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MedImmune LLC

http://www.medimmune.com

Latest From MedImmune LLC

EU Accelerated Assessment Tracker

The EU marketing authorization application for Takeda's dengue vaccine candidate is no longer being fast-tracked. Also, five requests for accelerated assessment were decided on at the latest meeting of the European Medicines Agency's drug evaluation committee, the CHMP.

Europe Review Pathway

Oncology, Domestic Firms Dominate New China Approvals As Innovation Gathers Pace

China's top regulator grants approvals to a record number of novel drugs, including multiple oncology products from domestic companies, which are increasingly shifting to innovation, supported by positive regulatory changes over the past few years. 

China Approvals

Albireo Dashes Into PFIC Market As FDA, EMA Approve Bylvay

The company anticipates an addressable global market for progressive familial intrahepatic cholestasis of 2,500 patients, with initial plans to focus on around 100 physicians at 60 centers.

Rare Diseases Approvals

As US, China Intensify Cybersecurity Crackdown, Companies Urged To Be Conservative

The latest developments around data security and protection signal the need for rigorous implementation of procedures and potential significant cost increases for pharma and other companies operating in China.

Cybersecurity Policy & Regulation
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