Regulation

Alexion gets FDA priority review for Ultomiris to treat atypical hemolytic uremic syndrome

The US Food and Drug Administration (FDA) has accepted Alexion Pharmaceuticals’ supplemental biologics licence application (sBLA) for priority review of Ultomiris to treat people with aHUS and inhibition of complement-mediated thrombotic microangiopathy (TMA).

AstraZeneca, Merck get EC nod for Lynparza to treat advanced ovarian cancer

AstraZeneca and Merck have secured approval from the European Commission (EC) for Lynparza (olaparib) as a first-line maintenance treatment for women with BRCA-mutated advanced ovarian cancer.

Roche gets Japanese approval for personalised medicine Rozlytrek

Roche announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Rozlytrek (entrectinib) for the treatment of adult and paediatric patients with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive, advanced recurrent solid tumours.

Novo Nordisk’s Victoza secures FDA paediatric approval for type 2 diabetes

The US Food and Drug Administration (FDA) has extended approval for Novo Nordisk’s Victoza (liraglutide) injection for type 2 diabetes in paediatric patients, aged 10 years or older.

FDA approves Amgen and Allergan’s trastuzumab biosimilar Kanjinti

Amgen and Allergan have secured approval from the US Food and Drug Administration (FDA) for Kanjinti (trastuzumab-anns), a biosimilar to Roche’s Herceptin (trastuzumab).

FDA extends approval of Merck’s Keytruda in head and neck cancer

Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) has been approved by the US Food and Drug Administration (FDA) for two more indications in head and neck cancer.

Genentech secures FDA accelerated approval for Polivy, BR combo for DLBCL

Roche’s subsidiary Genentech has secured accelerated approval from the US Food and Drug Administration (FDA) for Polivy (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan (rituximab) (BR) for the treatment of diffuse large B-cell lymphoma (DLBCL).

Acucela gets European orphan designation for emixustat to treat Stargardt disease

Clinical-stage ophthalmology firm Acucela has secured orphan designation from the European Medicines Agency (EMA) for its emixustat hydrochloride to treat Stargardt disease.

Reata Pharmaceuticals gets orphan drug designation for bardoxolone methyl to treat ADPKD

Reata Pharmaceuticals, a clinical-stage biopharmaceutical company, announced the US Food and Drug Administration (FDA) has granted orphan drug designation to bardoxolone methyl (bardoxolone) for the treatment of autosomal dominant polycystic kidney disease (ADPKD).