Steve Duffy

Most Recent Articles by Steve Duffy

How the Government Shutdown Affects FDA Activities

How the Government Shutdown Affects FDA Activities

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The consequence of the shutdown means the budget appropriated by Congress for the Agency is on hold, resulting in ~7000 of it's 17,000 employees being furloughed.

NDA Submitted for Investigational Rheumatoid Arthritis Treatment

NDA Submitted for Investigational Rheumatoid Arthritis Treatment

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AbbVie has submitted a New Drug Application to the FDA for upadacitinib, their investigational oral treatment for rheumatoid arthritis.

TNFi Treatment Patterns Examined Among Pregnant Women

TNFi Treatment Patterns Examined Among Pregnant Women

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Using a validated claims-based algorithm, study authors identified pregnancies among women 15-54 years of age from the US Sentinel System between January 1 2004 and September 30 2015.

Ixekizumab Compared With Adalimumab in Head-to-Head PsA Study

Ixekizumab Compared With Adalimumab in Head-to-Head PsA Study

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The SPIRIT H2H trial (N=566) randomized PsA patients to receive ixekizumab (160mg starting dose followed by 80mg every 4 weeks) or adalimumab (40mg every 2 weeks) for 52 weeks.

BLA Submitted for Biosimilar Candidate to Remicade

BLA Submitted for Biosimilar Candidate to Remicade

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Amgen has submitted a Biologics License Application (BLA) for ABP 710, a biosimilar to infliximab (Remicade).

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