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Novo Nordisk AS

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Latest From Novo Nordisk AS

Roche's Hemlibra Priced And Labeled To Beat Competition, Safety Concern

Genentech/Roche's Hemlibra, now FDA-approved for hemophilia A patients with inhibitors, offers a once-weekly injection, impressive efficacy with a safety concern that appears to be manageable, and a price that's at least half the cost of the established prophylaxis regimen.

Approvals Blood & Coagulation Disorders

EU CHMP OKs New Treatments For MS, Esophagitis, CMV, Hemophilia – & First Biosimilar Avastin

The EMA’s scientific committee, the CHMP, has given the green light to new treatments for multiple sclerosis, eosinophilic esophagitis, CMV, hemophilia A, and vaginal atrophy, as well as the EU’s first biosimilar version of Roche’s Avastin. The committee upheld two earlier negative opinions, and two products have been withdrawn from the assessment process.

Drug Review Approvals

CHMP OKs Drugs For MS, Esophagitis, CMV & Hemophilia – And First EU Biosimilar Avastin

At its November meeting, the CHMP finally OKd Roche's Ocrevus for multiple sclerosis and gave the green light to new drugs for eosinophilic esophagitis, CMV, hemophilia A, and vaginal atrophy, as well as Amgen’s Mvasi, the first EU biosimilar version of Roche’s Avastin. The committee upheld two earlier negative opinions, and two products were withdrawn from the assessment process.

Drug Review Europe

Appointments: Ionis, ThromboGenics, Zelluna, Therapix, OncoSec, Orion, Storm Therapeutics and ALK

This week's round-up includes new CEOs at Zelluna, Therapix Biosciences and OncoSec Medical, a new COO at Ionis, two C-Suite appointments at ThromboGenics, and a new oncology head at Orion.

Appointments BioPharmaceutical
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