Government
The U.S. Food and Drug Administration has approved AbbVie’s biologic therapy HUMIRA® (adalimumab) as a treatment for moderate-to-severe active ulcerative colitis in children aged 5 years and older.
The hold comes just after patient dosing began in HGB-210, the company’s Phase III single-arm open-label LentiGlobin trial for SCD patients between the ages of 2 and 50.
The date set by the FDA’s independent advisors for debating that decision is Friday, February 26.
Although problems with actually getting shots into arms have been described thoroughly, manufacturing problems and scale-up haven’t been the focus of much reporting.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for February 23, 2021.
On Monday, the companies announced their checkpoint inhibitor Libtayo (cemiplimab-rwlc) won Food and Drug Administration approval for lung cancer.
The U.S. FDA issued new guidance for vaccine makers as it is preparing for the possibility of needing to approve COVID-19 booster shots against variants of the SARS-CoV-2 virus.
Otezla, an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) directed for cyclic adenosine monophosphate (cAMP), may indirectly modulate inflammatory mediators in certain conditions, but the specific underlying mechanisms are not clearly understood.
The U.S. Food and Drug Administration said that data from BrainStorm Cell Therapeutics’ ALS Phase III trial does not meet the threshold of substantial evidence needed to support a BLA for the company’s ALS NurOwn therapy.
The funding, provided by the Biomedical Advanced Research and Development Authority at the Department of Health and Human Services, is enough to advance the test to commercialization.
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