AstraZeneca's Symbicort 160/4.5 mcg is now approved for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including bronchitis and emphysema, with twice-daily inhalations, like GlaxoSmithKline's Advair 250/50 mcg. The original version of this story incorrectly reported Symbicort's indication and Advair's dosing (1"The Pink Sheet," March 9, 2009, p. 23). Also, AstraZeneca clarified that it will not promote Symbicort based on its risk profile and offered pricing data that differ from the estimates offered by a Decision Resources analyst in the story - the wholesale acquisition cost of Symbicort is listed as $5.87/day while the WAC for Advair is $6.35/day
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.
