Cell and gene therapy developers will have a close eye on cancer cases linked to Bluebird Bio’s LentiGlobin, say analysts. Earlier this month Bluebird halted two trials of LentiGlobin in sickle cell disease – specifically HGB 206 NCT02140554 and HGB 210 NCT04293185. It said the decision was prompted by a case of acute myeloid leukemia (AML) in a patient in group A of the Phase I/II HGB-206 study and a case of myelodysplastic syndrome (MDS) in a patient in Group C of the…
The FDA has approved J&J’s single dose COVID-19 vaccine (Ad26.COV2.S) paving the way for distribution in the US. Last week, the US Food and Drug Administration (FDA) issued Johnson & Johnson’s (J&J) adenovirus type 26 COVID-19 vaccine with Emergency Use Authorization (EUA) making it the third vaccine available to US citizens. “After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization…
Executives from Novavax, Fujifilm, and Biocon have called for standardized processes and simplified regulations after a Cytiva-led survey showed improving manufacturing agility is a major priority for biopharma. A survey of around 1,100 senior executives across 20 countries commissioned by bioprocess vendor Cytiva has highlighted industry’s confidence in the biopharma space. With respondents scoring several sectors within the industry, the Biopharma Resilience Index averaged an overall score of 6.6 out of 10. But according to Hannah Freegard, senior editor at…