|Retrophin Receives Fast Track Designation for RE-024; FDA Clears NovaBay Pharmaceuticals' New High-Tech Device intelli-Case|
|By Marilyn Mullen|
|Thursday, 04 June 2015 19:21|
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 4, 2015.
Retrophin, Inc. (NASDAQ: RTRX) announced the U.S. FDA has granted Fast Track designation for RE-024, the Company's novel investigational phosphopantothenate replacement therapy, for the treatment of pantothenate kinase-associated neurodegeneration (PKAN). PKAN is a rare and lethal autosomal recessive neurodegenerative disorder believed to affect approximately one to three persons per million worldwide, with no approved treatment currently available. Retrophin is currently enrolling healthy volunteers in its Phase 1 clinical trial evaluating the safety and tolerability of single oral doses of RE-024.
Fast Track designation is intended to aid the development of drugs to treat serious conditions with unmet medical needs, and expedite the review process with a goal of reaching patients earlier. A drug that receives Fast Track designation may be eligible for more frequent communication with the FDA to discuss development plans and clinical trial design, as well as Accelerated Approval and Priority Review. The developing company may also be eligible for Rolling Review, which enables the submission of completed sections of its New Drug Application (NDA) for review by the FDA before the company submits a complete application.
NovaBay® Pharmaceuticals, Inc. (NYSE MKT: NBY), a biopharmaceutical company commercializing and developing novel approaches for the global eye care market, including revolutionary non-antibiotic antimicrobial products, today announced receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its novel intelli-Case with hydrogen peroxide solutions.
“The intelli-Case is a highly innovative, extremely easy-to-use device for the millions of Americans who wear contact lenses and want to use the best disinfection system”
More than 24 million Americans now disinfect their contact lenses with a disinfection system to prevent potentially serious infections. But only about 2 million use the gold standard disinfection solution, hydrogen peroxide. That’s because hydrogen peroxide can be tricky to use. Too low a concentration and it doesn’t fully disinfect lenses; too high, and it can irritate the eye. Getting the concentration right is challenging because hydrogen peroxide degrades over time. Many ophthalmologists and optometrists favor the disinfection and lens material compatibility peroxide systems provide, yet side effects associated with misuse and non-compliance minimize peroxide system use.
“The intelli-Case is a highly innovative, extremely easy-to-use device for the millions of Americans who wear contact lenses and want to use the best disinfection system,” said Ron Najafi, Ph.D., NovaBay’s President and CEO. “We believe that intelli-Case can revolutionize contact lens care by making the peroxide disinfection system as simple as using multipurpose solutions. Following the launch of Avenova, intelli-Case is the second in a series of cutting-edge products being developed by NovaBay that target unmet needs in the eye care market and demonstrates our strong commitment to innovation.”
The intelli-Case monitors the neutralization of hydrogen peroxide during the disinfection cycle with sophisticated microprocessor electronics embedded in the cap of what otherwise looks like a standard peroxide lens case. The high-tech cap has three LED lights labeled UNSAFE, BUSY and READY. Lenses are placed into the case with hydrogen peroxide solution. The green light (READY) blinks when lenses are safe to insert into the eyes and continues to blink green until contact lenses are removed from the case.
“The intelli-Case can be co-packaged with a hydrogen peroxide disinfection/cleaning solution and we are actively seeking a partnership with a hydrogen peroxide manufacturer,” added Dr. Najafi. “Replacing the standard case that is typically boxed with hydrogen peroxide solutions with the intelli-Case will make for a highly differentiated product offering that we believe will be warmly welcomed by both eye care professionals and contact lens wearers.”
“Poor contact lens hygiene is a major risk factor for a range of eye complications,” explained David Stroman, Ph.D., NovaBay’s Senior Vice President for Ophthalmology. “Americans make more than a million visits each year to emergency rooms, clinics or their eye care professionals with contact lens-related issues. Patients often report irritation and/or red eye after insertion of their contact lenses, when the hydrogen peroxide solution has not been adequately neutralized. Failure to properly disinfect is a well-documented cause of contact lens-related infections. The intelli-Case is designed to ensure the adequacy of the peroxide disinfection cycle and that the contact lenses are safe for insertion into the eyes.
“The intelli-Case provides real-time information to the user through solution monitoring and blinking LED lights, indicating that their lenses can be safely placed into their eyes,” said Dr. Stroman. “The intelli-Case removes the guesswork.”
“The advantages of peroxide are well known, but compliance has remained a problem for many patients,” said Art Epstein, OD, FAAO, FABCO, FBCLA, DPNAP, a recognized authority on contact lens complications. “What I most like about intelli-Case is that it leverages high-tech, real-time analytics to foster improved patient compliance. From what I’ve seen, it can make a tremendous difference even for the compliance-challenged patients. I am really excited about this technology.”
Steven J. Lichtenstein, MD, FAAP, FACS, FAAO, a leading pediatric ophthalmologist, stated, “The responses I’m getting from patients who have tested the intelli-Case are very positive. For instance, one individual reported that intelli-Case was easy to use and loved the fact that each morning she could safely put her lenses in her eyes without worrying about them burning. Like many other contact wearers, she has experienced severe pain from residual hydrogen peroxide that can occur with other peroxide disinfecting solutions. I plan to move my contact lens patients from multipurpose solutions (MPS) to intelli-Case as soon as possible.”
