Regulation

Janssen seeks expanded use of Darzalex combination therapy for patients with newly diagnosed ASCT multiple myeloma

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Type II variation application to the European Medicines Agency (EMA) for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone (Rd) for the treatment of patients newly diagnosed with multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

Sage Therapeutics gets FDA nod for Zulresso to treat postpartum depression

Sage Therapeutics has secured approval from the US Food and Drug Administration (FDA) for its Zulresso (brexanolone) injection to treat postpartum depression (PPD) in adult women.

Novo Nordisk settles US patent litigation case on Victoza (liraglutide) with Teva

A settlement between Novo Nordisk and Teva Pharmaceuticals USA (Teva) has been reached on the US patent litigation case for Victoza (liraglutide).

Genentech gets FDA nod for Tecentriq plus chemotherapy to treat ES-SCLC

Roche Group member Genentech has secured approval from the US Food and Drug Administration (FDA) for its Tecentriq (atezolizumab) in combination with chemotherapy for the initial treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).

European Commission approves Roche’s MabThera for rare autoimmune disease

Roche have announced that the European Commission (EC) has approved MabThera (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV), a rare condition characterised by progressive painful blistering of the skin and/or mucous membranes.

European Commission approves Roche’s Hemlibra for people with severe haemophilia A without factor VIII inhibitors

Roche announced that the European Commission has approved Hemlibra (emicizumab) for routine prophylaxis of bleeding episodes in people with severe haemophilia A (congenital factor VIII deficiency, FVIII <1%) without factor VIII inhibitors.

FDA approves Dupixent for moderate-to-severe atopic dermatitis in adolescents

Regeneron Pharmaceuticals and Sanofi announced that the US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Pfizer gets FDA approval for oncology biosimilar Trazimera

Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Trazimera (trastuzumab-qyyp), an oncology biosimilar to Genentech’s Herceptin (trastuzumab).

Sanofi’s Dupixent secures FDA priority review for CRSwNP

Sanofi has secured priority review from the US Food and Drug Administration (FDA) for its human monoclonal antibody Dupixent (dupilumab) as an add-on maintenance treatment for severe chronic rhinosinusitis with nasal polyps (CRSwNP).