Regulatory Filings and Submissions

EC Approves Polpharma Biologics’ MS-Treating Biosimilar

September 28, 2023

The European Commission has granted approval for Tyruko (natalizumab), a biosimilar developed by Polpharma Biologics for treating multiple sclerosis.

FDA Inspections Face Overhaul

September 28, 2023

The agency will be reorganizing field force and compliance functions.

Phasing Out COVID-19 Regulatory Flexibilities

September 22, 2023

What impact will EMA’s decision to phase out COVID-19 regulatory flexibilities have on the pharma industry?

Continuous Manufacturing is Here to Stay (PDA/FDA Joint Regulatory Conference 2023)

September 20, 2023

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the importance of continuous manufacturing for the future.

Highlights of ICH Q13 Session (PDA/FDA Joint Regulatory Conference 2023)

September 20, 2023

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the highlights of her ICH Q13 session that she wants others to be aware of.

Barriers to the Development of Continuous Manufacturing and ICH Q13 (PDA/FDA Joint Regulatory Conference 2023)

September 18, 2023

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the barriers to the development of continuous manufacturing processes after implementing ICH Q13.

EMA Committee Issues Positive Opinion on Sandoz’ Biosimilar Trastuzumab

September 18, 2023

The EMA’s Committee for Medicinal Products for Human Use has given a positive opinion on Sandoz’ biosimilar trastuzumab for breast and gastric cancer.

FDA Issues Guidance on Biosimilar Labeling

September 18, 2023

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

Navigating the Intricacies of Lentiviral CGTs

September 15, 2023

Scientists are leveraging ddPCR technology to get an accurate read on viral titer and vector copy number.

Regeneron Gets FDA Approvals on New Biologic and New High Dose for Eye Disease Therapy

August 23, 2023

FDA has approved a new mAb therapy from Regeneron Pharmaceuticals as well as a higher dose version of Eylea, the company’s eye disease therapeutic.