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View More Analytical Methods BioBusiness Cell Culture/Fermentation Continuous Processing Drug Delivery Fill/Finish Formulation Process Chromatography Process Control/PAT Process Development QA/QC Separation and Purification Single-Use Systems Supply Chain

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Quality/GMPs

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Manufacturing Process Robustness

A structured assessment process can determine compliance for lifecycle process validation.

Track-and-Trace Progress

Technologies advance security efforts for drug supply chain.

Industry Organizations Assist Pharma During the Pandemic and Beyond

October 15, 2021

BioPharm International checked in with AAPS, IPEC-Americas, and PDA to get an update on how the organizations are navigating the pandemic and planning for the future.

FDA Approves Rethymic for Pediatric Congenital Athymia

October 14, 2021

Enzyvant’s Rethymic is the first FDA approved treatment for congenital athymia.

Roche Submits Marketing Authorization Application for COVID-19 Treatment to EMA

October 14, 2021

Roche has submitted a marketing authorization application to EMA for Ronapreve (casirivimab/imdevimab) as a treatment for COVID-19.

EMA Ends Rolling Review of CureVac’s COVID-19 Vaccine Candidate

October 14, 2021

EMA has halted the rolling review of CureVac's COVID-19 candidate, CVnCoV, due to the company withdrawing from the process.

MHRA Awards ‘Innovation Passport’ to CellResearch for Stem Cell Therapy

October 14, 2021

MHRA has awarded an ‘Innovation Passport’ to CellResearch for its umbilical cord lining stem cell therapy, CorLiCyte.

FDA Approves ChemoCentryx’s Tavenos

October 08, 2021

The approval of ChemoCentryx’s Tavenos (avacopan) provides a new treatment for active anti-neutrophil cytoplasmic autoantibody-associated vasculitis.

FDA Grants AstraZeneca's Tezepelumab Orphan Drug Designation

October 08, 2021

AstraZeneca’s tezelpelumab was granted orphan drug designation by FDA for the treatment of eosinophilic esophagitis.

FDA Grants Emergency Use Authorization for OTC COVID-19 Test

October 07, 2021

FDA’s emergency use authorization will double rapid at-home COVID-19 testing capacity.

Application for COVID-19 Treatment Submitted to EMA

October 07, 2021

The agency received a marketing authorization application a monoclonal antibody treatment for COVID-19 patients.

EMA Recommends Boosters of Pfizer and Moderna COVID-19 Vaccines for Some Individuals

October 07, 2021

The agency has concluded that an extra dose of the COVID-19 vaccines may be given to those individuals with severely weakened immune systems.