Business

Aerie Pharmaceuticals Announces Public Offering of Common Stock

IRVINE, Calif.–(BUSINESS WIRE)–Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye, today announced that it has commenced a registered underwritten public offering of $50 million of shares of its common stock. Cantor Fitzgerald & Co. is acting as the sole bookrunner for the offering. Aerie intends t

Dompé用于治疗中度或重度神经营养性角膜炎成人患者的Oxervate®(Cenegermin滴眼液)获得欧盟CHMP肯定意见

米兰–(BUSINESS WIRE)–(美国商业资讯) — 生物制药公司Dompé今天宣布,EMA(欧洲药品署)人用药品委员会(CHMP)发布了一项肯定意见,建议签发Oxervate®(cenegermin 滴眼液)用于治疗中度或重度神经营养性角膜炎成人患者的上市许可。该病是一种罕见的致残性眼病,可导致失明。迄今,该病缺乏满意的治疗方法。鉴于该病相关的风险及缺乏有效治疗选择,CHMP通过加速评估完成了审批。加速评估始于2016年11月,本周以肯定意见收尾。 神经营养性角膜炎的起源与三叉神经(负责眼解剖和功能的神经之一)损害有关,该损害可导致角膜敏感性丧失。该病最严重时可导致溃疡、溶解和角膜穿孔,影响患者的视力2。 若获得EMA孤儿药品委员会(COMP)证实及欧盟核准,Oxervate®将是世界上首个获准用于该适应证的生物技术孤儿药。 该活性药物的名称是Cenegermin,是人类神经生长因子(NGF)的重组版本,发现者是诺贝尔奖获得者Rita Levi Montalcini。该蛋白质由人体天然产生,参与神经细胞的发育、维护和生存3。Oxervate®以滴眼液的形式施用于神经营养

Aerie Pharmaceuticals Reports Positive Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% Phase 3 Topline Efficacy Results

IRVINE, Calif.–(BUSINESS WIRE)–Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye, today reported the successful primary efficacy results of the Company’s 90-day Phase 3 “Mercury 2” registration trial for its fixed-dose combination product candidate, Roclatan™. The results of Mercury 2 were consistent

Dompé obtiene la opinión positiva del CHMP en Europa para Oxervate® (colirio de cenegermin) para el tratamiento de la queratitis neurotrófica de moderada a grave en pacientes adultos

MILÁN–(BUSINESS WIRE)–La empresa biofarmacéutica Dompé ha anunciado hoy que el Comité para Productos Médicos de Uso Humano (CHMP) de la Agencia Europea del Medicamento (EMA) ha emitido una opinión positiva que recomienda la autorización para la comercialización de Oxervate® (colirio de cenegermin) para el tratamiento de la querartitis neurotrófica de moderada a grave en pacientes adultos. Se trata de una enfermedad rara e incapacitante que puede derivar en pérdida de la visión. A fecha de hoy

FDA Approves Genentech’s Actemra (Tocilizumab) for Giant Cell Arteritis

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Actemra® (tocilizumab) subcutaneous injection for the treatment of GCA, a chronic and severe autoimmune condition. Actemra is the first therapy approved by the FDA for the treatment of adult patients with GCA. This is the sixth FDA approval for Actemra since the medicine was launched in 2010. “Today’s FDA

ClearSight Announces Sale of Parent Company, Sharklet Technologies

AURORA, Colo.–(BUSINESS WIRE)–ClearSight LLC is pleased to announce the acquisition of its parent company Sharklet Technologies, Inc., by Peaceful Union, an equity medical device firm in Hangzhou, China. ClearSight LLC was co-founded by Drs. Kevin Cuevas and Shravanthi Reddy to develop the next generation intraocular lens (IOL) implant. “We believe that the biomimetic approach used by Sharklet Technologies will not only produce the most advanced IOL, but will most likely enhance the performan

NovaBay Pharmaceuticals Receives Noncompliance Notice from NYSE MKT

EMERYVILLE, Calif.–(BUSINESS WIRE)–NovaBay® Pharmaceuticals, Inc. (NYSE MKT: NBY) today announced receipt of a letter from NYSE MKT LLC (“NYSE MKT” or the “Exchange”) on May 16, 2017, stating that it is not in compliance with the continued listing standards (requiring stockholders’ equity of $6.0 million or more if it has reported losses from continuing operations and/or net losses in its five most recent fiscal years) as set forth in Section 1003(a)(iii) of the NYSE MKT Company Guide (“Compa

Retinal Surgery Devices Market to Reach $3Bn by 2025 – Analysis By Product (Vitrectomy Machines, Vitrectomy Packs, Surgical Instruments, Microscopic Illumination Equipment, Retinal Laser Equipment) – Research and Markets

DUBLIN–(BUSINESS WIRE)–Research and Markets has announced the addition of the “Retinal Surgery Devices Market, 2014 – 2025″ report to their offering. The global retinal surgery devices market is expected to reach USD 3.06 billion by 2025. The unprece…

Aerie Pharmaceuticals Announces New Hires

IRVINE, Calif.–(BUSINESS WIRE)–Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of glaucoma and other diseases of the eye, today announced the appointments of Jessica Crespo, CPA, as Director of Accounting, Minh Lu as Director of Supply Chain, and Lorcan O’Toole as Operations Director for the Aerie plant in Athlone, Ireland. In connection with the accepta

Aerie Pharmaceuticals Announces FDA Acceptance of NDA Submission for Rhopressa™ (netarsudil ophthalmic solution) 0.02%

IRVINE, Calif.–(BUSINESS WIRE)–Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye, today reported that it has received notification from the U.S. Food and Drug Administration (FDA) that the FDA has completed its initial 60–day review of the RhopressaTM NDA (new drug application) and determined that the

Noted Surgeons Dr. Raymond Douglas and Dr. Terry Smith Unveil First-Ever Non-Surgical Treatment for Graves’ Eye Disease

LOS ANGELES & ANN ARBOR, Mich.–(BUSINESS WIRE)–Beverly Hills, California surgeon Dr. Raymond Douglas and Ann Arbor, Michigan’s Dr. Terry Smith – two prominent physicians specializing in thyroid-associated diseases – have unveiled a dramatic new non-surgical treatment for thyroid eye disease, one of the more serious symptoms of Graves’ disease. In develop for nearly 15 years by Dr.’s Douglas and Smith, Teprotumumab has been designated by the FDA as a “breakthrough” therapy, a term reserved exc

NovaBay Pharmaceuticals Reports First Quarter 2017 Financial Results

EMERYVILLE, Calif.–(BUSINESS WIRE)–NovaBay® Pharmaceuticals, Inc. (NYSE MKT: NBY), a pharmaceutical company focused on commercializing its prescription Avenova® lid and lash hygiene product for the domestic eye care market, reports financial results for the three months ended March 31, 2017 and provides a business update. “Avenova product sales for the quarter increased 165% over the prior year on record unit volume from our higher-margin prescription ophthalmology channel as we continued the

LENSAR® accorde le contrat de distribution européenne à Teleon Surgical

ORLANDO, Floride–(BUSINESS WIRE)–LENSAR, Inc. est un leader mondial de la nouvelle génération de technologie laser femtoseconde pour la chirurgie réfractive de la cataracte. Aujourd’hui, l’entreprise annonce avoir choisi Teleon Surgical comme distributeur européen du système laser LENSAR® avec la technologie Streamline™, sa plateforme de cataracte laser femtoseconde leader de l’industrie. Cette annonce intervient alors que Topcon Europe Medical B.V. (TEM) arrête la distribution de la platefor