FDA is incentivizing drug manufacturers through higher data integrity requirements.

Data Integrity as Current Good Manufacturing Practice

Establishing a quality culture from the top of an organization down to each and every employee ensures a safe and effective product, and saves costs.

A Robust Quality Culture Benefits All

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

Manufacturing Process Robustness

Topic

Articles

Charles River has received approval to commercially produce allogeneic cell therapy products for distribution in Europe from EMA. 

Charles River Receives EMA Approval to Commercially Produce Allogeneic Cell Therapy Drug Products

The UK’s MHRA has granted marketing authorization for Novartis’ radioligand therapy, Pluvicto, for the treatment of advanced prostate cancer in Great Britain. 

UK Grants Marketing Authorization for Novartis’ Radioligand Therapy for Advanced Prostate Cancer 

Séverine Allard is Head of Global Regulatory Affairs at RegCMC Vaccines.

Thierry Gastineau is Global Head of Quality Advocacy, Culture, & Innovation at Sanofi.

A case study discussing why post-approval changes present a very low risk, and therefore can be downgraded from a prior-approval to a notification after implementation and managed in the PQS with immediate implementation effect. 

Changes That Bring an Additional Restriction on the Product Compared to Registered Conditions

The United Kingdom has approved Moderna’s bivalent COVID-19 vaccine, which targets the original variant and Omicron.

UK Approves First Bivalent COVID-19 Booster Vaccine

Moderna and the European Commission have amended their agreement to convert contractually agreed doses of Moderna’s COVID-19 vaccine to the company’s Omicron-containing bivalent vaccines for supply in 2022.

Moderna and European Commission Amend COVID-19 Vaccine Agreement

Roche announced that FDA has approved Roche’s Xofluza (baloxavir marboxil) to treat influenza in children aged five years and older.

FDA Approves Roche’s Influenza Treatment for Use in Young Children

Daiichi Sankyo’s Enhertu (fam-trastuzumab-deruxtecan-nxki) is the first targeted therapy for HER2-low breast cancer.

FDA Approves First Targeted Therapy for HER2-Low Breast Cancer

B.S Sathya Durga is Director at Acute Market Reports.

Guest contributor B.S. Sathya Durga discusses the importance of modernizing India's pharmaceutical manufacturing industry.

Modernization of India’s Pharma Manufacturing Industry: “Leader” or “Laggard”

FDA has approved Coherus’ Cimerli (ranibizumab-eqrn) as an interchangeable biosimilar for all five indications of Lucentis.

FDA Approves Coherus’ Interchangeable Biosimilar for Lucentis

 Washington Editor, jillwechsler7@gmail.com.

Democrats approve curbs for Medicare plans, but not for commercial drug coverage. 

Quality/GMPs

Data Integrity as Current Good Manufacturing Practice

A Robust Quality Culture Benefits All

Manufacturing Process Robustness