Regulation

FDA approves supplemental applications of two hepatitis C drugs for pediatric patients

Gilead Sciences has secured approval from the US Food and Drug Administration (FDA) for supplemental indications of Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) tablets and Sovaldi (sofosbuvir 400 mg) tablets for chronic hepatitis C virus (HCV) infection treatment in adolescents without cirrhosis or with compensated cirrhosis, 12 years of age and older, or weighing at least 35kg.

EU approves Novartis Tafinlar + Mekinist combination for NSCLC treatment

Novartis’ drug combination of Tafinlar (dabrafenib) and Mekinist (trametinib) has been approved by the European Commission for the treatment of patients having BRAF V600-positive advanced or metastatic non-small cell lung cancer (NSCLC).

FDA approves AstraZeneca’s Tagrisso to treat mutation-positive NSCLC

AstraZeneca has secured approval from the US Food and Drug Administration (FDA) for its Tagrisso (osimertinib) 80mg once-daily tablets to treat patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).

Amgen’s Amgevita secures approval in Europe for certain inflammatory diseases

Amgen’s Amgevita (biosimilar adalimumab) has been granted the marketing authorization by the European Commission (EC) in all available indications.

FDA approves Serenity’s Noctiva to treat nocturia

Serenity Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for Noctiva (desmopressin acetate) to treat frequent urination at night due to overproduction of urine.

Actavis UK and Concordia accused of fixing price of life-saving drug

Pharmaceutical companies Concordia International and Actavis UK have been alleged of illegally colluding to keep prices of hydrocortisone tablets high in the UK.

UK’s NICE backs use of Intercept’s Ocaliva for primary biliary cholangitis

Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) has been approved by the UK's National Institute for Health and Care Excellence (NICE) for routine use by the National Health Service (NHS) in England, Wales and Northern Ireland.

FDA grants priority review to Enasidenib for IDH2-Mutant AML

The US Food and Drug Administration (FDA) has accepted under priority review Celgene's new drug application (NDA) seeking approval of enasidenib to treat patients with relapsed/refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation.

EMA’s CHMP recommends approval of Novartis’ Tafinlar in combination with Mekinist

The Committee for Medicinal Products for Human Use (CHMP) has recommended approval to the European Medicines Agency (EMA) of Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) as therapy for advanced or metastatic non-small cell lung cancer (NSCLC) patients whose tumors express the BRAF V600 mutation.