Analogic Corporation (Nasdaq:ALOG), enabling the world's medical imaging and aviation security technology, today announced results for its third quarter ended April 30, 2015.
Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH), a biopharmaceutical company focused on advancing the development and commercialization of innovative medicines that benefit patients with unmet medical needs, today announced that additional data from its Phase 2b PEARL-SC study will be presented in a poster at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in Rome, Italy.
Argos Therapeutics Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer based on the Arcelis® technology platform, today announced an independent data monitoring committee (IDMC) has recommended the continuation of the company's pivotal phase 3 ADAPT clinical trial of AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC) following the first of three planned interim data analyses.
Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company primarily focused on the development of therapeutics for cancer and other life threatening diseases, today announced that United States Patent Number 9,046,534 has been issued by the U.S. Patent and Trademark Office (USPTO) related to the methods and systems for identifying and treating patients with anti-progestin sensitive tumors using the Company's lead product candidate, onapristone.
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced that Jean-Jacques Bienaimé, Chief Executive Officer at BioMarin, will present a company update at the Goldman Sachs 36th Annual Global Healthcare Conference on June 11th at 8:00a.m. PT.
CannaVEST Corp. (OTCMKTS:CANV), developer, producer, marketer and distributor of hemp-based Cannabidiol products to the nutraceutical industry, will be presenting at the Small-Cap Stars Spring Conference 2015 at Convene in Times Square New York on Wednesday, June 10.
The Cooper Companies, Inc. (NYSE:COO) today announced financial results for the fiscal second quarter ended April 30, 2015.
Cytokinetics, Incorporated (Nasdaq:CYTK) and The ALS Association announced an expanded partnership in which the company will provide Gold Level Sponsorship of the National Walks to Defeat ALS® as well as Platinum Level Sponsorship for ALS Association Golden West Chapter initiatives.
Del Mar Pharmaceuticals Inc. (OTCMKTS:DMPI), a biopharmaceutical development and exploration company, will be presenting at the Small-Cap Stars Spring Conference 2015 at Convene in Times Square New York on Wednesday, June 10.
Horizon Technology Finance Corporation (Nasdaq:HRZN), a leading specialty finance company that provides capital in the form of secured loans to venture capital backed companies in the technology, life science, healthcare information and services and cleantech industries, announced today it has closed a $10 million venture loan facility to The NanoSteel Company, Inc., a leader in nano-structured steel materials design.
Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that the Richard Gorelick, Corporate Vice President, General Counsel, Administration and Secretary, was named as 2015 NJBIZ General Counsel of the Year of public companies with annual revenues up to $1 billion.
Jonas Fitness, a leader in gym and facility management software and Textmunication (OTCBB:TXHD), a leader in mobile marketing communications have partnered with a unique software integration solution.
Lombard Medical, Inc. (Nasdaq:EVAR), a CA-based medical device company, will be presenting at the Small-Cap Stars Spring Conference 2015 at Convene in Times Square New York on Wednesday, June 10.
Moffitt Cancer Center has treated the first patient nationally in Kite Pharma's (Nasdaq:KITE) Phase 1/2 clinical trial of KTE-C19.
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that new data from studies of the Company's novel autoimmune programs will be presented at the European League Against Rheumatism Annual Congress (EULAR) 2015 Annual Meeting in Rome, Italy.
Novadaq Technologies Inc. (Nasdaq:NVDQ) (TSX:NDQ), the leading developer and provider of clinically relevant fluorescence imaging solutions for use in surgical and diagnostic procedures, announced today that management will present an update on the Company's business at the 35th Annual William Blair Stock Conference on Wednesday, June 10, 2015 at 12:40 p.m. Central Time.
Restorgenex Corporation (OTCMKTS:RESX), a specialty biopharmaceutical company focused on developing products for oncology, ophthalmology and dermatology, will be presenting at the Small-Cap Stars Spring Conference 2015 at Convene in Times Square New York on Wednesday, June 10.
StemCells, Inc. (Nasdaq:STEM), a world leader in the research and development of cell-based therapeutics for the treatment of central nervous system diseases and disorders, announced today that it has enrolled its first subject in Cohort 2 of its Phase II Pathway Study.
Medgenics, Inc. (NYSE MKT:MDGN), the developer of a proprietary platform for the sustained production and delivery of therapeutic proteins and peptides in patients using ex vivo gene therapy and their own tissue for the treatment of rare and orphan diseases, today announced that clinical data from the ongoing Phase 1/2 study of the Company's TARGTEPOTM (Transduced Autologous Restorative Gene Therapy) system in end stage renal disease will be presented at the 20th Congress of the European Hematology Association (EHA) taking place June 11-14, 2015 in Vienna, Austria.
Theralase Technologies Inc. (TSX-V:TLT), a designer, developer, manufacturer and marketer of laser technology, will be presenting at the Small-Cap Stars Spring Conference 2015 at Convene in Times Square New York on Wednesday, June 10.
Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced it has appointed Dennis Huang as its Chief Technical Operations Officer.
Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) and Parion Sciences today announced that the companies will collaborate to develop investigational epithelial sodium channel (ENaC) inhibitors for the potential treatment of cystic fibrosis (CF) and other pulmonary diseases.