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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
July 08, 2021
The approved changes to the API manufacturing plant in Leiden, the Netherlands will enable an increase in API capacity.
June 23, 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
The new site in Monts, France, which is operated by Recipharm, will produce finished COVID-19 vaccine product.
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.
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 01, 2021
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.
May 19, 2021
The agency’s human medicines committee has recommended extending the approved storage period of unopened thawed vials at 2–8 0C from five days to 31 days.
March 30, 2021
NICE has issued a positive recommendation for Sobi's Kineret (anakinra) to be used as a first-line biologic therapeutic option for Still’s disease.
March 29, 2021
Celltrion Group has revealed that EMA's CHMP has issued a positive scientific opinion for regdanvimab (CT-P59)—an anti-COVID-19 monoclonal antibody treatment candidate.