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Sanofi
NEWS

Sanofi Reports the EC Approval of MenQuadfi for Use in Infants from Age 6 Weeks Against Invasive Meningococcal Disease

Shots: The EC has approved an extension of the indication of MenQuadfi to incl. infants (≥6wks.) for protection against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, & Y Approval was supported by extensive data from the MET58 clinical study, which evaluated the immunogenicity, safety, & tolerability of MenQuadfi in infants from 6wks. of…
August 4, 2026

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Elanco
NEWS

Elanco Receives the USDA Approval for TruCan Ultra Lyme-L4 Combination Vaccine to Protect Dogs Against Lyme and Leptospirosis

Shots: The USDA has approved Elanco's TruCan Ultra Lyme-L4 to protect dogs against both Lyme disease and leptospirosis, expanding its extensive TruCan Ultra Portfolio TruCan Ultra Lyme-L4 uses Elanco’s PureFil Tech to reduce vaccination reactions & is available in a 1/2mL formulation that delivers the same broad protection as the 1 mL version, enabling comprehensive…
June 16, 2026

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NEWS

NMPA Accepts GSK’s Arexvy Submission to Prevent Lower Respiratory Tract Disease in Adults

Shots: The Chinese NMPA has accepted the application of Arexvy RSV vaccine for the prevention of LRTD caused by respiratory syncytial virus (RSV) in adults aged ≥60yrs.; regulatory decision is expected by 2027 Submission was based on extensive clinical data, incl. results from the P-III trial assessing safety & immunogenicity of Arexvy in adults (≥60yrs.)…
February 10, 2026

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Bavarian Nordic
NEWS

Bavarian Nordic Announces Topline P-II Trial Data of MVA-BN Mpox/Smallpox Vaccine in Younger Population

Shots: Bavarian Nordic has reported topline P-II trial results evaluating two standard doses of the MVA-BN mpox/smallpox vaccine in 460 participants, incl. children (2–11 yrs) & adults (18–50 yrs) across 2 cohorts in the DRC & Uganda In the trial, 227 children among 451 evaluable subjects showed a non-inferior immune response to adults (n=224) 2wks.…
October 8, 2025

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New Drug Designations - August 2024
INSIGHTS+

New Drug Designations – August 2024 

Shots:   PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. August month’s report includes designations allotted to 10 small molecules, 9 biologics, 7 cell & gene therapies, 1 vaccine, 2 radiopharmaceutical, 1 peptide, 1 antineoplastic and 2 devices   In August 2024, Invenra’s INV724 received the…
September 25, 2024

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New Drug Designations - May 2024
INSIGHTS+

New Drug Designations – May 2024

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. This month’s report includes designations allotted to 12 small molecules, 7 biologics, 9 cell & gene therapies, 1 vaccine, 1 peptide, 1 RNA candidate, 1 recombinant fusion protein, 1 imaging agent and 6 devices  This…
June 25, 2024

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thoughtspot_alyssa bladon
THOUGHTSPOT

What Are The Signs Of A Vaccine Injury?

The signs and symptoms of a potential vaccine injury can vary. They may include symptoms such as severe pain or swelling at the injection site, whole-body rashes or hives, fever, difficulty breathing or swallowing, extreme fatigue, vomiting, or swollen lymph nodes. Other adverse reactions that could be attributed to a vaccine injury include neurological disorders…
February 28, 2023

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Viewpoints_Yoshio Okubo
VIEWPOINTS

Yoshio Okubo, Senior Director, Head of Pandemic Global Product Team for Takeda Shares Insights on the Approval of its Covid-19 Vaccine

Shots: Yoshio spoke about the approval of the Nuvaxovid COVID-19 Vaccine for Primary and Booster Immunization in Japan. Nuvaxovid Intramuscular Injection is the first recombinant protein-based COVID-19 vaccine approved for use in Japan Yoshio also talked about Takeda’s collaboration with Novavax for the development, manufacturing, and commercialization of Nuvaxovid in Japan Further, the interview highlighted…
October 4, 2022

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