BioNet, a biotechnology company developing and manufacturing next generation vaccines including recombinant and mRNA vaccines, announced on Tuesday that it has received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the granting of marketing authorisation in the European Union for VacPertagen, a standalone acellular pertussis vaccine.
The benefits of VacPertagen were demonstrated in three clinical studies in adults, adolescents and pregnant women.
Pertussis is a highly contagious respiratory disease that poses a significant risk to newborns and older adults.
Prof. Emeritus Stanley Plotkin, chairman of the BioNet Scientific Advisory Board, said: "Receiving a positive CHMP opinion for VacPertagen reflects years of scientific innovation and clinical development with collaborative efforts across continents."
Philippe Guillot-Chene, CEO of BioNet Europe, added: "This is the first standalone pertussis vaccine to receive a CHMP favourable opinion through the centralised procedure in the European Union. This marks a historic milestone for BioNet and validates our vision to develop an improved pertussis-only vaccine specifically designed to address the re-emergence of pertussis globally."
BioInvent secures EMA positive opinion for Orphan Drug Designation of BI-1808 in CTCL
Lupin launches Risperidone long-acting injectable with 180-day CGT exclusivity in US market
BodyLogicMD supports recommendation to remove black box warnings on certain forms of oestrogen
Fondazione Telethon reports positive opinion for Waskyra marketing authorisation in Europe
Maxx Orthopedics Receives FDA 510(k) Clearance for Its Libertas® Bipolar Hip System
CHMP issues positive opinion for DAWNZERA in hereditary angioedema
Merck to acquire Cidara Therapeutics in USD9.2bn deal to expand antiviral portfolio
Ingenus Pharmaceuticals' generic equivalent to Premarin receives US FDA approval
Ascletis Pharma announces ASC36 and ASC35 co-formulation for clinical development
EirGenix signs second global exclusive licensing deal with Sandoz