Oct 7, 2021 | News, Regulatory
Following the release of a Nordic study, Finland joins Sweden and Denmark in pausing the distribution of the Moderna COVID-19 vaccine for young adult males (under 30) after reports of a rare cardiovascular side effect. The unpublished study will be sent to the...
Sep 17, 2021 | News, Regulatory
European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has announced their approval of diroximel fumarate (Vumerity, Biogen Inc) for adults diagnosed with relapsing-remitting multiple sclerosis (MS). Although Diroximel fumarate is...
Sep 16, 2021 | EMA, FDA, News, Regulatory
The US FDA (Food & Drug Administration) and the EMA (European Medicines Agency) have launched a joint pilot designed to give parallel scientific advice (PSA) to sponsors of complex generic drugs, or hybrid medicines (as they’re referred to in the EU). The aim of...
Aug 19, 2021 | News, Regulatory
Rentschler Biopharma is in the final stages of preparations to begin commercial production of CureVac’s COVID-19 Shot. The German contract drug manufacturer built a production site for CureVac’s Vaccine and intends to deliver at least 100 million doses per year....
Jun 15, 2021 | News, Regulatory
The European Medicines Agency (EMA) has added another blood condition side effect to the growing list for AstraZeneca’s COVID-19 vaccine. The rare blood condition known as capillary leak syndrome causes blood to spill from blood vessels to nearby muscles and...
