BioPharm News

Jun 22, 2018
By BioPharm International Editors
The three-year collaboration will focus on developing vaccines for up to five infectious disease pathogens.
Jun 22, 2018
By BioPharm International Editors
FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.
Jun 22, 2018
By BioPharm International Editors
The agency launched a secure online portal for orphan drug designation applications.
Jun 22, 2018
By BioPharm International Editors
The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.
Jun 22, 2018
By BioPharm International Editors
The International Society for Pharmaceutical Engineering (ISPE) launched its philanthropic division, the ISPE Foundation, to support industry demands.
Jun 22, 2018
By BioPharm International Editors
The company has completed the first phase of expansion at its headquarters in Freiburg, Germany, in anticipation of increasing demand as cell and gene therapies approach commercialization.
Jun 21, 2018
By BioPharm International Editors
The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.
Jun 20, 2018
By BioPharm International Editors
The acquisition is expected to strengthen Roche’s personalized healthcare strategy.
Jun 20, 2018
By BioPharm International Editors
The acquisition is expected to strengthen Sanofi’s R&D strategy with Ablynx’s nanobody technology platform.
Jun 20, 2018
By BioPharm International Editors
The company has resubmitted a biologics license application to FDA for its proposed biosimilar to Roche’s Herceptin.
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