Regulatory Oversight and Compliance

Introducing a New Legal Framework, Fees, and Charges

February 03, 2025

EMA introduced its New Fee Regulation in January 2025, but what impact will the new fees and charges have on medicine developers?

The Social Media Code

February 02, 2025

Bio/pharma companies have a lot to consider when tackling social media communications, especially within Europe.

EMA Recommends Eight New Medicines for Approval in January

February 02, 2025

Another eight medications already authorized in the EU were recommended for extensions of various indications.

FDA Approves Ozempic Indications for Reducing Risk of Kidney Failure, Cardiovascular Death

January 29, 2025

Drug manufacturer Novo Nordisk said the approval establishes Ozempic as the most broadly indicated GLP-1 RA in its class.

European Drug Shortage Monitoring Platform Fully Operational

January 29, 2025

The platform is live with full functionality for use by marketing authorization holders and national competent authorities to report drug supply information.

European Commission Approves Johnson & Johnson Non-Small Cell Lung Cancer Treatment

January 28, 2025

Data from a Phase III study that evaluated lazertinib, in combination with amivantamab, in comparison to osimertinib as a first-line treatment resulted in the EC’s decision.

Two AstraZeneca Treatments Recommended for Lung Cancer Patients in England and Wales

January 23, 2025

Imfinzi received an expanded indication for lung cancer from FDA in August 2024, and Tagrisso had been approved to treat lung cancer in China in June 2024.

FDA Warns Sanofi About API CGMP Deviations, Issues Clinical Hold on Atara Immunotherapies

January 23, 2025

The agency’s newly issued letter to Sanofi amends one sent in December 2024, and stems from inspections at its Massachusetts drug manufacturing facility in June and July 2024.

Sustainability in Pharmaceutical Manufacturing

January 17, 2025

Pharmaceutical Technology® spoke with Charles Ruban, president and CEO, Verdot, about the focus of moving to sustainability practices in pharmaceutical manufacturing.

EMA Prepared for Health Technology Assessment Regulation Implementation

January 10, 2025

The HTAR, which aims to increase access to new medicines, becomes effective Jan. 12, 2025.