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FDA Approves First Interchangeable Humira Biosimilar + Gene Silencing Treatment for Porphyria Gets Nod From England’s NICE – Xtalks Life Science Podcast Ep. 34

XTalks

In this episode, the editorial team discusses the FDA approval of Cyltezo as the first interchangeable biosimilar for AbbVie’s Humira. The approval lends to the growing Humira biosimilars market, which will take off in 2023 with Boehringer Ingelheim’s Cyltezo and biosimilars from Amgen, Merck and Alvotech.

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FDA approves Alnylam’s ultra-rare disease drug Oxlumo

pharmaphorum

The FDA has approved Alnylam’s gene silencing drug Oxlumo, the first treatment for primary hyperoxaluria type 1 (PH1), an ultra-rare and life-threatening genetic disorder. The post FDA approves Alnylam’s ultra-rare disease drug Oxlumo appeared first on.

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Vevye: A New Cyclosporine Solution for Dry Eye Disease

XTalks

Novaliq, a biopharmaceutical company specializing in ocular therapeutics, recently announced that their product Vevye (cyclosporine ophthalmic solution) 0.1 percent received approval from the US Food and Drug Administration (FDA) to treat dry eye disease. This mechanism reduces eye swelling and promotes tear production.

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Novo Nordisk bulks up in rare diseases with $1.2bn Prothena deal

pharmaphorum

The bulk of Novo Nordisk’s revenues come from its diabetes products, although it also active in the development and sale of drugs for growth disorders, haemophilia and sickle cell disease. All told, the deal could be worth up to $1.2

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2020 review – Pharma’s progress outside of COVID-19

pharmaphorum

There was some steady progress in neurology – in February FDA approved Lundbeck’s eptinezumab prophylactic treatment for migraine, the last from a gang of four drugs from a new class. Biogen and Denali will co-market the lead LRRK2 product in the US and China, and Biogen will commercialise in all other markets.

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FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1

The Pharma Data

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

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Two biotechs target dry eye disease after Novartis’ Xiidra problems

pharmaphorum

billion for its FDA-approved dry eye drug Xiidra during the Japanese pharma’s merger with Shire in 2019, outlining the sales potential in this market niche. Sylentis, part of PharmaMar Group, has just announced FDA approval of a phase 3 trial for eye drops containing tivanisiran, in dry eye disease associated with Sjogren’s Syndrome.