|EnteroMedics Spikes Up Following FDA Approval Of Neuroblocking Obesity Device; pSivida Reports Commencement of ILUVIEN® Sales in Portugal|
|By Marilyn Mullen|
|Wednesday, 14 January 2015 17:24|
The U.S. FDA announced Wednesday that it has approved the EnteroMedics Inc. (NASDAQ: ETRM) Maestro Rechargeable System for certain obese adults, the first weight-loss treatment device that targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness.
The Maestro Rechargeable System, the first FDA-approved obesity device since 2007, is approved to treat patients aged 18 and older who have not been able to lose weight with a weight-loss program, and who have a body mass index of 35 to 45 with at least one other obesity-related condition, such as type 2 diabetes.
“Obesity and its related medical conditions are major public health problems,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “Medical devices can help physicians and patients to develop comprehensive obesity treatment plans.”
Shares of EnteroMedics soared on the news and recently traded at $1.44, up 22.03 percent.
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug delivery products for treating eye diseases, today announced that the sale of ILUVIEN® for diabetic macular edema (DME) has begun in Portugal. Also sold in the UK and Germany, ILUVIEN is indicated in the EU for treatment of vision impairment associated with chronic DME insufficiently responsive to available treatments.
Sales of ILUVIEN in the U.S. are scheduled to commence in the first quarter of 2015 for DME patients previously treated with a course of corticosteroids who did not have a clinically significant rise in intraocular pressure, a broader indication than that approved for Europe. “We are pleased with the expanded commercialization of ILUVIEN in Portugal and greatly look forward to the U.S. launch early this year and ultimately to its commercialization in the other 14 EU countries where it has been or is expected to be approved. pSivida is entitled to 20% of net profits from sales of ILUVIEN by its licensee on a country-by-country, quarter-by-quarter basis,” said Dr. Paul Ashton, President and CEO of pSivida. “ILUVIEN provides retinal doctors a new treatment to help patients with DME, which can often cause significant vision loss and greatly affect quality of life for patients.”
Adamis Pharmaceuticals Corporation (Nasdaq:ADMP), a specialty biopharmaceutical company focused on developing and commercializing products in the therapeutic areas of respiratory disease, allergy, oncology and immunology, announced today the closing of its previously announced underwritten public offering of 2,000,000 shares of common stock at a public offering price of $5.00 per share, as well as 300,000 additional shares of its common stock pursuant to the full exercise of the over-allotment option granted to the underwriters.
athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based services and mobile applications for medical groups and health systems, today announced it will acquire RazorInsights, a leader in cloud-based electronic health record (EHR) and financial solutions for rural, critical access and community hospitals.
Auspex Pharmaceuticals, Inc. (Nasdaq:ASPX), a biopharmaceutical company dedicated to developing innovative medicines for people with movement disorders and other rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Auspex's investigational compound SD-809 for the treatment of Tourette syndrome in the pediatric population (defined as zero through 16 years of age).
BioCryst Pharmaceuticals, Inc., (Nasdaq:BCRX) today announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) issued a positive opinion on the application for orphan drug designation for BCX4161 for the treatment of patients with hereditary angioedema (HAE).
FBR & Co. (Nasdaq:FBRC) (FBR), a leading investment bank serving the middle market, announced the hiring of Edward P. White as Senior Vice President, Senior Research Analyst in its Equity Research Department.
FutureWorld Corp. (OTCQB: FWDG), a leading provider of advanced technologies and solutions to the global cannabis industry, announces today the launch of EssenceTM CBD, a high concentration, all-natural, Cannabidiol-rich Hemp Oil through its subsidiary, NutraCann Labs, Inc.
Human Longevity, Inc. (HLI), the human health information technology and health care company, today announced a multi-year agreement with Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), to conduct whole genome sequencing of tens of thousands of de-identified samples from Genentech. HLI, using proprietary tools and unique expertise, will sequence genomes to 30x coverage and analyze the data.
Integra LifeSciences Holdings Corporation (Nasdaq:IART) will release its fourth quarter 2014 financial results and issue 2015 financial guidance on Tuesday, February 24, 2015.
ManTech International Corporation (Nasdaq:MANT) has named Stephen J. Comber senior vice president and general manager of ManTech Health, the company's federal health business unit.
Masimo (NASDAQ: MASI) and Inova Fair Oaks Hospital -- listed among the 2014 Truven Health Analytics Top 100 Hospitals® for delivering the best care in its community -- announced that the hospital has installed Masimo Patient SafetyNet™, a remote monitoring and clinician notification system shown to keep patients safer while reducing cost of care.1
As the market for legal medical and recreational marijuana extracts and as safer, more convenient ways of consuming them converges, mCig (OTCBB:MCIG) today announced that it is rolling out its EM-J™, a new pre-loaded vaporizing pen thru its Colorado-based subsidiary mCig, CBD Technologies.
Natus Medical Incorporated (Nasdaq:BABY) today announced that the Company will release its 2014 fourth quarter financial results before the market opens on Wednesday, January 28th. Natus management will host an investment-community conference call the same day beginning at 8:00 a.m. Pacific Time (11:00 a.m. Eastern Time) to discuss those results and to answer questions.
OraSure Technologies, Inc. (Nasdaq:OSUR) has scheduled its regular earnings conference call covering 2014 full year and fourth quarter results and certain 2015 financial guidance for 5:00 pm ET (2:00 pm PT) on Wednesday, February 4, 2015.
Pazoo, Inc. (OTCQB:PZOO) (German WKN#: A1J3DK) is pleased to report that marijuana testing lab Harris Lee, LLC, is now a 100% wholly owned subsidiary of Pazoo.
Sabra Health Care REIT, Inc. (Nasdaq:SBRA) announced today that Rick Matros, the Company's Chairman and Chief Executive Officer, Harold Andrews, the Company's Chief Financial Officer, and Talya Nevo-Hacohen, the Company's Chief Investment Officer, will be participating in the 2015 Stifel Senior Housing and Healthcare Real Estate Conference on Tuesday, January 27, 2015 in Dana Point, California.
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) will present at the Eleventh Annual Noble Financial Capital Markets Investor Conference in Sandpiper Bay, FL. Seth Lederman, M.D., Tonix's president and chief executive officer, will deliver a corporate overview on Tuesday, January 20 at 3:30 p.m. ET.