Quality Systems

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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

FDA’s CDER SBIA is hosting a three-day virtual conference regarding regulatory best practices for global access to medicines. 

FDA to Host Multi-Day Global Access Virtual Conference

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

FDA Approves Coherus’ Interchangeable Biosimilar for Lucentis

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

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

Senate Advances Drug Price Negotiations

The European Commission has approved AstraZeneca and Merck’s Lynparza (olaparib) as an adjuvant treatment for BRCA-mutated HER2-negative high-risk early breast cancer.

EC Approves Additional Indication for Lynparza as Adjuvant Treatment in Breast Cancer

Better clinical data are needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety. 

Top Priority for Califf Is Combatting Health Misinformation 

Andrew Feilden is the European E&L strategic director for Element.

A comprehensive understanding of potential material change can mitigate its impact on patient safety.

Regulatory Oversight and Compliance