Pertussis cases surge: Over 60,000 reported in Europe; infants most at risk. Maternal vaccination expands: Finland, Norway, and UK updated pregnancy vaccine strategies. BioNet advances: Submitted recombinant pertussis vaccine to EMA; secured EU-GMP approval. Nasal vaccine progresses: ILiAD’s BPZE1 granted … Read the full press release
Posted in Denmark, European Union, Finland, France, Germany, Healthcare, Ireland, News, Norway, Pharma & Biotech, Science, United Kingdom
Tagged acellular pertussis vaccine, Adacel, antibody avidity, antigen dose, ASEAN, Bio Farma, BioNet, biotechnology, booster dose, Boostrix-IPV, BPZE1, certification, Chulalongkorn University, clinical trial, compliance, Dario Cresci, dTap, ECDC, EMA, EU-GMP, EU-GMP certification, EU/EEA, Europe Confronts Pertussis Resurgence as Infant Cases Rise Amid Falling Immunity and Vaccination Gaps, Europe Faces Pertussis Resurgence Amid Waning Immunity and Falling Maternal Vaccination Rates, European Medicines Agency, European Union, European Union Good Manufacturing Practice, Europe’s Pertussis Vaccine Market Opens to New Entrants as Demand Rises, From EU-GMP Certification to ASEAN Partnerships BioNet Broadens Its Global Vaccine Strategy, GMP production facilities, GSK, Hanna Nohynek, health policy, HPRA, human challenge trial, hVIVO, ILiAD Biotechnologies, immunization strategy, infant protection, Innovation Passport, Institut Pasteur, intranasal vaccine, Ireland Health Products Regulatory Authority, Lancet Infectious Diseases, maternal vaccination, MHRA, mucosal immunity, outbreak, pandemic recovery, Pertagen®, pertussis, pertussis vaccine, Pertussis Vaccine Manufacturing, pharmaceutical quality, Phase 3, Philippe Guillot-Chêne, pregnancy immunization, public health, recombinant pertussis vaccine, recombinant pertussis vaccines, regulatory approval, Sanofi, Tdap, TdaP combination vaccine, V, vaccine, vaccine blunting, vaccine development, Vaccine Hesitancy, vaccine pipeline, vaccine rollout, vaccine shortage, vaccine supply, vaccine uptake, VacPertagen, whooping cough
BioNet earns EU-GMP certification for its acellular pertussis vaccine, confirming compliance with EU manufacturing and quality standards. Inspection by Ireland’s HPRA supports EMA review of BioNet’s recombinant vaccine candidate VacPertagen. Partnerships expanding: MoU with Indonesia’s Bio Farma to accelerate TdaP … Read the full press release
Posted in European Union, France, Healthcare, Ireland, Pharma & Biotech, Science
Tagged acellular pertussis vaccine, BioNet, BioNet’s EU-GMP Certification Marks Strategic Step Toward EMA Review and Expands Global Vaccine Reach, BioNet’s Manufacturing Accreditation Aligns with Growing International Efforts to Reinforce Pertussis Vaccine Supply, biotechnology, certification, compliance, Dario Cresci, EMA, EU-GMP certification, European Medicines Agency, European Union, European Union Good Manufacturing Practice, From EU-GMP Certification to ASEAN Partnerships BioNet Broadens Its Global Vaccine Strategy, GMP production facilities, HPRA, Ireland Health Products Regulatory Authority, Pertagen®, pertussis, pertussis vaccine, Pertussis Vaccine Manufacturing, pharmaceutical quality, Philippe Guillot-Chêne, recombinant pertussis vaccines, Regulatory Milestone and Research Progress Signal BioNet’s Expanding Role in Next-Generation Vaccine Development, V, vaccine, VacPertagen
(IN BRIEF) BioNet has achieved European Union Good Manufacturing Practice (EU-GMP) certification, a key international standard that validates its facilities and processes for producing high-quality pharmaceuticals. This certification, granted after inspection by Ireland’s Health Products Regulatory Authority (HPRA), allows BioNet … Read the full press release
Posted in European Union, France, Healthcare, Ireland, Pharma & Biotech
Tagged acellular pertussis vaccine, BioNet, biotechnology, certification, compliance, Dario Cresci, EMA, EU-GMP certification, European Medicines Agency, European Union, European Union Good Manufacturing Practice, GMP production facilities, HPRA, Ireland Health Products Regulatory Authority, Pertagen®, pertussis, pertussis vaccine, Pertussis Vaccine Manufacturing, pharmaceutical quality, Philippe Guillot-Chêne, recombinant pertussis vaccines, vaccine, VacPertagen
EMA, MHRA and FDA among regulatory agencies participating (PRESS RELEASE) BERLIN, 10-Jun-2019 — /EuropaWire/ — The Parenteral Drug Association (PDA) is excited to host its 4th Annual European Meeting: Global Healthcare of the Present and the Future, June 25-26 in … Read the full press release
Posted in France, Germany, Healthcare, Ireland, Media, Netherlands, News, Pharma & Biotech, Science, Switzerland, United Kingdom
Tagged 4th PDA European Annual Meeting, Amsterdam, automation, Basel, Berlin, biopharmaceuticals, data quality management, data science, digitalization, Dublin, EMA, European Medicines Agency, FDA, Felix G. Rebitschek, Healthcare, HPRA, London, Manufacturing, manufacturing technologies, Max Planck Institute, medicines, MHRA, Paris, PDA, pharmaceuticals, PIC/S, regulators, Virtual Reality, Walter Morris, WHO, Zurich
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