Moderna’s Post

The JN.1 vaccine just received approval in key regions and markets; EU, Japan & Taiwan. As someone who’s lived and worked across borders, I’ve seen firsthand how important it is to stay informed and proactive. COVID-19 still requires boosters to stay protected against evolving variants. If you or someone you know is vulnerable, now’s the time to talk to your doctor. #JN1Vaccine #COVID19 #Booster #TakeAction #StayProtected #HealthMatters

The Therapeutic Goods Administration (TGA) denies that the #Pfizer mRNA Covid vaccine is contaminated, as at least four independent labs around the world claim to have detected plasmid DNA contamination in vials of the mRNA Pfizer and #Moderna shots, most well over regulatory limits. #auspol #ausnews #auspol2024 #COVID19Aus #CovidVaccines #medicine #healthcare

FDA Guidance for Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization The Food and Drug Administration (FDA) issued updated guidance for the development of monoclonal antibody products targeting SARS-CoV-2 for emergency use authorization. This updated guidance supersedes the guidance issued on February 22, 2021, entitled, “Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency.” The recommendations guide industry sponsors on addressing the impact of emerging SARS-CoV-2 variants and the development of monoclonal antibody products targeting the SARS-CoV-2 intended to prevent or treat COVID-19. View the FDA Guidance here: https://lnkd.in/g9gRaKhZ

Valneva and Pfizer Present Results from the P-II (VLA15-221) Study of VLA15 Vaccine for Lyme Disease #valneva #pfizer #vla15 #lymedisease #clinicaltrial #phase2 #vaccine #immunogenicity #phase3

In an attempt to minimize the number of human trials required to compare a biosimilar medication in development with the reference product, the European Medicines Agency is suggesting waiving comparative efficacy studies (CES) for #biosimilars with a simple mechanism of action (MOA), such as recombinant proteins and monoclonal antibodies. #ema #biosimilars #biopharmaceuticals #medicine #regulatoryaffairs #regorbit #europe

Vaccine Milestone: FDA Grants Priority Review to Bavarian Nordic’s Chikungunya Vaccine BLA The FDA has granted priority review to Bavarian Nordic's Biologics License Application for its chikungunya vaccine candidate, CHIKV VLP, a virus-like particle-based vaccine for individuals aged 12 and older. With a decision expected by February 2025, this accelerated review could lead to the first approved vaccine for chikungunya virus, a mosquito-borne disease affecting over 100 countries. The European Medicines Agency is also assessing the vaccine for potential approval by mid-2025. CHIKV VLP's single-dose format and promising clinical trial results reflect Bavarian Nordic's expertise and could provide a critical tool in combating global outbreaks and reducing the long-term effects of chikungunya. For more details please click the link! https://lnkd.in/dQWGZvy4 #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

Continuous improvement of FEV1 in severe eosinophilic asthmatics on anti-interleukin-5 therapy. First author:Alain Michils; corresponding author: Alain Van Muylem Read the article here: doi.org/10.1111/all.16139 In a retrospective study, Michils et al. evaluate the FEV1 trajectory in severe eosinophilic asthmatics receiving treatment with IL-5-targeting biologics. #Allergy_journal Read more articles published in #Allergy on #biologics here: https://lnkd.in/dVsjXuR8

The COVID-19 pandemic drove the approval of vaccines based on a variety of platforms—adenoviral vectors, mRNA, DNA, VLPs, protein subunits and inactivated vaccines. In our white paper, we analyze the opportunities and challenges for each. Explore which one is right for your goals: https://bit.ly/4bDeKxx #pharma #vaccines

Intas Pharmaceutical #ImmunityBooster #Antibacterial #Antiinflammatory Intas introduces Thymotas 12.5mg. Thymotas is a patented research formulation of Thymoquinone, an immune booster for these Pandemic times. Thymotas fortifies immunity and fights infections through multimodal actions such as Anti-viral, Anti-bacterial, Anti-inflammatory, Immuno-modulatory, and Antioxidant. Thymoquinone (Thymotas) is the active biological component of Nigella sativa, (Also known as Kalonji, Black cumin, Kali Jeera). Thymotas' anti-viral effects have been demonstrated via an in-vitro test against SARS-CoV2 and has potential as an add-on to the standard treatment in COVID-19. The recommended dose for Thymotas 12.5mg is... - As immune booster: one tablet 12.5 mg per day - As adjunct to infection treatment: up to 50 mg per day based on severity of infection or as directed by the physician. Intas Pharmaceutical

Imagine if vaccines or lifesaving biologic medicines could be administered without the need for needles? Nasal spray vaccines or orally inhaled therapeutics are a promising route of administration and offer several advantages, especially in the prevention of infectious diseases that are transmitted via the respiratory tract. Did you know that at Intertek, we are building a community dedicated to this complex area of drug delivery? We host the Annual Inhaled and Nasal Biologics/DNA Forum every year in Cambridge, UK. In 2023, we welcomed over 100 delegates to the event - why not join us in 2024? Find out more> https://lnkd.in/eaKWrFKj #YoullBeAmazed #Intertek #inhaledbiologics #inhalation #DrugDelivery #DrugDevelopment #INBDF