO Chemotherapy Administration Safety Standards ONS/ONCC Chemotherapy Immunotherapy Certificate Course ONS Standard for Educating Nurses Who Administer Chemotherapy and Biotherapy Lilly National Cancer Institute's dictionary of cancer terms Regeneron's casirivimab and imdevimab combination

This week's stories include a caution about remdesivir; New and updated Emergency Use Authorizations; And new approvals in sleep apnea and for Botox.

On this week's pod: The Moderna vaccine and what we know about its effectiveness against emerging variants; Merck ends it's development of two vaccines; Two separate treatment combos show promise in reducing hospitalizations and preventing COVID, respectivel; And the FDA approve a new treatment for lupus nephritis. 

Using a synthetic monoclonal antibody (Bamlanivimab) may be a good treatment for people in eminent danger of onset of COVID-19 before getting the vaccine. --- Send in a voice message: https://anchor.fm/covidupdates/message

Bamlanivimab es un medicamento basado en anticuerpos monoclonales para el tratamiento de casos no hospitalizados de pacientes con covid-19. El Dr. Huerta explica más detalles de este tratamiento que fue aprobado por la Administración de Medicamentos y Alimentos de EE.UU. Además, analiza la declaración del presidente electo Joe Biden, quien asegura que más personas podrían morir por el virus si Trump no coopera con la transición del poder.Para conocer sobre cómo CNN protege la privacidad de su audiencia, visite CNN.com/privacidad

Major developments in COVID-19 vaccine and antibody treatments: Are we close to having a vaccine gain Emergency Use Authorization? The antibody bamlanivimab is given Emergency Use Authorization; An NIH study concluded that hydroxychloroquine has no clinical benefit; And unrelated to COVID, but still big news, the Advisory Committee have voted on what would-be the first Alzheimer disease treatment in decades.

Should Christians (especially Catholics) be more public? This week on A Podcast About Catholic Things, Eric and Dan talk about the obligation of Catholics to show their faces (even their rosaries) to their friends, family, neighbors, and even coworkers. The overall agreement between them is that Catholics must use their freedom of religion or lose it--and that things would not have gotten this bad if we had been more vocal in the 60s, 70s, and 80s. Catholics need to 'take up space.' In current events, we continue to talk about the American election and encourage all Christians to support the one man in Washington who is fighting for us. Facebook bans efforts to overcome the fake election. China condemns Mike Pompeo for not designating Turkish Muslim group as terrorists. Trump fires Mark Esper. In the land of nonsense, Seattle hires pimp as alternative to police force. Rhode Island signs checks as Walt Disney and Mickey Mouse. Statue in Palencia, Spain gets refaced as a potato head (pictured below), while Cincinnati puts up a Charlie Brown Christmas tree (also pictured below). Hasbro sells offensive squeeze doll. Eli Lilly gives us bamlanivimab. A fat guy in China falls through a well. Japan adds another great invention to the toilet industry.

This week on the pod; the latest COVID news, including encouraging news on antibody therapies; Updated on Emergency Use Authorization guidelines for vaccines; Remdesivir distribution; A HIV drug fails to have an impact; And why the FDA want a preterm birth treatment withdrawn from the market.