Regulatory
There were two reported cases of trials restarting and one pausing this week. Here’s a look.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for February 2, 2021.
The U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug application that will allow Boston-based Vertex Pharmaceuticals to proceed with a clinical trial of its investigational stem cell-derived, fully differentiated pancreatic islet cell treatment for type 1 diabetes (T1D).
February is kicking off with a number of PDUFA dates for the U.S. FDA as well as a cancer advisory committee meeting. Here’s a look.
The decision by the FDA on the drug application was expected on March 7, but is now delayed until June 7, 2021.
The FDA is on a roll granting approvals. Three companies announced IND updates today.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for January 26, 2021.
Pfizer, Moderna, AstraZeneca, and Johnson & Johnson all have trials of their respective vaccines underway in various age-groups.
AstraZeneca spinout Albireo Pharma is moving closer to securing regulatory approval for its treatment known as odevixibat, for pruritus in patients with PFIC.
The drug, a combination of cabotegravir and rilpivirine, is a complete therapy for HIV-1 infection in adults who are virologically suppressed.
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