Regulation

Roche secures cancer drug approvals in Europe and US

Switzerland-based drug manufacturer Roche has secured approvals for two cancer drugs in Europe and the US.

Spark’s gene therapy Luxturna secures FDA approval for rare form of blindness

Spark Therapeutics’ gene therapy Luxturna (voretigene neparvovec) has been approved by the US Food and Drug Administration (FDA) for the treatment of children and adults having a rare inherited form of vision loss that could lead to blindness.

Alnylam, Sanofi submit MAA to EMA for patisiran to treat hereditary ATTR amyloidosis

Alnylam Pharmaceuticals and Sanofi Genzyme have submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for patisiran, an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of adults with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis).

FDA proposes risk-based enforcement approach to homeopathic drugs

The US Food and Drug Administration (FDA) is proposing new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs.

CHMP recommends approval of darvadstrocel to treat complex perianal fistulas in Crohn’s disease

Takeda Pharmaceutical and TiGenix reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), in conjunction with the Committee for Advanced Therapies (CAT), has adopted a positive opinion recommending a marketing authorization (MA) for investigational compound Cx601 (darvadstrocel).

Aclaris gets FDA nod for Eskata drug to treat raised seborrheic keratoses

Aclaris Therapeutics has secured approval from the US Food and Drug Administration (FDA) for Eskata (hydrogen peroxide) topical solution, 40% (w/w) for the treatment of raised seborrheic keratoses or SKs.

FDA approves Pfizer’s Xeljanz and Xeljanz XR to treat active psoriatic arthritis

The US Food and Drug Administration (FDA) has approved Pfizer’s Xeljanz 5 mg twice daily (BID) and Xeljanz XR (tofacitinib) extended release 11 mg once daily (QD) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).

Sanofi’s Admelog (insulin lispro injection) gets FDA approval to treat diabetes

Sanofi’s Admelog (insulin lispro injection) has been approved by the US Food and Drug Administration (FDA) to help diabetic patients control their blood sugar levels at mealtime.

Novo Nordisk’s Ozempic diabetic drug secures FDA approval

Novo Nordisk’s Ozempic (semaglutide injection) has been approved by the US Food and Drug Administration (FDA) to enhance glycaemic control in adults with type 2 diabetes mellitus.