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Genentech

FDA approves Genentech’s Susvimo drug-eluting eye implant

October 22, 2021 By Sean Whooley

Genentech Susvimo Implant Image 1 For Media

Genentech announced today that it received FDA approval for its Susvimo injection for treating macular degeneration (AMD). South San Francisco-based Genentech, a member of the Roche Group, designed its Susvimo ranibizumab injection (100 mg/mL) for intravitreal use via ocular implant for treating people with wet, or neovascular, age-related macular degeneration (AMD) who have previously responded […]

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Implants, Optical/Ophthalmic, Regulatory/Compliance Tagged With: FDA, Genentech, Roche

FDA accepts biologics license application for Genentech’s drug-eluting eye implant

June 24, 2021 By Sean Whooley

Genentech Susvimo PDS implant

Genentech announced that the FDA accepted its Biologics License Application (BLA) for its Port Delivery System (PDS) with ranibizumab. The PDS is a permanent, refillable eye implant that’s the approximate size of a grain of rice. It offers continuous delivery of a customized formulation of ranibizumab over a period of months to reduce the treatment […]

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Pharmaceuticals Tagged With: Genentech, Roche

Genentech touts study results for spinal muscular atrophy drug in babies

April 15, 2021 By Sean Whooley

Genentech logo updated

Genentech today touted two-year data evaluating the use of its Evrysdi therapeutic in infants with symptomatic Type 1 spinal muscular atrophy (SMA). South San Francisco, Calif.-based Genentech’s Firefish Phase 2/3 global study for Evrysdi (risdiplam) in infants between 1-7 months old showed that the orally administered (liquid or feeding tube) therapeutic continued to improve motor […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Neurological, Pediatrics Tagged With: Genentech, Roche

Genentech wins FDA approval for Xolair prefilled syringe

April 12, 2021 By Sean Whooley

Genentech logo updated

Genentech announced today that the FDA approved its supplemental biologics license application for the Xolair prefilled syringe. South San Francisco-based Genentech touts the Xolair (omalizumab) prefilled syringe for self-injection across all approved U.S. indications as the only FDA-approved biologic designed to target and block immunoglobulin E (IgE) for treating moderate to severe persistent allergic asthma, […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance Tagged With: FDA, Genentech

Enable Injections inks deal with Genentech

August 22, 2019 By Sean Whooley

Enable Injections

Enable Injections said yesterday that it entered a developmental partnership with Genentech for the Enable enFuse device. Cincinnati-based Enable’s enFuse is an on-body drug delivery platform containing a drug transfer system compatible with syringes and vial containers. Currently, the enFuse is being developed for subcutaneous delivery of large volumes potentially rising to 50 mL. The […]

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Pharmaceuticals Tagged With: Enable Injections, Genentech

FDA approves Genentech’s prefilled autoinjector for Actemra

November 26, 2018 By Sarah Faulkner

Genentech logo updated

Roche‘s (OTC:RHHBY) Genentech said today that the FDA approved its ACTPen single-dose prefilled autoinjector for Actemra as a new formulation for adults with moderate to severe active rheumatoid arthritis and for adults with giant cell arteritis. The U.S. regulatory agency also approved the device for administration by caregivers to patients as young as two years old […]

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

Genentech touts data for refillable eye implant in wet-AMD trial

October 29, 2018 By Sarah Faulkner

Genentech Susvimo PDS implant

Roche‘s (OTC:RHHBY) Genentech touted additional positive data last week from a Phase II study of its Port Delivery System, a refillable eye implant designed to deliver ranibizumab to treat wet age-related macular degeneration. The company first reported top-line results from the Phase II Ladder study in July. The implant is intended to allow wet-AMD patients to go […]

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

Genentech kicks off Phase III trial for eye implant

October 5, 2018 By Sarah Faulkner

Genentech logo updated

Roche‘s (OTC:RHHBY) Genentech reported this week that the company launched Phase III trials evaluating its Port drug-delivery implant in patients with wet age-related macular degeneration and the drug faricimab in patients with diabetic macular edema. The company’s Port device is a refillable eye implant designed to continuously release drugs over a period of several months. “Wet […]

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

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

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