Tags : Plegridy

Regulatory

Biogen’s Plegridy (peginterferon beta-1a, IM) Receives EC’s Approval for Relapsing-Remitting

Shots: The approval is based on data assessing bioequivalence and AEs associated with IM administration vs SC administration of Plegridy in healthy volunteers Result: The data showed that participants receiving therapy through IM experienced fewer injection site reactions (14.4 vs 32.1 %), safety profiles were similar. The frequency of injection site reactions and AEs were […]Read More

Regulatory

Biogen’s Plegridy (peginterferon beta-1a) and Avonex (interferon beta-1a) Receive CHMP’s

Shots: The CHMP recommended an update to MAA of approved interferon beta treatments (Plegridy & Avonex) to remove pregnancy contraindications and allow them to use during pregnancy and breastfeeding in women with relapsing multiple sclerosis The CHMP positive opinion is based on 1,000+ real-world pregnancy outcomes demonstrating no increased risk of major congenital anomalies after […]Read More