Pipeline news
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Clearside Biomedical confirms timeline for Xipere
22 October 2019
Clearside Biomedical (NSDQ:CLSD) last week said that the FDA found no efficacy issues with its Xipere drug-delivery technology and will not ask for further clinical efficacy studies. The Xipere device is a suprachoroidal injection designed for the treatment of macular edema associated with uveitis. In October 2018, Clearside touted data from a Phase III pivotal trial, which reported that 40% of people using Xipere experienced resolution of uveitis, compared to 0% in the control. The company submitted a new drug application the following December, and that NDA was accepted in February.
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18 October 2019
Clearside Biomedical , Inc. (Nasdaq:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that multiple oral presentations on Clearside’s pipeline and proprietary SCS Microinjector™ targeting the suprachoroidal space were given at the American Academy of Ophthalmology (AAO) 2019 Annual Meeting.
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23 September 2019
binx health, the pioneer in anywhere, anytime testing for women's health, today announced the first real-world use of the binx io platform, delivering same-visit diagnosis and treatment for chlamydia (CT) and gonorrhea (NG)—the two most tested-for sexually transmitted infections (STIs) globally. The World Health Organization (WHO) has previously indicated that the lack of reliable, low-cost, point-of-care tests that enable diagnosis and treatment in a single visit represents a major barrier to sexually transmitted infection (STI) control and prevention.
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Epic Sciences Expands Executive Leadership Team
09 September 2019
Epic Sciences, Inc. today announced the appointment of Joel Smith as its general counsel and executive vice president of corporate development. Mr. Smith joins the company's impressive roster of industry veterans.
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04 September 2019
REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, and Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, today announced an option and license agreement for exclusive worldwide rights to Clearside's proprietary, in-office SCS Microinjector™ for the delivery of RGX-314 to the suprachoroidal space to treat wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and other conditions for which anti-vascular endothelial growth factor (anti-VEGF) treatment is currently the standard of care. REGENXBIO plans to evaluate RGX-314 using Clearside's SCS Microinjector for in-office, non-surgical delivery into the suprachoroidal space, while continuing to advance its RGX-314 subretinal delivery program currently in development for wet AMD and DR.
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22 August 2019
Clearside Biomedical , Inc. (Nasdaq:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today an update regarding the Company’s 505(b)(2) New Drug Application (NDA) for XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension) with the U.S. Food and Drug Administration ( FDA ).
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binx health Appoints Healthcare Industry Veteran Gail Marcus to Board of Directors
12 August 2019
binx health, the pioneer in anywhere, anytime testing for women's health, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its first-of-kind, highly sensitive and specific, molecular point-of-care (POC) diagnostic testing platform, the binx io®. The binx ioplatform is a rapid, qualitative, fully-automated test, designed to be easy to use, and intended for use in POC or clinical laboratory settings, providing the world's first sample-to-answer result in about 30 minutes for the detection of chlamydia (CT) and gonorrhea (NG)—the two most tested-for STIs globally.
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08 August 2019
Eyevance Pharmaceuticals, a Fort Worth-based pharmaceutical company committed to developing and commercializing innovative and impactful ophthalmic products, today announced a worldwide licensing agreement with OcuNexus Therapeutics for NEXAGON®, a 30-base antisense oligomer being developed for the orphan indication of persistent corneal epithelial defect (PED) nonresponsive to standard of care.
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Marinus Pharmaceuticals Provides Business Update and Reports Second Quarter Financial Results
08 August 2019
Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, today provided a business update on its clinical development activities and reported its financial results for the second quarter ended June 30, 2019.
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Clearside Biomedical Announces Second Quarter 2019 Financial Results and Provides Corporate Update
07 August 2019
Clearside Biomedical , Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, today reported financial results for the second quarter of 2019 and provided a corporate update.
