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AbbVie Submits Skyrizi Application to EMA for Crohn's Disease Treatment
AbbVie (ABBV) announced that it has submitted an application to the European Medicines Agency, or EMA, seeking approval for Skyrizi for subcutaneous induction for the treatment of adult patients with moderately to severely active Crohn's disease. The application to the EMA is supported by the recently shared positive data from the Phase 3 AFFIRM study, which evaluated the efficacy and safety of risankizumab SC as an induction treatment in adult patients with moderately to severely active CD, in those with and without prior advanced therapy failure.
Canada Raises Tariffs on U.S. Steel and Aluminum to 50%
Catch up on the top industries and stocks that were impacted, or were predicted to be impacted, by the comments, actions and policies of President Donald Trump with this daily recap compiled by The Fly.RETALIATORY TARIFFS:Canada is matching Trump's weekend tariff escalation with a sweeping package of counter tariffs that directly targets U.S. steel, aluminum and downstream manufacturing. Prime Minister Mark Carney will double Canada's existing counter-tariffs on U.S. steel and aluminum to 50%, while adding new 50% duties on U.S. furniture, clothing, electronics, smartphones, and gaming consoles. Overall, the retaliatory levies cover roughly $20B in annual imports. The measures take effect on September 8 and represent a sharp reversal in Carney's earlier conciliatory stance after trade talks between Canada and U.S. collapsed on Friday. Publicly traded companies in the space include ArcelorMittal, Cleveland-Cliffs, Nucor, Steel Dynamicsand U.S. Steel. Publicly traded companies in the aluminum space include Alcoa, Kaiser Aluminum, Rio Tinto, Century Aluminum, and Constellium.DEPUTY ROLES:The Department of Health and Human Services is planning to create two new deputy commissioner roles at the Food and Drug Administration, one of which would focus on technology and the intersection of health and artificial intelligence, CNBC's Annika Kim Constantino. The other new position is for a deputy commissioner for drugs, according to two sources familiar with the plan. Publicly-traded companies operating in the space include Pfizer, Merck, Bristol Myers, Eli Lilly, AbbVie, Amgen, Medtronic, Abbott, Boston Scientific, Stryker, Intuitive Surgical, GE HealthCare, Teladoc, and Oracle.U.S.-IRAN:In a post on Truth Social, President Trump stated, "The failing Islamic Republic of Iran is not paying large segments of their military, while at the same time killing protesters, even when they are not protesting, at levels not seen before. It is a humanitarian crisis of epic proportions, and must be stopped, NOW."
Allergan Aesthetics Submits Botox Cosmetic Application for Review
Allergan Aesthetics, an AbbVie company, announced the FDA has accepted for review its supplemental Biologics License Application for Botox Cosmetic for the temporary improvement in the appearance of marked to very marked masseter muscle prominence associated with masseter muscle activity in adults. If approved, Botox Cosmetic would become the first and only neurotoxin indicated for this condition in the U.S. and expand its portfolio to a fifth aesthetic indication. The sBLA submission is supported by two Phase 3 clinical studies, M21-416 and M21-417, both of which met their primary endpoints and demonstrated statistically significant improvements in the severity of masseter muscle prominence compared with placebo, with p-values of 0.0046 and 0.0014, respectively.
Allergan Aesthetics' Botox Cosmetic Application Accepted for FDA Review
Allergan Aesthetics, an AbbVie company, announced the U.S. FDA has accepted for review its supplemental Biologics License Application for Botox Cosmetic for the temporary improvement in the appearance of marked to very marked masseter muscle prominence associated with masseter muscle activity in adults. If approved, Botox Cosmetic would become the first and only neurotoxin indicated for this condition in the U.S. and expand its portfolio to a fifth aesthetic indication.
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