Formulation and Drug Delivery

Developing Methods for Analyzing Biosimilars

July 06, 2022

Biosimilar data analysis must demonstrate a correlation between structure and function.

Getting Proactive with Pharma Packaging

July 03, 2022

Technological advances are progressing pharmaceutical packaging to overcome the challenges of the future.

Formulating Biologics: A Learning Curve

July 03, 2022

Biologics are forming a greater proportion of the development pipeline, but there are still some formulation difficulties to overcome to ensure clinical and commercial success.

Challenges to Formulation Development for Highly Potent APIs

July 03, 2022

Lack of toxicity data and poor physicochemical properties must be overcome.

FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses

June 30, 2022

Following the recommendation of an independent vaccine panel, FDA is advising vaccine manufacturers to include an Omicron BA.4 and BA.5 component to their booster doses.

First Successful Efficacy Study Against Omicron With COVID-19 Vaccine

June 27, 2022

The Sanofi-GSK vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial with a high-Omicron environment.

EMA Starts Rolling Review of Adapted COVID-19 Vaccines

June 21, 2022

The agency will review laboratory study and CMC data on the bivalent vaccine that targets two strains of the SARS-CoV-2 virus.

Batavia Biosciences Increases Capacity for Viral Vectors and Vaccine R&D in the Netherlands

June 17, 2022

Batavia Biosciences is expanding its headquarters and R&D capabilities in its Netherlands facility.

Seqirus Announces Completion of $156 Million Expansion of Vaccine Manufacturing Facility

June 10, 2022

The expansion at Seqirus’ Holly Springs, N.C., manufacturing facility will support the formulation and fill/finish of influenza vaccines.

FDA Approves GSK’s MMR Vaccine

June 08, 2022

FDA has approved GSK’s vaccine for the prevention of measles, mumps, and rubella in individuals 12 months of age and older.