Summary "Competitor Landscape: Rheumatoid Arthritis", briefings contain evaluations of ongoing development activities within the Rheumatoid Arthritis (RA) disease market, together with analysis of current & potential future product positioning.
Key Highlights from the report - - If the results of the Phase II MANTA safety trial are required by the FDA prior to filing for regulatory approval of filgotinib for Rheumatoid Arthritis (RA), this could delay US approval by 2 years. - Given that the Phase II NCT03241108 trial is limited to 90 patients in the EU, it is likely that NovImmune will need to initiate a second Phase II trial with a larger number of patients, including US patients, prior to proceeding with a Phase III program for NI-0101 in Rheumatoid Arthritis (RA). - The Phase II trial assessing the immunogenicity and safety of Zostavax in Rheumatoid Arthritis (RA) patients using abatacept, if positive, is likely to boost physician opinion of abatacept’s safety profile in Rheumatoid Arthritis (RA), and reduce potential physician concerns that the use of abatacept may negatively impact the effectiveness of some immunizations, as suggested by its US FDA label.
The report comprises five key sections.
Executive Summary: Contains analysis of key market events that have occurred during the previous month and which have impacted the Rheumatoid Arthritis (RA) landscape.
Landscape Updates - - ‘Order of Entry’ analysis, detailing timeline forecasts for each drug in Phase II development or higher. - Timeline forecasts for each approved product’s lifecycle management initiatives. - ‘Market Entry’ & ‘Direction of Travel’ positioning analysis for pipeline & currently approved therapies.
Pipeline Landscape - - An overview of pipeline candidates, containing snapshots of current development status. - Expected drug-specific events & milestones until YE 2019.
Approved Product Landscape - - An overview of pipeline candidates, containing snapshots of current development status. - Expected drug-specific events & milestones until YE 2019.
Appendix - - Current early stage RA pipeline & candidate ‘Watch List’, - Timeline assumptions, including standard assumptions & drug-specific assumptions.
Scope - The briefing is based on Sociable Pharma’s analysis of clinical trial data from company announcements (press releases, earnings calls) and clinical trial databases (clinicaltrials.gov) - Sociable Pharma applies disease & drug specific assumptions in order to forecast US & EU approvals for drugs in Phase II development, or higher - these are outlined in the report Appendix - Forecasts are presented in pipeline forecast figures & detailed tables - ‘Market Entry’ & ‘Direction of Travel’ positioning analysis for pipeline & currently approved therapies is also provided.
Reasons to buy - Provides details on forecast US & EU approvals for pipeline drugs in Phase II development or higher - Includes potential positioning strategies that companies may adopt for their novel assets once they are approved & launched in the market - Reviews ongoing lifecycle management strategies for existing players in the market - A detailed methodology allows you to understand the forecast assumptions made, enabling cross comparison with your own internal forecasts.
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