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The FDA today issued updated guidance regarding modified vaccines that target variants of COVID-19 stating that long trials won’t be required for Emergency Use Authorization.
The document says that efficacy of the modified vaccine can be based in part on the authorized vaccine’s efficacy endpoint study.
However, the FDA says companies will need to demonstrate effectiveness of the modified vaccine against the variant(s) by conducting clinical immunogenicity studies.
These studies should compare immune response of the modified vaccine against variant(s) with the response induced by the original vaccine against the virus upon which that vaccine was tested on.
“The emergence of SARS-CoV-2 variants with multiple mutations in the United Kingdom (B.1.1.7 lineage) and in South Africa (B.1.351 lineage) have raised concerns because of their increased transmission rates and because of the possibility that current COVID-19 vaccines…authorized under EUA or otherwise in clinical development will provide reduced protection against these variants,” the document states.
New Jersey Gov. Phil Murphy (Dem.) today signed a series of laws that legalize the possession of marijuana for recreational use.
Adults 21 years of age and older can possess 6 ounces of cannabis.
The laws allow for the setup of state-licensed dispensaries, though it is likely to be at least a year before those open for business.
Last November, New Jersey voters overwhelmingly voted in favor of a ballot measure for legalization.
New Jersey is now the 13th state in the country to legalize marijuana for recreational purposes, and just the fourth on the East Coast (the others are Maine, Massachusetts, and Vermont) to do so.
AbbVie (NYSE:ABBV) announces that upadacitinib (45 mg, once daily) met the primary endpoint of clinical remission and all ranked secondary endpoints in the Phase 3 induction study, U-ACCOMPLISH in adults with moderate to severe ulcerative colitis.
In the study, 33% of patients receiving upadacitinib achieved clinical remission at week 8 compared to 4% receiving placebo (p<0.001).
All ranked secondary endpoints were met, including clinical, endoscopic and histologic outcomes.
74% of upadacitinib-treated patients achieved clinical response at week 8 versus 25% receiving placebo.
Additionally, 63% of patients treated with upadacitinib achieved clinical response at week 2 versus 26% in placebo.
At week 8, 44% of patients treated with upadacitinib achieved endoscopic improvement vs. 8% of patients receiving placebo.
And significantly more upadacitinib-treated patients achieved histologic-endoscopic mucosal improvement at week 8 compared to patients receiving placebo (37% vs. 6%).
The safety profile of upadacitinib (45 mg) was consistent with previous induction study in ulcerative colitis, with no new safety risks observed.