Remove clinical gout
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FDA expands approval for Horizon’s Krystexxa for uncontrolled gout

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for the supplemental Biologics License Application (sBLA) of Horizon Therapeutics for the Krystexxa (pegloticase) injection, given along with methotrexate, to help uncontrolled gout patients attain a complete response to treatment.

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Novo Nordisk grabs NASH drug from Ventus in $703m deal

pharmaphorum

Roche’s Genentech unit bought Jecure Therapeutics and its portfolio of NLRP3 drugs in 2018, focusing on peripheral drugs for NASH, liver fibrosis, gout, inflammatory bowel disease, and cardiovascular diseases, and followed that with the takeover of Inflazome with both peripheral and brain-penetrating candidates in 2020.

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Q32 Bio and Horizon partner to develop autoimmune disease treatment

Pharmaceutical Technology

According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials. Recently, Q32 concluded a Phase I clinical trial to evaluate the pharmacokinetics, pharmacodynamics and safety of ADX-914, which showed a pharmacological effect on T cells in healthy subjects.

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Risk adjusted net present value: What is the current valuation of Novartis’s Gevokizumab?

Pharmaceutical Technology

According to Globaldata, it is involved in 34 clinical trials, of which 20 were completed, 1 is ongoing, and 13 were terminated. The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress.

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Sobi and Selecta Bio Gout Drug Hits Phase 3 Goals, Paving Way for FDA Submission

MedCity News

Sobi said it plans to seek FDA approval of the gout drug, SEL-212, in 2024. If approved, it would compete against Krystexxa, a Horizon Therapeutics drug projected to become a blockbuster seller.

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Turmoil at FDA or just another day?

World of DTC Marketing

(PBS.org) Nuplazid, a drug for hallucinations and delusions associated with Parkinson’s disease, failed two clinical trials. In a third trial, under a revised standard for measuring its effect, it showed minimal benefit. Overall, more patients died or had serious side effects on Nuplazid than after receiving no treatment.

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