Approvals

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.

Valeant gets FDA approval for SILIQ to treat moderate-to-severe plaque psoriasis

The US Food and Drug Administration (FDA) has approved Valeant Pharmaceuticals International's Biologics License Application (BLA) for SILIQ (brodalumab) injection, for subcutaneous use, a monoclonal antibody that targets the IL-17 receptor for patients with moderate-to-severe plaque psoriasis.

FDA plans to not to hold advisory committee meeting for Portola’s betrixaban NDA

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) is not planning to hold an Advisory Committee meeting for Portola Pharmaceuticals' New Drug Application (NDA) for betrixaban.

FDA accepts Intellipharmaceutics’ NDA for Rexista to treat moderate to severe pain

The US Food and Drug Administration has accepted for filing of Intellipharmaceutics International’s New Drug Application ("NDA") seeking authorization to market its Rexista abuse-deterrent oxycodone hydrochloride extended release tablets in the 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg strengths.

Abeona gets orphan drug status in EU for ABO-101 gene therapy in Sanfilippo syndrome type B

Abeona Therapeutics has secured orphan drug designation from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products for its gene therapy program ABO-101 for children impacted by Sanfilippo syndrome type B (MPS IIIB).

ProMetic’s alstrom syndrome treatment gets orphan drug status in Europe

The European Commission has granted orphan drug designation to ProMetic Life Sciences' PBI-4050 drug for the treatment of Alström Syndrome.

European Commission approves Suliqua to treat adults with type 2 diabetes

Sanofi has secured approval from the European Commission for Suliqua, the once-daily titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes.