|Aegerion Presents Data From Phase 3 Extension Study of JUXTAPID(TM); Salix Receives FDA CDRH Approval for Deflux|
|By Staff and Wire Reports|
|Monday, 18 November 2013 19:45|
Aegerion Pharmaceuticals (Nasdaq: AEGR), a biopharmaceutical company dedicated to the development and commercialization of novel, life-altering therapies for patients with debilitating, often fatal, rare diseases, today presented data from its open-label Phase 3 extension study of JUXTAPID™ (lomitapide) capsules in patients with homozygous familial hypercholesterolemia (HoFH). The data were presented in a poster at the American Heart Association's Scientific Sessions taking place in Dallas.
Nineteen of 23 patients who completed the 78 week pivotal study entered the extension study and continued lomitapide at their individualized maintenance dose, with 17 (89%) completing 126 weeks of treatment. The primary efficacy endpoint of the extension study was mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Week 126.
Salix Pharmaceuticals, Ltd. (NASDAQ: SLXP) announced The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has approved the Deflux® premarket approval (PMA) supplement, which requested approval of labeling changes to add two additional techniques for injection, a single intra-ureteric injection (HIT procedure) and a double (proximal and distal) intra-ureteric injection (Double-HIT procedure).
“Deflux® has always been an effective, minimally invasive option for children suffering from vesicoureteral reflux grades II-IV. This approval and update to the Deflux® labeling provides pediatric urologists even more confidence to offer Deflux to families,” said Carolyn Logan, President and CEO of Salix.
Several techniques have been described for the endoscopic treatment of vesicoureteral reflux (VUR) including a subureteric injection (STING procedure), the HIT procedure and the Double-HIT procedure. The Double-HIT procedure is a refinement of the original STING and HIT procedures and has been reported to result in greater clinical success rates.
“Our experience has shown that there is a correlation between the location of the injection and physician experience with greater Deflux® success rates. This update recognizes the evolution of the endoscopic technique and I believe it may improve the results following a single Deflux® injection,” said Dr. Andrew Kirsch, Chief of Pediatric Urology at Children's Healthcare of Atlanta and Professor of Urology at Emory University School of Medicine.
Accuray Incorporated (Nasdaq: ARAY), announced today that its management is scheduled to present at the Piper Jaffray 25th Annual Healthcare Conference in New York on Wednesday, December 4, 2013 at 1:00 p.m. EST/10:00 a.m. PST.
Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR), a biopharmaceutical company dedicated to the development and commercialization of novel, life-altering therapies for patients with debilitating, often fatal, rare diseases, today presented data from its open-label Phase 3 extension study of JUXTAPID™ (lomitapide) capsules in patients with homozygous familial hypercholesterolemia (HoFH).
Air Methods Corporation (Nasdaq:AIRM), the global leader in air medical transportation, announced today that it has entered into a definitive agreement to acquire Blue Hawaiian Helicopters and its affiliates, a helicopter tour operator based in Hawaii.
Albany Molecular Research, Inc. (NASDAQ: AMRI) announced its intention to privately offer $100 million principal amount of cash convertible senior notes due 2018, subject to market and other conditions, to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended.
Amgen (NASDAQ: AMGN) today announced interim overall survival (OS) results from a pivotal Phase 3 trial evaluating talimogene laherparepvec in patients with unresected stage IIIB, IIIC or IV melanoma compared to granulocyte-macrophage colony-stimulating factor (GM-CSF).
Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company focused on the development of targeted oncology therapeutics, today announced that Steven D. Rubin, Executive Vice President, Administration and Director of OPKO Health, Inc. (NYSE:OPK) has been designated by OPKO Health as a non-voting observer to Arno's Board of Directors, effective immediately.
Baxano Surgical, Inc. (Nasdaq:BAXS) announced today that it will participate in two healthcare conferences in November and December, 2013.
Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based diagnostics, announced that its proprietary DNA-based test for cervical cancer, FHACT™, has received regulatory approval from the Clinical Laboratory Improvement Amendments (CLIA) as a Laboratory Developed Test (LDT).
