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. 
Read more: Sonoma Pharmaceuticals ( SNOA )

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. 
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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.”
Read more: Tonix Pharmaceuticals Holding Corp ( TNXP )

RXi Pharmaceuticals Granted Patent in Japan for Lead Clinical Candidate RXI-109

RXI-109 is a self-delivering RNAi compound (sd-rxRNA) in development to reduce dermal and ocular fibrosis
 
MARLBOROUGH, Mass., March 28, 2017  -- RXi Pharmaceuticals Corporation (NASDAQ: RXII), a clinical-stage RNAi company developing innovative therapeutics that address significant unmet medical needs, today announced that it was granted a patent from the Japan Patent Office (JPO) for the composition of matter of sd-rxRNAs targeting connective tissue growth factor (CTGF) for the treatment or prevention of fibrotic disorders, including but not limited to skin fibrosis and proliferative retinopathy (Japanese Patent #: 6060071).  This patent includes the Company's lead clinical candidate RXI-109, an sd-rxRNA therapeutic compound, which is currently being evaluated in Phase 2 clinical trials. The patent, once issued, will be set to expire in 2031.
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Catalyst Biosciences Announces IND Approval in South Korea for Next-Generation Subcutaneous Factor IX Program

-- Investigational New Drug (IND) approval from Korean Ministry of Food and Drug Safety represents a key milestone in Catalyst’s Factor IX development program ------ Catalyst’s collaborator, ISU Abxis, plans to initiate a Phase 1/2 proof-of-concept study in individuals with severe hemophilia B in the second quarter of 2017 --
 
SOUTH SAN FRANCISCO, Calif., March 28, 2017  -- Catalyst Biosciences, Inc. (Nasdaq:CBIO), a clinical-stage biopharmaceutical company focused on developing novel medicines to address hematology indications, today announced that the Korean Ministry of Food and Drug Safety (MFDS) approved the Investigational New Drug Application (IND) for CB 2679d/ISU304. Hemophilia is a serious bleeding disorder that results in spontaneous bleeding episodes as well as substantially prolonged bleeding times upon injury.
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