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Genentech

Genentech wins FDA nod for subcutaneous formulation of arthritis drug

September 14, 2018 By Sarah Faulkner

Genentech logo updated

Roche‘s (OTC:RHHBY) Genentech reported this week that the FDA approved the subcutaneous formulation of tocilizumab for the treatment of active systemic juvenile idiopathic arthritis in patients two years and older. The U.S. agency approved the intravenous formulation of Actemra for the same indication in 2011. Systemic juvenile idiopathic arthritis affects roughly 30,000 children in the U.S., according […]

Filed Under: Featured, Food & Drug Administration (FDA), Orthopedics, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Genentech

Genentech touts positive data for tiny, refillable eye implant

July 25, 2018 By Sarah Faulkner

Genentech

Roche‘s (OTC:RHHBY) Genentech touted positive top-line data today from a Phase II study of its Port Delivery System, an eye implant designed to administer a sustained dose of ranibizumab in patients with wet age-related macular degeneration. The refillable device, which is slightly longer than a grain of rice, is intended to enable wet-AMD patients to go for […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Optical/Ophthalmic, Pharmaceuticals, Wall Street Beat Tagged With: Genentech, Roche

Genentech’s pre-filled syringe for diabetic retinopathy wins FDA nod

March 21, 2018 By Sarah Faulkner

Lucentis 0.3mg pre-filled syringe from Genentech

Roche‘s (OTC:RHHBY) Genentech announced today that the FDA approved its 0.3-mg pre-filled syringe as a new way to administer Lucentis to diabetic retinopathy patients. The company’s drug is the only FDA-approved medicine indicated for the treatment of diabetic retinopathy. The 0.3-mg pre-filled syringe is the first device of its kind approved to deliver an anti-vascular endothelial […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Genentech, Roche

Study evaluates drug-device combo therapy for deep vein thrombosis

March 6, 2017 By Sarah Faulkner

Study evaluates drug-device combo therapy for deep vein thrombosis

A National Institutes of Health-sponsored study found that most patients with deep vein thrombosis should be treated with anticoagulant drugs alone, without a procedure-based intervention. However, the same study showed that a minimally-invasive catheter-director therapy, pharmacomechanical catheter-directed thrombolysis, provided greater initial pain relief and could prevent disability in DVT patients. The research was presented today […]

Filed Under: Clinical Trials, Featured, Research & Development, Vascular Tagged With: Boston Scientific, BSN Medical, Genentech, Medtronic, National Institutes of Health, Society of Interventional Radiology

FDA approves Genentech’s Lucentis pre-filled ranibizumab syringe

October 14, 2016 By Sarah Faulkner

Genentech

Genentech, a member of the Roche group (PINK:RHHBY), said today that it won FDA clearance for its Lucentis (ranibizumab injection) pre-filled syringes. The anti-VEGF medicine is FDA-approved to treat wet age-related macular degeneration and macular edema after retinal vein occlusion. The pre-filled syringe enables physicians to eliminate steps in preparation and administration process, the company […]

Filed Under: Food & Drug Administration (FDA), Optical/Ophthalmic, Regulatory/Compliance Tagged With: Genentech, Roche

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