Formulation and Drug Delivery

FDA Approves Biosimilar for Treatment of Eye Disease

September 21, 2021

The agency approved Byooviz (ranibizumab-nuna), a biosimilar to Lucentis (ranibizumab injection), for the treatment of several eye diseases.

Pfizer and BioNTech Announce Positive Results In COVID-19 Vaccine Trial for Children Ages 5 to 11

September 21, 2021

The topline data from Pfizer and BioNTech’s trial suggests that a 10 µg vaccine is safe and effective among the 5 to 11 age group.

Vaccine Booster Battle Reveals Rifts Among Regulators and Sponsors

September 20, 2021

FDA advisors agreed unanimously on a more limited booster plan after rejecting Pfizer’s original request to authorize its third shot for everyone over age 16.

Moderna Releases New Clinical Data on COVID-19 Vaccine

September 17, 2021

Moderna’s newest insights include an overall efficacy review, a study on breakthrough infections, and a study on long-term immunity.

Considering Titanium Dioxide Regulatory Changes

September 16, 2021

EFSA’s evaluation of risk in food products raises implications for drug product formulations.

Best Practices in Manufacturing Inhalation Drugs

September 13, 2021

When designing and manufacturing a pMDI or DPI combination drug-delivery device, the commercial stage should be kept in mind from the beginning of development.

Biden Bolsters Vaccine Production in Pandemic Preparedness Plan

September 10, 2021

The White House announced a nearly $3 billion program to ramp up production of vaccines and their components.

Moderna and ILCM Announce Collaboration to Develop mRNA Therapeutic for CN-1

September 09, 2021

Moderna announced a collaboration to develop a new mRNA therapeutic for Crigler-Najjar Syndrome Type 1 at no cost to patients.

Setting a Clear Strategy for Primary Packaging

September 03, 2021

Alternative materials, as well as supply-chain planning, are essential to ensure a reliable supply for parenteral drug packaging.

On Time Delivery: Challenges of Controlled-Release Formulations

September 03, 2021

Consistency, robustness, and understanding of the API and controlled-release excipients are essential for successful drug dosing.