Ophthalmologist Pleads Guilty to Using Misbranded Medication
FDA OCI, James Heroman, Charlotte NC, M.D., guilty plea, misbranded medication, opthalmologist, Carolina Retina, Vitreous Consultants, CRVC, unapproved, foreign, cheap, macular degeneration, Lucentis, Medicare, bill, price difference, profit, False Claims Act, violations, health care fraud (Source: Office of Criminal Investigations (OCI) Press Releases)
Source: Office of Criminal Investigations (OCI) Press Releases - October 7, 2021 Category: Medical Law Authors: DOJ Source Type: news
Byooviz (Ranibizumab-nuna Injection, for Intravitreal Use) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - September 29, 2021 Category: Drugs & Pharmacology Source Type: news
FDA Approves Ranibizumab Biosimilar FDA Approves Ranibizumab Biosimilar
Byooviz has the potential to be less expensive than Lucentis, the reference product.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 20, 2021 Category: Consumer Health News Tags: Ophthalmology News Alert Source Type: news
FDA accepts application for Roche ’s faricimab for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME)
Basel, 29 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company ’s Biologics License Application (BLA), under Priority Review, for faricimab for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME). The FDA has also accepted the company’s submission for diabetic retinopathy.Faricimab will be the first and only bispecific antibody designed for the eye, if approved. It targets two distinct pathways – via angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) ...
Source: Roche Investor Update - July 29, 2021 Category: Pharmaceuticals Source Type: news
FDA accepts application for Roche ’s faricimab for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME)
Basel, 29 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company ’s Biologics License Application (BLA), under Priority Review, for faricimab for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME). The FDA has also accepted the company’s submission for diabetic retinopathy.Faricimab will be the first and only bispecific antibody designed for the eye, if approved. It targets two distinct pathways – via angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) ...
Source: Roche Media News - July 29, 2021 Category: Pharmaceuticals Source Type: news
FDA accepts application for Roche ’s Port Delivery System with ranibizumab (PDS) for treatment of neovascular or “wet” age-related macular degeneration (nAMD)
Basel, 24 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company ’s Biologics License Application (BLA), under Priority Review, for Port Delivery System with ranibizumab (PDS) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD). Neovascular AMD is a leading cause of blindness for people aged 60 and over and impacts approximatel y 20 million people worldwide.1,2,3 If approved, PDS would be a first-of-its-kind therapeutic approach, offering people living with nAMD an alternative to frequent eye injections of...
Source: Roche Investor Update - June 24, 2021 Category: Pharmaceuticals Source Type: news
FDA accepts application for Roche ’s Port Delivery System with ranibizumab (PDS) for treatment of neovascular or “wet” age-related macular degeneration (nAMD)
Basel, 24 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company ’s Biologics License Application (BLA), under Priority Review, for Port Delivery System with ranibizumab (PDS) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD). Neovascular AMD is a leading cause of blindness for people aged 60 and over and impacts approximatel y 20 million people worldwide.1,2,3 If approved, PDS would be a first-of-its-kind therapeutic approach, offering people living with nAMD an alternative to frequent eye injections of...
Source: Roche Media News - June 24, 2021 Category: Pharmaceuticals Source Type: news
Lucentis (ranibizumab)
Title: Lucentis (ranibizumab)Category: MedicationsCreated: 2/18/2021 12:00:00 AMLast Editorial Review: 2/18/2021 12:00:00 AM (Source: MedicineNet Eyesight General)
Source: MedicineNet Eyesight General - February 18, 2021 Category: Opthalmology Source Type: news
Roche ’s faricimab meets primary endpoint in two global phase III studies and shows potential to extend time between treatments up to 16 weeks for people with neovascular age-related macular degeneration
Basel, 25 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from two identically designed global phase III studies, TENAYA and LUCERNE, evaluating its investigational bispecific antibody, faricimab, in people living with neovascular or “wet” age-related macular degeneration (nAMD). Both studies met their primary endpoint and showed that people receiving faricimab injections at fixed intervals of up to every 16 weeks achieved visual acuity outcomes that were non-inferior to those receiving aflibercept injections every eight wee ks. Nearly half (45%) of people in both studies were...
