Controlling certain atmospheric conditions in a closed cell system can reduce bioburden.

Controlling Conditions to Reduce Disinfectant Need

Bio/pharma can learn ways to prevent recurring events and ineffective CAPA.

Getting to the Root of Bio/Pharma Quality Issues

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Articles

The new site in Monts, France, which is operated by Recipharm, will produce finished COVID-19 vaccine product.

EMA Approves New Manufacturing Site for Moderna COVID-19 Vaccine

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.

EU Regulators Recommend Not Releasing Batches of Janssen COVID-19 Vaccine

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.

Immodulon Gains Allowability of Claims for Key European Patent Application

 Washington Editor, jillwechsler7@gmail.com.

FDA’s approval of Biogen’s treatment for Alzheimer’s disease has raised questions about the agency’s accelerated approval process. 

New Alzheimer’s Drug Heightens Debate Over FDA Accelerated Approval Process

The vaccine is now authorized for ages 12 and older in European Union member states and the UK.

Pfizer and BioNTech COVID-19 Vaccine Authorized in UK and Europe for Adolescents

The agency issued two final and two draft guidance documents to help identify and trace drug products in the supply chain.

FDA Publishes Guidance Documents to Enhance Supply Chain Security

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.

Boehringer Ingelheim and Zealand Pharma Receive FDA Fast Track Designation for NASH Treatment

FDA has granted Janssen breakthrough therapy designation for teclistamab, an investigational bispecific antibody under development for treating relapsed or refractory multiple myeloma.

Janssen Receives FDA Breakthrough Therapy Designation for Multiple Myeloma mAb

FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.

FDA Grants Accelerated Approval for Biogen’s Alzheimer’s Drug

The Biden administration supports a notable increase in funding for public health and research as a lead priority for the coming year. 

Quality/GMPs

Controlling Conditions to Reduce Disinfectant Need

Getting to the Root of Bio/Pharma Quality Issues