Pipeline news

• Marinus Pharmaceuticals Appoints Joe Hulihan, M.D., as Chief Medical Officer

  29 October 2019

  

  Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS) (“Marinus” or “Company”), a pharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy, depression and other neuropsychiatric disorders, today announced that Joe Hulihan, MD, has been appointed Chief Medical Officer. Dr. Hulihan will succeed outgoing CMO, Lorianne Masuoka, MD, who is retiring from the position.

• Clearside Biomedical Announces Option Exercise by REGENXBIO for Global License for Use of SCS Microinjector™ in AAV Gene Therapy Delivery

  29 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  REGENXBIO Inc.  (Nasdaq: RGNX) has exercised its option under the previously announced option and license agreement to license Clearside’s proprietary, in-office SCS Microinjector™ for the delivery of adeno-associated virus (AAV)-based therapeutics, including but not limited to RGX-314 delivery to the suprachoroidal space to potentially treat wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR), and other conditions for which chronic anti-vascular endothelial growth factor (anti-VEGF) treatment is currently the standard of care.

• Bausch Health Licenses Clearside Biomedical's XIPERE™ (Triamcinolone Acetonide Suprachoroidal Injectable Suspension), An Investigational Treatment For Macular Edema Associated With Uveitis

  24 October 2019

  

  Bausch Health Companies Inc.  (NYSE/TSX: BHC) (" Bausch Health ") and Bausch + Lomb, its leading global eye health business, and  Clearside Biomedical, Inc., a biopharmaceutical company dedicated to developing and delivering treatments that can restore and preserve vision for people with serious back of the eye diseases, announced today that an affiliate of  Bausch Health  has acquired an exclusive license for the commercialization and development of XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) in  the United States  and  Canada .

• Clearside Biomedical confirms timeline for Xipere

  22 October 2019 Sean Whooley / Drug Delivery Business News

  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.

• Clearside Biomedical Suprachoroidal Injection Platform Featured in Multiple Presentations at the American Academy of Ophthalmology (AAO) 2019 Annual Meeting

  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.

• binx health Announces First Patients Benefiting From Single-Visit Test and Treatment for Chlamydia and Gonorrhea

  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.

• 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.

• REGENXBIO Announces Exclusive Worldwide Option and License Agreement with Clearside Biomedical for Evaluation of In-Office Delivery Platform for RGX-314

  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.

• Clearside Biomedical Provides New Drug Application Update for XIPEREᵀᴹ (triamcinolone acetonide suprachoroidal injectable suspension)

  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 ).

• 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.