Novan Reports Positive Topline Results with SB208 in Phase 2 Trial

MORRISVILLE, N.C., April 12, 2017  -- Novan, Inc. (“the Company” or “Novan”) (NASDAQ:NOVN) today announced positive topline results from the Company’s Phase 2 clinical trial with SB208, a topical, silicone based-gel under development for the treatment of infections caused by dermatophytes such as Trichophyton rubrum, or T. rubrum. Novan is developing SB208 as a broad-spectrum antifungal gel for the treatment of superficial cutaneous fungal infections of the skin and nails, including tinea pedis and onychomycosis. Novan’s SB208 Gel, at both the 4% and 16% concentrations, demonstrated a statistically significant effect (p<0.05) compared to vehicle in a clinical trial in patients with tinea pedis, or athlete’s foot. Clinical activity against dermatophytes was measured by incidence of a negative fungal culture after two weeks of treatment.
Published: 12 April 2017
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Positive Results from RepliCel's RCS-01 Phase I Skin Trial are the Company's Most Compelling to Date

Interim trial results lead researchers to conclude that the injection of RCS-01 is not only very safe, but also has the potential to reverse effects of aging skin, representing a natural alternative to existing anti-aging treatments
 
VANCOUVER, April 4, 2017  - RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) ("RepliCel" or the "Company") is pleased to report statistically and clinically significant positive data from the interim analysis of its phase I study evaluating RCS-01 for the treatment of aging and sun-damaged skin.
Published: 04 April 2017
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Sonoma Pharmaceuticals Receives U.S. FDA Clearance of Loyon ® Skin Descaler for Relief of Scaling Associated with Various Dermatoses

PETALUMA, Calif., March 29, 2017  -- Sonoma Pharmaceuticals, Inc. (NASDAQ: SNOA, warrants SNOAW), a specialty pharmaceutical company that develops and markets unique and effective solutions for the treatment of dermatological conditions and advanced tissue care, today announced it has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company’s newest product, Loyon® Skin Descaler.  Loyon is intended to manage skin scaling experienced with various types of dermatoses.
 
Loyon Skin Descaler is a unique and patented combination of the dry emollient Cetiol® CC and the medical silicone oil dimethicone. The product is easily applied and spreads exceptionally well into the cracks and crevices of the scale due to its low surface tension.  U.S. commercialization via Sonoma’s dermatology division IntraDerm Pharmaceuticals’ 30-plus-person direct sales team is slated for summer 2017. 
Published: 29 March 2017
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Innocoll announces regulatory path forward after receiving formal FDA Type A meeting minutes regarding its XARACOLL ® (bupivacaine HCl collagen-matrix implant) New Drug Application

ATHLONE, Ireland, March 29, 2017  -- Innocoll Holdings plc (NASDAQ:INNL) ("Innocoll" or the "Company"), a global, commercial-stage, specialty pharmaceutical and medical device company, today announced receipt of formal Type A Meeting minutes from the United States Food and Drug Administration (FDA) relating to its New Drug Application (NDA) for XARACOLL (bupivacaine HCl collagen-matrix implant).  XARACOLL is the company’s product in development for the treatment of postsurgical pain.
 
Innocoll received a Refusal to File (RTF) Letter from the FDA in December 2016 pertaining to the XARACOLL NDA initially submitted on October 31, 2016.  In the RTF letter, the FDA indicated among other things, that XARACOLL should be characterized as a drug/device combination, which would require that the Company submit additional information. 
Published: 29 March 2017
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Tonix Pharmaceuticals Enrolls First Participant in Military-Related PTSD Phase 3 Trial of FDA Breakthrough Therapy-Designated TNX-102 SL

NEW YORK, March 28, 2017  -- Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a company that is developing innovative pharmaceutical products to address public health challenges, announced today that it has enrolled the first participant in the Phase 3 HONOR study of TNX-102 SL 5.6 mg, for the treatment of posttraumatic stress disorder (PTSD).
 
"Enrolling the first participant in the HONOR study is an important event not only to Tonix, but potentially to millions who suffer worldwide from both civilian and military-related PTSD," said Seth Lederman, M.D., Tonix's president and chief executive officer. “The HONOR study is designed to confirm the clinical benefit of TNX-102 SL to improve PTSD symptoms across several measures as demonstrated in our Phase 2 AtEase study in military-related PTSD.”
Published: 29 March 2017
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