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 […]
Roche
Europe approves Roche’s Enspryng subcutaneous NMOSD treatment
Roche (SWX: RO, ROG) announced today that the European Commission approved its Enspryng subcutaneous NMOSD treatment. Basel, Switzerland-based Roche developed Enspryng (satralizumab) to treat adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD). Approval comes for the treatment as a monotherapy or for use in […]
FDA accepts biologics license application for Genentech’s drug-eluting eye 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 […]
Pharma 50: Here’s how the world’s largest pharma companies are doing
The global pharmaceutical industry held up well during the pandemic, with 10 of the largest businesses only seeing a roughly –3% drop in revenue in 2020. Eight of the 10 even came out ahead. That’s one of the big takeaways from our sister publication Drug Discovery & Development’s inaugural Pharma 50, a compilation of data […]
Lilly partners with four companies on insulin pen tech
Eli Lilly (NYSE:LLY) today announced deals with four companies whose diabetes management tech will work with Lilly’s latest insulin pen. The Tempo Pen is a modified version of Lilly’s existing prefilled, disposable insulin pen to which the Tempo Smart Button — in late-stage development – attaches. Through these new agreements, the Tempo Smart Button will […]
Genentech touts study results for spinal muscular atrophy drug in babies
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 […]
BioCorp, Roche launch Mallya smart insulin pen in France
BioCorp and Roche Diabetes Care France announced the launch of the Mallya smart insulin pen device in France. Developed by BioCorp, Mallya is an intelligent sensor for insulin injection pens that has CE mark approval in Europe. The platform is compatible with any disposable insulin pen. It enables reliable monitoring for doses selected for injection and it offers […]
Roche, Diabeloop partner on insulin pump management
Roche (SWX: RO, ROG) announced today that it is partnering with Diabeloop to advance insulin pump therapy management. Basel, Switzerland-based Roche said in a news release that the partnership will create new opportunities to lower the burden of constant insulin dose adjustment for those with diabetes while also improving therapy outcomes. Roche also said the partnership with Paris-based […]
Senseonics extends distribution agreement with Roche Diabetes Care
Senseonics Holdings (NYSE-American: SENS) — maker of an implantable continuous glucose monitoring system for people with diabetes — has extended its distribution agreement with Roche Diabetes Care. The agreement extension, announced yesterday, has Roche continuing as Senseonics’ exclusive distributor in Europe, the Middle East and Africa — excluding Scandinavia and Israel. The agreement also adds 17 […]
Genentech touts data for refillable eye implant in wet-AMD trial
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 […]