Formulation and Drug Delivery

EMA’s PRAC Recommends Warning on Very Rare Side Effects of Janssen’s COVID-19 Vaccine

April 23, 2021

EMA's PRAC has concluded that there is a possible link to rare cases of blood clots with low blood platelets with Janssen’s COVID-19 vaccine.

Evonik Delivers First Batch of Lipids to BioNTech for its COVID-19 Vaccine

April 22, 2021

Lipid production at Evonik’s Hanau, Germany, site was set up in eight weeks and met high-quality requirements, accelerating delivery time, which was originally set for mid-2021.

DFE Pharma to Launch New Biopharma Excipient Solution

April 22, 2021

DFE’s new line will offer market purity and low endotoxin excipients for use in formulation, while providing drug developers and manufacturers high-quality excipient technology and services.

Bristol Myers Squibb Plans Cell Therapy Manufacturing Site in the Netherlands

April 22, 2021

Design for a new BMS multi-product cell therapy manufacturing site in Leiden is underway, with construction to start later in 2021.

FDA Unveils Extensive Manufacturing Violations at Emergent

April 21, 2021

A FDA report cites multiple ongoing violations that undermine assurance of quality in products from this plant and the need for a continuing “pause” in production.

Pfizer and BioNTech to Supply EU with 100 Million Additional COVID-19 Vaccine Doses

April 19, 2021

The additional doses are a result of the European Commission’s expanded advance purchase agreement, which brings the total number of doses delivered to the EU to 600 million.

MHRA and EC Grant Marketing Authorization for Biogen’s MS Treatment

April 16, 2021

Biogen UK has announced that the UK’s MHRA and the EC have granted marketing authorization for the subcutaneous (SC) formulation of Tysabri (natalizumab).

Hyalo Technologies Unveils Room Temperature Drug-Stabilizing Technology

April 15, 2021

This new technology could eliminate the need for cold chain storage, transport, and distribution of temperature-sensitive molecules.

FDA Recommends Pausing Use of J&J COVID-19 Vaccine After Reports of Blood Clots

April 13, 2021

CDC and FDA are reviewing data from reported cases of a rare type of blood clot in people that received the Johnson & Johnson COVID-19 vaccine.

FDA Makes Revisions to Moderna’s COVID-19 Vaccine EUA to Increase Available Doses

April 05, 2021

The first revision further clarifies the number of doses per vial for the vials that are already available, while the second revision allows for the availability of an additional multi-dose vial.