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December 19, 2017
The company has completed development of a first-generation production process for its chimeric antigen receptor regulatory T cell product portfolio and is selecting a CMO for clinical supply.
The European Commission has closed its infringement procedure against Roche after the company completed remedial actions.
December 18, 2017
The US Court of Appeals for the Federal Circuit has decided in favor of Novartis’ Sandoz in rendering the opinion that Amgen cannot use state laws to prohibit or delay the marketing of biosimilars.
Cycle and Aprecia will use Aprecia's 3DP Technology to improve rare disease drug formulations.
December 14, 2017
The company is seeking approval from FDA for use of the drug, migalastat, to treat Fabry disease in patients who have amenable mutations.
December 13, 2017
The approval for Admelog (insulin lispro injection) marks the first short-acting insulin approved as a “follow-on” product.
In partnership with Indian pharmaceutical firm, Torrent Pharmaceuticals, Novo Nordisk has expanded an insulin manufacturing facility at Torrent’s Indrad, Gujarat, India site.
The companies will co-develop and co-commercialize the lead candidate generated from their earlier collaboration to treat genetic blood disorders.
December 12, 2017
The partnership aims to develop and commercialize a skin-care drug candidate being developed to treat actinic keratosis, which, left untreated, can progress to cancer.
The agency has approved Nucala (mepolizumab) to treat Eosinophilic Granulomatosis with Polyangiitis (EGPA) to GlaxoSmithKline. This indication is the first FDA-approved therapy specifically to treat EGPA.