Regulation

Kyowa Kirin EMEA’s Crysvita approved by EC for infants with XLH

Kyowa Kirin subsidiary Kyowa Kirin EMEA has received approval from the European Commission (EC) to expand the use of Crysvita (burosumab) for treating X-linked hypophosphataemia (XLH) in infants aged one month to one year across the EU and European Economic Area.

FDA grants traditional approval to Novartis’ Fabhalta for IgAN

The US Food and Drug Administration (FDA) has issued traditional approval to Novartis for Fabhalta (iptacopan), to slow the decline of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression.

FDA grants priority review to Roche’s Gazyva/Gazyvaro for pMN

The US Food and Drug Administration (FDA) has granted priority review to Roche’s supplemental biologics licence application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) to treat adults with primary membranous nephropathy (pMN).

FDA approves MSD’s Keytruda combinations for MIBC

The US Food and Drug Administration (FDA) has approved two of Merck & Co’s (MSD) Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), each combined with Padcev (enfortumab vedotin-ejfv), for adults with muscle-invasive bladder cancer (MIBC).

US FDA rejects approval of Unicycive’s kidney disease therapy

The US Food and Drug Administration (FDA) has declined to approve Unicycive Therapeutics’ resubmitted new drug application (NDA) for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis.

Eli Lilly and Innovent agree Verzenios commercialisation deal in China

Eli Lilly and Company has entered into an agreement with Innovent Biologics for the commercialisation of Verzenios (abemaciclib) in mainland China.

Anixa Biosciences secures Korean patent for breast cancer vaccine

Anixa Biosciences has secured a patent from the Korean Ministry of Intellectual Property (MOIP) for its breast cancer vaccine technology.

Japan approves Sanofi’s Sarclisa combo for MM treatment

Sanofi has received approval from Japan’s Ministry of Health, Labour and Welfare for its subcutaneous (SC) formulation of Sarclisa (isatuximab) in combination with standard therapies to treat multiple myeloma (MM).

Alkermes’ alixorexton secures FDA and EC orphan designations

Alkermes has received orphan drug designations (ODD) from both the US Food and Drug Administration (FDA) and the European Commission (EC) for alixorexton, its investigational oral orexin 2 receptor (OX2R) agonist to treat idiopathic hypersomnia (IH) and narcolepsy.