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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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Vevye: A New Cyclosporine Solution for Dry Eye Disease

XTalks

The clinical trials consistently showed significant therapeutic improvements in ocular surface damage and associated symptoms, while pioneering visual function improvement analysis”, said John D. Additionally, the clinical trials underscored the favorable tolerability profile of Vevye.

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

pharmaphorum

The Danish drugmaker is paying $100 million upfront for rights to antibody drug PRX004, which is heading for phase 2 trials in cardiomyopathy associated with ATTR amyloidosis, a life-threatening disease affecting the heart and nervous system. 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

The American Society of Clinical Oncology (ASCO) annual conference was one of the highlights of the year in cancer research and the fact it was held virtually did not distract from some stunning clinical lung cancer trial results presented by AstraZeneca. In the 500 patient trial, patients treated with Trodelvy lived for a median of 12.1

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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.

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World RNA Day: What impact RNA it had on drug discovery?  

Drug Discovery World

This Phase I trial will test the experimental vaccine, known as H1ssF-3928 mRNA-LNP, for safety and its ability to induce an immune response.

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