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EMA Marketing Authorization of New Drugs in November 2025  

Shots:  Innovation in drug development continues to redefine the future of healthcare, fueling bold scientific partnerships and transforming how diseases are understood, managed, and treated across every therapeutic frontier  In November, the EMA issued positive CHMP opinions for six significant therapies and 2 EU approval: Sanofi’s Teizeild (Teplizumab) to delay the onset of stage 3 type 1 diabetes, and Ionis and Otsuka’s Dawnzera (Donidalorsen) for the routine prevention of HAE attacks  In…

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BioNet’s VacPertagen Receives the CHMP’s Positive Opinion for Pertussis Disease 

Shots:  The CHMP has recommended VacPertagen as a booster aganist Pertussis for pts (age≥12) and for passive infant protection via maternal immunization during pregnancy   VacPertagen is an acellular pertussis vaccine with two components, including recombinant Pertussis Toxin (PTgen) and filamentous haemagglutinin (FHA), providing targeted protection without unnecessary antigens   VacPertagen’s benefits have been demonstrated in three clinical studies involving adults, adolescents, and pregnant women  Ref: BioNet| Image: BioNet| Press Release…

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