United States Analysis

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Industry Trend Analysis - Offsetting Remicade Decline Will Be A Priority For J&J - MAR 2018

Remicade continues to dominate Johnson & Johnson's Immunology sales, but its sales are in decline as biosimilar competition intensifies; questions over biosimilar interchangeability suggest that sales are falling largely as a result of a failure to gain new customers. J&J is working to offset falling Remicade revenues, however, and in Q417 for the first time, non-Remicade...

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Industry Trend Analysis - Novartis On Track To Remain A Leader In MS - FEB 2018

Within the multiple sclerosis (MS) drugs arena, Novartis is facing the arrival of generic Gilenya and competition from Celgene's ozanimod, a likely blockbuster drug of the future. Novartis is looking to sustain its leadership in this disease area, and is pursuing paediatric and secondary progressive MS, which represent areas of unmet need. A paediatric indication for Gilenya would extend the...

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Industry Trend Analysis - FDA Focus On REMS Is A Substantial Victory For Generic Industry - JAN 2018

Concerns over potential Risk Evaluation and Mitigation Strategies (REMS) programme abuses have been gaining traction in 2017 at a regulatory and political level. Having already accepted that the REMS programme is potentially open to abuse to delay generic competition, the FDA is somewhat duty-bound to find solutions, and the draft guidance now issued is a first step towards addressing that, and...

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