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July 08, 2021
The approved changes to the API manufacturing plant in Leiden, the Netherlands will enable an increase in API capacity.
July 02, 2021
The draft revisions of Annex 1 are driven by a quality risk management approach and will provide more clarity and detail for manufacturers.
June 28, 2021
Pharmaceutical Technology discussed the potential increased risk of counterfeit medicines in the UK post-Brexit and how blockchain could be a useful tool to tackle the issue.
June 22, 2021
EMA's recent positive opinion for a recombinant vaccine for rabbits developed using Algenex’s proprietary and patent protected Baculovirus vector-mediated expression platform, CrisBio, should push the full commercialization of the platform forward.
June 11, 2021
As a safety measure, supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 vaccine with API manufactured at Emergent BioSolutions’ Maryland facility.
The new site in Monts, France, which is operated by Recipharm, will produce finished COVID-19 vaccine product.
Immodulon has received an indication of allowability from the European Patent Office for the claims in its patent application relating to its lead drug candidate.
June 02, 2021
International pharmacovigilance for biotechs brings about a particular set of challenges, especially for small companies, which face the same rigour as large pharma companies.
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about regulatory filings.
May 24, 2021
The agency’s human medicines committee concluded sotrovimab can be used to treat COVID-19 in adults and adolescents who do not require supplemental oxygen therapy and are at risk for severe COVID-19.