Rotel74 schreef op 21 september 2018 10:44:
Ter kennisgeving:
(CercleFinance.com) - Ipsen announces that the Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion on Cabomantx (cabozantinib) as a monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have been previously treated with sorafenib.
The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).
Ipsen says that its application for marketing authorisation is based on the results of the Celestial Phase 3 international controlled study versus placebo, which met its primary endpoint of overall survival.
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Cercle Finance - 10:30
(CercleFinance.com) - A late stage trial of Novo Nordisk's oral semaglutide found that the experimental drug reduced levels of blood glucose level (HbA1c) and body weight in Japanese people with type 2 diabetes.
The phase 3a trial achieved its primary endpoint, by demonstrating a comparable number of adverse events with oral semaglutide compared to Lilly's dulaglutide, the Danish drugmaker said.
The proportion of people treated with 3, 7 and 14 mg oral semaglutide who experienced gastro-intestinal adverse events were 31%, 39% and 54%, respectively, compared to 40% with dulaglutide, it added.
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