Category: Business

Horizon Pharma plc Completes Enrollment of Confirmatory Phase 3 Trial of Teprotumumab Ahead of Schedule

DUBLIN–(BUSINESS WIRE)–Horizon Pharma plc (NASDAQ:HZNP) announced the early completion of enrollment for the confirmatory Phase 3 trial of teprotumumab in patients living with moderate-to-severe active thyroid eye disease (TED). The study (NCT03298867 and EudraCT 2017-002763-18) enrolled 83 patients at 13 sites across the United States, Germany and Italy. Topline results are expected in the second quarter of 2019. “Our success in rapidly enrolling this trial speaks to the significant unmet ne

Patient-Driven Gene Therapy Company ReflectionBio Receives Orphan Drug Designation From U.S. FDA For the Treatment of Bietti’s Crystalline Dystrophy (BCD)

HONG KONG & NEW YORK–(BUSINESS WIRE)–Reflection Biotechnologies Limited (“ReflectionBio”), a gene therapy company committed to the research and development of life-changing treatments for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ReflectionBio’s RBIO-101 program (AAV.CYP4V2), an AAV-based gene therapy product for treating Bietti’s Crystalline Dystrophy (BCD). “Receiving orphan drug designation from the FDA is a miles

EyeSouth Expands into South Florida Through Affiliation with Florida Eye Microsurgical Institute

ATLANTA–(BUSINESS WIRE)–EyeSouth Partners (“EyeSouth” or the “Company”) is pleased to announce that it has completed a strategic partnership with Florida Eye Microsurgical Institute and Boynton Beach ASC (“Florida Eye Microsurgical”), expanding its presence into the South Florida region. EyeSouth is an eye care-focused physician services organization formed by Shore Capital Partners, a leading lower middle market healthcare private equity firm. Florida Eye Microsurgical is led by ophthalmolog

EyeQue Amplía la Supervisión de la Visión para Consumidores, al Agregar Pruebas de Sensibilidad de Color y Contraste al Detector de la Visión Interna

NEWARK, California–(BUSINESS WIRE)–EyeQue®, el líder galardonado en dispositivos de salud para la visión a precios accesibles en el hogar, anunció hoy la adición de dos nuevas pruebas de visión a su detector de la visión EyeQue Insight™, prueba de sensibilidad de color y contraste de la visión. EyeQue Insight combina un visor binocular, una aplicación móvil y un servicio basado en la nube para crear el primer detector de visión controlado por teléfono inteligente del mundo. Desde su disponibi

MC2 Therapeutics maakt positieve resultaten bekend van Fase 3 klinisch onderzoek dat MC2-01 Cream vergelijkt met Taclonex® bij volwassenen met psoriasis

KOPENHAGEN, Denemarken–(BUSINESS WIRE)–MC2 Therapeutics A/S, een opkomend farmaceutisch bedrijf dat de volgende generatie patiëntvriendelijke lokale therapieën voor huid- en oogziekten ontwikkelt, heeft vandaag de volgende goede gegevens van haar Amerikaanse Fase 3-studie (n = 796) over het onderzoeksmedicijn MC2-01 Cream (calcipotrieen en betamethasondipropionaat, w/w 0,005%/0,064%) van het bedrijf aangekondigd: Primaire eindpunt MC2-01 Cream is beter dan Taclonex® Topical Suspension (‘Taclo

MC2 Therapeutics meldet positive Topline-Ergebnisse aus der klinischen Phase-3-Studie zum Vergleich von MC2-01-Creme und Taclonex® bei erwachsenen Patienten mit Psoriasis

KOPENHAGEN, Dänemark–(BUSINESS WIRE)–MC2 Therapeutics A/S, ein aufstrebendes Pharmaunternehmen, das patientenfreundliche topische Therapeutika der nächsten Generation für Haut- und Augenkrankheiten entwickelt, gab heute die folgenden Topline-Daten aus seiner US-amerikanischen Phase-3-Studie (n=796) zu dem Prüfpräparat des Unternehmens, MC2-01-Creme (Calcipotriol und Betamethason-Dipropionat, w/w 0,005 %/0,064 %), bekannt: Primärer Endpunkt MC2-01-Creme ist Taclonex® Topical Suspension („Taclo

MC2 Therapeutics anuncia resultados positivos de primera línea del ensayo clínico de fase 3 que compara la crema MC2-01 con Taclonex ® en adultos con psoriasis

COPENHAGUE, Dinamarca–(BUSINESS WIRE)–MC2 Therapeutics A/S, una empresa farmacéutica emergente que desarrolla terapias tópicas de próxima generación cómodas para el paciente para enfermedades cutáneas y oculares, ha anunciado los siguientes datos de primera línea de su estudio de fase 3 en Estados Unidos (n=796) de su fármaco en fase de investigación, la crema MC2-01 (calcipotrieno y dipropionato betametasona, al 0,005%/0,064%): Principal criterio de evaluación La crema MC2-01 es superior a l

MC2 Therapeutics annuncia risultati top-line positivi della sperimentazione clinica di fase 3 di raffronto tra la crema MC2-01 e Taclonex® negli adulti con psoriasi

COPENAGHEN, Danimarca–(BUSINESS WIRE)–MC2 Therapeutics A/S, casa farmaceutica emergente dedita allo sviluppo di terapie topiche di nuova generazione pratiche da usare per le affezioni della cute e degli occhi, ha annunciato in data odierna i seguenti dati top-line della sperimentazione di fase 3 condotta negli USA (n=796) del farmaco in sperimentazione dell’azienda, la crema MC2-01 (calcipotriolo e betametasone dipropionato, m/m 0,005%/0,064%). Endpoint primario La crema MC2-01 è superiore a

MC2 Therapeutics Announces Positive Top-line Results from Phase 3 Clinical Trial Comparing MC2-01 Cream to Taclonex® in Adults with Psoriasis

COPENHAGEN, Denmark–(BUSINESS WIRE)–MC2 Therapeutics A/S, an emerging pharmaceutical company developing next generation patient-friendly topical therapies for skin and eye diseases, today announced the following top-line data from its US Phase 3 study (n=796) on the company’s investigational drug, MC2-01 Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%): Primary end-point MC2-01 Cream is superior to Taclonex® Topical Suspension (“Taclonex®”) at Week 8 based on treatment