FDA Accepts PMA Submission for ReVision Optics’ Raindrop Near Vision Inlay
10 November 2015
ReVision Optics, Inc. (RVO®), a leader in implantable presbyopia-correcting corneal inlay technology, announces that the U.S. Food and Drug Administration (FDA) has accepted and deemed fileable the company’s premarket approval (PMA) submission for the Raindrop® Near Vision Inlay. The Raindrop is a microscopic hydrogel inlay designed to correct presbyopia, thus reducing or eliminating the need for reading glasses. Acceptance and filing of the submission means the FDA has made a threshold determination that the Raindrop PMA submission is sufficiently complete to move forward in the FDA review and approval process.
Marinus Pharmaceuticals Announces Public Offering of Common Stock
06 November 2015
Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS) ("Marinus" or the "Company") today announced that it intends to offer and sell shares of its common stock in an underwritten public offering. Jefferies LLC and RBC Capital Markets, LLC are acting as joint bookrunning managers for the offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
03 November 2015
NovaDigm Therapeutics, a company developing innovative vaccines for fungal and bacterial infections, today announced that Timothy Cooke, Ph.D., NovaDigm’s Chief Executive Officer, has been appointed to a four-year term on the National Vaccine Advisory Committee (NVAC) by Karen B. DeSalvo, M.D., MPH, MSc, Acting Assistant Secretary for Health at the U.S. Department of Health and Human Services.
02 November 2015
After successive cancer therapies, multiple subpopulations of cancer cells arise, each with divergent genetic aberrations that may confer drug resistance or susceptibility. Tissue biopsies may not detect these subpopulations, but a liquid biopsy of blood using Epic Sciences' no cell left behind® technology may help identify these important tumor cells and characterize how a patient's tumors have evolved over time.
02 November 2015
ReVision Optics, Inc. (RVO), a leader in implantable presbyopia-correcting corneal inlay technology, announces that clinical data on the company’s Raindrop® Near Vision Inlay was published in the peer-reviewed Journal of Cataract Refractive Surgery. The Raindrop Inlay is a microscopic hydrogel inlay designed to improve near and intermediate vision, thus reducing the need for reading glasses.
Marinus Pharmaceuticals Provides Business Update and Reports Third Quarter 2015 Financial Results
29 October 2015
Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical 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 third quarter ended September 30, 2015.
Marinus Announces Clinical Development Plans for Ganaxolone Intravenous Formulation
29 October 2015
Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, announced today the initiation of the clinical phase of its intravenous (IV) ganaxolone program in Status Epilepticus (SE). Data from preclinical studies yielded positive results testing ganaxolone IV in benzodiazepine-resistant SE, which support progressing ganaxolone IV to human clinical trials. Ganaxolone IV promoted survival and showed better or comparable reversal of seizures than the endogenous neurosteroid, allopregnanolone, in clinically translatable rodent models of SE. The studies were conducted at two separate laboratories using different measurements.
Marinus Announces Key Initial Observations From Study in PCDH19 Female Pediatric Epilepsy
26 October 2015
Marinus Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, today announced key observations from patients enrolled in its ongoing study evaluating ganaxolone, a synthetic analog of the endogenous neurosteroid allopregnanolone, as a treatment for PCDH19 female pediatric epilepsy. PCDH19 is a serious and rare epileptic syndrome characterized by highly variable early-onset cluster seizures, and cognitive and behavioral disturbances. Enrollment is continuing in the study with full data expected in 2016.
12 October 2015
Clearside Biomedical, Inc., a clinical-stage biopharmaceutical company developing innovative first-in-class drug therapies to treat blinding diseases of the eye, today announced completion of enrollment in the company’s Phase 2 clinical trial (Dogwood) of CLS-TA, Clearside’s proprietary form of triamcinolone acetonide, using SCS™ drug administration for the treatment of macular edema associated with non-infectious uveitis. Clearside remains on track to report top-line Phase 2 CLS-TA data by the end of 2015.
08 October 2015
Celtaxsys, a clinical stage drug development company focused on advancing care for patients suffering from orphan inflammatory diseases, announced today the commencement of the US arm of an international phase 2 clinical trial for its flagship compound, acebilustat, in patients with cystic fibrosis (CF). The study will be conducted at approximately 60 sites inthe United States and European Union, with the EU sites anticipated to begin enrollment early 2016.
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