In a telling example of the growing importance of the gastrointestinal (GI) market, the main quibbles in last week's Arthritis Advisory Committee (adcom) meeting to discuss the application for CT-P13 (infliximab) – Celltrion Inc.'s biosimilar to Remicade (infliximab, Janssen Biotech Inc.) – focused more on the FDA's willingness to extrapolate clinical findings in rheumatoid arthritis and ankylosing spondylitis to inflammatory bowel disease (IBD) and related GI conditions than to the indications supported by clinical studies. Read More
NEW YORK – Despite the appeal of shorter development timelines – and the potential of a multibillion-dollar market – ophthalmology drug development has lagged behind work in other disease areas in terms of new targets, biomarker development and even the number of players operating in the space. Read More
Last week, The National Academies' Committee on Human Gene Editing began gathering information for its Consensus Study on Human Gene Editing. The study, which is expected to be released in late 2016, will represent the official view of the National Academy of Sciences and the National Academy of Medicine on "the scientific underpinnings of human gene-editing technologies, their potential use in biomedical research and medicine – including human germline editing – and the clinical, ethical, legal and social implications of their use." Read More
