Novo Nordisk has a good start for its ultra-long acting insulin Degludec, with much-anticipated Phase II data released at the American Diabetes Association annual scientific sessions June 25 showing that Degludec is as good as Sanofi-Aventis's Lantus (insulin glargine). However, to unseat the market leader, the Danish firm will need to show its insulin analog is superior in either maintaining blood glucose control or reducing the incidence of hypoglycemia
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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.’
Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.
Cooperation between health technology assessment bodies across the EU will lead to a better joint clinical assessment process over time, but patients cannot afford a lengthy wait for improvements, speakers at a cell & gene therapy conference said.
European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.
