EMA Starts Rolling Review of Sanofi’s COVID-19 Vaccine
EMA's CHMP has taken the decision to start a rolling review of Vidprevtyn—Sanofi Pasteur’s COVID-19 vaccine.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has taken the decision to start a rolling review of Vidprevtyn—Sanofi Pasteur’s COVID-19 vaccine—based on preliminary non-clinical and early clinical results. According to a July 20, 2021 press release, the early trial data suggest that Sanofi’s vaccine triggers the production of antibodies that target SARS-CoV-2 and may help protect against the disease.
Rolling reviews are employed by EMA to accelerate assessment of promising drug candidates during public health emergencies. All data on Vidprevtyn will be evaluated by EMA as soon as they become available, so that a decision on whether the vaccine benefits outweigh the risks can be made.
The rolling review process will be performed until sufficient evidence is acquired for a formal marketing authorization application. EMA has specified that further communication will be published once a formal application for marketing authorization has been submitted.
Source: EMA
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
Intertek to Expand UK GMP Facility with 6000 Square Feet of Lab and Office Space
May 7th 2025The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.