Cempra, Inc., (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing differentiated antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced results of an in vivo preclinical study suggesting that solithromycin (CEM-101) may provide an effective antimicrobial approach for the prevention and treatment of intrauterine infections during pregnancy.
Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs today announced that the U.S. Food and Drug Administration ("FDA") has granted final approval of the Company's dexmethylphenidate hydrochloride extended-release capsules for the 15 and 30 mg strengths.
NanoString Technologies, Inc. (Nasdaq:NSTG) today announced that its management is scheduled to participate in the Piper Jaffray 25th Annual Healthcare Conference on December 3, 2013 in New York.
Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP), a development stage pharmaceutical company focused on the acquisition, development and commercialization of innovative pharmaceutical products, announced today that it has completed its previously announced public offering of 7,666,667 shares of its common stock, including 1,000,000 shares of common stock that were issued upon exercise in full of the over-allotment option granted to the underwriters.
OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, announced that data from a Phase 1 study of its dual-mechanism vascular disrupting agent OXi4503, demonstrating antitumor activity in patients with relapsed and refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), will be presented at the Annual Meeting of the American Society of Hematology (ASH) being held in New Orleans, December 7-10, 2013.
OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, announced that researchers from Baylor University, with whom OXiGENE has a collaboration, are continuing to advance their discovery program focused on several small-molecule anticancer agents belonging to the benzosuberene class which are potent inhibitors of tubulin polymerization and are highly cytotoxic (in the picomolar to sub-picomolar range) against human cancer lines.
Prosensa Holding N.V. (Nasdaq:RNA), the Dutch biopharmaceutical company focusing on RNA-modulating therapeutics for rare diseases with high unmet need, today reported financial results for the quarter ending September 30, 2013.
RCM Technologies, Inc. (Nasdaq:RCMT), a premier provider of business and technology solutions designed to enhance and maximize the operational performance of its customers through the adaptation and deployment of advanced information technology, engineering and specialty healthcare services, today announced that its Board of Directors approved an amendment to RCM's limited duration stockholder rights plan to accelerate the final expiration date of the rights under the plan to November 18, 2013.
RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary formulations and combinations of existing drugs, today reported that the Company and its co-development partner, IntelGenx Corp. ("IntelGenx"), have recently concluded a positive European Scientific Advice meeting with the German Federal Institute for Drugs and Medical Devices (BfArM) regarding RHB-103, a proprietary, oral thin film formulation of rizatriptan for the treatment of acute migraine.
Sagent Pharmaceuticals, Inc. (Nasdaq:SGNT) today announced the launch of Propofol Injectable Emulsion USP 1%, in two Single-Dose, Single-Patient vial presentations of 20 mL and 100 mL.
Varian Medical Systems, Inc. (NYSE: VAR) today announced that Regina E. Dugan, Ph.D., Senior Vice President of Advanced Technology and Projects (ATAP) at Google's Motorola Mobility LLC, has been appointed to the Varian Board of Directors, effective December 15, 2013.
Vical Incorporated (Nasdaq:VICL) today announced that Robert H.I. Andtbacka, M.D., C.M., will present detailed results from the completed Phase 3 trial of Allovectin® (velimogene aliplasmid) at 4:45 p.m. EST today, November 18, at the 10th International Meeting of the Society for Melanoma Research (Philadelphia, PA – November 17-20).
Vision-Sciences, Inc. (Nasdaq:VSCI), a leading provider of unique flexible endoscopic products utilizing its proprietary sterile disposable EndoSheath® technology, announced today that for the fourth consecutive year, the ECRI Institute listed "Inadequate Reprocessing of Endoscopes and Surgical Instruments" among the top ten most dangerous technology hazards.
Z Trim Holdings, Inc. (OTC Markets: ZTHO), a bio-technology company providing value-added ingredients to a variety of industries, today announced that it completed a registered public offering of 1,866,667 shares of common stock at a price per share of $0.75 and warrants to purchase 1,400,000 shares of common stock at an exercise price of $1.00 per share, representing gross proceeds to Z Trim of $1,400,000.