Regulation - Approvals

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.

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.

ALK’s EURneffy secures MHRA approval for anaphylaxis treatment

ALK has received marketing authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for EURneffy 1mg, a needle-free adrenaline treatment for children with anaphylaxis.

FDA grants priority review for Roche’s Tecentriq combo sBLA

Roche has received the US Food and Drug Administration (FDA) priority review for its supplemental biologics licence application (sBLA) for adjuvant Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combination with chemotherapy for colon cancer.

Pfizer’s Hympavzi secures FDA expanded indications for haemophilia

Pfizer has received approval from the US Food and Drug Administration (FDA) for an expanded indication of Hympavzi (marstacimab-hncq) for the treatment of haemophilia A or B.

EC grants marketing authorisation for IntraBio’s Aqneursa

The European Commission (EC) has granted marketing authorisation for IntraBio’s Aqneursa (levacetylleucine) to treat neurological symptoms of Niemann-Pick disease type C (NPC).