Monday, August 13, 2018 Daily Archives

Samsung Bioepis: From biosimilars to novel biologics

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Following success with several biosimilars, bringing a novel biologic into the clinic is the “next logical step†in becoming a fully integrated biopharma firm, says Samsung Bioepis. Almost a year to the date it announced a co-development agreement, Samsung Bioepis and Takeda Pharmaceuticals are preparing to begin a Phase I trial for its lead candidate, SB26, also known as TAK-671. The news signals the latest stage in the development of Samsung Bioepis – a joint venture between South Korean contract…

August 13, 2018

Alnylam’s success brings first RNAi therapeutic to US

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The US Food and Drug Administration (FDA) has approved the first ever RNA interference (RNAi) therapy: Alnylam’s Onpattro (patisiran). Alnylam announced last week Onpattro has been approved in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. The product was hailed by the FDA as the first in a new class of drugs: small interfering ribonucleic acid (siRNA) treatments. “New technologies like RNA inhibitors, that alter the genetic drivers of a disease, have the…

August 13, 2018