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Calliditas reveals results from vital NefIgArd study

Pharma Times

The study concerns the use of Nefecon among adult patients with primary IgA nephropathy - News - PharmaTimes

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Sibeprenlimab’s Promising Phase II Results Lead to FDA Breakthrough Designation

XTalks

have announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for sibeprenlimab, an investigational drug intended for treating immunoglobulin A (IgA) nephropathy, commonly known as Berger’s disease. APRIL has been identified as a key driver of IgA and Gd-IgA1 production.

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FDA advisors unconvinced by Reata’s kidney disease drug

pharmaphorum

The news is also a massive disappointment to patients and their carers, as there are currently no FDA-approved therapies for Alport syndrome, which affects approximately 30,000 to 60,000 people in the US. .” Trading in Reata’s shares was halted ahead of the meeting, but the stock was down 38% pre-market this morning.

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Novartis key growth drivers and launches continue momentum in Q1, maintaining confidence in growth. Group guidance for FY 2021 confirmed. | Novartis

The Pharma Data

Iptacopan in IgA nephropathy met its primary endpoint in Ph2b enabling Ph3 initiation. Ph2 study in primary IgA nephropathy met the primary endpoint with efficacy and safety results supporting continuation into Ph3. 177 Lu-PSMA-617 Ph3 VISION study met both primary endpoints in patients with prostate cancer.

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