Regulation

TGA grants provisional approval to Hansa’s Idefirix as desensitisation treatment

The Australian Therapeutic Goods Administration (TGA) has granted provisional approval to Hansa Biopharma’s Idefirix (imlifidase) as desensitisation treatment for highly sensitised patients before kidney transplantation either from living or deceased donors.

FDA approves label update of Novartis’ Leqvio to treat high LDL-C

The US Food and Drug Administration (FDA) has approved a label update of Novartis’ Leqvio (inclisiran) to allow earlier use in patients suffering with high LDL-C who have an increased risk of heart disease, as an adjunct to diet and statin therapy.

FDA clears 280Bio’s IND to start Phase I trial of YL-17231

The US Food and Drug Administration (FDA) has granted clearance to 280Bio’s investigational new drug (IND) application, thereby enabling initiation of a Phase I study of YL-17231 to treat patients with advanced cancer with RAS mutations.

European Commission grants full MA to Novavax’s Covid-19 vaccine

The European Commission has granted full Marketing Authorization (MA) to Novavax’s Nuvaxovid (NVX-CoV2373) vaccine for Covid-19.

NMPA grants approval to Toray’s antipruritus medication

China’s National Medical Products Administration (NMPA) has granted approval to Toray Industries’ REMITCH nalfurafine hydrochloride orally disintegrating tablets to treat pruritus.

Taiho’s LYTGOBI tablets receive European Commission marketing authorisation

Taiho Pharmaceutical and its subsidiary Taiho Oncology Europe have received conditional marketing authorisation from the European Commission for LYTGOBI (futibatinib) tablets to treat adults with cholangiocarcinoma (CCA).

FDA grants IND clearance for Phase I/IIa trial of Skyline’s SKG0106

The US Food and Drug Administration (FDA) has granted clearance for Skyline Therapeutics’ investigational new drug (IND) application for Phase I/IIa clinical trial of gene therapy SKG0106 to treat neovascular age-related macular degeneration (nAMD).

Regeneron receives FDA response letter for aflibercept’s BLA

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Regeneron Pharmaceuticals for its Biologics License Application (BLA) for aflibercept 8mg to treat wet diabetic macular oedema (DME), age-related macular degeneration (wAMD) and diabetic retinopathy (DR).

FDA accepts BLA for Pfizer’s haemophilia B gene therapy

The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) submitted by Pfizer for haemophilia B gene therapy, fidanacogene elaparvovec.