Showing 2531-2540 of 5646 results for "".
- Eyevensys Receives FDA Orphan Drug Designation for EYS611 for Treatment of Retinitis Pigmentosahttps://modernod.com/news/eyevensys-receives-fda-orphan-drug-designation-for-eys611-for-treatment-of-retinitis-pigmentosa/2478365/Eyevensys announced that the FDA has granted an orphan-drug designation for EYS611 for the treatment of retinitis pigmentosa (RP). Eyevensys is developing EYS611, a DNA plasmid that encodes for the human transferrin protein, to benefit patients diagnosed with RP, as well as other degenerat
- iSTAR Medical Reports Positive 6-Month Data for MINIject Devicehttps://modernod.com/news/istar-medical-reports-positive-6-month-data-for-miniject-device/2478354/iSTAR Medical announced that its microinvasive glaucoma surgery (MIGS) device MINIject showed consistently positive safety and efficacy outcomes in a larger patient population from ongoing trials. The pooled analysis reviewed data from over 130 patients implanted with MINIject into the supracilia
- Novavax Begins Phase 3 Coronavirus Vaccine Trial in UKhttps://modernod.com/news/novavax-begins-phase-3-coronavirus-vaccine-trial-in-uk/2478330/Novavax said Thursday it has initiated its first phase 3 study to evaluate the efficacy, safety and immunogenicity of its COVID-19 vaccine candidate NVX-CoV2373. The trial, which is being conducted in the UK, is expected to enroll up to 10,000 individuals between the ages of 18 and 84 years, with
- FDA Grants Orphan Drug Designation for Neurophth Therapeutics’ Gene Therapy for LHONhttps://modernod.com/news/fda-grants-orphan-drug-designation-for-neurophth-therapeutics-gene-therapy-for-lhon/2478326/Neurophth Therapeutics announced that its leading candidate, NR082, was granted an orphan drug designation (ODD) by the FDA for the treatment of Leber’s Hereditary Optic Neuropathy (LHON) associated with ND4 mutation. LHON is a maternall
- Whitney Hauser, OD, FAAO, Joins Novartis Ophthalmicshttps://modernod.com/news/whitney-hauser-od-faao-joins-novartis-ophthalmics/2478318/Novartis has announced that Whitney Hauser, OD, FAAO, will be joining the team as Director, Peer Education for US Ophthalmics. In this capacity, Dr. Hauser will bring her experience as a professor, clinician and founder of the Dry Eye Coach to help shape Novartis’ education and engagement
- Gyroscope Therapeutics Granted FDA Fast Track Designation for Investigational Gene Therapy for Dry AMDhttps://modernod.com/news/gyroscope-therapeutics-granted-fda-fast-track-designation-for-investigational-gene-therapy-for-dry-amd/2478305/Gyroscope Therapeutics announced that the FDA has granted Fast Track designation to GT005 for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). GT005 is an investigational one-time AAV-based gene therapy that is delivered under the retina and is i
- BioNTech Snaps Up Novartis’ German Site to Expand Coronavirus Vaccine Outputhttps://modernod.com/news/biontech-snaps-up-novartis-german-site-to-expand-coronavirus-vaccine-output/2478296/BioNTech announced that it signed a share purchase agreement to acquire Novartis’ manufacturing facility in Marburg, Germany, a move it says will bolster its COVID-19 vaccine production capacity by up to 750 million doses per year, or over 60 million doses per month. BioNTech, whose Pfizer-
- European Medicines Agency (EMA) Approves Safety Label Update for Novartis’ Beovuhttps://modernod.com/news/european-medicines-agency-ema-approves-safety-label-update-for-novartis-beovu/2478279/Novartis announced that the Committee for Medicinal Products for Human Use (CHMP), has approved an update to the Beovu (brolucizumab) Summary of Product Characteristics (SmPC) to include additional information regarding retinal vasculitis and retinal vascular occlusion.1 Typically, the
- Keeler Partners With Medical Device Maker Olleyeshttps://modernod.com/news/keeler-partners-with-medical-device-maker-olleyes/2478278/Keeler has announced a partnership with Olleyes, a developer of eye care-based office and home-based diagnostic products. Terms of the deal were not disclosed. Olleyes is the maker of VisuALL VRP (Virtual Reality Perimetry), a platform designed for standardized and mobile assessment
- First Patient Dosed in Phase 3 Clinical Trial of Dextenza for the Treatment of Post-Surgical Ocular Inflammation and Pain in Childrenhttps://modernod.com/news/ocular-therapeutix-announces-first-patient-dosed-in-phase-3-clinical-trial-of-dextenza-for-the-treatment-of-post-surgical-ocular-inflammation-and-pain-in-children/2478274/Ocular Therapeutix announced that it has dosed the first patients in a phase 3 clinical trial of Dextenza (dexamethasone ophthalmic insert) 0.4 mg for the treatment of post-surgical ocular inflammation and pain in children following cataract surgery. “We are pleased to announce the start o