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CMV Vaccine Trials: Moderna’s CMV mRNA Vaccine Enters Phase III

XTalks

Moderna has been testing an experimental mRNA vaccine aimed at combating the human cytomegalovirus (CMV), which poses significant health risks to newborns and immunocompromised patients. The team used the data and patient samples from a gB/MF59 Phase II trial in adolescent girls as a benchmark to assess the new mRNA-based vaccine.

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Novavax Vaccine Becomes First FDA-Authorized Protein Vaccine for COVID-19

XTalks

The US Food and Drug Administration (FDA) has given emergency use authorization (EUA) to Novavax’s COVID-19 vaccine, making it the fourth authorized vaccine in the US against COVID-19. The vaccine is branded as Nuvaxovid outside the US with approvals/authorizations in Canada, the EU, UK, Australia and South Korea.

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Novavax’s Covid-19 vaccine gets approval in South Korea for adolescents

Pharmaceutical Technology

Novavax and its partner SK bioscience have obtained a Post Approval Change Application approval from the Korean Ministry of Food and Drug Safety (KMFDS) for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), to be used in adolescents of the age 12 to 17 years. It enrolled 2,247 adolescents across 73 US sites.

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Pfizer and BioNTech seek FDA EUA for Omicron-based Covid-19 vaccine

Pharmaceutical Technology

5-adapted bivalent vaccine for Covid-19 in people aged 12 years and above. 1-adapted vaccine. The FDA also sought the vaccine’s pre-clinical and manufacturing data for addressing the SARS-CoV-2 virus’ evolution. 5-adapted bivalent vaccine will be made readily available for shipping. 5 variant spike protein.

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Pfizer launches Phase III trial for Lyme disease vaccine  

Drug Discovery World

Pfizer has launched a Phase III clinical trial of a vaccine to protect people against Lyme disease, in collaboration with pharmaceutical company Valneva. . The trial will enrol up to 6,000 participants aged five years and older and will be conducted across 50 sites where Lyme disease is highly endemic. References .

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Eyam Vaccines and Immunotherapeutics Reaches Agreement to License Next-Generation COVID-19 Vaccine Candidates from the University of British Columbia

The Pharma Data

This License Agreement represents an important corporate milestone. The License provides EYAM with the exclusive right to develop several proprietary COVID-19 vaccine candidates in a self-amplifying mRNA vaccine platform. EYAM anticipates rapid commencement of animal trials for these COVID-19 vaccine candidates.

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FDA accepts to review ImmunityBio’s BLA for bladder cancer treatment

Pharmaceutical Technology

The Food and Drug Administration (FDA) has acc epted to review ImmunityBio’s Biologics License Application (BLA) for N-803 to treat Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients with or without Ta or T1 disease.

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