J.P. Morgan Notebook Day 1: Pfizer, Gilead, Alnylam, Novartis, Sarepta, Deal Trends And Cell Therapy Challenges
News and notes from the 2019 J.P. Morgan Healthcare Conference. Pfizer CEO Bourla underscores need for scientific and commercial innovation, Gilead makes M&A a priority, Novartis' new R&D chief reflects on first meeting with CEO Narasimhan, Sarepta CEO Ingram clarifies regulatory path for micro-dystrophin, J.P. Morgan outlines deal and macro biopharma trends in 2019, and cell therapy panel discusses manufacturing challenges.
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Pivotal studies of the first two drugs approved for treating hereditary transthyretin-mediated amyloidosis did not provide cardiac efficacy data on how patients feel, function or survive, reviewers said; the agency approved Alnylam’s patisiran and Ionis’ inotersen for patients with the polyneuropathy form of the disease but not the cardiomyopathy form.
Pfizer's fourth-quarter call will be the first with new CEO Albert Bourla, while Amgen will provide reassurances after US Neulasta and Epogen biosimilar launches. Also, concerns swirl around the impending impact of generics on Allergan's blockbuster Restasis, Biogen investors await news on Alzheimer's programs and M&A, and Novartis will face scrutiny of recent launches.
CEO Doug Ingram talked with Scrip about Sarepta's plans to quickly build out a gene therapy pipeline, potentially launch another exon-skipping drug this year and to develop micro-dystrophin for Duchenne muscular dystrophy.