Source: Roche Media News - January 25, 2021 Category: Pharmaceuticals Source Type: news
Roche ’s faricimab meets primary endpoint in two global phase III studies and shows potential to extend time between treatments up to 16 weeks for people with neovascular age-related macular degeneration
Basel, 25 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from two identically designed global phase III studies, TENAYA and LUCERNE, evaluating its investigational bispecific antibody, faricimab, in people living with neovascular or “wet” age-related macular degeneration (nAMD). Both studies met their primary endpoint and showed that people receiving faricimab injections at fixed intervals of up to every 16 weeks achieved visual acuity outcomes that were non-inferior to those receiving aflibercept injections every eight wee ks. Nearly half (45%) of people in both studies were...
Source: Roche Investor Update - January 25, 2021 Category: Pharmaceuticals Source Type: news
Roche ’s faricimab meets primary endpoint and shows strong durability across two global phase III studies for diabetic macular edema, a leading cause of blindness
Basel, 21 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from two identically designed global phase III studies, YOSEMITE and RHINE, evaluating its investigational bispecific antibody, faricimab, in people living with diabetic macular edema (DME). Both studies met their primary endpoint and showed that faricimab given every eight weeks and at personalised dosing intervals of up to 16 weeks demonstrated non-inferior visual acuity gains compared to aflibercept given every eight weeks. Faricimab was generally well-tolerated, with no new safety signals identified. The studies each h...
Source: Roche Investor Update - December 21, 2020 Category: Pharmaceuticals Source Type: news
Roche ’s faricimab meets primary endpoint and shows strong durability across two global phase III studies for diabetic macular edema, a leading cause of blindness
Basel, 21 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from two identically designed global phase III studies, YOSEMITE and RHINE, evaluating its investigational bispecific antibody, faricimab, in people living with diabetic macular edema (DME). Both studies met their primary endpoint and showed that faricimab given every eight weeks and at personalised dosing intervals of up to 16 weeks demonstrated non-inferior visual acuity gains compared to aflibercept given every eight weeks. Faricimab was generally well-tolerated, with no new safety signals identified. The studies each h...
Source: Roche Media News - December 21, 2020 Category: Pharmaceuticals Source Type: news
Ranibizumab Biosimilar Shows Equivalent Efficacy to Branded Drug for Neovascular AMD Ranibizumab Biosimilar Shows Equivalent Efficacy to Branded Drug for Neovascular AMD
In a phase 3 study, the ranibizumab biosimilar SB11 demonstrated equivalent efficacy and similar safety and immunogenicity profiles compared with ranibizumab for patients with neovascular age-related macular degeneration (nAMD).Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 1, 2020 Category: Consumer Health News Tags: Ophthalmology News Source Type: news
Implant Reduces Treatment Burden in Wet Macular Degeneration Implant Reduces Treatment Burden in Wet Macular Degeneration
The administration of ranibizumab with an implant, rather than intravitreal injection, looks promising for neovascular age-related macular degeneration, interim results from a phase 3 study indicate.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 13, 2020 Category: Consumer Health News Tags: Ophthalmology News Source Type: news
Phase III data show Roche ’s Port Delivery System with ranibizumab enabled over 98% of patients to go six months between treatments for neovascular age-related macular degeneration
Basel, 22 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced detailed results from the phase III Archway study evaluating its investigational Port Delivery System with ranibizumab (PDS) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD), a leading cause of blindness globally.1 In Archway, 98.4% of PDS patients were able to go six months without needing additional treatment and achieved vision outcomes equivalent to patients receiving monthly ranibizumab eye injections, a current standard of care. In the study, PDS was generally well-tolerated, with a favourable benefit-risk pr...
Source: Roche Investor Update - July 22, 2020 Category: Pharmaceuticals Source Type: news
