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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
Controlling certain atmospheric conditions in a closed cell system can reduce bioburden.
Bio/pharma can learn ways to prevent recurring events and ineffective CAPA.
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 10, 2021
FDA’s approval of Biogen’s treatment for Alzheimer’s disease has raised questions about the agency’s accelerated approval process.
June 08, 2021
The vaccine is now authorized for ages 12 and older in European Union member states and the UK.
The agency issued two final and two draft guidance documents to help identify and trace drug products in the supply chain.
FDA has granted fast track designation to a GLP-1/glucagon dual agonist in development by Boehringer Ingelheim and Zealand Pharma for the treatment of NASH.
FDA has granted Janssen breakthrough therapy designation for teclistamab, an investigational bispecific antibody under development for treating relapsed or refractory multiple myeloma.
June 07, 2021
FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.
The Biden administration supports a notable increase in funding for public health and research as a lead priority for the coming year.